nintedanib 100 mg Capsule, 60-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Kinase Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Nintedanib is used to treat idiopathic pulmonary fibrosis (IPF; scarring of the lungs with an unknown cause). It is also used to treat certain types of chronic fibrosing interstitial lung diseases (ILD; an ongoing disease in which there is increased scarring of the lungs). Nintedanib is also used to slow the rate of decline in lung function in people with systemic sclerosis-associated interstitial lung disease (SSc-ILD; also known as scleroderma-associated ILD: a disease in which there is scarring of the lungs that is often fatal). Nintedanib is in a class of medications called kinase inhibito...
Read the full MedlinePlus article ↗- Nintedanib works by blocking certain proteins — called kinases — that tell your lung tissue to keep scarring. It can't undo damage that's already there, but it slows the process do...
- What exactly is nintedanib doing for my lungs?
- Yes, diarrhea is the most common side effect, and it does affect most people — often starting within the first few months. The good news is it's usually manageable. Drink plenty of...
- I've heard diarrhea is really common with this medication. What should I do if it happens?
Patient education
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UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
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Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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UNII 1T8387508X
Gelatin Type B is a protein derived from cattle bones and skin, processed to specific strength standards. In medicines, it forms capsule shells that hold and protect the drug contents until they dissolve in the digestive system.
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Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
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UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
7 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Nintedanib Capsules, 100 mg and 150 mg 76282-0786-60 | EXELAN | 60 capsules | — | AB | FDA listed | — |
| Ofev 100 mg 00597-0143-60 | Boehringer | 60 capsules | — | AB | FDA listed | — |
| Nintedanib 100 mg 42799-0972-01 | Edenbridge | 60 capsules | — | AB | FDA listed | — |
| Nintedanib 100 mg 43598-0148-60 | Dr. | 60 capsules | — | AB | FDA listed | — |
| Nintedanib 100 mg 51407-0984-60 | Golden | 60 capsules | — | AB | FDA listed | — |
| nintedanib 100 mg 00781-2492-60 | Sandoz | 60 capsules | — | AB | FDA listed | — |
| Nintedanib 100 mg 60505-4818-06 | Apotex | 60 capsules | — | AB | FDA listed | — |
| Nintedanib 100 mg 69097-0641-03 | Cipla | 60 capsules | — | AB | FDA listed | — |
| nintedanib 100 mg 42806-0569-60 | EPIC | 60 capsules | — | AB | FDA listed | — |
| nintedanib 100 mgthis 68462-0802-60 | Glenmark | 60 capsules | — | AB | FDA listed | — |
| nintedanib 100 mg 73190-0096-60 | AvKARE | 60 capsules | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 68462-0802-60 You're viewing this | 1 BOTTLE in 1 CARTON (68462-802-60) / 60 CAPSULE in 1 BOTTLE | 2026-07-09 | Active |
🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Nintedanib capsules are a kinase inhibitor indicated in adults for: • Treatment of idiopathic pulmonary fibrosis (IPF) ( 1.1 ) • Treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype ( 1.2 )
1.1Idiopathic Pulmonary Fibrosis Nintedanib capsules are indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF).
1.2Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype Nintedanib capsules are indicated for the treatment of adults with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype [see Clinical Studies ( 14.2 )] .
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • Recommended dosage: 150 mg taken orally twice daily approximately 12 hours apart taken with food. ( 2.2 ) • Recommended dosage in patients with mild hepatic impairment (Child Pugh A): 100 mg taken orally twice daily approximately 12 hours apart taken with food. ( 2.3 , 8.6 ) • Consider temporary dose reduction to 100 mg, treatment interruption, or discontinuation for management of adverse reactions.
( 2.4 , 5.2 , 5.3 , 6 ) • Prior to treatment initiation, conduct liver function tests in all patients and a pregnancy test in females of reproductive potential. ( 2.1 , 5.2 , 5.4 )
2.1Testing Prior to Nintedanib Capsules Administration Conduct liver function tests in all patients and a pregnancy test in females of reproductive potential prior to initiating treatment with nintedanib capsules [see Warnings and Precautions ( 5.2 , 5.4 )].
