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Nintedanib

Generic Name: nintedanib (nin-TED-a-nib)
Brand Name: Ofev

Nintedanib is used for:

Treating idiopathic pulmonary fibrosis (IPF).

Nintedanib is a kinase inhibitor. It works by blocking certain substances that may cause IPF.

Do NOT use nintedanib if:

  • you are allergic to any ingredient in nintedanib
  • you have moderate to severe liver problems
  • you take carbamazepine, phenytoin, rifampin, or St. John's wort

Contact your doctor or health care provider right away if any of these apply to you.

Before using nintedanib:

Some medical conditions may interact with nintedanib. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver problems, stomach or bowel problems, or heart or blood vessel problems
  • if you have a bleeding problem or a family member with a bleeding problem
  • if you have had recent stomach or bowel surgery
  • if you have a history of blood clots
  • if you smoke

Some MEDICINES MAY INTERACT with nintedanib. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticoagulants or blood thinners (eg, aspirin, warfarin) because the risk of bleeding may be increased
  • Erythromycin or ketoconazole because they may increase the risk of nintedanib's side effects
  • Carbamazepine, phenytoin, rifampin, or St. John's wort because they may decrease nintedanib's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if nintedanib may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use nintedanib:

Use nintedanib as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with nintedanib. Talk to your pharmacist if you have questions about this information.
  • Take nintedanib by mouth with food and liquid.
  • Swallow nintedanib whole. Do not break, crush, or chew before swallowing.
  • Take nintedanib on a regular schedule to get the most benefit from it.
  • If you miss a dose of nintedanib, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use nintedanib.

Important safety information:

  • Tell your doctor or dentist that you take nintedanib before you receive any medical or dental care, emergency care, or surgery.
  • Do NOT take more than the recommended dose, change your dose, or stop taking nintedanib without checking with your doctor.
  • Nintedanib may increase the risk of bleeding. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • If you smoke: Stop smoking before starting nintedanib. Avoid smoking while taking it. Smoking may decrease nintedanib's effectiveness. Discuss any questions or concerns with your doctor.
  • Diarrhea, nausea, and vomiting happen often with nintedanib. If you have any of these side effects, talk with your doctor. There may be ways to lower these side effects.
  • Nintedanib may increase the risk of holes or tears in the stomach or bowels. Call your doctor right away if you have stomach swelling or severe stomach pain.
  • Serious blood clots (eg, heart attack) have happened with nintedanib. Call your doctor right away if you have symptoms of heart attack (eg, chest pain or pressure; arm, back, neck, or jaw pain; shortness of breath). Call your doctor right away if you have symptoms of stroke (eg, confusion, numbness or weakness on 1 side of your body, severe dizziness or headache, speech or vision changes).
  • If you may become pregnant, you must use an effective form of birth control while you take nintedanib and for 3 months after you stop taking it. If you have questions about effective birth control, talk with your doctor.
  • Lab tests may be performed while you take nintedanib. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • PREGNANCY and BREAST-FEEDING: Nintedanib may cause harm to the fetus. Do not become pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. You will need to discuss the benefits and risks of taking nintedanib while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking nintedanib.

Possible side effects of nintedanib:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Decreased appetite; diarrhea; headache; nausea; stomach pain; vomiting; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe or persistent diarrhea, nausea, or vomiting; symptoms of bleeding (eg, vomiting blood or vomit that looks like coffee grounds; coughing up blood; blood in the urine; black, bloody, or tarry stools; bleeding from the gums; unusual vaginal bleeding; bruises without a reason or that get bigger; any bleeding that is severe or that you cannot stop); symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, severe stomach pain, yellowing of the eyes or skin).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of nintedanib:

Store nintedanib at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep nintedanib out of the reach of children and away from pets.

General information:

  • If you have any questions about nintedanib, please talk with your doctor, pharmacist, or other health care provider.
  • Nintedanib is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take nintedanib or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about nintedanib. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to nintedanib. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using nintedanib.

Review Date: August 8, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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