nintedanib

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Pronunciation: nin TED a nib

Brand: Ofev

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

Do not use nintedanib if you are pregnant. Use effective birth control while you are using this medicine and for at least 3 months after your treatment ends.

What is nintedanib?

Nintedanib is used to treat a lung disease called idiopathic pulmonary fibrosis (IPF). IPF causes scar tissue to form deep within your lungs. The scar tissue thickens and becomes stiff over time, which can make it harder for your lungs to work. Decreased lung function can make it hard for you to breathe. Other medical problems can occur when your brain, heart, and other organs do not get enough oxygen.

The cause of IPF is often unknown, but this condition is a progressive disease that can be fatal. Nintedanib is not a cure for IPF, but this medicine may slow the progress of this disease.

Nintedanib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking nintedanib?

You should not use nintedanib if you are allergic to it, or if you are pregnant.

To make sure nintedanib is safe for you, tell your doctor if you have:

  • liver disease;
  • heart disease, coronary artery disease (hardened arteries);
  • a history of blood clots;
  • kidney disease;
  • a bleeding or blood clotting disorder such as hemophilia;
  • recent history of surgery on your stomach or intestines;
  • if you smoke; or
  • if you take laxatives, stool softeners, or any medicine or supplements that can cause diarrhea.

Using nintedanib during pregnancy could harm the unborn baby. Do not use this medicine if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 months after your last dose.

You may need to have a negative pregnancy test before starting this treatment.

If you are a woman, this medicine may affect fertility (your ability to have children). Talk to your doctor about your risk.

It is not known whether nintedanib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take nintedanib?

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using nintedanib.

Nintedanib is usually taken 2 times per day, every 12 hours. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Take with food and a full glass of water.

Do not crush or chew a nintedanib capsule. Swallow it whole.

You may be given medication to treat diarrhea or vomiting. Take only the type and amount of medicine your doctor recommends.

Drink plenty of liquids and call your doctor at once if you have diarrhea while taking nintedanib.

You may need frequent medical tests to be sure nintedanib is not causing harmful effects on your liver. Your next few doses may be delayed based on the results of these tests.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not more than 300 milligrams of nintedanib in one day.

What should I avoid while taking nintedanib?

Smoking can make nintedanib less effective. Avoid smoking while taking this medicine, or try to quit before you start this treatment.

What are the possible side effects of nintedanib?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using nintedanib and call your doctor at once if you have:

  • severe ongoing nausea, vomiting, or diarrhea;
  • chronic cough, chest tightness;
  • easy bruising or bleeding (nosebleeds, bleeding gums);
  • signs of stomach bleeding --stomach pain or swelling, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • heart attack symptoms --chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • liver problems --nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • signs of a stroke --sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

Common side effects may include:

  • nausea, vomiting, loss of appetite;
  • stomach pain;
  • diarrhea;
  • weight loss; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect nintedanib?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with nintedanib, especially:

  • St. John's wort;
  • a blood thinner --warfarin, Coumadin, Jantoven; or
  • seizure medication --carbamazepine, phenytoin, and others.

This list is not complete. Other drugs may interact with nintedanib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about nintedanib.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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