Dosing & Uses
Dosing Forms & Strengths
tablet for oral suspension (Exjade)
- 125mg
- 250mg
- 500mg
oral tablet (Jadenu)
- 90mg
- 180mg
- 360mg
oral granules (Jadenu Sprinkle)
- 90mg
- 180mg
- 360mg
Transfusional Hemosiderosis
Indicated for treatment of chronic iron overload caused by blood transfusion
Exjade: 20 mg/kg PO qDay; may increase by 5- to 10-mg increments based on serum ferritin; if not controlled on 30 mg/kg/day (ie, serum ferritin persistently >2500 mcg/L), may increase up to 40 mg/kg qDay
Jadenu: 14 mg/kg PO qDay (round to nearest whole tablet); adjust dose in 3.5-7 mg/kg according to response and goals; if not adequately controlled on 21 mg/kg/day (serum ferritin levels persistently >2500 mcg/L), may increase to 28 mg/kg/day; do not exceed 28 mg/kg
Converting from Exjade to Jadenu
- Reduce dose of Jadenu by about 30%, round to nearest whole tablet
Nontransfusion-Dependent Thalassemia
Indicated for treatment of chronic iron overload caused by nontransfusion-dependent thalassemia syndromes and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (dw) and a serum ferritin >300 mcg/L
This indication is based on achievement of an LIC <5 mg Fe/g dw; improvement in survival or disease-related symptoms has not been established
Exjade: 10 mg/kg PO qDay (calculate dose to nearest tablet size); if LIC >15 mg Fe/g dw after 4 weeks, consider increasing dose by 5-10 mg/kg up to 20 mg/kg/day
Jadenu: 7 mg/kg PO qDay (calculate dose to nearest whole tablet); if LIC >7 mg Fe/g dw after 6 months, increase dose by 3.5-7 mg/kg up to 14 mg/kg/day; do not exceed 14 mg/kg/day
Converting from Exjade to Jadenu
- Reduce dose of Jadenu by about 30%, round to nearest whole tablet
Dosage Modifications
Coadministration with potent UGT inducers or bile acid sequestrants
- UGT inducers (eg, rifampin, phenytoin, phenobarbital, ritonavir) and bile acid sequestrants (eg, cholestyramine, colesevelam, colestipol) may decrease systemic exposure of deferasirox
- Avoid coadministration
- If unable to avoid coadministration, consider increasing initial deferasirox dose by 50% and monitor serum ferritin levels and clinical responses for further dose modifications
Renal impairment
-
Baseline renal impairment
- CrCl 40-60 mL/min: Reduce initial dose by 50%
- Serum Cr >2x ULN or CrCl <40 mL/min: Do not use
-
While taking for transfusional iron overload
- Adults and adolescents (aged 16 yr or older): Reduce daily dose by 10 mg/kg if serum creatinine increases by >33% (on 2 consecutive visits) above pretreatment levels
- Serum creatinine >2x ULN or CrCl <40 mL/min (all patients): Contraindicated; discontinue if these measurements occur during treatment
-
While taking for nontransfusion-dependent thalassemia
- Adults and adolescents (aged 16 yr or older): If serum creatinine increases by >33% (on 2 consecutive visits) above pretreatment levels, interrupt therapy if dose is 5 mg/kg, or reduce by 50% if dose is 10-20 mg/kg
- Serum creatinine >2x ULN or CrCl <40 mL/min (all patients): Contraindicated; discontinue if these measurement occur during treatment
Hepatic impairment
- Mild (Child-Pugh A): No dose adjustment required
- Moderate (Child-Pugh B): Decrease initial dose by 50%
- Severe (Child-Pugh C): Avoid use
Dosing considerations
Before initiation
-
Transfusional Hemosiderosis
- Obtain serum ferritin level, baseline serum creatinine (in duplicate) and determine creatinine clearance, serum transaminases, bilirubin, baseline auditory and ophthalmic examinations
- Measure serum ferritin qMonth to assess patient’s response to therapy and to minimize risk of overchelation
-
Nontransfusion-Dependent Thalassemia
- Obtain LIC by liver biopsy or other approved method, serum ferritin level (based on at least 2 measurements 1 month apart), baseline serum creatinine (in duplicate) and determine creatinine clearance, serum transaminases, bilirubin, and baseline auditory and ophthalmic examinations
- Monitor serum ferritin monthly; interrupt treatment if serum ferritin <300 mcg/L and obtain an LIC to determine whether the LIC has fallen to <3 mg Fe/g dw
- Measure LIC q6Months
- If the LIC remains >7 mg Fe/g dw after 6 months, increase dose to a maximum of 20 mg/kg/day
- If after 6 months of therapy, the LIC is 3-7 mg Fe/g dw, continue treatment at no more than 10 mg/kg/day
- When the LIC is <3 mg Fe/g dw, interrupt treatment and continue to monitor LIC
- Monitor blood counts, hepatic function, and renal function
Limitation of use
- Safety and efficacy when administered with other iron chelation therapy have not been established
Dosing Forms & Strengths
tablet for oral suspension (Exjade)
- 125mg
- 250mg
- 500mg
oral tablet (Jadenu)
- 90mg
- 180mg
- 360mg
oral granules (Jadenu Sprinkle)
- 90mg
- 180mg
- 360mg
Transfusional Hemosiderosis
Indicated for treatment of chronic iron overload caused by blood transfusion
<2 years: Safety and efficacy not established
≥2 years
- Exjade: 20 mg/kg PO qDay; may increase by 5- to 10-mg increments based on serum ferritin; if not controlled on 30 mg/kg/day (ie, serum ferritin persistently >2500 mcg/L), may increase up to 40 mg/kg qDay
- Jadenu: 14 mg/kg PO qDay (round to nearest whole tablet); adjust dose in 3.5-7 mg/kg according to response and goals; if not adequately controlled with doses of 21 mg/kg/day (serum ferritin levels persistently >2500 mcg/L), may increase up to 28 mg/kg/day ; do not exceed 28 mg/kg
-
Converting from Exjade to Jadenu
- Reduce dose of Jadenu by about 30% lower, round to nearest whole tablet
Nontransfusion-Dependent Thalassemia
Indicated for treatment of chronic iron overload caused by nontransfusion-dependent thalassemia syndromes and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (dw) and a serum ferritin >300 mcg/L
This indication is based on achievement of an LIC <5 mg Fe/g dw; improvement in survival or disease-related symptoms has not been established
<10 years: Safety and efficacy not established
≥10 years
- Exjade: 10 mg/kg PO qDay (calculate dose to nearest tablet size); if LIC >15 mg Fe/g dw after 4 weeks, consider increasing dose by 5-10 mg/kg up to 20 mg/kg/day
- Jadenu: 7 mg/kg PO qDay (calculate dose to nearest whole tablet); if LIC >7 mg Fe/g dw after 6 months, increase dose by 3.5-7 mg/kg up to 14 mg/kg/day; do not exceed 14 mg/kg/day
-
Converting from Exjade to Jadenu
- Reduce dose of Jadenu by about 30% lower, round to nearest whole tablet
Dosage Modifications
Coadministration with potent UGT inducers or bile acid sequestrants
