Dosing & Uses
Dosage Forms & Strengths
capsule
- 100mg
- 150mg
Idiopathic Pulmonary Fibrosis
Indicated for idiopathic pulmonary fibrosis
150 mg PO q12hr
Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype
Indicated for chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype
Unclassifiable ILDs, autoimmune ILDs, chronic hypersensitivity pneumonitis, sarcoidosis, myositis, Sjögren syndrome, coal workers pneumoconiosis, and idiopathic forms of interstitial pneumonias (eg, idiopathic nonspecific interstitial pneumonia) are among the diseases that may develop a progressive form of chronic fibrosing ILD
150 mg PO q12hr
Systemic Sclerosis-associated Interstitial Lung Disease
Indicated to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD)
150 mg PO q12hr
Dosage Modifications
Dosage modifications due to adverse reactions
- Adverse reactions may require dose reduction or temporary interruption until the specific adverse reaction resolves
- Resumed at 150 mg q12hr, or at 100 mg q12hr, which subsequently may be increased to the full dose (150 mg q12hr)
- If 100 mg q12hr is not tolerated, discontinue treatment
Elevated liver enzymes
- AST/ALT >3 to <5x ULN without signs of severe liver damage: Interrupt treatment or reduce to 100 mg BID; once LFTs return to normal, may reintroduce at 100 mg BID, which subsequently may be increased to 150 mg BID
- AST/ALT >5x ULN or >3x ULN with signs/symptoms of severe liver damage: Discontinue
Hepatic impairment
- Mild (Child Pugh A): 100 mg PO q12hr
- Moderate-to-severe (Child Pugh B or C): Not recommended (not studied)
Renal impairment
- Mild-to-moderate: No dosage adjustment required
- Severe (CrCl <30 mL/min) or ESRD: Not studied
Dosing Considerations
Laboratory testing before initiating
- Conduct liver function tests in all patients
- Obtain pregnancy test in females of reproductive potential
Mesothelioma (Orphan)
Orphan designation for treatment of mesothelioma
Sponsor
- Boehringer Ingelheim Pharmaceuticals, Inc; 900 Ridgebury Rd, Box 368; Ridgefield, CT 06877
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (14)
- carbamazepine
carbamazepine decreases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration, particularly for P-gp inducers that are also CYP3A4 inducers; nintedanib is a substrate of P-gp and to a less extent CYP3A4.
- erdafitinib
erdafitinib will increase the level or effect of nintedanib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If coadministration unavoidable, separate administration by at least 6 hr before or after administration of P-gp substrates with narrow therapeutic index.
- erythromycin lactobionate
erythromycin lactobionate increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy.
- fosphenytoin
fosphenytoin decreases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration, particularly for P-gp inducers that are also CYP3A4 inducers; nintedanib is a substrate of P-gp and to a less extent CYP3A4.
- lasmiditan
lasmiditan increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.
- nefazodone
nefazodone will increase the level or effect of nintedanib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.
- phenobarbital
phenobarbital decreases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration, particularly for P-gp inducers that are also CYP3A4 inducers; nintedanib is a substrate of P-gp and to a less extent CYP3A4.
- phenytoin
phenytoin decreases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration, particularly for P-gp inducers that are also CYP3A4 inducers; nintedanib is a substrate of P-gp and to a less extent CYP3A4.
- primidone
primidone decreases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration, particularly for P-gp inducers that are also CYP3A4 inducers; nintedanib is a substrate of P-gp and to a less extent CYP3A4.
- rifampin
rifampin decreases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration, particularly for P-gp inducers that are also CYP3A4 inducers; nintedanib is a substrate of P-gp and to a less extent CYP3A4.
- St John's Wort
St John's Wort decreases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration, particularly for P-gp inducers that are also CYP3A4 inducers; nintedanib is a substrate of P-gp and to a less extent CYP3A4.
- tenofovir DF
tenofovir DF decreases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration, particularly for P-gp inducers that are also CYP3A4 inducers; nintedanib is a substrate of P-gp and to a less extent CYP3A4.
