What is nintedanib?
Nintedanib is a drug that has been approved by the FDA for some types of Interstitial lung disease (ILD) which have symptoms of shortness of breath, a dry cough, feeling tired and chest discomfort. It is used for types of ILD that cause scarring in the lungs such as idiopathic pulmonary fibrosis (IPF), certain chronic fibrosing interstitial lung diseases (ILDs) and nintedanib helps lung function in people with systemic sclerosis-associated interstitial lung disease.
Nintedanib is a tyrosine kinase inhibitor (TKI), which blocks enzymes in cells in the lungs called tyrosine kinases. Blocking these enzymes helps decrease fibrous tissue forming in the lungs and so stops the symptoms of lung disease getting worse. This medicine is a capsule that is usually taken twice a day with food.
What is nintedanib used for?
Nintedanib is a prescription medicine used:
- to treat adults with a lung disease called idiopathic pulmonary fibrosis (IPF).
- to treat adults with a long-lasting (chronic) interstitial lung disease in which lung fibrosis continues to worsen (progress).
- to slow the rate of decline in lung function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD) (also known as scleroderma-associated ILD).
It is not known if this medicine is safe and effective in children.
- Nintedanib can cause birth defects or death to an unborn baby. Women should not become pregnant while taking nintedanib. Women who are able to become pregnant should have a pregnancy test before starting treatment with nintedanib.
- See below for more information about nintedanib and pregnancy.
What should I tell my doctor before taking nintedanib?
Before you take this medicine, tell your doctor about all of your medical conditions, including if you:
- have liver problems.
- have heart problems.
- have a history of blood clots.
- have a bleeding problem or a family history of a bleeding problem.
- have had recent surgery in your stomach (abdominal) area.
- are a smoker.
- are pregnant or plan to become pregnant. Nintedanib can harm your unborn baby. Nintedanib can cause birth defects or death to an unborn baby. See "Pregnancy and breastfeeding” section on the page below
- are breastfeeding or plan to breastfeed. It is not known if nintedanib passes into your breast milk. You should not breastfeed while taking nintedanib.
- Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements such as St. John's wort. Keep a list of the medicines you take and show it to your doctor and pharmacist when you get a new medicine.
How should I take nintedanib?
- Take nintedanib exactly as your doctor tells you to take it.
- Your doctor will tell you how much of this medicine to take and when to take it.
- Take nintedanib with food. Swallow the capsules whole with a liquid.
- Do not chew, crush, or open capsules. If you or your caregiver accidently comes in contact with the content of the capsule, wash hands well right away.
- If you miss a dose of this medicine, take your next dose at your regular time. Do not take the missed dose.
- Do not take more than 300 mg of nintedanib in 1 day.
- If you take too much of this medicine, call your doctor or go to the nearest hospital emergency room right away.
- Your doctor should do certain blood tests before you start taking this medicine.
The usual recommended dosage of nintedanib is a 150 mg capsule swallowed whole with liquid, taken twice daily approximately 12 hours apart.
Your dose may be decreased or treatment paused if you have side effects or changes in your liver tests.
What are the side effects of nintedanib?
Nintedanib may cause serious side effects, including:
- See “Important information” section above.
- liver problems. Call your doctor right away if you have unexplained symptoms such as yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal, feeling tired, or loss of appetite. Your doctor will do blood tests to check how well your liver is working before starting and during your treatment with nintedanib.
- diarrhea, nausea, and vomiting. While you are taking this medicine, your doctor may recommend that you drink fluids or take medicine to treat these side effects. Tell your doctor if you have diarrhea, nausea, or vomiting or if these symptoms do not go away or become worse. Tell your doctor if you are taking over-the-counter laxatives, stool softeners, and other medicines or dietary supplements that can cause diarrhea.
- heart attack. Tell your doctor right away if you have symptoms of a heart problem. These symptoms may include chest pain or pressure, pain in your arms, back, neck or jaw, or shortness of breath.
- stroke. Tell your doctor right away if you have symptoms of a stroke. These symptoms may include numbness or weakness on one side of your body, trouble talking, headache, or dizziness.