- UGT inducers (eg, rifampin, phenytoin, phenobarbital, ritonavir) and bile acid sequestrants (eg, cholestyramine, colesevelam, colestipol) may decrease systemic exposure of deferasirox
- Avoid coadministration
- If unable to avoid coadministration, consider increasing initial deferasirox dose by 50% and monitor serum ferritin levels and clinical responses for further dose modifications
Renal impairment
-
Baseline renal impairment
- CrCl 40-60 mL/min: Reduce initial dose by 50%
- Serum Cr >2x ULN or CrCl <40 mL/min: Do not use
-
Transfusional iron overload
- Adults and adolescents (aged ≥16 yr): Reduce daily dose by 10 mg/kg if serum creatinine increases by >33% (on 2 consecutive visits) above pretreatment levels
- Children aged 2-15 yr: Reduce dose by 10 mg/kg if serum creatinine increases by >33% above the average baseline measurement and greater than the age appropriate upper limit of normal
- Serum creatinine >2x ULN or CrCl <40 mL/min (all patients): Contraindicated; discontinue if these measurements occur during treatment
-
Nontransfusion-dependent thalassemia
- Adults and adolescents (aged ≥16 yr): If serum creatinine increases by >33% (on 2 consecutive visits) above pretreatment levels, interrupt therapy if dose is 5 mg/kg, or reduce by 50% if dose is 10-20 mg/kg
- Children aged 10-15 yr: Reduce dose by 5 mg/kg if serum creatinine increases by >33% above the average baseline measurement and greater than the age appropriate upper limit of normal
- Serum creatinine >2x ULN or CrCl <40 mL/min (all patients): Contraindicated; discontinue if these measurement occur during treatment
Hepatic impairment
- Mild (Child-Pugh A): No dose adjustment required
- Moderate (Child-Pugh B): Decrease initial dose by 50%
- Severe (Child-Pugh C): Avoid use
Dosing considerations
Before initiation
-
Transfusional Hemosiderosis
- Obtain serum ferritin level, baseline serum creatinine (in duplicate) and determine creatinine clearance, serum transaminases, bilirubin, baseline auditory and ophthalmic examinations
- Measure serum ferritin qMonth to assess patient’s response to therapy and to minimize risk of overchelation
-
Nontransfusion-Dependent Thalassemia
- Obtain LIC by liver biopsy or other approved method, serum ferritin level (based on at least 2 measurements 1 month apart), baseline serum creatinine (in duplicate) and determine creatinine clearance, serum transaminases, bilirubin, and baseline auditory and ophthalmic examinations
- Monitor serum ferritin monthly; interrupt treatment if serum ferritin <300 mcg/L and obtain an LIC to determine whether the LIC has fallen to <3 mg Fe/g dw
- Measure LIC q6Months
- If the LIC remains >7 mg Fe/g dw after 6 months, increase dose to a maximum of 20 mg/kg/day
- If after 6 months of therapy, the LIC is 3-7 mg Fe/g dw, continue treatment at no more than 10 mg/kg/day
- When the LIC is <3 mg Fe/g dw, interrupt treatment and continue to monitor LIC
- Monitor blood counts, hepatic function, and renal function
- Increase monitoring frequency for children and adolescents who have acute illnesses which may cause volume depletion, such as vomiting, diarrhea, or prolonged decreased oral intake; consider dose interruption until oral intake and volume status are normal
Limitation of use
- Safety and efficacy when administered with other iron chelation therapy have not been established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (3)
- betibeglogene autotemcel
betibeglogene autotemcel increases effects of deferasirox by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Discontinue iron chelators at least 7 days before starting conditioning. Some iron chelators are myelosuppressive. After infusion, avoid use of these iron chelators for 6 months. If iron chelation is needed, consider administration of nonmyelosuppressive iron chelators. Phlebotomy can be used in lieu of iron chelation, when appropriate.
- pacritinib
deferasirox will decrease the level or effect of pacritinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- tucatinib
deferasirox will increase the level or effect of tucatinib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of tucatinib (a CYP2C8 substrate) with a strong or moderate CYP2C8 inhibitors increases tucatinib plasma concentrations and risk of toxicities.
Monitor Closely (228)
- abciximab
deferasirox, abciximab. Other (see comment). Use Caution/Monitor. Comment: Gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including anticoagulants.
- alendronate
deferasirox, alendronate. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- alfentanil
deferasirox will decrease the level or effect of alfentanil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- alfuzosin
deferasirox will decrease the level or effect of alfuzosin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- almotriptan
deferasirox will decrease the level or effect of almotriptan by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- alosetron
deferasirox increases levels of alosetron by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- alprazolam
deferasirox will decrease the level or effect of alprazolam by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- aluminum hydroxide
aluminum hydroxide will decrease the level or effect of deferasirox by Other (see comment). Use Caution/Monitor. Avoid combination. Although deferasirox has a lower affinity for aluminum than for iron, do not administer deferasirox with aluminum-containing antacid preparations.
- amikacin
deferasirox, amikacin. Other (see comment). Use Caution/Monitor. Comment: Acute renal failure has been reported during treatment with deferasirox. Coadministration of deferasirox with other potentially nephrotoxic drugs, including aminoglycosides, may increase the risk of this toxicity. Monitor serum creatinine and/or creatinine clearance in patients who are receiving deferasirox and nephrotoxic drugs concomitantly.
- amiodarone
deferasirox will decrease the level or effect of amiodarone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- amlodipine
deferasirox will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- anagrelide
deferasirox, anagrelide. Other (see comment). Use Caution/Monitor. Comment: Acute renal failure has been reported during treatment with deferasirox. Coadministration of deferasirox with other potentially nephrotoxic drugs, including aminoglycosides, may increase the risk of this toxicity. Monitor serum creatinine and/or creatinine clearance in patients who are receiving deferasirox and nephrotoxic drugs concomitantly.
