Nintedanib

Nintedanib is a prescription medication used to treat Idiopathic Pulmonary Fibrosis, Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype, and Systemic Sclerosis-associated Interstitial Lung Disease

• Nintedanib is available under the following different brand names: Ofev.

Dosages of Nintedanib:

Adult dosage

Capsule

• 100mg
• 150mg

Idiopathic Pulmonary Fibrosis

• 150 mg orally every 12 hours

Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype

• 150 mg orally every 12 hours

Systemic Sclerosis-associated Interstitial Lung Disease

• 150 mg orally every 12 hours

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”.

Common side effects of Nintedanib include:

• nausea, 
• vomiting, 
• loss of appetite, 
• stomach pain, 
• diarrhea, 
• weight loss, 
• increased blood pressure, 
• headache, and
• abnormal liver function tests

Serious side effects of Nintedanib include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• severe ongoing nausea, 
• vomiting, 
• diarrhea, 
• severe stomach pain, 
• abdominal bloating, 
• stomach tenderness, 
• bleeding from the rectum, 
• blood in stools, 
• easy bruising, 
• unusual bleeding, 
• any wound that will not heal, 
• fever, 
• chills, 
• cough with mucus, 
• chest pain, 
• shortness of breath, 
• chest pain or pressure, 
• pain spreading to the jaw or shoulder, 
• nausea, 
• sweating, 
• stomach pain (upper right side), 
• loss of appetite, 
• tiredness, 
• dark urine,
• yellowing of the skin or eyes (jaundice), 
• sudden numbness or weakness (especially on one side of the body), 
• slurred speech, and 
• problems with vision or balance

Rare side effects of Nintedanib include:

• none 

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.  Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Nintedanib has severe interactions with no other drugs.
• Nintedanib has serious interactions with at least 14 other drugs. 
• Nintedanib has moderate interactions with at least 68 other drugs.
• Nintedanib has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drugs interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use.  Keep a list of all your medications with you, and share this information with your doctor and pharmacist.  Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Nintedanib?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Nintedanib?”

Cautions

• Severe liver injury with fatal outcome reported; the 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 every 3months 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 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 treating 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 the postmarketing period non-serious and serious bleeding events were reported; use therapy in patients with known risk of bleeding only if the anticipated benefit outweighs the potential risk
• In the 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 the 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 and Lactation

• 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 before treatment and during treatment as appropriate
• 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