nintedanib (Rx)

Brand and Other Names:Ofev
  • Print

Dosing & Uses

AdultPediatric

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

Next:

Interactions

Interaction Checker

and nintedanib

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            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 (68)

              • 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 .

              • 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. 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 .

              Minor (0)

                Previous
                Next:

                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

                Previous
                Next:

                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

                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
                Previous
                Next:

                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

                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.

                Previous
                Next:

                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

                Previous
                Next:

                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

                Previous
                Next:

                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Ofev oral
                -
                150 mg capsule
                Ofev oral
                -
                100 mg capsule

                Copyright © 2010 First DataBank, Inc.

                Previous
                Next:

                Patient Handout

                Patient Education
                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.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 persist or worsen, tell your doctor or pharmacist promptly. Diarrhea, nausea, and vomiting can be persistent and/or 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, 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 August 2021. Copyright(c) 2021 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.

                Previous
                Next:

                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
                Additional Offers
                Email to Patient

                From:

                To:

                The recipient will receive more details and instructions to access this offer.

                By clicking send, you acknowledge that you have permission to email the recipient with this information.

                Email Forms to Patient

                From:

                To:

                The recipient will receive more details and instructions to access this offer.

                By clicking send, you acknowledge that you have permission to email the recipient with this information.

                Previous
                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.