2.2Recommended Dosage The recommended dosage of nintedanib capsules is 150 mg taken orally twice daily administered approximately 12 hours apart. Administration Information Nintedanib capsules should be taken with food [see Clinical Pharmacology ( 12.3 )] and swallowed whole with liquid. Nintedanib capsules should not be chewed because of a bitter taste.
Nintedanib capsules should not be opened or crushed. If contact with the content of the capsule occurs, wash hands immediately and thoroughly. The effect of chewing or crushing of the capsule on the pharmacokinetics of nintedanib is not known.
Information for Missed Dose If a dose of nintedanib capsules is missed, the next dose should be taken at the next scheduled time. Advise the patient to not make up for a missed dose. Do not exceed the recommended maximum daily dosage of 300 mg.
2.3Recommended Dosage for Patients with Hepatic Impairment Mild Hepatic Impairment In patients with mild hepatic impairment (Child Pugh A), the recommended dosage of nintedanib capsules is 100 mg orally twice daily approximately 12 hours apart taken with food [see Use in Specific Populations (8.6)]. Moderate or Severe Hepatic Impairment Treatment with nintedanib capsules is not recommended [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.6 )].
2.4Dosage Modification due to Adverse Reactions In addition to symptomatic treatment, if applicable, the management of adverse reactions of nintedanib capsules may require dose reduction or temporary interruption until the specific adverse reaction resolves to levels that allow continuation of therapy. Nintedanib capsules treatment may be resumed at the full dosage (150 mg twice daily), or at the reduced dosage (100 mg twice daily), which subsequently may be increased to the full dosage. If a patient does not tolerate 100 mg twice daily, discontinue treatment with nintedanib capsules [see Warnings and Precautions ( 5.2 , 5.3 , 5.5 , 5.7 ) and Adverse Reactions ( 6.1 )] .
Elevated Liver Enzymes Dose modifications or interruptions may be necessary for liver enzyme elevations. Conduct liver function tests (aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin) prior to initiation of treatment with nintedanib capsules, at regular intervals during the first three months of treatment, and periodically thereafter or as clinically indicated. Measure liver tests promptly in patients who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.
Discontinue nintedanib capsules in patients with AST or ALT greater than 3 times the upper limit of normal (ULN) with signs or symptoms of liver injury and for AST or ALT elevations greater than 5 times the upper limit of normal. For AST or ALT greater than 3 times to less than 5 times the ULN without signs of liver damage, interrupt treatment or reduce nintedanib capsules to 100 mg twice daily. Once liver enzymes have returned to baseline values, treatment with nintedanib capsules may be reintroduced at a reduced dosage (100 mg twice daily),…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Capsules: 150 mg, Brown, opaque, oblong, soft capsules laser printed with “G 629”. 100 mg, Peach, opaque, oblong, soft capsules laser printed with “G 628”. Capsules: 150 mg and 100 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None None ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Hepatic impairment: Nintedanib is not recommended for use in patients with moderate or severe hepatic impairment. In patients with mild hepatic impairment (Child Pugh A), the recommended dosage is 100 mg twice daily approximately 12 hours apart taken with food. Consider treatment interruption, or discontinuation for management of adverse reactions in these patients.
( 2.3 , 2.4 , 5.1 , 8.6 , 12.3 ) • Elevated liver enzymes and drug-induced liver injury: ALT, AST, and bilirubin elevations have occurred with nintedanib, including cases of drug-induced liver injury. In the postmarketing period, non-serious and serious cases of drug-induced liver injury, including severe liver injury with fatal outcome, have been reported. The majority of hepatic events occur within the first three months of treatment.
Liver enzyme and bilirubin increases were reversible with dose modification or interruption in the majority of cases. Monitor ALT, AST, and bilirubin prior to initiation of treatment, at regular intervals during the first three months of treatment, and periodically thereafter or as clinically indicated. Temporary dosage reductions or discontinuations may be required.
