Nintedanib

Nintedanib is a drug approved by the FDA for certain types of Interstitial lung disease (ILD) that cause symptoms like shortness of breath, a dry cough, feeling tired, and chest discomfort. It is used for ILD types that lead to scarring in the lungs, such as idiopathic pulmonary fibrosis (IPF) and certain chronic fibrosing interstitial lung diseases (ILDs). Nintedanib also helps improve lung function in people with systemic sclerosis-associated interstitial lung disease.

Nintedanib is a tyrosine kinase inhibitor (TKI), which blocks enzymes in lung cells called tyrosine kinases. By blocking these enzymes, it helps reduce the formation of fibrous tissue in the lungs, preventing the symptoms of lung disease from worsening. This medicine comes in a capsule form and is usually taken twice a day with food.

Nintedanib is a prescription medicine used:

• to treat adults with a lung disease called idiopathic pulmonary fibrosis (IPF).
• to treat adults with a long-lasting (chronic) interstitial lung disease where lung fibrosis keeps getting worse (progress).
• 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 this medicine is safe and effective in children.

• Take nintedanib exactly as your doctor instructs you.
• Your doctor will specify how much of this medicine to take and when to take it.
• Take nintedanib with food. Swallow the capsules whole with a drink.
• Do not chew, crush, or open the capsules. If you or your caregiver accidentally come into contact with the contents of the capsule, wash your hands thoroughly right away.
• If you miss a dose of this medicine, take your next dose at your usual time. Do not take the missed dose.
• Do not take more than 300 mg of nintedanib in one day.
• If you take too much of this medicine, call your doctor or go to the nearest hospital emergency room immediately.
• Your doctor should perform certain blood tests before you start taking this medicine.

• Nintedanib can cause birth defects or death to an unborn baby. Women should not become pregnant while taking nintedanib. Women who can become pregnant should have a pregnancy test before starting treatment with nintedanib.
• See below for more information about nintedanib and pregnancy.

Before you take this medicine, 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. Nintedanib can harm your unborn baby. Nintedanib can cause birth defects or death to an unborn baby. See "Pregnancy and breastfeeding” section on the page below.
• are breastfeeding or plan to breastfeed. It is not known if nintedanib passes into your breast milk. You should not breastfeed while taking nintedanib.

• 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.

Nintedanib may cause serious side effects, including:

• See “Important information” section above.
• 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 in 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 nintedanib.
• diarrhea, nausea, and vomiting. While you are taking this medicine, 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 get worse. Tell your doctor if you are taking over-the-counter laxatives, stool softeners, or 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 one side of your body, trouble talking, headache, or dizziness.
• bleeding problems. Nintedanib 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). This medicine 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). This medicine 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 in your hands, arms, legs, or feet, or sudden weight gain.

The most common side effects of nintedanib 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 nintedanib. 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.

The usual recommended dosage of nintedanib is a 150 mg capsule swallowed whole with liquid, taken twice daily approximately 12 hours apart. Your dose may be decreased or treatment paused if you have side effects or changes in your liver tests.

Sometimes it is not safe to use certain medications together. Some drugs can change how much of another drug is in your blood, which may increase side effects or make the medications less effective.

Other drugs may affect nintedanib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all the medicines you are currently taking and any medicine you start or stop using.

Pregnancy

If you are pregnant or planning a pregnancy:

• Nintedanib can cause birth defects or death to an unborn baby.
• Women should not become pregnant while taking nintedanib. Women who can become pregnant should have a pregnancy test before starting treatment with nintedanib.
• Women who can 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 which birth control method is best for you during this time.
• Birth control pills may not work as well in women experiencing vomiting, diarrhea, or other issues that affect drug absorption. If you have any of these issues, talk with your doctor about which highly effective birth control method is best for you.
• If you become pregnant or think you are pregnant while taking nintedanib, tell your doctor immediately.

Breastfeeding

If you are breastfeeding or planning to breastfeed:

• It is not known if nintedanib passes into your breast milk.
• You should not breastfeed while taking nintedanib.

• Store nintedanib at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep this medicine dry and protect it from high heat.
• Keep all medicines out of the reach of children.

Active ingredient: nintedanib

Ofev Inactive ingredients: Fill Material: triglycerides, hard fat, lecithin. Capsule Shell: gelatin, glycerol, titanium dioxide, red ferric oxide, yellow ferric oxide, black ink

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