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.

What is nintedanib used for?

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 in which lung fibrosis continues to worsen (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.

• 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.

• Take nintedanib exactly as your doctor tells you to take it.
• Your doctor will tell you how much of this medicine to take and when to take it.
• Take nintedanib with food. Swallow the capsules whole with a liquid.
• Do not chew, crush, or open 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 this medicine, take your next dose at your regular time. Do not take the missed dose.
• Do not take more than 300 mg of nintedanib in 1 day.
• If you take too much of this medicine, call your doctor or go to the nearest hospital emergency room right away.
• Your doctor should do certain blood tests before you start taking this medicine.

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.

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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

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.

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.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to nintedanib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.