Dosing & Uses
Dosage Forms & Strengths
tablet
- 200mg
Renal Cell Carcinoma
Indicated for advanced renal cell carcinoma
400 mg PO q12hr
If skin toxicity, discontinue/decrease dose frequency to qDay or every other day as recommended by Manufacturer
Hepatocellular Carcinoma
Indicated for unresectable hepatocellular carcinoma
400 mg PO q12hr
If skin toxicity, discontinue/decrease dose frequency to qDay or every other day as recommended by Manufacturer
Thyroid Cancer
Indicated for locally recurrent or metastatic, progressive, differentiated thyroid cancer (DTC) that is refractory to radioactive iodine treatment
400 mg PO q12hr
Dosage modification for DTC
- Dose reduction for dermatologic toxicities (see prescribing information for specific toxicity grades 2 or 3 dosage modifications)
- First dose reduction: 600 mg/day (divided as 2 doses of 400 mg and 200 mg 12 hr apart)
- Second dose reduction: 200 mg q12hr
- Third dose reduction: 200 mg qDay
Dosage Modifications
Dermatologic toxicities (HCC or RCC)
Grade 1
- Any occurrence: Continue treatment and consider topical therapy for symptomatic relief
Grade 2
- First occurrence: Continue treatment and consider topical therapy for symptomatic relief; if no improvement within 7 days, interrupt treatment and decrease dose (see below)
- No improvement within 7 days or second or third occurrence: Withhold drug until toxicity resolves to grade 0-1, then decrease dose by 1 level (ie, 400 mg daily or 400 mg every7 other day)
- Fourth occurrence: Discontinue
Grade 3
- First or second occurrence: Withhold drug until toxicity resolves to grade 0-1, then decrease dose by 1 level (ie, 400 mg daily or 400 mg every7 other day)
- Third occurrence: Discontinue
Dermatologic toxicities (DTC)
Dose reduction schedule
- First reduction to 600 mg/day: 400 mg and 200 mg administered 12 h apart
- Second reduction to 400 mg/day: 200 mg q12hr
- Third reduction to 200 mg/day: 200 mg once daily
Grade 1
- Any occurrence: Continue treatment
Grade 2
- First occurrence: Decrease dose to 600 mg/day; if no improvement, see below
- No improvement within 7 days at reduced dose or second occurrence: Withhold drug until toxicity resolves to grade 1; if drug resumed, decrease dose per schedule
- Third occurrence: Withhold drug until toxicity resolves to grade 1; if drug resumed, decrease dose per schedule
- Fourth occurrence: Discontinue
Grade 3
- First occurrence: Withhold drug until toxicity resolves to grade 1; if drug resumed, decrease dose by 1 dose level
- Second occurrence: Withhold drug until toxicity resolves to grade 1; if drug resumed, decrease dose by 2 dose levels
- Third occurrence: Discontinue
Renal Impairment
- Mild-to-moderate: Dose adjustment not necessary
- Severe: Not studied
Hepatic Impairment
- Mild-to-moderate: Dose adjustment not necessary
- Severe: Not studied
Melanoma (Orphan)
Treatment of stage IIB through stage IV melanoma
Orphan indication sponsor
- EMD Serono, Inc; One Technology Plc; Rockland, MA 02370
Desmoid Tumors aggressive fibromatosis (Orphan)
Orphan designation for treatment of desmoid tumors or aggressive fibromatosis
Orphan sponsor
- Bayer HealthCare Pharmaceuticals, Inc; 100 Bayer Boulevard, P.O. Box 915; Whippany, New Jersey 07981
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (6)
- dronedarone
sorafenib and dronedarone both increase QTc interval. Contraindicated.
- lefamulin
lefamulin will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Lefamulin is contraindicated with CYP3A substrates know to prolong the QT interval.
- pimozide
sorafenib and pimozide both increase QTc interval. Contraindicated.
- saquinavir
saquinavir will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.
- thioridazine
sorafenib and thioridazine both increase QTc interval. Contraindicated.
- ziprasidone
sorafenib and ziprasidone both increase QTc interval. Contraindicated.
Serious - Use Alternative (74)
- abametapir
abametapir will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.
- adagrasib
adagrasib, sorafenib. Either increases effects of the other by QTc interval. Avoid or Use Alternate Drug. Each drug prolongs the QTc interval, which may increased the risk of Torsade de pointes, other serious arryhthmias, and sudden death. If coadministration unavoidable, more frequent monitoring is recommended for such patients.
- alfuzosin
alfuzosin and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- amiodarone
sorafenib and amiodarone both increase QTc interval. Avoid or Use Alternate Drug.
