Nintedanib

Generic name: Nintedanib
Brand names: Ofev
Dosage form: capsule
Drug class: Multikinase inhibitors

Usage of Nintedanib

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

Nintedanib is a tyrosine kinase inhibitor (TKI), which blocks enzymes in cells in the lungs called tyrosine kinases. Blocking these enzymes helps decrease fibrous tissue forming in the lungs and so stops the symptoms of lung disease getting worse. This medicine is a capsule that is usually taken twice a day with food.

Nintedanib side effects

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 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 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 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 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, including 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.

Before taking Nintedanib

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 are able to become pregnant should have a pregnancy test before starting treatment with nintedanib.

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 nintedanib, tell your doctor right away.

Breastfeeding

If you are breastfeeding or are planning to breastfeed:

It is not known if nintedanib passes into your breast milk.

You should not breastfeed while taking nintedanib.

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How to use Nintedanib

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.

Warnings

Nintedanib can cause birth defects or death to an unborn baby. Women should not become pregnant while taking nintedanib. Women who are able to become pregnant should have a pregnancy test before starting treatment with nintedanib.

See below for more information about nintedanib and pregnancy.

What other drugs will affect Nintedanib

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, 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 your current medicines and any medicine you start or stop using.

Disclaimer

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