What are nintedanib capsules?

Nintedanib capsules are 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 in which lung fibrosis continues to worsen (progress).

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

What is the most important information I should know about nintedanib capsules?

• Nintedanib capsules can cause birth defects or death to an unborn baby. Women should not become pregnant while taking nintedanib capsules. Women who are able to become pregnant should have a pregnancy test before starting treatment with nintedanib capsules.
• 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 capsules, tell your doctor right away.

What should I tell my doctor before taking nintedanib capsules?

Before you take nintedanib capsules, 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 capsules can harm your unborn baby. Nintedanib capsules 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 should not breastfeed while taking nintedanib capsules.

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.

What are the possible side effects of nintedanib capsules?

Nintedanib capsules may cause 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, 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 capsules.
• Diarrhea, nausea, and vomiting. While you are taking nintedanib capsules, 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 capsules 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 capsules 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). Nintedanib capsules 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 capsules 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 capsules. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information and Medication Guide.