( 2.1 , 2.4 , 5.2 ) • Gastrointestinal disorders: Diarrhea, nausea, and vomiting have occurred with nintedanib. Treat patients at first signs with adequate hydration and antidiarrheal medicine (e.g., loperamide) or anti-emetics. Discontinue nintedanib if severe diarrhea, nausea, or vomiting persists despite symptomatic treatment.
( 5.3 ) • Embryo-Fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use highly effective contraception. Advise women taking oral hormonal contraceptives experiencing vomiting, diarrhea, or other conditions where the drug absorption may be reduced to use alternative highly effective contraception.
( 5.4 , 8.1 , 8.3 ) • Arterial thromboembolic events have been reported. Use caution when treating patients at higher cardiovascular risk including known coronary artery disease. ( 5.5 ) • Bleeding events have been reported.
Use nintedanib in patients with known bleeding risk only if anticipated benefit outweighs the potential risk. ( 5.6 ) • Gastrointestinal perforation has been reported. Use nintedanib with caution when treating patients with recent abdominal surgery, previous history of diverticular disease or receiving concomitant corticosteroids or NSAIDs.
Discontinue nintedanib in patients who develop gastrointestinal perforation. Only use nintedanib in patients with known risk of gastrointestinal perforation if the anticipated benefit outweighs the potential risk. ( 5.7 ) • Nephrotic range proteinuria has been reported.
Consider treatment interruption in patients who develop new or worsening proteinuria. ( 5.8 )
5.1Hepatic Impairment Treatment with nintedanib is not recommended in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )] . Patients with mild hepatic impairment (Child Pugh A) can be treated with a reduced dose of nintedanib [see Dosage and Administration ( 2.3 )] .
5.2Elevated Liver Enzymes and Drug-Induced Liver Injury Cases of drug-induced liver injury (DILI) have been observed with nintedanib treatment. In the clinical trials and postmarketing period, non-serious and serious cases of DILI were reported. Cases of severe liver injury with fatal outcome have been reported in the postmarketing period.
The majority of hepatic events occur within the first three months of treatment. In clinical trials, administration of nintedanib was associated with elevations of liver enzymes (ALT, AST, ALKP, GGT) and bilirubin. Liver enzyme and bilirubin increases were reversible with dose modification or interruption in the majority of cases.
In IPF studies (Study 1, Study 2, and Study 3), the majority (94%) of patients with ALT and/or AST elevation…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: • Elevated Liver Enzymes and Drug-Induced Liver Injury [see Warnings and Precautions ( 5.2 )] • Gastrointestinal Disorders [see Warnings and Precautions ( 5.3 )] • Embryo-Fetal Toxicity [see Warnings and Precautions ( 5.4 )] • Arterial Thromboembolic Events [see Warnings and Precautions ( 5.5 )] • Risk of Bleeding [see Warnings and Precautions ( 5.6 )] • Gastrointestinal Perforation [see Warnings and Precautions ( 5.7 )] • Nephrotic Range Proteinuria [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (≥5%) are: diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, weight decreased, and hypertension.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals, Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of nintedanib was evaluated in over 1000 IPF patients, 332 patients with chronic fibrosing ILDs with a progressive phenotype. Over 200 IPF patients were exposed to nintedanib for more than 2 years in clinical trials.
Idiopathic Pulmonary Fibrosis Nintedanib was studied in three randomized, double-blind, placebo-controlled, 52-week trials. In the phase 2 (Study 1) and phase 3 (Study 2 and Study 3) trials, 723 patients with IPF received nintedanib 150 mg twice daily and 508 patients received placebo. The median duration of exposure was 10 months for patients treated with nintedanib and 11 months for patients treated with placebo.
Subjects ranged in age from 42 to 89 years (median age of 67 years). Most patients were male (79%) and Caucasian (60%). The most frequent serious adverse reactions reported in patients treated with nintedanib, more than placebo, were bronchitis (1.2% vs.