- antithrombin alfa
deferasirox, antithrombin alfa. Other (see comment). Use Caution/Monitor. Comment: Gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including anticoagulants.
- antithrombin III
deferasirox, antithrombin III. Other (see comment). Use Caution/Monitor. Comment: Gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including anticoagulants.
- aprepitant
deferasirox will decrease the level or effect of aprepitant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- argatroban
deferasirox, argatroban. Other (see comment). Use Caution/Monitor. Comment: Gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including anticoagulants.
- aripiprazole
deferasirox will decrease the level or effect of aripiprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- armodafinil
deferasirox will decrease the level or effect of armodafinil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- artesunate
deferasirox will increase the level or effect of artesunate by decreasing metabolism. Use Caution/Monitor. Coadministration may increase active artesunate metabolite (DHA) by inhibiting UGT. Monitor for increased adverse effects.
- ascorbic acid
deferasirox, ascorbic acid. unknown mechanism. Use Caution/Monitor. Coadministration of deferasirox and ascorbic acid has not been formally studied. Doses up to ascorbic acid 200 mg per day have not been associated with adverse consequences.
- asenapine
deferasirox increases levels of asenapine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- aspirin
deferasirox, aspirin. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- aspirin/citric acid/sodium bicarbonate
deferasirox, aspirin/citric acid/sodium bicarbonate. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- atazanavir
deferasirox will decrease the level or effect of atazanavir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- atogepant
deferasirox will decrease the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- atorvastatin
deferasirox will decrease the level or effect of atorvastatin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- avanafil
deferasirox will decrease the level or effect of avanafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- axitinib
deferasirox decreases levels of axitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- bazedoxifene/conjugated estrogens
deferasirox will decrease the level or effect of bazedoxifene/conjugated estrogens by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- beclomethasone, inhaled
beclomethasone, inhaled increases toxicity of deferasirox by unspecified interaction mechanism. Use Caution/Monitor. Increases risk for GI ulceration/irritation or GI bleeding.
- betamethasone
betamethasone, deferasirox. Other (see comment). Use Caution/Monitor. Comment: Gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including corticosteroids.
- bivalirudin
deferasirox, bivalirudin. Other (see comment). Use Caution/Monitor. Comment: Gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including anticoagulants.
- bortezomib
deferasirox will decrease the level or effect of bortezomib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- bosentan
deferasirox will decrease the level or effect of bosentan by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- budesonide
deferasirox will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including corticosteroids.
- buspirone
deferasirox will decrease the level or effect of buspirone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- busulfan
deferasirox increases toxicity of busulfan by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Discontinue iron chelating agents well in advance of administration of busulfan to avoid increased exposure to busulfan.
- caffeine
deferasirox increases levels of caffeine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- carbamazepine
deferasirox will decrease the level or effect of carbamazepine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Caution is advised. Combination use may lead to increased or decreased carbamazepine levels.
- carbonyl iron
deferasirox decreases levels of carbonyl iron by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Deferasirox chelates iron.
- cholestyramine
cholestyramine decreases levels of deferasirox by Other (see comment). Use Caution/Monitor. Comment: Avoid concomitant use of cholestyramine with deferasirox. If co-administration is required then consider increasing initial dose of deferasirox to 30 mg/kg and monitor serum ferritin levels and clinical response.
- cilostazol
deferasirox will decrease the level or effect of cilostazol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- cinacalcet
deferasirox will decrease the level or effect of cinacalcet by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- clarithromycin
deferasirox will decrease the level or effect of clarithromycin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- clomipramine
deferasirox increases levels of clomipramine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- clopidogrel
deferasirox, clopidogrel. Other (see comment). Use Caution/Monitor. Comment: Gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including anticoagulants.
- clozapine
deferasirox increases levels of clozapine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- colchicine
deferasirox will decrease the level or effect of colchicine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- conivaptan
deferasirox will decrease the level or effect of conivaptan by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- conjugated estrogens
deferasirox will decrease the level or effect of conjugated estrogens by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- conjugated estrogens, vaginal
deferasirox will decrease the level or effect of conjugated estrogens, vaginal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- cortisone
deferasirox will decrease the level or effect of cortisone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- cyclobenzaprine
deferasirox will increase the level or effect of cyclobenzaprine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- cyclosporine
deferasirox will decrease the level or effect of cyclosporine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- dabigatran
deferasirox, dabigatran. Other (see comment). Use Caution/Monitor. Comment: Gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including anticoagulants.
- dacarbazine
deferasirox increases levels of dacarbazine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- dalteparin
deferasirox, dalteparin. Other (see comment). Use Caution/Monitor. Comment: Gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including anticoagulants.
- dapsone
deferasirox will decrease the level or effect of dapsone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- darifenacin
deferasirox will decrease the level or effect of darifenacin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- darunavir
deferasirox will decrease the level or effect of darunavir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- dasatinib
deferasirox will decrease the level or effect of dasatinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- dexamethasone
deferasirox will decrease the level or effect of dexamethasone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- diazepam
deferasirox will decrease the level or effect of diazepam by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- diclofenac
deferasirox, diclofenac. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- diclofenac topical
deferasirox, diclofenac topical. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- dienogest/estradiol valerate
deferasirox will decrease the level or effect of dienogest/estradiol valerate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- diflunisal
deferasirox, diflunisal. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- dihydroergotamine
deferasirox will decrease the level or effect of dihydroergotamine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Use ergot alkaloids with caution with less potent CYP3A4 inhibitors.
- dihydroergotamine intranasal
deferasirox will decrease the level or effect of dihydroergotamine intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Use ergot alkaloids with caution with less potent CYP3A4 inhibitors.
- diltiazem
deferasirox will decrease the level or effect of diltiazem by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- dipyridamole
deferasirox, dipyridamole. Other (see comment). Use Caution/Monitor. Comment: Gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including anticoagulants.
- disopyramide
deferasirox will decrease the level or effect of disopyramide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- dronedarone
deferasirox will decrease the level or effect of dronedarone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- duloxetine
deferasirox increases levels of duloxetine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- efavirenz
deferasirox will decrease the level or effect of efavirenz by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- eletriptan
deferasirox will decrease the level or effect of eletriptan by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- enoxaparin
deferasirox, enoxaparin. Other (see comment). Use Caution/Monitor. Comment: Gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including anticoagulants.