- amisulpride
amisulpride and sorafenib both increase QTc interval. Avoid or Use Alternate Drug. ECG monitoring is recommended if coadministered.
- anagrelide
anagrelide and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- apalutamide
apalutamide will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.
- aripiprazole
aripiprazole and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- artemether
artemether and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- atomoxetine
atomoxetine and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine
buprenorphine and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine buccal
buprenorphine buccal and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine subdermal implant
buprenorphine subdermal implant and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine transdermal
buprenorphine transdermal and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine, long-acting injection
buprenorphine, long-acting injection and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- carbamazepine
carbamazepine decreases levels of sorafenib by increasing metabolism. Avoid or Use Alternate Drug.
carbamazepine will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. - ceritinib
ceritinib and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- clarithromycin
clarithromycin will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- dabrafenib
sorafenib increases levels of dabrafenib by decreasing metabolism. Avoid or Use Alternate Drug. Strong CYP2C8 inhibitors may increase dabrafenib levels.
- desflurane
desflurane and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- dofetilide
dofetilide increases toxicity of sorafenib by QTc interval. Avoid or Use Alternate Drug.
- donepezil
donepezil and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- efavirenz
efavirenz will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
efavirenz and sorafenib both increase QTc interval. Avoid or Use Alternate Drug. - eliglustat
eliglustat and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- encorafenib
encorafenib and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- entrectinib
sorafenib and entrectinib both increase QTc interval. Avoid or Use Alternate Drug.
- enzalutamide
enzalutamide will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- erdafitinib
sorafenib will increase the level or effect of erdafitinib by affecting hepatic enzyme CYP2C9/10 metabolism. Avoid or Use Alternate Drug. If coadministration of a strong CYP2C9 inhibitors is unavoidable, closely monitor adverse reactions and modify dose of erdafitinib accordingly. If strong CYP2C9 inhibitor is discontinued, consider increasing erdafitinib dose in the absence of any drug-related toxicities.
- eribulin
eribulin and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- escitalopram
escitalopram increases toxicity of sorafenib by QTc interval. Avoid or Use Alternate Drug.
- fexinidazole
fexinidazole and sorafenib both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of fexinidazole with drugs known to block potassium channels or prolong QT interval.
fexinidazole will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates. - fingolimod
fingolimod and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- fosphenytoin
fosphenytoin will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- gilteritinib
gilteritinib and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- glasdegib
sorafenib and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.
- granisetron
granisetron and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- hydroxychloroquine sulfate
hydroxychloroquine sulfate and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- hydroxyzine
hydroxyzine and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- idelalisib
idelalisib will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates
- inotuzumab
inotuzumab and sorafenib both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.
- isoflurane
isoflurane and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- itraconazole
itraconazole and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- ivosidenib
ivosidenib and sorafenib both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of QTc prolonging drugs with ivosidenib or replace with alternate therapies. If coadministration of a QTc prolonging drug is unavoidable, monitor for increased risk of QTc interval prolongation.
ivosidenib will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternative therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs. - lithium
lithium and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- lonafarnib
lonafarnib will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration with sensitive CYP3A substrates. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling.
- lopinavir
lopinavir will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- macimorelin
macimorelin and sorafenib both increase QTc interval. Avoid or Use Alternate Drug. Macimorelin causes an increase of ~11 msec in the corrected QT interval. Avoid coadministration with drugs that prolong QT interval, which could increase risk for developing torsade de pointes-type ventricular tachycardia. Allow sufficient washout time of drugs that are known to prolong the QT interval before administering macimorelin.
- mirtazapine
mirtazapine and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- mobocertinib
mobocertinib and sorafenib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce mobocertinib dose and monitor QTc interval more frequently.
- oxaliplatin
oxaliplatin and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- palifermin
palifermin increases toxicity of sorafenib by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.
- panobinostat
sorafenib and panobinostat both increase QTc interval. Avoid or Use Alternate Drug. Panobinostat is known to significantly prolong QT interval. Panobinostat prescribing information states use with drugs known to prolong QTc is not recommended.
- phenobarbital
phenobarbital will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- phenytoin
phenytoin will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- pitolisant
sorafenib and pitolisant both increase QTc interval. Avoid or Use Alternate Drug.
- posaconazole
posaconazole will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- primaquine
primaquine and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- primidone
primidone will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- ribociclib
ribociclib will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
ribociclib increases toxicity of sorafenib by QTc interval. Avoid or Use Alternate Drug. - rifabutin
rifabutin decreases levels of sorafenib by increasing metabolism. Avoid or Use Alternate Drug.
rifabutin will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. - rifampin
rifampin decreases levels of sorafenib by increasing metabolism. Avoid or Use Alternate Drug.
rifampin will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. - rifapentine
rifapentine will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- ropeginterferon alfa 2b
ropeginterferon alfa 2b, sorafenib. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.