- tipranavir
tipranavir decreases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration, particularly for P-gp inducers that are also CYP3A4 inducers; nintedanib is a substrate of P-gp and to a less extent CYP3A4.
- vinblastine
vinblastine decreases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration, particularly for P-gp inducers that are also CYP3A4 inducers; nintedanib is a substrate of P-gp and to a less extent CYP3A4.
Monitor Closely (69)
- abiraterone
abiraterone increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- afatinib
afatinib increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- amiodarone
amiodarone increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- apixaban
nintedanib increases effects of apixaban by anticoagulation. Use Caution/Monitor. Nintedanib is a VEGFR inhibitor, and may increase the risk of bleeding; monitor patients on full anticoagulation therapy; monitor closely for bleeding and adjust therapy as needed .
- argatroban
nintedanib increases effects of argatroban by anticoagulation. Use Caution/Monitor. Nintedanib is a VEGFR inhibitor, and may increase the risk of bleeding; monitor patients on full anticoagulation therapy; monitor closely for bleeding and adjust therapy as needed .
- atorvastatin
atorvastatin increases effects of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- azithromycin
azithromycin increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- berotralstat
berotralstat will increase the level or effect of nintedanib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor or titrate P-gp substrate dose if coadministered.
- bivalirudin
nintedanib increases effects of bivalirudin by anticoagulation. Use Caution/Monitor. Nintedanib is a VEGFR inhibitor, and may increase the risk of bleeding; monitor patients on full anticoagulation therapy; monitor closely for bleeding and adjust therapy as needed .
- carvedilol
carvedilol increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy.
- clarithromycin
clarithromycin increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy.
- cobicistat
cobicistat increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy.
- crizotinib
crizotinib increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy.
- cyclosporine
cyclosporine increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy.
- dabigatran
nintedanib increases effects of dabigatran by anticoagulation. Use Caution/Monitor. Nintedanib is a VEGFR inhibitor, and may increase the risk of bleeding; monitor patients on full anticoagulation therapy; monitor closely for bleeding and adjust therapy as needed .
- dalteparin
nintedanib increases effects of dalteparin by anticoagulation. Use Caution/Monitor. Nintedanib is a VEGFR inhibitor, and may increase the risk of bleeding; monitor patients on full anticoagulation therapy; monitor closely for bleeding and adjust therapy as needed .
- darunavir
darunavir increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- dipyridamole
dipyridamole increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- dronedarone
dronedarone increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- elagolix
elagolix will increase the level or effect of nintedanib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- eliglustat
eliglustat increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- enoxaparin
nintedanib increases effects of enoxaparin by anticoagulation. Use Caution/Monitor. Nintedanib is a VEGFR inhibitor, and may increase the risk of bleeding; monitor patients on full anticoagulation therapy; monitor closely for bleeding and adjust therapy as needed .
- erythromycin base
erythromycin base increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy.
- erythromycin ethylsuccinate
erythromycin ethylsuccinate increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy.
- erythromycin stearate
erythromycin stearate increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy.
- etravirine
etravirine increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy.
- glecaprevir/pibrentasvir
glecaprevir/pibrentasvir will increase the level or effect of nintedanib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- grapefruit
grapefruit increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- heparin
nintedanib increases effects of heparin by anticoagulation. Use Caution/Monitor. Nintedanib is a VEGFR inhibitor, and may increase the risk of bleeding; monitor patients on full anticoagulation therapy; monitor closely for bleeding and adjust therapy as needed .
- istradefylline
istradefylline will increase the level or effect of nintedanib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of P-gp substrates in clinical trials. Consider dose reduction of sensitive P-gp substrates.