- bleeding problems. Nintedanib may increase your chances of having bleeding problems. Tell your doctor if you have unusual bleeding, bruising, or wounds that do not heal. Tell your doctor if you are taking a blood thinner, including prescription blood thinners and over-the-counter aspirin.
- tear in your stomach or intestinal wall (perforation). This medicine may increase your chances of having a tear in your stomach or intestinal wall. Tell your doctor if you have pain or swelling in your stomach area.
- increased protein in your urine (proteinuria). This medicine may increase your chances of having protein in your urine. Tell your doctor if you have any signs and symptoms of protein in the urine such as foamy urine, swelling, including in your hands, arms, legs, or feet, or sudden weight gain.
The most common side effects of nintedanib are:
- stomach pain,
- liver problems,
- decreased appetite,
- weight loss, and
- high blood pressure.
These are not all the possible side effects of nintedanib. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Other drugs may affect nintedanib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Pregnancy and breastfeeding
If you are pregnant or planning a pregnancy:
- Nintedanib can cause birth defects or death to an unborn baby.
- Women should not become pregnant while taking nintedanib. Women who are able to become pregnant should have a pregnancy test before starting treatment with nintedanib.
- Women who are able to become pregnant should use highly effective birth control at the start of treatment, during treatment, and for at least 3 months after treatment. Talk with your doctor about what birth control method is right for you during this time.
- Birth control pills may not work as well in women having vomiting, diarrhea, or other problems reducing the drug absorption. If you have any of these problems, talk with your doctor about which highly effective birth control method is right for you.
- If you become pregnant or think you are pregnant while taking nintedanib, tell your doctor right away.
If you are breastfeeding or are planning to breastfeed:
- It is not known if nintedanib passes into your breast milk.
- You should not breastfeed while taking nintedanib.
How should I store nintedanib?
- Store nintedanib at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep this medicine dry and protect from high heat.
- Keep all medicines out of the reach of children
What are the ingredients in nintedanib?
Active ingredient: nintedanib
Ofev Inactive ingredients:
Fill Material: triglycerides, hard fat, lecithin.
Capsule Shell: gelatin, glycerol, titanium dioxide, red ferric oxide, yellow ferric oxide, black ink
Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA
Licensed from: Boehringer Ingelheim International GmbH
Nintedanib inhibits a variety of receptor and nonreceptor tyrosine kinases – these are signaling proteins that work as an ON/OFF switch in many cell-to-cell communications. Tyrosine kinases play an important role in cell growth, differentiation, and metabolism and there is substantial evidence that certain tyrosine kinases, notably platelet-derived growth factor receptor (PDGFR), vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), as well as non-receptor tyrosine kinases, are associated with scar tissue and the progression of pulmonary fibrosis and other interstitial lung diseases. Nintedanib inhibits the following RTKs:
- PDGFR α and β
- FGFR 1-3
- VEGFR 1-3
- colony-stimulating factor 1 receptor (CSF1R)
- Fms-like tyrosine kinase-3 (FLT-3)
- Non-receptor tyrosine kinases: Lck, Lyn, and Src kinases.
Research has shown that nintedanib starts to improve FVC within 6 weeks of starting the medication. FVC (forced vital capacity) is a lung function test that measures the total amount of air exhaled during the forced expiratory volume (FEV) test. This tells your doctor the effect your lung disease has on your ability to inhale and exhale, and this measurement, alongside others such as worsening symptoms or worsening imaging, determine how effective nintedanib is for you at slowing disease progression. Generally, nintedanib is well tolerated and effectively slows disease progression for up to 3 years.
Nintedanib can be taken long-term, and research has shown it is safe for up to 51 months, possibly longer. As long as you are tolerating nintedanib, and it is still slowing your condition's progression, you can keep taking it.
There has been one phase 4 trial that has investigated the combination of Ofev (nintedanib) and Esbriet (pirfenidone) for idiopathic pulmonary fibrosis (IPF) that showed a slightly increased risk of side effects with combination treatment, but the trial was not large enough to make a solid conclusion about increased/decreased effectiveness. Both Ofev and Esbriet slow IPF’s worsening but do not stop its progression, and neither medication is recommended over the other. Because they work on different aspects of the fibrotic cascade, there has been some suggestion that there may be some benefit in combining them. Continue reading
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