Nintedanib (nin-TED-a-nib)

Treats idiopathic pulmonary fibrosis and systemic sclerosis-associated interstitial lung disease. Also used to treat people with a chronic (long-lasting) interstitial lung disease in which lung fibrosis continues to progress or becomes worse.

Brand Name(s):

Ofev

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine with food or milk.
• Swallow the capsule whole with liquids. Do not crush, break, or chew it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Skip the missed dose and go back to your regular dosing schedule. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how nintedanib works. Tell your doctor if you are using the following:
  • Carbamazepine, erythromycin, ketoconazole, phenytoin, rifampicin, St John's wort
  • Blood thinner (including aspirin, warfarin)
  • NSAIDs (including diclofenac, ibuprofen, naproxen)
  • Steroid medicine
• Do not smoke before and during treatment with this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment and for at least 3 months after the last dose.
• Do not breastfeed during treatment with this medicine.
• Tell your doctor if you have liver disease, bleeding problems, or heart or blood vessel disease. Tell your doctor if you have stomach or digestion problems or have had recent surgery in your abdomen or stomach.
• This medicine may cause the following problems:
  • Liver problems
  • Stomach or bowel problems (including diarrhea, nausea, vomiting)
  • Increased risk of bleeding, heart attack, or stroke
  • Increased risk of a tear (perforation) in your stomach or bowels
  • Increased protein in the urine (proteinuria)
• Some women who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody or cloudy urine, difficult or painful urination, swelling of the face, feet, or lower legs, weight gain
• Chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, unusual sweating, faintness
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Severe diarrhea, nausea, vomiting, stomach pain
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Dizziness
• Headache, back pain
• Tiredness
• Weight loss or loss of appetite

If you notice other side effects that you think are caused by this medicine, tell your doctor

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