Nintedanib

Nintedanib is a prescription medication used to treat a lung disease called idiopathic pulmonary fibrosis (IPF).

Nintedanib belongs to a group of drugs called tyrosine kinase inhibitors. These work by by blocking multiple pathways that may be involved in the scarring of lung tissue.

This medication comes in capsule form and is usually taken twice daily, with food. Swallow capsules whole.

Common side effects of nintedanib include those affecting the stomach such as stomach pain.

Nintedanib is a prescription medication used to treat of idiopathic pulmonary fibrosis (IPF).

• It is not known if nintedanib is safe and effective in children.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Nintedanib may be found in some form under the following brand names:

• Ofev

Serious side effects have been reported with nintedanib. See the “Nintedanib Precautions” section.

Common side effects of nintedanib include the following:

• diarrhea
• nausea
• stomach pain
• vomiting
• liver enzyme elevation
• decreased appetite
• headache
• decreased weight
• high blood pressure

This is not a complete list of nintedanib side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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 use birth control during treatment and for at least 3 months after treatment. If you become pregnant while taking nintedanib, tell your doctor right away.

Nintedanib may cause other serious side effects, including:

• 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, or feeling tired.
  Your doctor will do blood tests regularly to check how well your liver function is working during your treatment with nintedanib.
• diarrhea, nausea, and vomiting. While you are taking nintedanib, 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. 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). nintedanib 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

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of nintedanib, there are no specific foods that you must exclude from your diet when receiving this medication.

• 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
• have any other medical conditions
• are pregnant or plan to become pregnant. Nintedanib can harm your unborn baby. Nintedanib can cause birth defects or death to an unborn baby. 
• are breastfeeding or plan to breastfeed. It is not known if nintedanib passes into your breast milk. You and your doctor should decide if you will take nintedanib or breastfeed. You should not do both.

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.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Nintedanib falls into category D. It has been shown that use of nintedanib in pregnant women caused some babies to be born with problems. See nintedanib precautions.

It is not known if nintedanib crosses into human milk. Nintedanib and/or its metabolites are excreted into the milk of lactating rats. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using nintedanib.

• Take nintedanib exactly as your doctor tells you to take it.
• Your doctor will tell you how much nintedanib to take and when to take it.
• Take nintedanib with food. Swallow the nintedanib capsules whole with a liquid.
• Do not chew or crush nintedanib capsules.
• If you miss a dose of nintedanib, take your next dose at your regular time. Do not take the missed dose.
• Your doctor should do certain blood tests before you start taking nintedanib.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dosage of nintedanib is 150 mg twice daily administered approximately 12 hours apart.

• Do not take more than 300 mg of nintedanib in 1 day.
• If you take too much nintedanib, call your doctor or go to the nearest hospital emergency room right away.

• Store nintedanib at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep nintedanib dry and protect from high heat.
• Safely throw away any nintedanib that is out of date or no longer needed.