0.8%) and myocardial infarction (1.5% vs. 0.4%). The most common adverse events leading to death in patients treated with nintedanib, more than placebo, were pneumonia (0.7% vs.
0.6%), lung neoplasm malignant (0.3% vs. 0%), and myocardial infarction (0.3% vs. 0.2%).
In the predefined category of major adverse cardiovascular events (MACE) including MI, fatal events were reported in 0.6% of nintedanib-treated patients and 1.8% of placebo-treated patients. Adverse reactions leading to permanent dose reductions were reported in 16% of nintedanib-treated patients and 1% of placebo-treated patients. The most frequent adverse reaction that led to permanent dose reduction in the patients treated with nintedanib was diarrhea (11%).
Adverse reactions leading to discontinuation were reported in 21% of nintedanib-treated patients and 15% of placebo-treated patients. The most frequent adverse reactions that led to discontinuation in nintedanib-treated patients were diarrhea (5%), nausea (2%), and decreased appetite (2%). The most common adverse reactions with an incidence of greater than or equal to 5% and more frequent in the nintedanib than placebo treatment group are listed in Table 1.
Table 1 Adverse Reactions Occurring in ≥5% of Nintedanib-treated Patients with Idiopathic Pulmonary Fibrosis and More Commonly Than Placebo in Study 1, Study 2, and Study 3 Adverse Reaction Nintedanib, 150 mg n=723 Placebo n=508 Gastrointestinal disorders Diarrhea 62% 18% Nausea 24% 7% Abdominal pain a 15% 6% Vomiting 12% 3% Hepatobiliary disorders Liver enzyme elevation b 14% 3% Metabolism and nutrition disorders Decreased appetite 11% 5% Nervous system disorders Headache 8% 5% Investigations Weight decreased 10% 3% Vascular disorders Hypertension c 5% 4% a Includes abdominal pain, abdominal pain upper, abdominal pain lower, g…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • Coadministration of P-gp and CYP3A4 inhibitors may increase nintedanib exposure. Monitor patients closely for tolerability of nintedanib. ( 7.1 )
7.1P-glycoprotein (P-gp) and CYP3A4 Inhibitors and Inducers Nintedanib is a substrate of P-gp and, to a minor extent, CYP3A4 [see Clinical Pharmacology ( 12.3 )] . Coadministration with oral doses of a P-gp and CYP3A4 inhibitor, ketoconazole, increased exposure to nintedanib by 60%. Concomitant use of P-gp and CYP3A4 inhibitors (e.g., erythromycin) with nintedanib may increase exposure to nintedanib [see Clinical Pharmacology ( 12.3 )] .
In such cases, patients should be monitored closely for tolerability of nintedanib. Management of adverse reactions may require interruption, dose reduction, or discontinuation of therapy with nintedanib [see Dosage and Administration ( 2.4 )] . Coadministration with oral doses of a P-gp and CYP3A4 inducer, rifampicin, decreased exposure to nintedanib by 50%.
Concomitant use of P-gp and CYP3A4 inducers (e.g., carbamazepine, phenytoin, and St. John’s wort) with nintedanib should be avoided as these drugs may decrease exposure to nintedanib [see Clinical Pharmacology ( 12.3 )].
7.2Anticoagulants Nintedanib is a VEGFR inhibitor and may increase the risk of bleeding. Monitor patients on full anticoagulation therapy closely for bleeding and adjust anticoagulation treatment as necessary [see Warnings and Precautions ( 5.6 )].
7.3Pirfenidone In a multiple-dose study conducted to assess the pharmacokinetic effects of concomitant treatment with nintedanib and pirfenidone, the coadministration of nintedanib with pirfenidone did not alter the exposure of either agent [see Clinical Pharmacology ( 12.3 )] . Therefore, no dose adjustment is necessary during concomitant administration of nintedanib with pirfenidone.