- selinexor
selinexor, sorafenib. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.
- sevoflurane
sevoflurane and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- siponimod
sorafenib will increase the level or effect of siponimod by affecting hepatic enzyme CYP2C9/10 metabolism. Avoid or Use Alternate Drug. Coadministration of siponimod with drugs that cause moderate CYP2C9 AND a moderate or strong CYP3A4 inhibition is not recommended. Caution if siponimod coadministered with moderate CYP2C9 inhibitors alone.
siponimod and sorafenib both increase QTc interval. Avoid or Use Alternate Drug. - St John's Wort
St John's Wort decreases levels of sorafenib by increasing metabolism. Avoid or Use Alternate Drug.
- tetrabenazine
tetrabenazine and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- toremifene
sorafenib and toremifene both increase QTc interval. Avoid or Use Alternate Drug.
- tucatinib
tucatinib will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.
- umeclidinium bromide/vilanterol inhaled
sorafenib increases toxicity of umeclidinium bromide/vilanterol inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- vilanterol/fluticasone furoate inhaled
sorafenib increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- voriconazole
voriconazole will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- voxelotor
voxelotor will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.
Monitor Closely (175)
- albuterol
albuterol and sorafenib both increase QTc interval. Use Caution/Monitor.
- alfuzosin
sorafenib and alfuzosin both increase QTc interval. Use Caution/Monitor.
- amitriptyline
sorafenib and amitriptyline both increase QTc interval. Use Caution/Monitor.
- amobarbital
amobarbital decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- amoxapine
sorafenib and amoxapine both increase QTc interval. Use Caution/Monitor.
- apomorphine
sorafenib and apomorphine both increase QTc interval. Use Caution/Monitor.
- arformoterol
sorafenib and arformoterol both increase QTc interval. Use Caution/Monitor.
- arsenic trioxide
sorafenib and arsenic trioxide both increase QTc interval. Use Caution/Monitor.
- artemether/lumefantrine
sorafenib and artemether/lumefantrine both increase QTc interval. Use Caution/Monitor.
- artesunate
sorafenib 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.
- asenapine
sorafenib and asenapine both increase QTc interval. Use Caution/Monitor.
- asenapine transdermal
asenapine transdermal and sorafenib both increase QTc interval. Use Caution/Monitor.
- atazanavir
atazanavir will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- azithromycin
sorafenib and azithromycin both increase QTc interval. Use Caution/Monitor.
- bedaquiline
sorafenib and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- bevacizumab
bevacizumab, sorafenib. Other (see comment). Use Caution/Monitor. Comment: Monitor for development of hand-foot skin reactions during combination therapy.
- bosentan
bosentan decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- budesonide
budesonide decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- bupropion
sorafenib, bupropion. decreasing metabolism. Use Caution/Monitor. Incr levels of bupropion, but decr levels of active metabolites. .
- butabarbital
butabarbital decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- butalbital
butalbital decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- cenobamate
cenobamate will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.
- chlorpromazine
sorafenib and chlorpromazine both increase QTc interval. Use Caution/Monitor.
- ciprofloxacin
sorafenib and ciprofloxacin both increase QTc interval. Use Caution/Monitor.
- citalopram
sorafenib and citalopram both increase QTc interval. Use Caution/Monitor.
- clarithromycin
sorafenib and clarithromycin both increase QTc interval. Use Caution/Monitor.
- clomipramine
sorafenib and clomipramine both increase QTc interval. Use Caution/Monitor.
- clozapine
sorafenib and clozapine both increase QTc interval. Use Caution/Monitor.
- cortisone
cortisone decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- crizotinib
sorafenib and crizotinib both increase QTc interval. Use Caution/Monitor.
- cyclophosphamide
sorafenib will increase the level or effect of cyclophosphamide by affecting hepatic enzyme CYP2B6 metabolism. Use Caution/Monitor.
- darunavir
darunavir will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- dasatinib
sorafenib and dasatinib both increase QTc interval. Use Caution/Monitor.
- deflazacort
deflazacort decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- degarelix
sorafenib and degarelix both increase QTc interval. Use Caution/Monitor.
- denosumab
sorafenib, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- desipramine
sorafenib and desipramine both increase QTc interval. Use Caution/Monitor.
- deutetrabenazine
deutetrabenazine and sorafenib both increase QTc interval. Use Caution/Monitor. At the maximum recommended dose, deutetrabenazine does not prolong QT interval to a clinically relevant extent. Certain circumstances may increase risk of torsade de pointes and/or sudden death in association with drugs that prolong the QTc interval (eg, bradycardia, hypokalemia or hypomagnesemia, coadministration with other drugs that prolong QTc interval, presence of congenital QT prolongation).