- eplerenone
deferasirox will decrease the level or effect of eplerenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- eptifibatide
deferasirox, eptifibatide. Other (see comment). Use Caution/Monitor. Comment: Gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including anticoagulants.
- ergotamine
deferasirox will decrease the level or effect of ergotamine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Use ergot alkaloids with caution with less potent CYP3A4 inhibitors.
- erlotinib
deferasirox will decrease the level or effect of erlotinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- erythromycin base
deferasirox will decrease the level or effect of erythromycin base by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- erythromycin ethylsuccinate
deferasirox will decrease the level or effect of erythromycin ethylsuccinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- erythromycin lactobionate
deferasirox will decrease the level or effect of erythromycin lactobionate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- erythromycin stearate
deferasirox will decrease the level or effect of erythromycin stearate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- estradiol
deferasirox will decrease the level or effect of estradiol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- estrogens conjugated synthetic
deferasirox will decrease the level or effect of estrogens conjugated synthetic by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- estrogens esterified
deferasirox will decrease the level or effect of estrogens esterified by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- estropipate
deferasirox will decrease the level or effect of estropipate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- ethinylestradiol
deferasirox will decrease the level or effect of ethinylestradiol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- etidronate
deferasirox, etidronate. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- etodolac
deferasirox, etodolac. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- etonogestrel
deferasirox will decrease the level or effect of etonogestrel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- etoposide
deferasirox will decrease the level or effect of etoposide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- etravirine
deferasirox will decrease the level or effect of etravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- everolimus
deferasirox will decrease the level or effect of everolimus by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- exemestane
deferasirox will decrease the level or effect of exemestane by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- felodipine
deferasirox will decrease the level or effect of felodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- fenoprofen
deferasirox, fenoprofen. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- ferric maltol
deferasirox decreases levels of ferric maltol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Deferasirox chelates iron.
- ferrous fumarate
deferasirox decreases levels of ferrous fumarate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Deferasirox chelates iron.
- ferrous gluconate
deferasirox decreases levels of ferrous gluconate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Deferasirox chelates iron.
- ferrous sulfate
deferasirox decreases levels of ferrous sulfate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Deferasirox chelates iron.
- fesoterodine
deferasirox will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- fludrocortisone
deferasirox will decrease the level or effect of fludrocortisone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- flurbiprofen
deferasirox, flurbiprofen. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- fluvoxamine
deferasirox will increase the level or effect of fluvoxamine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- fondaparinux
deferasirox, fondaparinux. Other (see comment). Use Caution/Monitor. Comment: Gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including anticoagulants.
- fosamprenavir
deferasirox will decrease the level or effect of fosamprenavir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- fosaprepitant
deferasirox will decrease the level or effect of fosaprepitant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- fosphenytoin
fosphenytoin decreases levels of deferasirox by Other (see comment). Use Caution/Monitor. Comment: Avoid concomitant use of potent UGT inducers with deferasirox. If co-administration is required then consider increasing initial dose of deferasirox to 30 mg/kg and monitor ferritin levels and clinical response.
- gentamicin
deferasirox, gentamicin. Other (see comment). Use Caution/Monitor. Comment: Acute renal failure has been reported during treatment with deferasirox. Coadministration of deferasirox with other potentially nephrotoxic drugs, including aminoglycosides, may increase the risk of this toxicity. Monitor serum creatinine and/or creatinine clearance in patients who are receiving deferasirox and nephrotoxic drugs concomitantly.
- green tea
green tea, deferasirox. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of bleeding.
- haloperidol
deferasirox will increase the level or effect of haloperidol by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- heparin
deferasirox, heparin. Other (see comment). Use Caution/Monitor. Comment: Gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including anticoagulants.
- hydrocortisone
deferasirox will decrease the level or effect of hydrocortisone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- hydroxyprogesterone caproate (DSC)
deferasirox will decrease the level or effect of hydroxyprogesterone caproate (DSC) by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- ibandronate
deferasirox, ibandronate. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- ibuprofen
deferasirox, ibuprofen. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- ibuprofen IV
deferasirox, ibuprofen IV. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- imatinib
deferasirox will decrease the level or effect of imatinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- indinavir
deferasirox will decrease the level or effect of indinavir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- indomethacin
deferasirox, indomethacin. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- iron dextran complex
deferasirox decreases levels of iron dextran complex by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Deferasirox chelates iron.
- iron sucrose
deferasirox decreases levels of iron sucrose by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Deferasirox chelates iron.
- isavuconazonium sulfate
deferasirox will decrease the level or effect of isavuconazonium sulfate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- isradipine
deferasirox will decrease the level or effect of isradipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- itraconazole
deferasirox will decrease the level or effect of itraconazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- ixabepilone
deferasirox will decrease the level or effect of ixabepilone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- ketoconazole
deferasirox will decrease the level or effect of ketoconazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- ketoprofen
deferasirox, ketoprofen. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- ketorolac
deferasirox, ketorolac. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- lapatinib
deferasirox will decrease the level or effect of lapatinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- levoketoconazole
deferasirox will decrease the level or effect of levoketoconazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- linagliptin
deferasirox will increase the level or effect of linagliptin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Use of alternative treatments is strongly recommended when linagliptin is to be administered with a CYP3A4 inducer
- lopinavir
deferasirox will decrease the level or effect of lopinavir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- loratadine
deferasirox will decrease the level or effect of loratadine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- lovastatin
deferasirox will decrease the level or effect of lovastatin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- maraviroc
deferasirox will decrease the level or effect of maraviroc by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- meclofenamate
deferasirox, meclofenamate. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- mefenamic acid
deferasirox, mefenamic acid. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- meloxicam
deferasirox, meloxicam. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- mestranol
deferasirox will decrease the level or effect of mestranol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- methadone
deferasirox will decrease the level or effect of methadone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- methylprednisolone
deferasirox will decrease the level or effect of methylprednisolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- mexiletine
deferasirox will increase the level or effect of mexiletine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- midazolam
deferasirox will decrease the level or effect of midazolam by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- mirtazapine
deferasirox increases levels of mirtazapine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- mometasone inhaled
mometasone inhaled increases toxicity of deferasirox by Other (see comment). Use Caution/Monitor. Comment: Corticosteroids increase risk of gastrointestinal ulceration/irritation.
- mometasone topical
mometasone topical decreases effects of deferasirox by unspecified interaction mechanism. Use Caution/Monitor. Due to the risk for GI bleeding and irritation/ulceration associated with deferasirox, exercise caution when using with corticosteroids, that can also cause gastrointestinal ulceration and/or bleeding.