7.4Bosentan Coadministration of nintedanib with bosentan did not alter the pharmacokinetics of nintedanib [see Clinical Pharmacology ( 12.3 )] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS • Lactation: Breastfeeding is not recommended. ( 8.2 ) • Renal impairment: The safety and efficacy of nintedanib have not been studied in patients with severe renal impairment and end-stage renal disease. ( 8.7 , 12.3 ) • Smokers: Decreased exposure has been noted in smokers which may alter the efficacy profile of nintedanib. ( 8.8 )
8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology ( 12.1 )] , nintedanib can cause fetal harm when administered to a pregnant woman. There are no data on the use of nintedanib during pregnancy. In animal studies of pregnant rats and rabbits treated during organogenesis, nintedanib caused embryo-fetal deaths and structural abnormalities at less than (rats) and approximately 5 times (rabbits) the maximum recommended human dose [see Data].
Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects is 2% to 4% and miscarriage in clinically recognized pregnancies is 15% to 20%.
Data Animal Data In animal reproduction toxicity studies, nintedanib caused embryo-fetal deaths and structural abnormalities in rats and rabbits at less than and approximately 5 times the maximum recommended human dose (MRHD) in adults (on a plasma AUC basis at maternal oral doses of 2.5 and 15 mg/kg/day in rats and rabbits, respectively). Malformations included abnormalities in the vasculature, urogenital, and skeletal systems. Vasculature anomalies included missing or additional major blood vessels.
Skeletal anomalies included abnormalities in the thoracic, lumbar, and caudal vertebrae (e.g., hemivertebra, missing, or asymmetrically ossified), ribs (bifid or fused), and sternebrae (fused, split, or unilaterally ossified). In some fetuses, organs in the urogenital system were missing. In rabbits, a significant change in sex ratio was observed in fetuses (female:male ratio of approximately 71%:29%) at approximately 15 times the MRHD in adults (on an AUC basis at a maternal oral dose of 60 mg/kg/day).
Nintedanib decreased post-natal viability of rat pups during the first 4 post-natal days when dams were exposed to less than the MRHD (on an AUC basis at a maternal oral dose of 10 mg/kg/day).
8.2Lactation Risk Summary 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 [see Data] . Because of the potential for serious adverse reactions in nursing infants from nintedanib, advise women that breastfeeding is not recommended during treatment with nintedanib.
Data Milk and plasma of lactating rats have similar concentrations of nintedanib and its metabolites.
8.3Females and Males of Reproductive Potential Based on findings from animal studies and its mechanism of action, nintedanib can cause fetal harm when administered to a pregnant woman and may reduce fertility in females of reproductive potential [see Use in Specific Populations ( 8.1 ), Clinical Pharmacology ( 12.1 , 12.3 ), and Nonclinical Toxicology ( 13.1 )] . Counsel patients on pregnancy prevention and planning. Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to treatment with nintedanib and during treatment as appropriate [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.4 ), and Use in Specific Populations ( 8.1 )].
Contraception Nintedanib can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to avoid becoming pregnant while receiving treatment with nintedanib. Advise females of reproductive potential to use highly effective contraception at initiation of, during treatment, and for at least 3 months after taking the la…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology ( 12.1 )] , nintedanib can cause fetal harm when administered to a pregnant woman. There are no data on the use of nintedanib during pregnancy. In animal studies of pregnant rats and rabbits treated during organogenesis, nintedanib caused embryo-fetal deaths and structural abnormalities at less than (rats) and approximately 5 times (rabbits) the maximum recommended human dose [see Data].
Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects is 2% to 4% and miscarriage in clinically recognized pregnancies is 15% to 20%.
Data Animal Data In animal reproduction toxicity studies, nintedanib caused embryo-fetal deaths and structural abnormalities in rats and rabbits at less than and approximately 5 times the maximum recommended human dose (MRHD) in adults (on a plasma AUC basis at maternal oral doses of 2.5 and 15 mg/kg/day in rats and rabbits, respectively). Malformations included abnormalities in the vasculature, urogenital, and skeletal systems. Vasculature anomalies included missing or additional major blood vessels.
