Ofev
Ofev (nintedanib) is a brand-name medication used to treat adults with certain types of interstitial lung disease (ILD), like idiopathic pulmonary fibrosis. It belongs to a group of medications called tyrosine kinase inhibitors, which work by slowing down the build up of scar tissue in the lungs. You typically take a dose by mouth twice a day with food to lower the chance of side side effects. Some common side effects include diarrhea, nausea, and stomach pain.
What is Ofev (nintedanib)?
What is Ofev (nintedanib) used for?
Ofev (nintedanib) treats certain types of interstitial lung disease (ILD):
How Ofev (nintedanib) works
Ofev (nintedanib) is a tyrosine kinase inhibitor (TKI). It works by blocking certain proteins in the body that are involved in making scar tissue in the lungs. By doing this, the medication helps slow down the worsening of lung function in people who have interstitial lung disease (ILD).
Drug facts
Side effects of Ofev (nintedanib)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
IPF
- Diarrhea (62%)
- Nausea (24%)
- Stomach pain (15%)
- Rise in liver enzymes (14%)
- Vomiting (12%)
- Reduced appetite (11%)
- Weight loss (10%)
PF-ILD
- Diarrhea (67%)
- Nausea (29%)
- Vomiting (18%)
- Reduced appetite (15%)
- Common cold symptoms (13%)
- Rise in liver enzymes (up to 13%)
- Bronchitis (12%)
- Weight loss (12%)
- Shortness of breath (11%)
- Headache (11%)
- Cough (10%)
- Stomach pain (10%)
- Tiredness (10%)
SSc-ILD
- Diarrhea (76%)
- Nausea (32%)
- Vomiting (25%)
- Skin ulcer (18%)
- Stomach pain (18%)
- Rise in liver enzymes (11%)
Less Common Side Effects
IPF
- Headache
- High blood pressure
- Low thyroid hormone
- Hair loss
PF-ILD
- Upper respiratory tract infection
- Urinary tract infection
- Back pain
SSc-ILD
- Reduced appetite
- Headache
- Fever
- Back pain
- Dizziness
- High blood pressure
Ofev (nintedanib) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Liver problems: yellowing of the skin or eyes, dark urine, pain on the upper right side of your stomach, bleeding or bruising easily, feeling tired, loss of appetite
- Heart attack: chest pain, short of breath, pain in the jaw, neck, or back
- Stroke: numbness or weakness on one side of the body, trouble talking, headache, dizziness
- Serious bleeds: bleeds that are difficult to stop, bruises that don't go away, weakness, tiredness, headaches, dizziness, bloody stool or blood in the urine
- Tear in the stomach or intestines: sudden and severe pain or tenderness in stomach area, bloating, nausea, vomiting, blood in stool, change in appetite
The following Ofev (nintedanib) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
- Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
- Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Stomach pain that is severe, does not go away, or gets worse
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
- Diarrhea
- Headache
- Loss of appetite with weight loss
- Nausea
- Stomach pain
- Vomiting
Pros and cons of Ofev (nintedanib)
Pros
- One of only a few medications approved to treat certain types of ILD
- Available as capsules taken by mouth
- Might help you live longer
Cons
- Commonly causes stomach side effects like diarrhea, nausea, and vomiting
- Need regular blood tests to check liver health
- Raises the risk of bleeding or bruising
Pharmacist tips for Ofev (nintedanib)
- Take Ofev (nintedanib) with food and swallow capsules whole. Don't chew, crush, or open the capsules. If you accidentally touch the contents inside the capsule, wash your hands well right away.
- Ofev (nintedanib) can interact with many products. Tell your prescriber and pharmacist about all prescriptions, over-the-counter medications, vitamins, and supplements you take.
- Try to quit smoking before starting Ofev (nintedanib) because smoking can lower how much of the medication your body absorbs. This can make it work less well in treating your condition.
- You'll need regular blood tests while taking Ofev (nintedanib) to check your liver health. Tell your care team right away if you notice yellowing of your skin or eyes, dark urine, easy bruising or bleeding, tiredness, or loss of appetite.
- Ofev (nintedanib) commonly causes stomach side effects like diarrhea, nausea, or vomiting. Let your prescriber know if you have any of these side effects. They might recommend drinking more fluids or taking medications to help you feel better.
- Ofev (nintedanib) can raise your risk of bleeding. Tell your care team right away if you notice any unusual bleeding or bruising.
- Ofev (nintedanib) isn't safe to use during pregnancy. If you're able to get pregnant, use birth control while taking it and for at least 3 months after your last dose.
- It’s not known if Ofev (nintedanib) passes into human breast milk. To be safe, breastfeeding isn't recommended while you're taking this medication. Talk to your prescriber if you have questions about other feeding options.
More on Ofev (nintedanib) tips
Common questions about Ofev (nintedanib)
No, Ofev (nintedanib) isn't chemotherapy. Ofev (nintedanib) is a tyrosine kinase inhibitor (TKI) that targets specific proteins) involved in forming scar tissue in your lungs. Unlike chemotherapy, which can harm both healthy and unhealthy cells, Ofev (nintedanib) is more precise, reducing damage to healthy cells.