- dexamethasone
dexamethasone decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- dichlorphenamide
dichlorphenamide and sorafenib both decrease serum potassium. Use Caution/Monitor.
- disopyramide
sorafenib and disopyramide both increase QTc interval. Use Caution/Monitor.
- dofetilide
sorafenib and dofetilide both increase QTc interval. Use Caution/Monitor.
- dolasetron
sorafenib and dolasetron both increase QTc interval. Use Caution/Monitor.
- doxepin
doxepin and sorafenib both increase QTc interval. Use Caution/Monitor.
- doxorubicin
sorafenib, doxorubicin. unknown mechanism. Use Caution/Monitor. In clinical studies, an increase of 21% and 47% and no changes in the AUC of doxorubicin were observed with coadministration of sorafenib 400 mg twice daily. The clinical importance of these findings is unknown.
- doxorubicin liposomal
sorafenib, doxorubicin liposomal. unknown mechanism. Use Caution/Monitor. In clinical studies, an increase of 21% and 47% and no changes in the AUC of doxorubicin were observed with coadministration of sorafenib 400 mg twice daily. The clinical importance of these findings is unknown.
- droperidol
sorafenib and droperidol both increase QTc interval. Use Caution/Monitor.
- efavirenz
efavirenz decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- elagolix
elagolix decreases levels of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.
- encorafenib
encorafenib, sorafenib. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents.
- erythromycin base
sorafenib and erythromycin base both increase QTc interval. Use Caution/Monitor.
- erythromycin ethylsuccinate
sorafenib and erythromycin ethylsuccinate both increase QTc interval. Use Caution/Monitor.
- erythromycin lactobionate
sorafenib and erythromycin lactobionate both increase QTc interval. Use Caution/Monitor.
- erythromycin stearate
sorafenib and erythromycin stearate both increase QTc interval. Use Caution/Monitor.
- escitalopram
sorafenib and escitalopram both increase QTc interval. Use Caution/Monitor.
- eslicarbazepine acetate
eslicarbazepine acetate decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- ethotoin
ethotoin decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- etravirine
etravirine will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- ezogabine
sorafenib and ezogabine both increase QTc interval. Use Caution/Monitor. Slight and transient QT-prolongation observed, particularly when ezogabine dose titrated to 1200mg/day.
- fedratinib
fedratinib will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.
- fingolimod
sorafenib increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .
- flecainide
sorafenib and flecainide both increase QTc interval. Use Caution/Monitor.
- fluconazole
sorafenib and fluconazole both increase QTc interval. Use Caution/Monitor.
- fludrocortisone
fludrocortisone decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- fluoxetine
sorafenib and fluoxetine both increase QTc interval. Use Caution/Monitor.
- fluphenazine
sorafenib and fluphenazine both increase QTc interval. Use Caution/Monitor.
- formoterol
sorafenib and formoterol both increase QTc interval. Use Caution/Monitor.
- foscarnet
sorafenib and foscarnet both increase QTc interval. Use Caution/Monitor.
- fosphenytoin
fosphenytoin decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- fostemsavir
sorafenib and fostemsavir both increase QTc interval. Use Caution/Monitor. QTc prolongation reported with higher than recommended doses of fostemsavir.
- gemifloxacin
sorafenib and gemifloxacin both increase QTc interval. Use Caution/Monitor.
- gemtuzumab
sorafenib and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- goserelin
goserelin increases toxicity of sorafenib by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- grapefruit
grapefruit will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- griseofulvin
griseofulvin decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- haloperidol
sorafenib and haloperidol both increase QTc interval. Use Caution/Monitor.
- histrelin
histrelin increases toxicity of sorafenib by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- hydrocortisone
hydrocortisone decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- ibutilide
sorafenib and ibutilide both increase QTc interval. Use Caution/Monitor.
- iloperidone
sorafenib and iloperidone both increase QTc interval. Use Caution/Monitor.
- indapamide
sorafenib and indapamide both increase QTc interval. Use Caution/Monitor.
- indinavir
indinavir will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- irinotecan
sorafenib increases levels of irinotecan by Other (see comment). Use Caution/Monitor. Comment: Competition for UGT1A1 pathway.
- irinotecan liposomal
sorafenib increases levels of irinotecan liposomal by Other (see comment). Use Caution/Monitor. Comment: Competition for UGT1A1 pathway.
- isradipine
sorafenib and isradipine both increase QTc interval. Use Caution/Monitor.