- itraconazole
itraconazole increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- ivacaftor
ivacaftor increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- ketoconazole
ketoconazole increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- lapatinib
lapatinib increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- ledipasvir/sofosbuvir
ledipasvir/sofosbuvir increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- levoketoconazole
levoketoconazole increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- lomitapide
lomitapide increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- lonafarnib
lonafarnib will increase the level or effect of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Lonafarnib is a weak P-gp inhibitor. Monitor for adverse reactions if coadministered with P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. Reduce P-gp substrate dose if needed.
- lopinavir
lopinavir increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- mefloquine
mefloquine increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- nelfinavir
nelfinavir increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- nicardipine
nicardipine increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy.
- nifedipine
nifedipine increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy.
- nilotinib
nilotinib increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy.
- paliperidone
paliperidone increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy.
- ponatinib
ponatinib increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- posaconazole
posaconazole increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- progesterone micronized
progesterone micronized increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- propafenone
propafenone increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- propranolol
propranolol increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- quinidine
quinidine increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- quinine
quinine increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- ranolazine
ranolazine increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- ritonavir
ritonavir increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- rivaroxaban
nintedanib increases effects of rivaroxaban by anticoagulation. Use Caution/Monitor. Nintedanib is a VEGFR inhibitor, and may increase the risk of bleeding; monitor patients on full anticoagulation therapy; monitor closely for bleeding and adjust therapy as needed .
- saquinavir
saquinavir increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- sarecycline
sarecycline will increase the level or effect of nintedanib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor for toxicities of P-gp substrates that may require dosage reduction when coadministered with P-gp inhibitors.
- stiripentol
stiripentol will increase the level or effect of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing the dose of P-glycoprotein (P-gp) substrates, if adverse reactions are experienced when administered concomitantly with stiripentol.
- sunitinib
sunitinib increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- suvorexant
suvorexant increases effects of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- tacrolimus
tacrolimus increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- tamoxifen
tamoxifen increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- ticagrelor
ticagrelor increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- tucatinib
tucatinib will increase the level or effect of nintedanib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.
- ulipristal
ulipristal increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- vandetanib
vandetanib increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- vemurafenib
vemurafenib increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- verapamil
verapamil increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- warfarin
nintedanib increases effects of warfarin by anticoagulation. Use Caution/Monitor.
Minor (0)
Adverse Effects
>10%
Idiopathic pulmonary fibrosis
- Diarrhea (62%)
- Nausea (24%)
- Abdominal pain (15%)
- Elevated liver enzymes (14%)
- Vomiting (12%)
- Decreased appetite (11%)
SSc-ILD
- Diarrhea (76%)
- Nausea (32%)
- Vomiting (25%)
- Skin ulcer (18%)
- Abdominal pain (18%)
- Liver enzyme elevation (13%)
- Decreased weight (12%)
- Fatigue (11%)
1-10%
Idiopathic pulmonary fibrosis
- Decreased weight (10%)
- Bleeding events (10%)
- Headache (8%)
- Hypertension (5%)
- Arterial thromboembolic events (2.5%)
- Myocardial infarction (1.5%)
- Bronchitis (1.5%)
- Hypothyroidism (1.1%)
SSc-ILD
- Decreased appetite (9%)
- Headache (9%)
- Pyrexia (6%)
- Back pain (6%)
- Dizziness (6%)
- Hypertension (5%)
<1%
Idiopathic pulmonary fibrosis
- Pneumonia (0.7%)
- Lung neoplasm malignant (0.3%)
- Gastrointestinal perforation (0.3%)
Postmarketing Reports
Pancreatitis
Thrombocytopenia
Drug-induced liver injury
Rash
Pruritus
Alopecia
Nephrotic range proteinuria
Warnings
Contraindications
None
Cautions
