WARNINGS
What is the most important information I should know about OFEV?
OFEV can cause birth defects or death to an unborn baby. Women should not become pregnant while taking OFEV.
Women who are able to become pregnant should have a pregnancy test before starting treatment with OFEV.
Women who are able to become pregnant should use highly effective birth control at the start of treatment, during treatment, and for at least 3 months after treatment. Talk with your doctor about what birth control method is right for you during this time.
Birth control pills may not work as well in women having vomiting, diarrhea, or other problems reducing the drug absorption. If you have any of these problems, talk with your doctor about which highly effective birth control method is right for you.
If you become pregnant or think you are pregnant while taking OFEV, tell your doctor right away.
USES
OFEV is a prescription medicine used:
o to treat adults with a lung disease called idiopathic pulmonary fibrosis (IPF).
o to treat adults with a long-lasting (chronic) interstitial lung disease in which lung fibrosis continues to worsen
(progress).
o to slow the rate of decline in lung function in adults with systemic sclerosis-associated interstitial lung disease
(SSc-ILD) (also known as scleroderma-associated ILD).
It is not known if OFEV is safe and effective in children.
HOW TO USE
How should I take OFEV?
Take OFEV exactly as your doctor tells you to take it.
Your doctor will tell you how much OFEV to take and when to take it.
Take OFEV with food. Swallow the OFEV capsules whole with a liquid.
Do not chew, crush, or open OFEV capsules. If you or your caregiver accidently comes in contact with the content of the capsule, wash hands well right away.
If you miss a dose of OFEV, take your next dose at your regular time. Do not take the missed dose.
Do not take more than 300 mg of OFEV in 1 day.
If you take too much OFEV, call your doctor or go to the nearest hospital emergency room right away.
Your doctor should do certain blood tests before you start taking OFEV.
What are the possible side effects of OFEV?
OFEV may cause serious side effects, including:
See “What is the most important information I should know about OFEV?”
Liver problems. Call your doctor right away if you have unexplained symptoms such as yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal, feeling tired, or loss of appetite. Your doctor will do blood tests to check how well your liver is working before starting and during your treatment with OFEV.
Diarrhea, nausea, and vomiting. While you are taking OFEV, your doctor may recommend that you drink fluids or take medicine to treat these side effects. Tell your doctor if you have diarrhea, nausea, or vomiting or if these symptoms do not go away or become worse. Tell your doctor if you are taking over-the-counter laxatives, stool softeners, and other medicines or dietary supplements that can cause diarrhea.
Heart attack. Tell your doctor right away if you have symptoms of a heart problem. These symptoms may include chest pain or pressure, pain in your arms, back, neck or jaw, or shortness of breath.
Stroke. Tell your doctor right away if you have symptoms of a stroke. These symptoms may include numbness or weakness on 1 side of your body, trouble talking, headache, or dizziness.
Bleeding problems. OFEV may increase your chances of having bleeding problems. Tell your doctor if you have unusual bleeding, bruising, or wounds that do not heal. Tell your doctor if you are taking a blood thinner, including prescription blood thinners and over-the-counter aspirin.
Tear in your stomach or intestinal wall (perforation). OFEV may increase your chances of having a tear in your stomach or intestinal wall. Tell your doctor if you have pain or swelling in your stomach area.
Increased protein in your urine (proteinuria). OFEV may increase your chances of having protein in your urine. Tell your doctor if you have any signs and symptoms of protein in the urine such as foamy urine, swelling, including in your hands, arms, legs, or feet, or sudden weight gain.
The most common side effects of OFEV are diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, weight loss, and high blood pressure.
These are not all the possible side effects of OFEV. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of OFEV.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use OFEV for a condition for which it was not prescribed. Do not give OFEV to other people, even if they have the same symptoms you have. It may harm them. This Patient Information leaflet summarizes the most important information about OFEV. If you would like more information, talk to your doctor. You can ask your pharmacist or doctor for information about OFEV that is written for health professionals.
What are the ingredients in OFEV? Active ingredient: nintedanib
Inactive ingredients: Fill Material: hard fat, lecithin, triglycerides. Capsule Shell: ferric oxide red, ferric oxide yellow, gelatin, glycerol, titanium dioxide
OVERDOSE
Do not take more than 300 mg of OFEV in 1 day. If you take too much OFEV, call your doctor or go to the nearest hospital emergency room right away.
MISSED DOSE
If you miss a dose of OFEV, take your next dose at your regular time. Do not take the missed dose.
STORAGE
How should I store OFEV?
Store OFEV at room temperature between 68-degrees F to 77-degrees F (20-degrees C to 25-degrees C).
Keep OFEV dry and protect from high heat. Keep OFEV and all medicines out of the reach of children.
NOTES
Medication Guide: revision date 05/2025
Prescribing Information: revision date 05/2025
P-glycoprotein (P-gp) and CYP3A4 Inhibitors and Inducers
Nintedanib is a substrate of P-gp and, to a minor extent, CYP3A4.
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 OFEV may increase exposure to nintedanib. In such cases, patients should be monitored closely for tolerability of OFEV. Management of adverse reactions may require interruption, dose reduction, or discontinuation of therapy with OFEV.
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 OFEV should be avoided as these drugs may decrease exposure to nintedanib.
Anticoagulants
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.
Pirfenidone
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. Therefore, no dose adjustment is necessary during concomitant administration of nintedanib with pirfenidone.
Bosentan
Coadministration of nintedanib with bosentan did not alter the pharmacokinetics of nintedanib.
What should I tell my doctor before taking OFEV?
Before you take OFEV, tell your doctor about all of your medical conditions, including if you:
have liver problems.
have heart problems.
have a history of blood clots.
have a bleeding problem or a family history of a bleeding problem.
have had recent surgery in your stomach (abdominal) area.
are a smoker.
are pregnant or plan to become pregnant. OFEV can harm your unborn baby. OFEV can cause birth defects or death to an unborn baby. See “What is the most important information I should know about OFEV?”
are breastfeeding or plan to breastfeed. It is not known if OFEV passes into your breast milk. You should not breastfeed while taking OFEV.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements such as St. John’s wort. Keep a list of the medicines you take and show it to your doctor and pharmacist when you get a new medicine.