- montelukast
deferasirox will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- nabumetone
deferasirox, nabumetone. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- naproxen
deferasirox, naproxen. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- nelfinavir
deferasirox will decrease the level or effect of nelfinavir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- nicardipine
deferasirox will decrease the level or effect of nicardipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- nifedipine
deferasirox will decrease the level or effect of nifedipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- nilotinib
deferasirox will decrease the level or effect of nilotinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- nimodipine
deferasirox will decrease the level or effect of nimodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- nisoldipine
deferasirox will decrease the level or effect of nisoldipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- olanzapine
deferasirox will increase the level or effect of olanzapine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- ondansetron
deferasirox will decrease the level or effect of ondansetron by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- oxaprozin
deferasirox, oxaprozin. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- paclitaxel
deferasirox will decrease the level or effect of paclitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
deferasirox will increase the level or effect of paclitaxel by Other (see comment). Use Caution/Monitor. Paclitaxel levels/toxicity may increase when coadministered with CYP2C8 inhibitors - paclitaxel protein bound
deferasirox will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
deferasirox will increase the level or effect of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Paclitaxel levels/toxicity may increase when coadministered with CYP2C8 inhibitors - pazopanib
deferasirox will decrease the level or effect of pazopanib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- phenobarbital
phenobarbital decreases levels of deferasirox by Other (see comment). Use Caution/Monitor. Comment: Avoid concomitant use of potent UGT inducers with deferasirox. If co-administration is required then consider increasing initial dose of deferasirox to 30 mg/kg and monitor ferritin levels and clinical response.
- phenytoin
phenytoin decreases levels of deferasirox by Other (see comment). Use Caution/Monitor. Comment: Avoid concomitant use of potent UGT inducers with deferasirox. If co-administration is required then consider increasing initial dose of deferasirox to 30 mg/kg and monitor ferritin levels and clinical response.
- pimozide
deferasirox will decrease the level or effect of pimozide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
deferasirox increases levels of pimozide by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. - piroxicam
deferasirox, piroxicam. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- polysaccharide iron
deferasirox decreases levels of polysaccharide iron by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Deferasirox chelates iron.
- prasugrel
deferasirox, prasugrel. Other (see comment). Use Caution/Monitor. Comment: Gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including anticoagulants.
- prednisone
deferasirox will decrease the level or effect of prednisone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- propafenone
deferasirox will decrease the level or effect of propafenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- propranolol
deferasirox increases levels of propranolol by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- quetiapine
deferasirox will decrease the level or effect of quetiapine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- quinidine
deferasirox will decrease the level or effect of quinidine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- quinine
deferasirox will decrease the level or effect of quinine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- ramelteon
deferasirox increases levels of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- ranolazine
deferasirox will decrease the level or effect of ranolazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- rasagiline
deferasirox increases levels of rasagiline by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- repaglinide
deferasirox will decrease the level or effect of repaglinide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Consider repaglinide dose reduction and carefully monitor blood glucose levels when repaglinide is used concomitantly with deferasirox.
- rifampin
rifampin decreases levels of deferasirox by Other (see comment). Use Caution/Monitor. Comment: Avoid concomitant use of potent UGT inducers with deferasirox. If co-administration is required then consider increasing initial dose of deferasirox to 30 mg/kg and monitor ferritin levels and clinical response.
- risedronate
deferasirox, risedronate. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- ritonavir
ritonavir decreases levels of deferasirox by Other (see comment). Use Caution/Monitor. Comment: Avoid concomitant use of potent UGT inducers with deferasirox. If co-administration is required then consider increasing initial dose of deferasirox to 30 mg/kg and monitor ferritin levels and clinical response.
- romidepsin
deferasirox will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- ropinirole
deferasirox increases levels of ropinirole by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- saquinavir
deferasirox will decrease the level or effect of saquinavir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- selexipag
deferasirox will increase the level or effect of selexipag by decreasing metabolism. Modify Therapy/Monitor Closely. Reduce selexipag dose to once daily if coadministered with moderate CYP2C8 inhibitors.
- sildenafil
deferasirox will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- silodosin
deferasirox will decrease the level or effect of silodosin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- simvastatin
deferasirox will decrease the level or effect of simvastatin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- sirolimus
deferasirox will decrease the level or effect of sirolimus by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- streptomycin
deferasirox, streptomycin. Other (see comment). Use Caution/Monitor. Comment: Acute renal failure has been reported during treatment with deferasirox. Coadministration of deferasirox with other potentially nephrotoxic drugs, including aminoglycosides, may increase the risk of this toxicity. Monitor serum creatinine and/or creatinine clearance in patients who are receiving deferasirox and nephrotoxic drugs concomitantly.
- sufentanil
deferasirox will decrease the level or effect of sufentanil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- sulindac
deferasirox, sulindac. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- sunitinib
deferasirox will decrease the level or effect of sunitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- tacrolimus
deferasirox will decrease the level or effect of tacrolimus by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of deferasirox with potentially nephrotoxic drugs, including tacrolimus, may increase the risk of this toxicity. Monitor serum creatinine and/or creatinine clearance in patients.
- tadalafil
deferasirox will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- tamoxifen
deferasirox will decrease the level or effect of tamoxifen by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- tazemetostat
deferasirox will decrease the level or effect of tazemetostat by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- temsirolimus
deferasirox will decrease the level or effect of temsirolimus by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- theophylline
deferasirox will increase the level or effect of theophylline by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Avoid the concomitant use of theophylline with deferasirox. If you must co-administer theophylline and deferasirox, monitor theophylline concentration and consider theophylline dose modification.
- ticlopidine
deferasirox, ticlopidine. Other (see comment). Use Caution/Monitor. Comment: Gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including anticoagulants.
- tiludronate
deferasirox, tiludronate. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- tinidazole
deferasirox will decrease the level or effect of tinidazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- tipranavir
deferasirox will decrease the level or effect of tipranavir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- tirofiban
deferasirox, tirofiban. Other (see comment). Use Caution/Monitor. Comment: Gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including anticoagulants.
- tizanidine
deferasirox will increase the level or effect of tizanidine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- tobramycin
deferasirox, tobramycin. Other (see comment). Use Caution/Monitor. Comment: Acute renal failure has been reported during treatment with deferasirox. Coadministration of deferasirox with other potentially nephrotoxic drugs, including aminoglycosides, may increase the risk of this toxicity. Monitor serum creatinine and/or creatinine clearance in patients who are receiving deferasirox and nephrotoxic drugs concomitantly.