Severe liver injury with fatal outcome reported; majority of hepatic events occur within first 3 months of treatment; conduct liver function tests (ALT, AST, and bilirubin) before initiating, monthly for 3 months, and then q3months thereafter and as clinically indicated
Not recommended in patients with moderate or severe hepatic impairment (Child Pugh B or C); reduced dose for patients with mild hepatic impairment (Child Pugh A)
Nausea, and/or vomiting may occur; treat with adequate hydration and antidiarrheal/antiemetic medications; if persists, treatment interruption and dose reduction may be needed
Diarrhea may occur; treat at first signs with adequate hydration and antidiarrheal medication (eg, loperamide); consider treatment interruption if diarrhea continues; treatment may be resumed at full dosage (150 mg twice daily), or at reduced dosage (100 mg twice daily); may subsequently increase to full dosage; if severe diarrhea persists despite symptomatic treatment, discontinue treatment
Arterial thromboembolic events reported, including myocardial infarction; caution when treatment patients at higher cardiovascular risk
May increased risk of bleeding or gastrointestinal perforation (based on mechanism of action [VEGFR inhibition]); monitor for bleeding if on full anticoagulant therapy and adjust anticoagulation treatment as needed
Smoking associated with decreased systemic exposure; encourage patients to quit smoking
Can cause fetal harm; use adequate contraception during treatment and for at least 3 months after the last dose
In postmarketing period non-serious and serious bleeding events reported; use therapy in patients with known risk of bleeding only if anticipated benefit outweighs potential risk
In postmarketing period, cases of gastrointestinal perforations reported; use caution when treating patients who have had recent abdominal surgery, previous history of diverticular disease or receiving concomitant corticosteroids or NSAIDs; discontinue therapy in patients who develop gastrointestinal perforation; only use in patients with known risk of gastrointestinal perforation if the anticipated benefit outweighs the potential risk
Cases of proteinuria within nephrotic range reported in postmarketing period; histological findings, when available, were consistent with glomerular microangiopathy with or without renal thrombi; improvement in proteinuria observed after therapy was discontinued; however, in some cases, residual proteinuria persisted; consider treatment interruption in patients who develop new or worsening proteinuria
Drug interaction overview
- Nintedanib is a substrate of CYP3A4 and P-gp transporter
- Coadministration with potent P-gp or CYP3A4 inhibitors may increase systemic exposure of nintedanib (monitor closely)
- Coadministration with P-gp or CYP3A4 inducers may decrease systemic exposure to nintedanib by 50%; avoid coadministration
- Nintedanib is a VEGFR inhibitor and may increase bleeding risk; monitor patients on full anticoagulation for bleeding and adjust anticoagulation treatment if needed
Pregnancy & Lactation
Pregnancy
Based on findings from animal studies and its mechanism of action, can cause fetal harm when administered to pregnant women; counsel patients on pregnancy prevention and planning
Verify pregnancy status of females of reproductive potential prior to treatment and during treatment as appropriate
Animal data
- In animal studies of pregnant rats and rabbits treated during organogenesis, nintedanib caused embryofetal deaths and structural abnormalities at less than (rats) and ~5 times (rabbits) the maximum recommended human dose
Contraception
- Advise females of reproductive potential to avoid becoming pregnant while receiving nintedanib
- Use effective contraception during treatment, and for at least 3 months after taking the last dose
- Drug does not change exposure to oral contraceptive containing ethinylestradiol and levonorgestrel in patients with SSc-ILD; however, efficacy of oral hormonal contraceptives may be compromised by vomiting and/or diarrhea or other conditions where drug absorption may be reduced
- Advise women taking oral hormonal contraceptives experiencing vomiting and/or diarrhea to use alternative highly effective contraception; verify pregnancy status prior to treatment and during treatment as appropriate
Infertility
- Based on animal data, may reduce fertility in females of reproductive potential
Lactation
There is no information on the presence of nintedanib in human milk, the effects on the breast-fed infant or the effects on milk production
Nintedanib and/or its metabolites are present in the milk of lactating rats
Because of the potential for serious adverse effects in breastfed infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the 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
Tyrosine kinase inhibitor; targets growth factors, which have been shown to be potentially involved in pulmonary fibrosis (eg, vascular endothelial growth factor receptor [VEGFR], fibroblast growth factor receptor [FGFR], platelet-derived growth factor receptor [PDGF])
Binds competitively to the adenosine triphosphate (ATP)-binding pocket of these receptors and blocks the intracellular signaling, which is crucial for the proliferation, migration, and transformation of fibroblasts, representing essential mechanisms of the IPF pathology