- istradefylline
istradefylline will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.
- lapatinib
sorafenib and lapatinib both increase QTc interval. Use Caution/Monitor.
- lenacapavir
lenacapavir will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lencapavir may increase CYP3A4 substrates initiated within 9 months after last SC dose of lenacapavir, which may increase potential risk of adverse reactions of CYP3A4 substrates.
- lenvatinib
sorafenib and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- letermovir
letermovir increases levels of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- leuprolide
leuprolide increases toxicity of sorafenib by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- levofloxacin
sorafenib and levofloxacin both increase QTc interval. Use Caution/Monitor.
- lopinavir
sorafenib and lopinavir both increase QTc interval. Use Caution/Monitor.
- lumefantrine
sorafenib and lumefantrine both increase QTc interval. Use Caution/Monitor.
- maprotiline
sorafenib and maprotiline both increase QTc interval. Use Caution/Monitor.
- mefloquine
sorafenib and mefloquine both increase QTc interval. Use Caution/Monitor.
- methadone
sorafenib and methadone both increase QTc interval. Use Caution/Monitor.
- methylprednisolone
methylprednisolone decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- mifepristone
mifepristone, sorafenib. QTc interval. Modify Therapy/Monitor Closely. Use alternatives if available.
mifepristone will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. - mitotane
mitotane decreases levels of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.
- modafinil
modafinil decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- moxifloxacin
sorafenib and moxifloxacin both increase QTc interval. Use Caution/Monitor.
- nafcillin
nafcillin decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- nefazodone
nefazodone will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- nelfinavir
nelfinavir will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- neomycin PO
neomycin PO decreases levels of sorafenib by unknown mechanism. Use Caution/Monitor. AUC decreased by 54% in healthy volunteers.
- nevirapine
nevirapine decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- nilotinib
sorafenib and nilotinib both increase QTc interval. Use Caution/Monitor.
- nortriptyline
sorafenib and nortriptyline both increase QTc interval. Use Caution/Monitor.
- octreotide
sorafenib and octreotide both increase QTc interval. Use Caution/Monitor.
- ofatumumab SC
ofatumumab SC, sorafenib. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.
- ofloxacin
sorafenib and ofloxacin both increase QTc interval. Use Caution/Monitor.
- olanzapine
sorafenib and olanzapine both increase QTc interval. Use Caution/Monitor. Limited data, including some case reports, suggest that olanzapine may be associated with a significant prolongation of the QTc interval in rare instances
- ondansetron
sorafenib and ondansetron both increase QTc interval. Use Caution/Monitor.
- osilodrostat
osilodrostat and sorafenib both increase QTc interval. Use Caution/Monitor.
- osimertinib
osimertinib and sorafenib both increase QTc interval. Use Caution/Monitor. Conduct periodic monitoring with ECGs and electrolytes in patients taking drugs known to prolong the QTc interval.
- oxaliplatin
oxaliplatin will increase the level or effect of sorafenib by Other (see comment). Use Caution/Monitor. Monitor for ECG changes if therapy is initiated in patients with drugs known to prolong QT interval.
- oxcarbazepine
oxcarbazepine decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- ozanimod
ozanimod and sorafenib both increase QTc interval. Modify Therapy/Monitor Closely. The potential additive effects on heart rate, treatment with ozanimod should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties.
- paclitaxel
sorafenib will increase the level or effect of paclitaxel by Other (see comment). Modify Therapy/Monitor Closely. Paclitaxel levels/toxicity may increase when coadministered with CYP2C8 inhibitors
- paclitaxel protein bound
sorafenib will increase the level or effect of paclitaxel protein bound by Other (see comment). Modify Therapy/Monitor Closely. Paclitaxel levels/toxicity may increase when coadministered with CYP2C8 inhibitors
- paliperidone
sorafenib and paliperidone both increase QTc interval. Use Caution/Monitor.
- pasireotide
sorafenib and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.
- pazopanib
sorafenib and pazopanib both increase QTc interval. Use Caution/Monitor.
- pentamidine
sorafenib and pentamidine both increase QTc interval. Use Caution/Monitor.
- pentobarbital
pentobarbital decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- perphenazine
sorafenib and perphenazine both increase QTc interval. Use Caution/Monitor.
- phenobarbital
phenobarbital decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- phenytoin
phenytoin decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- posaconazole
sorafenib and posaconazole both increase QTc interval. Use Caution/Monitor.
- prednisolone
prednisolone decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- prednisone
prednisone decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- primidone
primidone decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- procainamide
sorafenib and procainamide both increase QTc interval. Use Caution/Monitor.