Skeletal anomalies included abnormalities in the thoracic, lumbar, and caudal vertebrae (e.g., hemivertebra, missing, or asymmetrically ossified), ribs (bifid or fused), and sternebrae (fused, split, or unilaterally ossified). In some fetuses, organs in the urogenital system were missing. In rabbits, a significant change in sex ratio was observed in fetuses (female:male ratio of approximately 71%:29%) at approximately 15 times the MRHD in adults (on an AUC basis at a maternal oral dose of 60 mg/kg/day).
Nintedanib decreased post-natal viability of rat pups during the first 4 post-natal days when dams were exposed to less than the MRHD (on an AUC basis at a maternal oral dose of 10 mg/kg/day).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of nintedanib have not been established in pediatric patients for the treatment of fibrosing interstitial lung diseases. Effectiveness was not demonstrated in a randomized, double-blind, placebo-controlled study conducted in 26 nintedanib-treated pediatric patients aged 6 to 17 years with fibrosing interstitial lung diseases, who were treated with nintedanib based on weight. Animal Toxicity Data In repeat-dose toxicology studies, young animals (mice, rats, and monkeys) dosed with nintedanib showed changes in the bone and fast-growing teeth.
Bone changes include thickening of the growth plate in all species. These changes were fully or at least partially reversible in rats and monkeys; reversibility in mice has not been studied. Tooth changes include broken incisors and discoloration in rodents.
These changes were irreversible after discontinuation of nintedanib treatment .
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of subjects in phase 2 and 3 clinical studies of nintedanib in IPF (Study 1, Study 2, and Study 3), 61% were 65 and over, while 16% were 75 and over. In the chronic fibrosing ILDs with a progressive phenotype clinical study (Study 5), 61% were 65 and over, while 19% were 75 and older. In phase 3 studies, no overall differences in effectiveness were observed between subjects who were 65 and over and younger subjects; no overall differences in safety were observed between subjects who were 65 and over or 75 and over and younger subjects, but greater sensitivity of some older individuals cannot be ruled out .
🆘 Overdosage ▾
10 OVERDOSAGE In IPF trials, one patient was inadvertently exposed to a dose of 600 mg daily for a total of 21 days. A non-serious adverse event (nasopharyngitis) occurred and resolved during the period of incorrect dosing, with no onset of other reported events. Overdosage was also reported in two patients in oncology studies who were exposed to a maximum of 600 mg twice daily for up to 8 days.
Adverse events reported were consistent with the existing safety profile of nintedanib. Both patients recovered. In case of overdosage, interrupt treatment and initiate general supportive measures as appropriate.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Nintedanib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) and non-receptor tyrosine kinases (nRTKs). Nintedanib inhibits the following RTKs: platelet-derived growth factor receptor (PDGFR) α and β, fibroblast growth factor receptor (FGFR) 1 to 3, vascular endothelial growth factor receptor (VEGFR) 1 to 3, colony stimulating factor 1 receptor (CSF1R), and Fms-like tyrosine kinase-3 (FLT-3). These kinases except for FLT-3 have been implicated in pathogenesis of interstitial lung diseases (ILD).
Nintedanib binds competitively to the adenosine triphosphate (ATP) binding pocket of these kinases and blocks the intracellular signaling cascades, which have been demonstrated to be involved in the pathogenesis of fibrotic tissue remodeling in ILD. Nintedanib also inhibits the following nRTKs: Lck, Lyn and Src kinases. The contribution of FLT-3 and nRTK inhibition to nintedanib efficacy in ILD is unknown.
12.2Pharmacodynamics Cardiac Electrophysiology In a study in renal cell cancer patients, QT/QTc measurements were recorded and showed that a single oral dose of 200 mg nintedanib as well as multiple oral doses of 200 mg nintedanib administered twice daily for 15 days did not prolong the QTcF interval.
12.3Pharmacokinetics The PK properties of nintedanib were similar in healthy volunteers, patients with IPF, patients with chronic fibrosing ILDs with a progressive phenotype, and cancer patients. The PK of nintedanib is linear. Dose proportionality was shown by an increase of nintedanib exposure with increasing doses (dose range 50 to 450 mg once daily and 150 to 300 mg twice daily).
