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.
Ofev (nintedanib) treats certain types of interstitial lung disease (ILD):
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).
Source: DailyMed
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
One of only a few medications approved to treat certain types of ILD
Available as capsules taken by mouth
Might help you live longer
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
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
Ofev (nintedanib) treats certain types of interstitial lung disease (ILD):
Idiopathic pulmonary fibrosis (IPF) in adults
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