- propafenone
sorafenib and propafenone both increase QTc interval. Use Caution/Monitor.
- protriptyline
sorafenib and protriptyline both increase QTc interval. Use Caution/Monitor.
- quetiapine
sorafenib and quetiapine both increase QTc interval. Use Caution/Monitor.
- quinidine
sorafenib and quinidine both increase QTc interval. Use Caution/Monitor.
- quinine
sorafenib and quinine both increase QTc interval. Use Caution/Monitor.
- ranolazine
sorafenib and ranolazine both increase QTc interval. Use Caution/Monitor.
- rifapentine
rifapentine decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- risperidone
sorafenib and risperidone both increase QTc interval. Use Caution/Monitor.
- ritonavir
ritonavir will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- romidepsin
sorafenib and romidepsin both increase QTc interval. Use Caution/Monitor.
- rucaparib
rucaparib will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.
- saquinavir
sorafenib and saquinavir both increase QTc interval. Use Caution/Monitor.
- secobarbital
secobarbital decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- selpercatinib
selpercatinib increases toxicity of sorafenib by QTc interval. Use Caution/Monitor.
- sertraline
sorafenib and sertraline both increase QTc interval. Use Caution/Monitor.
- siponimod
siponimod and sorafenib both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- sipuleucel-T
sorafenib decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.
- solifenacin
sorafenib and solifenacin both increase QTc interval. Use Caution/Monitor.
- sotalol
sorafenib and sotalol both increase QTc interval. Use Caution/Monitor.
- stiripentol
stiripentol, sorafenib. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.
- sunitinib
sorafenib and sunitinib both increase QTc interval. Use Caution/Monitor.
- tacrolimus
sorafenib and tacrolimus both increase QTc interval. Use Caution/Monitor.
- tazemetostat
tazemetostat will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- tecovirimat
tecovirimat will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.
- telavancin
sorafenib and telavancin both increase QTc interval. Use Caution/Monitor.
- thiothixene
sorafenib and thiothixene both increase QTc interval. Use Caution/Monitor.
- tipranavir
tipranavir will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- trastuzumab
trastuzumab, sorafenib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.
- trastuzumab deruxtecan
trastuzumab deruxtecan, sorafenib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.
- triamcinolone acetonide injectable suspension
triamcinolone acetonide injectable suspension decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.
- triclabendazole
triclabendazole and sorafenib both increase QTc interval. Use Caution/Monitor.
- trimipramine
sorafenib and trimipramine both increase QTc interval. Use Caution/Monitor.
- triptorelin
triptorelin increases toxicity of sorafenib by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- valbenazine
valbenazine and sorafenib both increase QTc interval. Use Caution/Monitor.
- vandetanib
sorafenib and vandetanib both increase QTc interval. Use Caution/Monitor.
- vardenafil
sorafenib and vardenafil both increase QTc interval. Use Caution/Monitor.
- vemurafenib
sorafenib and vemurafenib both increase QTc interval. Use Caution/Monitor.
- voclosporin
voclosporin, sorafenib. Either increases effects of the other by QTc interval. Use Caution/Monitor.
- voriconazole
sorafenib and voriconazole both increase QTc interval. Use Caution/Monitor.
- vorinostat
sorafenib and vorinostat both increase QTc interval. Use Caution/Monitor.
- warfarin
sorafenib will increase the level or effect of warfarin by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.
Minor (8)
- acetazolamide
acetazolamide will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- anastrozole
anastrozole will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- chloroquine
chloroquine increases toxicity of sorafenib by QTc interval. Minor/Significance Unknown.
- cocaine topical
sorafenib will increase the level or effect of cocaine topical by affecting hepatic enzyme CYP2B6 metabolism. Minor/Significance Unknown.