Accumulation upon multiple administrations in patients with IPF was 1.76-fold for AUC. Steady-state plasma concentrations were achieved within one week of dosing. Nintedanib trough concentrations remained stable for more than one year.
The inter-individual variability in the PK of nintedanib was moderate to high (coefficient of variation of standard PK parameters in the range of 30% to 70%), intra-individual variability low to moderate (coefficients of variation below 40%). Absorption Nintedanib reached maximum plasma concentrations approximately 2 to 4 hours after oral administration as a soft gelatin capsule under fed conditions. The absolute bioavailability of a 100 mg dose was 4.7% (90% CI: 3.62 to 6.08) in healthy volunteers.
Absorption and bioavailability are decreased by transporter effects and substantial first-pass metabolism. After food intake, nintedanib exposure increased by approximately 20% compared to administration under fasted conditions (90% CI: 95.3% to 152.5%) and absorption was delayed (median t max fasted: 2 hours; fed: 3.98 hours), irrespective of the food type. Distribution Nintedanib follows bi-phasic disposition kinetics.
After intravenous infusion, a high volume of distribution which was larger than total body volume (V ss : 1050 L) was observed. The in vitro protein binding of nintedanib in human plasma was high, with a bound fraction of 97.8%. Serum albumin is considered to be the major binding protein.
Nintedanib is preferentially distributed in plasma with a blood to plasma ratio of 0.87. Elimination The effective half-life of nintedanib in patients with IPF was 9.5 hours (gCV 31.9%). Total plasma clearance after intravenous infusion was high (CL: 1390 mL/min; gCV 28.8%).
Urinary excretion of unchanged drug within 48 hours was about 0.05% of the dose after oral and about 1.4% of the dose after intravenous administration; the renal clearance was 20 mL/min. Metabolism The prevalent metabolic reaction for nintedanib is hydrolytic cleavage by esterases resulting in the free acid moiety BIBF 1202. 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 of nintedanib consisted of CYP pathways, with CYP3A4 being the predominant enzyme invol…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Nintedanib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) and non-receptor tyrosine kinases (nRTKs). Nintedanib inhibits the following RTKs: platelet-derived growth factor receptor (PDGFR) α and β, fibroblast growth factor receptor (FGFR) 1 to 3, vascular endothelial growth factor receptor (VEGFR) 1 to 3, colony stimulating factor 1 receptor (CSF1R), and Fms-like tyrosine kinase-3 (FLT-3). These kinases except for FLT-3 have been implicated in pathogenesis of interstitial lung diseases (ILD).
Nintedanib binds competitively to the adenosine triphosphate (ATP) binding pocket of these kinases and blocks the intracellular signaling cascades, which have been demonstrated to be involved in the pathogenesis of fibrotic tissue remodeling in ILD. Nintedanib also inhibits the following nRTKs: Lck, Lyn and Src kinases. The contribution of FLT-3 and nRTK inhibition to nintedanib efficacy in ILD is unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING 150 mg: Brown, opaque, oblong, soft capsules laser printed with “G 629”. They are packaged in HDPE bottles with a child-resistant closure, available as follows: Bottles of 60 NDC: 68462-803-60 100 mg: Peach, opaque, oblong, soft capsules laser printed with “G 628”. They are packaged in HDPE bottles with a child-resistant closure, available as follows: Bottles of 60 NDC: 68462-802-60 Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Protect from exposure to high humidity and avoid excessive heat. If repackaged, use USP tight container.
📋 Description ▾
11 DESCRIPTION Nintedanib capsules contain nintedanib, a kinase inhibitor [see Mechanism of Action ( 12.1 )]. Nintedanib is presented as the ethanesulfonate salt (esylate), with the chemical name (Z)-methyl 3-(((4-(N-methyl-2-(4-methylpiperazin-1-yl)acetamido)phenyl)amino) (phenyl)methylene)-2-oxoindoline-6-carboxylate ethanesulfonate. Its structural formula is: Nintedanib esylate is a bright yellow powder with a molecular formula of C 31 H 33 N 5 O 4 ·C 2 H 6 O 3 S and a molecular weight of 649.76 g/mol.