Absorption
Bioavailability: 4.7%; undergoes substantial first-pass metabolism
Peak plasma concentration: 2-4 hr
Food increases systemic exposure by ~20% and delays peak level to ~4 hr
Distribution
Protein bound: 97.8%
Vd: 1050 L
Metabolism
Hydrolytic cleavage by esterases resulting in the free acid moiety BIBF 1202 is the prevalent metabolic pathway (~25%); BIBF 1202 is subsequently glucuronidated by UGT enzymes, namely UGT 1A1, UGT 1A7, UGT 1A8, and UGT 1A10 to BIBF 1202 glucuronide
Only a minor extent of the biotransformation consists of CYP pathways (~5%), with CYP3A4 being the predominant enzyme involved
Elimination
Excretion: 93.4% feces/biliary; 0.65% urine
Administration
Oral Administration
Take with food
Swallow capsule whole with liquid; do not chew or crush (bitter taste); effect of crushing on the pharmacokinetics is unknown
Missed dose: Take next dose at next scheduled time; advise patient to not make up for a missed dose
Storage
Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF)
Protect from exposure to high humidity and avoid excessive heat
If repackaged, use USP tight container
Keep out of reach of children
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Ofev oral - | 150 mg capsule |  | |
| Ofev oral - | 100 mg capsule |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
nintedanib oral
NINTEDANIB - ORAL
(nin-TED-a-nib)
COMMON BRAND NAME(S): Ofev
USES: This medication is used to treat certain types of lung disease (idiopathic pulmonary fibrosis- IPF, interstitial lung disease). Both types of lung disease scar and stiffen your lungs, making it hard to breathe. Nintedanib may help slow down the worsening of your lung disease.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking nintedanib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with food as directed by your doctor, usually twice daily (about 12 hours apart). The dosage is based on your medical condition and response to treatment. Follow your doctor's instructions carefully.Swallow the capsule whole. Do not crush or chew because the drug has a bitter taste. Do not open the capsules. Wash your hands well right away if your skin comes in contact with the content inside the capsules.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.Tell your doctor if your condition worsens.
SIDE EFFECTS: Diarrhea, nausea, vomiting, abdominal pain, decreased appetite, and weight loss may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Diarrhea, nausea, and vomiting can be severe. Your doctor may have you drink more fluids if these symptoms occur and prescribe medications to treat the diarrhea, nausea, and vomiting.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.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.Tell your doctor right away if you have any serious side effects, including: unusual bruising/bleeding, cough/stuffy chest, foamy urine, swelling ankles/feet/hands, symptoms of liver problems (such as dark urine, yellowing eyes/skin).Get medical help right away if you have any very serious side effects, including: symptoms of a heart attack (such as chest/jaw/left arm pain, unusual sweating), symptoms of a stroke (such as weakness on one side of body, sudden vision problems, trouble speaking), sudden/severe back pain or headache, severe stomach/abdominal pain, abdominal swelling.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 nintedanib, 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: liver disease, heart disease (such as chest pain, heart attack), high blood pressure, blood clots, bleeding problems, blood vessel problems (such as an aneurysm or a tear/break in the aorta or other blood vessels), recent abdominal surgery, stomach/intestinal problems (such as ulcers, diverticular disease).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using nintedanib. Nintedanib may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control (such as condoms) while using this medication and for at least 3 months after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if nintedanib passes into breast milk. 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.Some products that may interact with this drug include: drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as warfarin/dabigatran).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.Other medications can affect the removal of nintedanib from your body, which may affect how nintedanib works. Examples include rifamycins (such as rifampicin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.Cigarette smoking decreases blood levels of this medication. Tell your doctor if you smoke or if you have recently stopped smoking.
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 function tests) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments.
MISSED DOSE: If you miss a 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.
Information last revised April 2022. Copyright(c) 2022 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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