- cyclophosphamide
cyclophosphamide will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- ketoconazole
ketoconazole will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- larotrectinib
larotrectinib will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- levoketoconazole
levoketoconazole will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
Adverse Effects
>10%
Thrombocytopenia (12-46%)
Anemia (44%)
Diarrhea (43%)
Rash/desquamation (40%)
Fatigue (37%)
Abdominal pain (31%)
Hand-foot skin reaction (30%)
Weight loss (30%)
Anorexia (29%)
Alopecia (27%)
Nausea (24%)
Lymphopenia (23%)
Neutropenia (18%)
Hemorrhage (15-18%)
Hypertension (9-17%)
Vomiting (16%)
Constipation (15%)
Neuropathy (13%)
Dry skin (11%)
1-10%
Headache (10%)
Joint pain (10%)
Congestive heart failure, MI (1.9%)
QT prolonation (rare)
<1%
Acute renal failure
Angioedema and arrhythmia may occur
Bone pain reported
Frequency Not Defined
Stevens-Johnson Syndrome
Hyperthyroidism
Interstitial lung disease
Postmarketing Reports
Hypersensitivity: Angioedema, anaphylactic reaction
Hepatobiliary disorders: Drug-induced hepatitis, including reports of hepatic failure and death
Dermatologic: Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN)
Musculoskeletal: Rhabdomyolysis, osteonecrosis of the jaw
Respiratory: Interstitial lung disease-like events
Blood and lymphatic disorders: Thrombotic microangiopathy (TMA)
Vascular: Arterial (including aortic) aneurysms, dissections, and rupture
Warnings
Contraindications
Hypersensitivity
Coadministration with carboplatin and paclitaxel in patients with squamous cell lung cancer
Cautions
Osteonecrosis of jaw reported
Increased risk of cardiac ischemia/HTN/hemorrhage; consider temporary or permanent discontinuation of therapy in patients who develop cardiovascular events
Withhold therapy for at least 10 days prior to elective surgery; do not administer for at least 2 weeks following major surgery and until adequate wound healing; safety of resumption of therapy after resolution of wound healing complications has not been established
Hepatitis reported; characterized by a hepatocellular pattern of liver damage with significant increases of transaminases which may result in hepatic failure and death
QT Prolongation: Monitor for prolonged QT intervals with CHF, bradyarrhythmias, drugs known to prolong QT interval, and electrolyte abnormalities; avoid with congenital long QT syndrome
Congestive heart failure reported; temporary or permanent discontinuation of therapy should be considered in patients who develop cardiovascular events
Monitor blood pressure weekly during first 6 weeks and periodically thereafter; consider temporary or permanent discontinuation for severe or persistent hypertension despite antihypertensive therapy
Avoid pregnancy
High incidence of skin toxicity and rash
Dermatologic toxicities reported; management of dermatologic toxicities may include topical therapies for symptomatic relief, temporary treatment interruption and/or dose reduction of the drug; in severe or persistent cases, permanent discontinuation should be considered; there have been reports of severe dermatologic toxicities, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN); these cases may be life-threatening; discontinue therapy if SJS or TEN are suspected
Impairs exogenous thyroid suppression; for patients with impaired TSH suppression while receiving sorafenib, the median maximal TSH was 1.6 mU/L and 25% had TSH levels >4.4 mU/L; monitor TSH levels monthly and adjust thyroid replacement medication as needed in patients with disseminated thyroid cancer
Temporarily discontinue before surgery, resumption should be based on adequate wound healing
Monitor liver function tests regularly; discontinue for unexplained transaminase elevations
An increased risk of bleeding may occur; if any bleeding necessitates medical intervention, consider permanent discontinuation of therapy; due to potential risk of bleeding, treat tracheal, bronchial, and esophageal infiltration with local therapy prior to administering therapy in patients with DTC
Gastrointestinal perforation reported in less than 1% of patients receiving therapy; in some cases this was not associated with apparent intra-abdominal tumor; in the event of gastrointestinal perforation, permanently discontinue
Drug interactions overview
- Infrequent bleeding or elevations in the International Normalized Ratio (INR) reported in some patients taking warfarin while on therapy; monitor patients taking concomitant warfarin regularly for changes in prothrombin time (PT), INR or clinical bleeding episodes
- Use of in combination with carboplatin/paclitaxel contraindicated in patients with squamous cell lung cancer; this drug in combination with gemcitabine/cisplatin not recommended in patients with squamous cell lung cancer; safety and effectiveness not established in patients with non-small cell lung cancer
- This drug can prolong QT/QTc interval; QT/QTc interval prolongation increases risk for ventricular arrhythmias; avoid therapy in patients with congenital long QT syndrome; monitor electrolytes and electrocardiograms in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong QT interval, including Class Ia and III antiarrhythmics; correct electrolyte abnormalities (magnesium, potassium, calcium); Interrupt therapy if QTc interval is greater than 500 milliseconds or for an increase from baseline of 60 milliseconds or greater
Pregnancy & Lactation
Pregnancy
There are no available data in pregnant women to inform a drug associated risk
Animal data
- Based on findings from animal studies and mechanism of action, therapy may cause fetal harm when administered to a pregnant woman; in animal reproduction studies, oral administration to pregnant rats and rabbits during period of organogenesis resulted in embryo-fetal toxicities at maternal exposures that were significantly lower than human exposures at recommended dose of 400 mg twice daily; apprise pregnant women and females of reproductive potential of potential risk to fetus
Pregnancy testing
- Verify pregnancy status of females of reproductive potential prior to initiation of therapy
Contraception
- Females: Therapy may cause fetal harm when administered to a pregnant woman; advise females of reproductive potential to use effective contraception during treatment and for 6 months following last dose of drug