- tobramycin inhaled
tobramycin inhaled and deferasirox both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- tolmetin
deferasirox, tolmetin. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- tolterodine
deferasirox will decrease the level or effect of tolterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- tolvaptan
deferasirox will decrease the level or effect of tolvaptan by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- trazodone
deferasirox will decrease the level or effect of trazodone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- triamcinolone acetonide injectable suspension
deferasirox will decrease the level or effect of triamcinolone acetonide injectable suspension by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- triazolam
deferasirox will decrease the level or effect of triazolam by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- ubrogepant
deferasirox will decrease the level or effect of ubrogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Dose adjustment is recommended with concomitant use of ubrogepant and moderate and weak CYP3A4 inducers. (see Dosage Modifications)
- vancomycin
deferasirox, vancomycin. Other (see comment). Use Caution/Monitor. Comment: Coadministration of deferasirox with potentially nephrotoxic drugs, including vancomycin may increase the risk of this toxicity. Monitor serum creatinine and/or creatinine clearance in patients.
- vardenafil
deferasirox will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- verapamil
deferasirox will decrease the level or effect of verapamil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- vinblastine
deferasirox will decrease the level or effect of vinblastine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- vincristine
deferasirox will decrease the level or effect of vincristine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- vincristine liposomal
deferasirox will decrease the level or effect of vincristine liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- vinorelbine
deferasirox will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- zileuton
deferasirox will increase the level or effect of zileuton by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- zolmitriptan
deferasirox will increase the level or effect of zolmitriptan by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Avoid concomitant use, but if necessary consider decreasing zolmitriptan dose.
- zolpidem
deferasirox will decrease the level or effect of zolpidem by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- zonisamide
deferasirox will decrease the level or effect of zonisamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
Minor (10)
- cevimeline
deferasirox will decrease the level or effect of cevimeline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- docetaxel
deferasirox will decrease the level or effect of docetaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- donepezil
deferasirox will decrease the level or effect of donepezil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- doxorubicin liposomal
deferasirox will decrease the level or effect of doxorubicin liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- dutasteride
deferasirox will decrease the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- galantamine
deferasirox will decrease the level or effect of galantamine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- imipramine
deferasirox will decrease the level or effect of imipramine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- oxybutynin
deferasirox will decrease the level or effect of oxybutynin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- pioglitazone
deferasirox will decrease the level or effect of pioglitazone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- saxagliptin
deferasirox will decrease the level or effect of saxagliptin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
Adverse Effects
>10%
Serum creatinine increase (dose related; 7-38%)
Abdominal pain (21-28%)
Nausea (11-23%)
Vomiting (10-21%)
Diarrhea (12-20%)
Proteinuria (19%)
Pyrexia (19%)
Headache (16%)
Cough (14%)
Nasopharyngitis (13%)
Pharyngolaryngeal pain (11%)
Influenza (11%)
Rash (8-11%)
1-10%
Respiratory tract infection (10%)
Bronchitis (9%)
ALT increased (2-8%)
Arthralgia, back pain (6-7%)
Acute tonsillitis (6%)
Rhinitis (6%)
Fatigue (6%)
Ear infection (5%)
Transaminitis (4%)
Urticaria (4%)
<1%
Anaphylaxis
Angioedema
Cytopenias, including agranulocytosis, neutropenia and thrombocytopenia; leukocytoclastic vasculitis
Postmarketing Reports
Skin and subcutaneous tissue disorders: Leukocytoclastic vasculitis, urticaria, alopecia, Stevens-Johnson syndrome, toxic epidermal necrolysis
Immune system disorders: Hypersensitivity reactions (including anaphylaxis and angioedema)
Renal and urinary disorders: Acute kidney injury, including acute renal failure requiring dialysis, and renal tubular toxicity including Fanconi syndrome, renal tubular necrosis, tubulointerstitial nephritis
Hepatobiliary disorders: Hepatic failure, acute pancreatitis with and without underlying biliary conditions
Gastrointestinal disorders: GI perforation and hemorrhage
Hematology: Hematuria
Endocrine: Hypokalemia
Warnings
Black Box Warnings
Renal failure
- Can cause acute renal failure and death, especially with comorbidities and advanced stages of hematologic disorders
- Evaluate baseline renal function prior to starting or increasing dosing in all patients; therapy is contraindicated in adult and pediatric patients with eGFR <40 mL/min/1.73 m²
- Measure serum creatinine and determine creatinine clearance in duplicate prior to treatment initiation; monitor renal function at least monthly thereafter
- If baseline renal impairment or increased risk of acute renal failure exist, monitor renal function weekly for the first month, then at least monthly
- Reduce starting dose in patients with pre-existing renal disease; during therapy, increase frequency of monitoring and modify dose for patients with an increased risk of renal impairment, including use of concomitant nephrotoxic drugs, and pediatric patients with volume depletion or overchelation
- Consider dose reduction, interruption, or discontinuation based on increases in serum creatinine
Hepatic failure
- Can cause hepatic injury including hepatic failure and death
- Obtain serum transaminases and bilirubin in all patients prior to initiating treatment, every 2 weeks during the first month, and at least monthly thereafter
- Avoid with severe (Child-Pugh C) hepatic impairment and reduce the dose with moderate (Child Pugh B) hepatic impairment
Gastrointestinal hemorrhage
- Can cause gastrointestinal (GI) hemorrhages, which may be fatal, especially in elderly patients who have advanced hematologic malignancies and/or low platelet counts
- Monitor and discontinue for suspected GI ulceration or hemorrhage
Contraindications
Hypersensitivity
Estimated GFR <40 ml/min/1.73 m² or serum creatinine >2 x ULN
Poor performance status and high-risk myelodysplastic syndromes or advanced malignancies
Platelet counts <50 x10^9/L
Cautions
Coadministration with aluminum-containing antacids decreases absorption
Concomitant cholestyramine (see Dosage Modifications)
Risk of hepatic failure, some with fatal outcome; most occurred with age >55 yr and with comorbid conditions (eg, liver cirrhosis, multiorgan failure); (see Black Box Warnings)
Consider dose reduction or closer monitoring of renal and hepatic function, and serum ferritin levels during periods when patients are receiving doses >25 mg/kg/day while their serum ferritin values were <1,000 mcg/L; use minimum effective dose to maintain low iron burden
