Nintedanib
Idiopathic Pulmonary Fibrosis
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DRUG STATUS
Government Approvals
US(FDA), UK(BNF)
WHO Essential Medicine
NO
Known Teratogen
Definite
Pharmaceutical Class
Kinase Inhibitor
Controlled Drug Substance
NO
Nintedanib
Learn more about this medicine -
Click HereSummary
Nintedanib is used for treating lung diseases like idiopathic pulmonary fibrosis, chronic fibrosing interstitial lung diseases, and systemic sclerosis-associated interstitial lung disease. These conditions cause scarring in the lungs and Nintedanib helps slow down this process.
Nintedanib is a kinase inhibitor. It targets multiple receptor tyrosine kinases that are involved in the development of fibrosis or scarring. By blocking these enzymes, it reduces the scarring and thickening of lung tissue, slowing the progression of diseases and improving lung function.
For adults, the recommended dose of Nintedanib is 150 mg taken orally twice daily, approximately 12 hours apart. It should be taken with food to improve absorption and reduce gastrointestinal side effects.
Common side effects of Nintedanib include diarrhea, nausea, vomiting, and abdominal pain. It can also cause weight loss, decreased appetite, headaches, dizziness, and fatigue. Serious adverse effects can include liver enzyme elevations, bleeding, and gastrointestinal perforations.
Nintedanib is contraindicated during pregnancy due to the risk of fetal harm. It should not be used in patients with moderate to severe hepatic impairment. Patients with a history of bleeding problems, recent abdominal surgery, or those on anticoagulants should use it with caution. Regular liver function tests are recommended due to the risk of liver enzyme elevations.
Indications and Purpose
What is Nintedanib used for?
Nintedanib is indicated for the treatment of idiopathic pulmonary fibrosis, chronic fibrosing interstitial lung diseases with a progressive phenotype, and systemic sclerosis-associated interstitial lung disease. These conditions involve scarring of the lungs, and Nintedanib helps to slow the decline in lung function associated with these diseases.
How does Nintedanib work?
Nintedanib is a kinase inhibitor that targets multiple receptor tyrosine kinases involved in the development of fibrosis. By blocking these enzymes, Nintedanib helps to reduce the scarring and thickening of lung tissue, slowing the progression of diseases like idiopathic pulmonary fibrosis and improving lung function.
Is Nintedanib effective?
Nintedanib has been shown to effectively reduce the rate of decline in lung function in patients with idiopathic pulmonary fibrosis, chronic fibrosing interstitial lung diseases, and systemic sclerosis-associated interstitial lung disease. Clinical trials have demonstrated its ability to slow disease progression, as evidenced by a reduced annual rate of decline in forced vital capacity (FVC) compared to placebo.
How does one know if Nintedanib is working?
The benefit of Nintedanib is evaluated through regular monitoring of lung function, typically by measuring forced vital capacity (FVC). Patients should have regular follow-up appointments with their healthcare provider to assess the effectiveness of the treatment and to monitor for any side effects or changes in their condition.
Directions for Use
What is the usual dose of Nintedanib?
For adults, the recommended dose of Nintedanib is 150 mg taken orally twice daily, approximately 12 hours apart. For children, the safety and effectiveness of Nintedanib have not been established, and it is not recommended for pediatric use.
How do I take Nintedanib?
Nintedanib should be taken with food to improve absorption and reduce gastrointestinal side effects. Swallow the capsules whole with liquid, and do not chew or crush them. There are no specific food restrictions, but patients should maintain a balanced diet and stay hydrated, especially if experiencing side effects like diarrhea.
For how long do I take Nintedanib?
Nintedanib is typically used as a long-term treatment for conditions like idiopathic pulmonary fibrosis and chronic fibrosing interstitial lung diseases. The duration of use depends on the patient's response and tolerance to the medication, as well as the progression of the disease. Always follow your doctor's guidance regarding the duration of treatment.
How long does it take for Nintedanib to start working?
Nintedanib begins to work within a few weeks, but noticeable improvements in lung function or slowing of disease progression may take longer to observe. Regular follow-up with a healthcare provider is essential to monitor the effectiveness of the treatment and make any necessary adjustments.
How should I store Nintedanib?
Nintedanib should be stored at room temperature, between 68°F to 77°F (20°C to 25°C). It should be kept dry and protected from high heat. Ensure the medication is stored in its original container, tightly closed, and out of reach of children to prevent accidental ingestion.
Warnings and Precautions
Who should avoid taking Nintedanib?
Nintedanib is contraindicated in pregnant women due to the risk of fetal harm. It should not be used in patients with moderate to severe hepatic impairment. Patients with a history of bleeding problems, recent abdominal surgery, or those on anticoagulants should use it with caution. Regular liver function tests are recommended due to the risk of liver enzyme elevations.
Can I take Nintedanib with other prescription drugs?
Nintedanib is a substrate of P-glycoprotein (P-gp) and CYP3A4. Co-administration with P-gp and CYP3A4 inhibitors (e.g., ketoconazole) can increase Nintedanib exposure, while inducers (e.g., rifampicin) can decrease its exposure. Patients should be monitored for tolerability, and dose adjustments may be necessary. Avoid using St. John's wort, a known P-gp inducer, with Nintedanib.
Can I take Nintedanib with vitamins or supplements?
Nintedanib may interact with St. John's wort, an herbal supplement that can decrease its effectiveness by inducing P-glycoprotein. Patients should inform their healthcare provider about all supplements they are taking to avoid potential interactions and ensure the effectiveness of Nintedanib.
Can Nintedanib be taken safely while pregnant?
Nintedanib is contraindicated during pregnancy due to the risk of fetal harm, including birth defects and fetal death. Women of childbearing potential should use effective contraception during treatment and for at least 3 months after the last dose. A pregnancy test is recommended before starting treatment to ensure the patient is not pregnant.
Can Nintedanib be taken safely while breastfeeding?
Breastfeeding is not recommended while taking Nintedanib due to the potential for serious adverse reactions in nursing infants. There is no information on the presence of Nintedanib in human milk, but it is present in the milk of lactating rats. Women should discuss alternative feeding options with their healthcare provider.
Is Nintedanib safe for the elderly?
For elderly patients, no specific dose adjustment is required. However, patients aged 75 and older may be more likely to require dose reduction to manage adverse effects. It's important for elderly patients to be closely monitored for side effects, especially liver enzyme elevations and gastrointestinal issues.
Is it safe to exercise while taking Nintedanib?
Nintedanib does not specifically limit the ability to exercise. However, due to its side effects like fatigue and gastrointestinal issues, some individuals may find it challenging to maintain their usual exercise routine. If you experience any side effects that affect your ability to exercise, consult your doctor for advice.
Is it safe to drink alcohol while taking Nintedanib?
From all available and reliable information, there is no confirmed data on this. Please consult a doctor for personalized advice.
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