- Males: Based on genotoxicity and findings in animal reproduction studies, advise male patients with female partners of reproductive potential and pregnant partners to use effective contraception during treatment and for 3 months after the last dose
Infertility
- Males: Based on findings in animal studies, therapy may impair fertility in males of reproductive potential
Lactation
There are no data on presence of drug or its metabolites in human milk, or its effects on breast-fed child or on milk production; drug was present in milk of lactating rats; because of potential for serious adverse reactions in breastfed child from drug, advise lactating women not to breastfeed during treatment and for 2 weeks after last dose
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
Multikinase inhibitor (including VEGF and PDGF receptor kinases), reduces tumor cell proliferation in vitro, may act at least partially by inhibiting tumor angiogenesis
Absorption
Bioavailability: 38-49%, reduced by high fat diet
Peak Plasma Time: 3 hr
Distribution
Protein Bound: 99.5%
Metabolism
Metabolism: in liver by CYP3A4 & UGT1A9
Elimination
Half-Life, Elimination: 25-48 hr
Excretion: Feces 77%; urine 19%
Administration
Oral Administration
Take 1 hr before or 2 hr after meals
Although partially metabolized by CYP3A4, dose modification appears to be unnecessary if coadministered with CYP3A4 inhibitors
Monitor: BP
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Nexavar oral - | 200 mg tablet |  | |
| sorafenib oral - | 200 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
sorafenib oral
SORAFENIB - ORAL
(soe-RAF-e-nib)
COMMON BRAND NAME(S): Nexavar
USES: Sorafenib is used to treat kidney, liver, and thyroid cancer. It works by slowing or stopping the growth of cancer cells.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking sorafenib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth on an empty stomach (at least 1 hour before or 2 hours after a meal) as directed by your doctor, usually twice a day.The dosage is based on your medical condition and response to treatment. 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 serious side effects will increase.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.
SIDE EFFECTS: Weight loss, nausea/vomiting, diarrhea, loss of appetite, changes in taste, dry skin, mouth sores, hair loss, voice changes, or tiredness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication.Treatment with this drug may sometimes cause your hands/feet to develop a skin reaction called hand-foot syndrome. Tell your doctor right away if you experience swelling, pain, redness, blisters, or tingling/burning of the hands/feet. Depending on how severe your hand-foot syndrome is, your doctor may give you an additional medication to reduce the symptoms, or may stop or delay your sorafenib treatment.This medication can affect how your thyroid works. Tell your doctor right away if you have signs of an underactive thyroid (such as weight gain, cold intolerance, slow heartbeat, constipation, or unusual tiredness) or signs of an overactive thyroid (such as mental/mood changes, heat intolerance, unusual weight loss).Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, signs of liver disease (such as nausea/vomiting that doesn't stop, stomach/abdominal pain, yellowing eyes/skin, dark urine), numb/tingling skin, slow wound healing, muscle spasms, signs of infection (such as sore throat that doesn't go away, fever), signs of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness).Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, unusual sweating, fast/irregular heartbeat, severe dizziness, fainting, vomit that looks like coffee grounds, black/bloody stools, sudden/severe back pain or headache, weakness on one side of the body, sudden vision changes, trouble speaking, confusion.Sorafenib 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 sorafenib, 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: bleeding problems, recent surgery/injury, heart disease (such as heart attack, coronary artery disease), high blood pressure, blood vessel problems (such as an aneurysm or a tear/break in the aorta or other blood vessels), liver disease.Sorafenib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using sorafenib, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using sorafenib safely.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication may cause wounds to heal slowly or poorly. Before having surgery, talk with your doctor about the risks and benefits of this medication. Your doctor may tell you to temporarily stop treatment with this medication at least 10 days before surgery. Ask your doctor for specific instructions about when to stop and when to restart treatment with sorafenib. Tell your doctor right away if you have wounds that are not healing well.Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using sorafenib. Sorafenib may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Females using this drug should ask about reliable forms of birth control during treatment and for 6 months after stopping treatment. Males using this drug should ask about reliable forms of birth control during treatment and for 3 months after stopping treatment. If you or your partner become pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 2 weeks after stopping the drug. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: 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.A product that may interact with this drug is: irinotecan.Other medications can affect the removal of sorafenib from your body, which may affect how sorafenib works. Examples include neomycin, rifamycins (such as rifampin, rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.
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 blood pressure, liver/thyroid function, complete blood count, electrolyte levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take 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.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised August 2021. 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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Adding plans allows you to:
- View the formulary and any restrictions for each plan.
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