Ofev (Nintedanib) - Oral

What Is Ofev?

Ofev (nintedanib) is a prescription medication used to treat types of lung diseases such as interstitial lung disease (ILD) or idiopathic pulmonary fibrosis (IPF), in which the small air sacs in the lungs (alveoli) become stiff and scarred. This prevents them from being able to move oxygen into the bloodstream.

Ofev is a type of medication called a tyrosine kinase inhibitor that works to interrupt the process that forms the scars around the alveoli.

This medication is available in 150-milligram (mg) and 100-milligram capsules.

Drug Facts

Generic Name: Nintedanib

Brand Name(s): Ofev

Drug Availability: Prescription

Administration Route: Oral 

Therapeutic Classification: Tyrosine kinase inhibitor

Available Generically: No

Controlled Substance: N/A

Active Ingredient: Nintedanib

Dosage Form(s): Capsule

What Is Ofev Used For?

The Food and Drug Administration (FDA) approved Ofev to treat multiple types of lung disease, including:

  • Idiopathic pulmonary fibrosis (IPF)
  • Forms of interstitial lung diseases (ILD) that get worse over time
  • Systemic-sclerosis-associated ILD (SSc-ILD)

These lung diseases can progress over time, making breathing more difficult as the lungs continue to have more scarring. However, taking Ofev can delay how long it takes for your condition to worsen.

How to Take Ofev

Take Ofev as prescribed by your healthcare provider. It is usually taken twice daily, with doses about 12 hours apart. Take this medication with food and swallow the capsules whole; do not open, crush, or chew them.

Storage

Ofev should be kept in its original packaging at room temperature (68 F to 77 F) and not be exposed to moisture or heat. Do not store this medication in the bathroom.

How Long Does Ofev Take to Work?

People who take Ofev may not notice any significant improvement in their symptoms. However, this does not mean the medication isn’t working. Ofev is given to delay the worsening of lung function.

What Are the Side Effects of Ofev?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.

Common Side Effects

You may experience some side effects when taking Ofev. Common side effects associated with this medication include:

  • Gastrointestinal problems such as nausea, vomiting, diarrhea, and abdominal pain
  • Decreased appetite or weight loss
  • High blood pressure (hypertension)
  • Elevated liver enzymes
  • Headache

Severe Side Effects

Ofev has the possibility of causing more severe side effects. Call your healthcare provider if you have any severe side effects. Call 911 or go to the nearest emergency room if you believe your symptoms are life-threatening.

Serious side effects and symptoms can include:

  • Liver problems: Yellowing of the skin (jaundice), abdominal pain or bloating, and tea-colored urine (dark or brown)
  • Heart attack: Chest pain, shortness of breath, and neck or jaw pain
  • Stroke: Weakness or numbness on one side of the body, dizziness, and headache
  • Tear in stomach or intestine wall (gastrointestinal or bowel perforation): Pain or swelling in the abdomen
  • Protein in the urine (proteinuria): Swelling to extremities and foamy urine
  • Severe bleeding

Report Side Effects

Ofev may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your healthcare provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much Ofev Should I Take?

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The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules):
    • For idiopathic pulmonary fibrosis, chronic fibrosing interstitial lung disease, or systemic sclerosis-associated interstitial lung disease:
      • Adults—150 milligrams (mg) two times a day, taken 12 hours apart.
      • Children—Use and dose must be determined by your doctor.

Modifications

A change to the dose of Ofev may be needed if any severe side effects are experienced. If this is the case, Ofev may be held and then resumed later at a lower dose. Your healthcare provider may also adjust your dose if your blood tests reveal elevated liver enzymes.

Missed Dose

If you miss a dose of Ofev, skip the missed dose and take your next one at the regularly scheduled time. Never double up on Ofev to make up for a missed dose.

Overdose: What Happens If I Take Too Much Ofev?