Nintedanib capsules for oral administration are available in 2 dose strengths containing 100 mg or 150 mg of nintedanib (equivalent to 120.4 mg or 180.6 mg nintedanib esylate, respectively). The inactive ingredients of nintedanib are the following: Fill Material: polyethylene glycol 400. Capsule Shell: ferric oxide red, ferric oxide yellow, gelatin type B bovine, glycerin, sorbitol sorbitan solution and titanium dioxide. structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Elevated Liver Enzymes and Drug-Induced Liver Injury Advise patients that they will need to undergo liver function testing periodically. Advise patients to immediately report any symptoms of a liver problem (e.g., skin or the whites of eyes turn yellow, urine turns dark or brown (tea colored), pain on the right side of stomach, bleed or bruise more easily than normal, lethargy, loss of appetite) [see Warnings and Precautions ( 5.2 )].
Gastrointestinal Disorders Inform patients that gastrointestinal disorders such as diarrhea, nausea, and vomiting were the most commonly reported gastrointestinal events occurring in patients who received nintedanib. Advise patients that their healthcare provider may recommend hydration, antidiarrheal medications (e.g., loperamide), or anti-emetic medications to treat these side effects. Temporary dosage reductions or discontinuations may be required.
Instruct patients to contact their healthcare provider at the first signs of diarrhea or for any severe or persistent diarrhea, nausea, or vomiting [see Warnings and Precautions ( 5.3 ) and Adverse Reactions ( 6.1 )]. Embryo-Fetal Toxicity Counsel patients on pregnancy prevention and planning. Advise females of reproductive potential of the potential risk to a fetus and to avoid becoming pregnant while receiving treatment with nintedanib.
Advise females of reproductive potential to use highly effective contraception at initiation of, during treatment, and for at least 3 months after taking the last dose of nintedanib. Advise women taking oral hormonal contraceptives who experience vomiting and/or diarrhea or other conditions where the drug absorption may be reduced to contact their doctor to discuss alternative highly effective contraception. Advise female patients to notify their doctor if they become pregnant or suspect they are pregnant during therapy with nintedanib capsules [see Warnings and Precautions ( 5.4 ) and Use in Specific Populations ( 8.1 , 8.3 )].
Arterial Thromboembolic Events Advise patients about the signs and symptoms of acute myocardial ischemia and other arterial thromboembolic events and the urgency to seek immediate medical care for these conditions [see Warnings and Precautions ( 5.5 )]. Risk of Bleeding Bleeding events have been reported. Advise patients to report unusual bleeding [see Warnings and Precautions ( 5.6 )].
Gastrointestinal Perforation Serious gastrointestinal perforation events have been reported. Advise patients to report signs and symptoms of gastrointestinal perforation [see Warnings and Precautions ( 5.7 )] . Nephrotic Range Proteinuria Nephrotic range proteinuria has been reported.
Advise patients to report signs and symptoms of proteinuria (e.g., fluid retention, foamy urine) [see Warnings and Precautions ( 5.8 )] . Lactation Advise patients that breastfeeding is not recommended while taking nintedanib capsules [see Use in Specific Populations ( 8.2 )]. Smokers Encourage patients to stop smoking prior to treatment with nintedanib capsules and to avoid smoking when using nintedanib capsules [see Clinical Pharmacology ( 12.3 )] .
Administration Instruct patients to take nintedanib capsules with food, to swallow nintedanib capsules whole with liquid, and not to chew or crush the capsules due to the bitter taste . Advise patients or caregivers not to open or crush nintedanib capsules and to wash hands immediately and thoroughly if contact with the content of the capsule occurs. Advise patients to not make up for a missed dose [see Dosage and Administration ( 2.2 )] .
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