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Ofev is used to treat certain serious lung conditions, including idiopathic pulmonary fibrosis (IPF) and other interstitial lung diseases. Common side effects include diarrhea, nausea and vomiting, and stomach pain. Serious side effects can include liver problems. So, you should keep all appointments for blood tests while taking Ofev. If you can become pregnant, you should use effective birth control while taking Ofev, as it can cause harm to a fetus. Ofev is a capsule that you take by mouth.

Uses

What is Ofev used for?

Ofev (nintedanib) is commonly used to treat certain long-term (chronic) interstitial lung diseases (ILDs). Specifically, it is also used for idiopathic pulmonary fibrosis (IPF) and systemic sclerosis-associated interstitial lung disease (SSc-ILD). These conditions can cause a buildup of scar tissue in the lungs, making it hard to breathe.

Ofev may also be used for other conditions as determined by your health care provider.

How does Ofev work (mechanism of action)?

Ofev is a kinase inhibitor. It works by blocking the action of specific proteins, called tyrosine kinases. These proteins play a role in causing scarring (fibrosis) in the lungs. This helps slow down the progression of certain serious lung diseases.

How is Ofev supplied (dosage forms)?

Brands and other names

  • Ofev

Dosage forms and strengths

  • 100 mg oral capsules
  • 150 mg oral capsules

How should I store Ofev?

Ofev should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. Protect from high humidity and heat.

Side Effects

What are the most common side effects of Ofev?

The most common side effects of Ofev are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Stomach problems, such as diarrhea, nausea and vomiting, and stomach pain (see below)
  • Changes in liver function tests or other liver problems (see below)
  • Reduced appetite
  • Headache
  • Weight loss
  • High blood pressure

There may be other side effects of Ofev that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Ofev?

While less common, the most serious side effects of Ofev are described below, along with what to do if they happen.

Severe Allergic Reactions. Ofev may cause allergic reactions, which can be serious. Stop taking Ofev and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Liver Problems. Liver damage, also called hepatotoxicity, can happen when taking Ofev. Keep all appointments for blood tests before starting and during treatment with Ofev. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Easy bruising or bleeding
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Stomach Problems. Ofev commonly causes stomach and digestive problems, including diarrhea, nausea, and vomiting. These side effects can sometimes be severe. If you are given medicine to prevent or treat stomach problems, take it exactly as your health care provider tells you. Follow your health care provider’s advice about how to stay hydrated. Let your health care provider know about any other medicines you take that may cause diarrhea, such as laxatives. Tell your health care provider right away about any stomach problems you have while taking Ofev, or if you have any symptoms that do not get better or get worse. Your health care provider may need to adjust your dose if you have bothersome stomach problems while taking Ofev.

Heart Attack and Stroke. Ofev may increase your risk of having a blood clot in your arteries, which could lead to a heart attack or stroke. The risk may be higher in people who already have heart disease. Get emergency help if you have any of the following symptoms of a heart attack or stroke.

  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Trouble breathing
  • Pain in your back, jaw, throat, or arm
  • Sweating, upset stomach, vomiting, or dizziness
  • Numbness or weakness on one side of your body
  • Sudden and severe headache
  • Slurred speech or trouble understanding speech

Bleeding. Ofev can increase your risk of bleeding, which can sometimes be severe. Some people with severe bleeding may need a blood transfusion or surgery. Call your health care provider right away if you have any of the following signs of bleeding while taking Ofev.

  • Unusual bleeding or bruising, including nosebleeds
  • Pink, red, or brown urine (pee)
  • Vomit with blood that looks like coffee grounds
  • Red or black stools (which look like tar)
  • Coughing up blood or blood clots

Tear in the Gut. Ofev may increase the risk of a tear (perforation) in your gut. The risk may be higher if you have recently had surgery in your stomach area, have diverticular disease, or are taking certain other medicines, such as a corticosteroid or a nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen, naproxen, and others. Stop taking Ofev and get emergency help if you have any of the following symptoms.

  • Stomach pain or swelling
  • Vomiting blood
  • Black or tarry poop
  • Feeling faint

Kidney Problems. Ofev may increase the risk of having a high amount of protein in your pee (proteinuria). Call your health care provider right away if you have any of the following symptoms of protein in your urine.

  • Foamy pee
  • Sudden weight gain
  • Swelling in your hands, arms, legs, or feet

Warnings & Precautions

Who should not use Ofev?

Allergies to Ingredients. People who are allergic to any of the following should not take Ofev.

  • Nintedanib
  • Ofev
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Ofev.

What should I know about Ofev before using it?

Do not take Ofev unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Ofev with other people, even if they have the same condition as you. It may harm them.

Keep Ofev out of the reach of children.

Ofev should be taken with food. Swallow the capsules whole with liquid. Do not chew, crush, or open the capsules. If you or someone helping you touches the medicine inside the capsule, wash your hands right away.

Keep all appointments, including for blood tests, before you start taking Ofev and during treatment. This helps your health care provider make sure it is safe for you to start and continue taking Ofev, or see if you need a different dose.

If you can become pregnant, you should use effective birth control while taking Ofev and for at least three months after your last dose. If you have diarrhea or vomiting and are taking a birth control pill, it may make it not work as well. Ask your health care provider which birth control option is best for you. See the Pregnancy section for more information.

What should I tell my health care provider before using Ofev?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Ofev is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have or have had any of the following.

Smoking. Tell your health care provider if you smoke. You should avoid smoking while taking Ofev. Ofev may not work as well if you smoke.

Other Medicines and Supplements. Ofev may interact with other medicines and supplements. Before taking Ofev, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Ofev may cause harm to a fetus. You should not take Ofev while you are pregnant or plan to become pregnant. If you can become pregnant, you should have a pregnancy test before starting Ofev to make sure you are not pregnant. Tell your health care provider if you are pregnant or plan to become pregnant. If you become pregnant or think you might be pregnant, stop taking Ofev and contact your health care provider right away.

Breastfeeding. It is not known if Ofev passes into breast milk. You should not breastfeed while taking Ofev. Tell your health care provider if you are breastfeeding or plan to breastfeed. 

How can I get more information about Ofev?

For more information about Ofev, you can visit the drugmaker’s website at www.ofev.com or call them at 866-673-6366.

Interactions

Does Ofev interact with foods or drinks?

There are no known interactions between Ofev and foods or drinks. Ofev should be taken with food.

It is unknown if drinking alcohol will affect Ofev, but both Ofev and alcohol can increase your risk of bleeding. It is best to limit the amount of alcohol you drink.

Does Ofev interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Ofev.

  • Ketoconazole, which is a medicine used for fungal infections
  • Erythromycin (Ery-Tab and others), which is a medicine used for bacterial infections
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • Any medicine for seizures, such as carbamazepine or phenytoin
  • St. John’s wort, which is a supplement that may be used for depression
  • A blood thinner, which is a medicine used to treat or prevent blood clots
  • Aspirin, which is in many prescription and OTC products, including those for pain, swelling, and fever

Many other medicines may alter the blood levels of Ofev. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Ofev. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Ofev?

If you or someone else has used too much Ofev, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Ofev?

If you miss a dose, skip the missed dose and only take the next dose at the regular time. Do not take double or extra doses.