If you take too much Ofev, you may be more likely to experience any side effects listed above. Consult your healthcare provider immediately if you've taken more than prescribed. You may need to stop treatment and receive supportive treatment if necessary.

What Happens If I Overdose on Ofev?

If you think you or someone else may have overdosed on Ofev, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Ofev, call 911 immediately.

Precautions

Drug Content Provided and Reviewed by IBM Micromedex®

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Women will receive a pregnancy test before starting this medicine. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 3 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. If mild diarrhea continues or gets worse, check with your doctor.

This medicine may increase your risk of bleeding, or your risk of having a heart attack or stroke. Check with your doctor right away if you have chest pain or discomfort, dizziness, headache, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, sweating, trouble breathing, or unusual bleeding or bruising.

This medicine may cause a tear (perforation) in your stomach or bowels. Check with your doctor right away if you have severe stomach pain that does not go away or blood in the stool.

This medicine could cause infertility in women. Talk with your doctor before using this medicine if you plan to have children.

Stop smoking before treatment with Ofev® and avoid smoking while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

What Are Reasons I Shouldn’t Take Ofev?

Do not take Ofev if you are pregnant or plan to become pregnant, as it can cause severe harm to the fetus. Also, avoid taking Ofev if you are breastfeeding.

What Other Medications Interact With Ofev?

Some medications should not be used along with Ofev or should be used with caution.

When taken with Ofev, certain drugs called P-glycoprotein (P-gp) and cytochrome P450 3A4 (CYP3A4) enzyme inhibitors may increase exposure to nintedanib in the body, causing more side effects. These medications include:

Medications known as P-gp and CYP3A4 inducers may decrease exposure to nintedanib, reducing its clinical effects. These include:

Additionally, taking Ofev with anticoagulants (blood thinners) may increase the risk of bleeding. These medications include:

Before starting Ofev, ask your healthcare provider or pharmacist for a complete list of drug interactions. Always tell them about your medications, including over-the-counter (OTC) products, vitamins, and herbal supplements.

What Medications Are Similar?

Esbriet (pirfenidone) is one other medication that can be used to treat IPF. It doesn’t work in the same manner as Ofev but does work in another pathway to decrease inflammation and the scar-forming process in the lungs.

Frequently Asked Questions

  • What is Ofev used for?

    Ofev is used to treat lung diseases such as ILD and IPF. It can help to slow the scarring of the alveoli air sacs in the lung.

  • How does Ofev work?

    Ofev is a small molecule inhibitor of certain receptor tyrosine kinases. It works by interfering with the process that leads to scarring in the lungs (fibrosis).

  • What are the side effects of Ofev?

    Side effects of Ofev can include nausea and vomiting, headache, diarrhea, abdominal pain, and high blood pressure.

  • How do I stop taking Ofev?

    Ofev should not be stopped unless first discussed with the prescribing healthcare team. You may not notice any significant improvement in your symptoms, but that doesn't mean the medication isn't working. Talk to your healthcare team before stopping any medication regimen.

How Can I Stay Healthy While Taking Ofev?

If you have been diagnosed with a lung disease like IPF, medications such as Ofev can help slow the progression of the disease. While IPF is not curable, it is treatable; therefore, it is important to continue taking your medications as prescribed.

Additionally, supportive treatments can help improve your quality of life. Work with your healthcare team to devise a plan to manage symptoms and learn more about your condition. Education about the disease can help you and your family or caregiver play an active role in your care.

It is also recommended to receive flu and pneumococcal vaccinations and quit smoking if you have IPF. In addition, support and patient advocacy groups can help improve well-being and offer avenues for more education.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended to replace medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

6 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
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  2. Boehringer Ingelheim. Ofev label.

  3. American Lung Association. Pulmonary fibrosis progression and exacerbation.

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By Julie Scott, MSN, ANP-BC, AOCNP
Julie is an Adult Nurse Practitioner with oncology certification and a healthcare freelance writer with an interest in educating patients and the healthcare community.