Frequency of auditory adverse events irrespective of causality may increase among pediatric patients who receive doses >25 mg/kg/day when serum ferritin is <1,000 mcg/L
Acute liver injury and failure, including fatal outcomes, have occurred in pediatric; liver failure have occurred in association with acute kidney injury in pediatric patients at risk for overchelation during a volume depleting event; interrupt therapy when acute liver injury or acute kidney injury is suspected and during volume depletion; monitor liver and renal function more frequently in pediatric patients who are receiving doses in the 20-40 mg/kg/day range and when iron burden is approaching normal; use minimum effective dose to achieve and maintain a low iron burden
Avoid use with severe (Child-Pugh C) hepatic impairment; closely monitor with mild or moderate hepatic impairment and decrease initial dose by 50%
Consider discontinuation if auditory/ocular disturbances occur
GI perforation and hemorrhage, including deaths reported, especially in elderly patients who had advanced hematologic malignancies and/or low platelet counts; nonfatal upper GI irritation, ulceration and hemorrhage reported; monitor for signs and symptoms of GI ulceration and hemorrhage during therapy and promptly initiate evaluation and treatment if serious GI adverse event is suspected; risk of gastrointestinal hemorrhage may be increased when administering in combination with drugs that have ulcerogenic or hemorrhagic potential, such as nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, oral bisphosphonates, or anticoagulants; there have been reports of ulcers complicated with gastrointestinal perforation (including fatal outcome; see Black Box Warnings)
Neutropenia, agranulocytosis, and thrombocytopenia, including fatal events, reported; preexisting hematologic disorders may increase this risk
Elderly: Monitor closely for toxicity due to the greater frequency of decreased hepatic, renal, and/or cardiac function
Serious hypersensitivity reactions (eg, anaphylaxis, angioedema) and erythema multiforme reported
Rashes may occur during treatment; for rashes of mild to moderate severity, therapy may be continued without dose adjustment; rash often resolves spontaneously; in severe cases, interrupt treatment; may consider reintroduction at lower dose after resolution of rash
Should not reintroduce patients that have experienced previous hypersensitivity reactions on deferasirox products; may cause anaphylactic shock
Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) which could be life- threatening or fatal reported during therapy; cases of multiforme observed; advise patients of signs and symptoms of severe skin reactions, and closely monitor; if any severe skin reactions suspected, discontinue drug immediately and do not reintroduce therapy
Auditory disturbances (eg, high frequency hearing loss, decreased hearing) and ocular disturbances (lens opacities, cataracts, increased IOP, retinal disorders) reported
Minimize risk of overchelation of iron by monitoring serum ferritin levels monthly to assess the patient’s response to therapy; when used for nontransfusion-dependent thalassemia, also measure LIC q6Months
Renal failure (see Black Box Warnings)
- Evaluate renal glomerular and tubular function before initiating therapy or increasing dose; use prediction equations validated for use in adult and pediatric patients to estimate GFR; obtain serum electrolytes and urinalysis in all patients to evaluate renal tubular function
- Risk of acute renal failure, fatal in some patients and requiring dialysis in others
- Dose reduction or interruption may be considered if abnormalities occur in levels of markers of renal tubular function and/or as clinically indicated
- Exercise caution in pediatric patients with eGFR of 40-60 mL/minute/1.73 m²; if treatment is needed use minimum effective dose and monitor renal function frequently; individualize dose titration based on improvement in renal injury; for patients with renal impairment (eGFR 40–60 mL/min/1.73 m²) reduce starting dose by 50%
- Therapy can cause acute kidney injury including renal failure requiring dialysis that has resulted in fatal outcomes; renal tubular toxicity, including acquired Fanconi Syndrome, reported in patients receiving therapy, most commonly in pediatric patients with beta-thalassemia and serum ferritin levels <1,500 mcg/L
- In pediatric patients, interrupt therapy during acute illnesses which can cause volume depletion, such as vomiting, diarrhea, or prolonged decreased oral intake, and monitor renal function more frequently; promptly correct fluid deficits to prevent renal injury; resume therapy as appropriate, based on assessments of renal function, when oral intake and volume status are normal
- Most fatalities reported with advanced stage hematologic disorder
- Monitor serum Cr level and CBC
- Closely monitor renal function if CrCl 40-60 mL/min, particularly in cases where there are additional risk factors that may impair renal function (eg, concomitant medications, dehydration, severe infections)
- Renal tubulopathy reported; majority of reports were in children and adolescents with beta-thalassemia and serum ferritin levels <1500 mcg/L
Pregnancy & Lactation
Pregnancy
There are no studies with use in pregnant women to inform drug-associated risks; administration of deferasirox to rats during pregnancy resulted in decreased offspring viability and an increase in renal anomalies in male offspring at doses that were about or less than recommended human dose on a mg/ m² basis; no fetal effects were noted in pregnant rabbits at doses equivalent to human recommended dose on a mg/ m² basis; drug should be used during pregnancy only if potential benefit justifies potential risk to fetus
Contraception
- Counsel patients to use non-hormonal method(s) of contraception since drug can render hormonal contraceptives ineffective
Lactation
No data are available regarding presence of drug or its metabolites in human milk, effects on breastfed infant, or on milk production; drug and its metabolites is excreted in rat milk; because many drugs are excreted in human milk and because of potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue breastfeeding or to discontinue drug, taking into account importance of drug to mother
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Selective chelator of trivalent iron; reduces liver iron concentration and serum ferritin levels
Absorption
Bioavailability: 70%
Peak Plasma Time: 1.5-4 hr
Peak plasma concentration and AUC increase in a linear fashion (accumulation factor ~1.3-2.3 following multiple doses)
Distribution
Protein Bound: 99% (mostly to albumin)
Vd: 14.37 L (adults)
Metabolism
Glucuronidation, mainly by UGT1A1 and to a lesser extent by UGT1A3
Inhibits CYP1A2, CYP2C8
Induces CYP3A4
Elimination
Half-life: 8-16 hr
Excretion: 84% feces; 8% urine
Administration
Oral Administration
Exjade
- Do not chew tablets or swallow tablet whole (disperse in water/liquid)
- Take once daily on an empty stomach at least 30 minutes before food, preferably at the same time each day
- Completely disperse tablets by stirring in water, orange juice, or apple juice until a fine suspension is obtained
- Disperse doses of <1 g in 3.5 ounces of liquid and doses ≥1 g in 7 ounces of liquid
- After swallowing the suspension, resuspend any residue in a small volume of liquid and swallow
- Do not take with aluminum-containing antacid products
Jandenu