If you stop taking Ofev (nintedanib), the scarring in your lungs might get worse faster. Ofev (nintedanib) doesn’t cure ILD, but it helps slow down the worsening of your lung function. Stopping the medication can cause your condition to progress more quickly. You might also notice more coughing, shortness of breath, or worsening breathing problems. If you're concerned with how well this medication is working, talk with your prescriber before making any changes.
Ofev (nintedanib) doesn’t start working right away — it can take 6 to 12 weeks to begin slowing down the worsening of your lung function. Even if you don’t notice a difference right away, it’s important to keep taking the medication exactly as prescribed. Staying consistent gives it time to work.
A dose of Ofev (nintedanib) can stay in your system for about 2 days. This is based on the medication's half-life, which is how long it takes for half of the medication to leave your body. Keep in mind, this can vary a bit from person to person.
Yes, it can. In general, studies show that people with IPF who take Ofev (nintedanib) can live longer by several years compared to those who don’t receive antifibrotic treatment. Ofev (nintedanib) has been linked to a lower risk of death. Taking this medication early and consistently might help protect your lungs and slow your condition from getting worse over time.
It’s best to limit or avoid alcohol while taking Ofev (nintedanib). This medication can affect your liver, and drinking alcohol can raise your risk of liver damage. If you have questions about drinking while on this medication, talk to your prescriber to see what’s safest for you.
Though hair loss isn't a common side effect of Ofev (nintedanib), a few people have reported it in clinical studies. If you notice hair loss while taking this medication, speak with your prescriber. They can help you figure out if it's related to the medication or if there might be another cause.
Yes. Fatigue, or tiredness, can be a side effect of Ofev (nintedanib). While it’s not one of the most common side effects, some people do report feeling more tired than usual while taking the medication. Talk to your prescriber if you're feeling fatigue while taking this medication.
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Risks and warnings for Ofev (nintedanib)
Ofev (nintedanib) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Liver problems
- Risk factors: History of liver problems | Low body weight (less than 143 lbs) | Asian ancestry | Female | Older age
Ofev (nintedanib) can cause liver problems, including serious liver injury. These issues usually appear within the first 3 months of starting treatment. Your risk might be higher if you're female, Asian, an older adult, or weigh less than 143 pounds (65 kg). You’ll need blood tests before and during treatment to make sure your liver is working properly. Tell your care team right away if you feel very tired, lose your appetite, have pain in the upper right part of your stomach, dark urine, or yellowing of your skin or eyes.
If you have mild liver problems, your prescriber will likely give you a lower dose of Ofev (nintedanib). But this medication isn't recommended if you have moderate or severe liver problems.
Stomach side effects
Diarrhea is the most common side effect of Ofev (nintedanib). In studies, more than half of the people who took the medication had diarrhea, usually within the first 3 months of treatment. Most cases were mild or moderate. If you get diarrhea, let your care team know. They might recommend drinking more fluids and taking antidiarrheal medication like loperamide.
Nausea and vomiting are also common side effects of Ofev (nintedanib). These symptoms were usually mild or moderate in studies. If you feel nauseous or start vomiting, let your care team know. They might suggest antinausea medication, or lower your dose or pause treatment if needed.
Harm to unborn babies
Ofev (nintedanib) can cause serious harm or even death to an unborn baby if taken during pregnancy. If you can get pregnant, you'll need a pregnancy test before starting treatment and must use birth control during treatment and for at least 3 months after your last dose.
While Ofev (nintedanib) doesn't affect how well birth control pills work, it can cause vomiting or diarrhea. These side effects might make it harder for your body to absorb birth control pills, which raises the risk of pregnancy. If you experience vomiting or diarrhea, talk to your prescriber about using alternative birth control.
Blood clots, including heart attacks
- Risk factors: Coronary artery disease (CAD)
Although rare, Ofev (nintedanib) raises your risk for blood clots, including heart attacks. Your risk is higher if you have coronary artery disease. Tell your care team right away if you have chest pain, shortness of breath, or other signs of a heart problem. If these symptoms happen, your prescriber might pause or stop your treatment.
Risk of bleeding
- Risk factors: History of bleeding problems | Taking blood thinners
Ofev (nintedanib) can raise your risk of bleeding. If you have a history of bleeding problems or are taking blood thinners, use this medication carefully. Let your care team know right away if you notice unusual bleeding or bruising during treatment.
Tear or hole in the stomach or intestines
- Risk factors: Recent stomach surgery | Diverticulitis | Taking corticosteroids or NSAIDs
Although rare, Ofev (nintedanib) can raise your risk of a serious condition called gastrointestinal perforation, which is when a hole forms in the stomach or intestines. Your risk is higher if you've had recent stomach surgery, a history of diverticulitis, or if you're also taking corticosteroids or nonsteroidal anti-inflammatory drugs (NSAIDs). If you develop severe stomach pain, fever, or notice blood in your stool, tell your care team right away.
High levels of protein in urine
Some people taking Ofev (nintedanib) have developed very high levels of protein in their urine, known as proteinuria, which can be a sign of kidney problems. If your care team notices new or worsening protein in your urine, they might pause your treatment to help protect your kidneys.
Ofev (nintedanib) dosage
Typical dosage for Ofev (nintedanib)
The typical dose is 150 mg taken by mouth twice a day, about 12 hours apart.
Your dose will differ if you have liver problems or experience side effects.
What are alternatives to Ofev (nintedanib)?
Ofev (nintedanib) treats certain types of interstitial lung disease (ILD):
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