- Do not take with aluminum-containing antacid products
- May be taken on an empty stomach or with a light meal (<7% fat content and approximately 250 calories)
- Light meal examples: 1 whole wheat English muffin, 1 packet jelly (0.5 ounces), and skim milk (8 fluid ounces) OR turkey sandwich (2 oz. turkey on whole wheat bread with lettuce, tomato, and 1 packet mustard)
Oral tablets
- Swallow tablets whole once daily with water or other liquids, preferably at the same time each day
Granules
- Take granules on an empty stomach or with a light meal, preferably at the same time each day
- Administer granules by sprinkling the full dose on soft food (eg, yogurt or apple sauce) immediately prior to use and administered orally
Storage
Store at room temperature 25°C (77°F); excursions are permitted to 15-30°C (59-86°F)
Protect from moisture
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Jadenu oral - | 360 mg tablet |  | |
| deferasirox oral - | 180 mg tablet |  | |
| deferasirox oral - | 90 mg tablet |  | |
| deferasirox oral - | 90 mg tablet |  | |
| deferasirox oral - | 500 mg tablet |  | |
| deferasirox oral - | 250 mg tablet |  | |
| deferasirox oral - | 125 mg tablet |  | |
| deferasirox oral - | 180 mg tablet |  | |
| deferasirox oral - | 360 mg tablet |  | |
| deferasirox oral - | 90 mg tablet |  | |
| deferasirox oral - | 500 mg tablet |  | |
| deferasirox oral - | 180 mg tablet |  | |
| deferasirox oral - | 90 mg tablet |  | |
| deferasirox oral - | 250 mg tablet |  | |
| deferasirox oral - | 125 mg tablet |  | |
| deferasirox oral - | 125 mg tablet |  | |
| deferasirox oral - | 360 mg tablet |  | |
| deferasirox oral - | 180 mg tablet |  | |
| deferasirox oral - | 180 mg tablet |  | |
| deferasirox oral - | 360 mg tablet |  | |
| deferasirox oral - | 90 mg tablet |  | |
| deferasirox oral - | 360 mg tablet |  | |
| deferasirox oral - | 500 mg tablet |  | |
| deferasirox oral - | 250 mg tablet |  | |
| Exjade oral - | 500 mg tablet |  | |
| Exjade oral - | 125 mg tablet |  | |
| Exjade oral - | 250 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
deferasirox oral
DEFERASIROX TABLET - FOR ORAL SUSPENSION
(deaf-ur-ES-ur-ox)
COMMON BRAND NAME(S): Exjade
WARNING: Deferasirox may rarely cause serious (even fatal) kidney disease, liver disease, and stomach/intestinal bleeding (see also Side Effects section). Kidney disease may be more likely to occur in people with kidney problems and in people with serious blood diseases. Liver disease may be more likely to occur in people with liver problems (such as cirrhosis) and in older adults. Stomach/intestinal bleeding may be more likely to occur in older adults with serious blood diseases (including blood cancers). Consult your doctor for more details.Your doctor will monitor you closely while you are taking this medication. Keep all regular medical and laboratory appointments.
USES: This medication is used to treat ongoing high levels of iron in the body caused by multiple blood transfusions. It is also used to treat high levels of iron in people with a certain blood disorder who do not require blood transfusions (non-transfusion-dependent thalassemia). It works by binding to iron, allowing the body to pass extra iron out in the stool. Deferasirox belongs to a class of drugs known as iron-chelating agents.Frequent blood transfusions are often needed in certain types of blood diseases (such as sickle cell disease, anemia). Blood transfusions have very helpful benefits, but they can cause the body to hold on to too much iron. The extra iron can build up in the body and cause problems such as heart failure, liver disease, and diabetes. Getting rid of extra iron can decrease the risk of these diseases.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking deferasirox and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Stir the tablet(s) into water, orange juice or apple juice until the tablets have completely broken apart and are well mixed into the liquid. If your dose is less than 1 gram, stir the tablets into about 1/2 cup (3.5 ounces/100 milliliters) of liquid. If your dose is more than 1 gram, use about 1 cup (7 ounces/200 milliliters) of liquid. Drink all of the mixture right away, then add more liquid to the empty container and stir to get any drug that may remain. Drink all of this rinsing liquid right away.Take this medication by mouth on an empty stomach at least 30 minutes before food as directed by your doctor, usually once daily. Do not chew the tablets or swallow them whole. Always mix this medication into liquid as directed.Antacids that contain aluminum can bind with deferasirox which may affect how deferasirox works. Avoid taking this medication with antacids that contain aluminum.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.The dosage is based on your medical condition, weight, laboratory tests, and response to treatment. Your dosage may need to be lowered or your treatment may need to be stopped if you get certain side effects. Follow your doctor's instructions carefully.
SIDE EFFECTS: Nausea, vomiting, diarrhea, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: hearing loss, vision changes (such as blurred vision).This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can worsen anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following unlikely symptoms: unusual tiredness, pale skin, signs of infection (such as sore throat that doesn't go away, fever, chills), easy bruising/bleeding.This drug may rarely cause serious stomach/intestinal problems (such as stomach/intestinal bleeding and ulcers). If you notice any of the following unlikely but serious side effects, stop taking deferasirox and consult your doctor or pharmacist right away: stomach/abdominal pain that doesn't go away, black/bloody stools, vomit that looks like coffee grounds.Deferasirox may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing of eyes/skin, dark urine.Deferasirox has rarely caused very serious (possibly fatal) kidney problems. Tell your doctor right away if you develop signs of kidney problems, such as: change in the amount of urine, frothy urine.Deferasirox can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking deferasirox, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, low platelet counts, advanced cancer, certain bone marrow disorders involving damaged blood-forming cells (high-risk myelodysplastic syndromes).This drug may make you dizzy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Tell the doctor right away if you develop any illness that may cause dehydration (including fever, diarrhea, or vomiting) or if you are unable to drink fluids. The doctor may need to stop or adjust deferasirox treatment, especially in children.Children may be more sensitive to the side effects of this drug, especially kidney problems and hearing loss.Older adults may be more sensitive to the side effects of this drug, especially liver problems, stomach/intestinal bleeding, and ulcers.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using deferasirox. Deferasirox may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: fezolinetant, other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as dabigatran/warfarin).Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually 81-162 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as serum ferritin, blood counts, urine tests, liver/kidney function, vision/hearing tests, liver iron concentration) must be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised May 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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