Mantedanib 150mg Cap

MANTEDANIB 150MG CAP by MANKIND PHARMA LTD.

Name

• Brand Name: Mantedanib 150mg Capsule
• Common Name (Active Ingredient): Nintedanib (150mg)

Composition Each capsule contains Nintedanib 150mg. Nintedanib is a tyrosine kinase inhibitor.

Uses Mantedanib 150mg Capsule is used to treat specific medical conditions by targeting pathways involved in disease progression. It is primarily prescribed for:

• Idiopathic Pulmonary Fibrosis (IPF): A chronic lung disease causing progressive scarring of the lungs.
• Non-small cell lung cancer (NSCLC): Often of the adenocarcinoma type, sometimes in combination with docetaxel, to halt or slow the spread of cancer cells.
• Chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.
• Systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Dosage and Administration Mantedanib 150mg Capsule should be taken orally with food, ideally at the same time each day to maximize effectiveness. The capsule should be swallowed whole and not cut, broken, or chewed. The precise dosage and frequency are determined by your doctor based on your condition and response to treatment. It is crucial not to discontinue the medication without consulting your doctor, as benefits may take several weeks or months to become noticeable.

Side Effects

• Common Side Effects: Diarrhea (very common), nausea, abdominal pain, vomiting, abnormal liver function test results, loss of appetite, headache, weight loss, and high blood pressure. Most side effects are usually mild and transient.
• Serious Side Effects (rare): Liver injury, heart attack, bleeding problems, kidney issues (protein in urine), gastrointestinal perforation, and arterial thromboembolic events (blood clots).

Precautions Before starting treatment, inform your doctor if you have any bleeding disorders, liver or kidney problems, or are taking other medications, especially blood thinners or those for infections, as interactions can occur. Mantedanib 150mg Capsule is not recommended during pregnancy or breastfeeding, and effective contraception is advised for both males and females during treatment. Patients with moderate to severe liver disease should not use this medication, and dose adjustments may be needed for mild liver impairment or kidney issues. Regular blood tests to monitor liver function may be required. Caution is advised if you have cardiovascular disease, a history of recent abdominal surgery, or if you experience tiredness or dizziness, which may affect driving or operating machinery. Alcohol consumption is generally not recommended. This medicine is not recommended for children under 18 years.

Storage Store Mantedanib 150mg Capsule in a cool, dry place, away from direct sunlight and moisture, preferably below 25°C or 30°C. Keep it out of the reach and sight of children and pets.

What is Mantedanib 150mg Capsule used for?

Mantedanib 150mg Capsule, which contains Nintedanib, is primarily used to treat Idiopathic Pulmonary Fibrosis (IPF), a chronic lung disease that causes progressive scarring of the lungs. It is also used to manage certain types of Non-Small Cell Lung Cancer (NSCLC), sometimes in combination with other anti-cancer medications like docetaxel. Additionally, it helps in managing progressive fibrosing interstitial lung diseases and systemic sclerosis-associated interstitial lung disease.

How does Mantedanib 150mg Capsule work?

Mantedanib 150mg Capsule works as a tyrosine kinase inhibitor. Its active ingredient, Nintedanib, blocks specific enzymes called tyrosine kinases that are involved in the development and progression of fibrosis (scarring) and inflammation in the lungs. It also inhibits Vascular Endothelial Growth Factor Receptors (VEGFRs) and Fibroblast Growth Factor Receptors (FGFRs), which play roles in scar tissue formation and tumor growth, thereby helping to slow down lung scarring and the growth and spread of cancer cells.

What is the usual dosage for Mantedanib 150mg Capsule?

The typical dosage is one 150mg capsule taken twice daily, approximately 12 hours apart, with food. It is crucial to take the medicine at about the same time each day for maximum effectiveness. Your doctor will determine the precise dosage and duration of treatment based on your condition, and it is vital to follow their instructions strictly. If side effects are not tolerated, your doctor may reduce the daily dose, potentially prescribing a 100mg capsule twice daily.

What are the possible side effects of Mantedanib 150mg Capsule?

Common side effects can include diarrhea, nausea, vomiting, abdominal pain, decreased appetite, headache, weight loss, high blood pressure, abnormal liver function test results, tiredness, indigestion, and photosensitivity. These are often mild and temporary. If any side effects persist or are concerning, you should consult your doctor. Rarely, more serious side effects such as liver injury, heart attack, bleeding problems, kidney issues (protein in urine), or gastrointestinal perforation may occur.

Is Mantedanib 150mg Capsule safe during pregnancy or breastfeeding?

Mantedanib 150mg Capsule is not recommended during pregnancy as it can harm the unborn baby and potentially cause birth defects. It is classified as Pregnancy Category D. Women of childbearing potential, as well as male patients, should use highly effective contraception during treatment and for at least 3 months after stopping the medication. It is also not recommended during breastfeeding, as it is unknown if the medicine passes into breast milk and could cause harm to an infant. Always consult your doctor if you are pregnant, planning a pregnancy, or breastfeeding.

Can Mantedanib 150mg Capsule be taken with other medications?

Mantedanib 150mg Capsule can interact with various other medications. It is important to inform your doctor about all prescription and non-prescription drugs, supplements, and herbal products you are taking. Taking Mantedanib with blood thinners (e.g., warfarin, heparin, clopidogrel) can increase the risk of bleeding. Certain medications like ketoconazole (antifungal) and erythromycin (antibiotic) can increase the levels of Nintedanib in your blood, potentially leading to more side effects. Conversely, drugs like rifampicin (antibiotic), carbamazepine and phenytoin (anti-seizure medications), and the herbal product St. John's wort can decrease Nintedanib levels, reducing its effectiveness.

What precautions should be taken while using Mantedanib 150mg Capsule?

Before starting treatment, inform your doctor if you have any bleeding disorders, liver or kidney problems, or have recently undergone abdominal surgery. Regular blood tests to monitor liver function are necessary during treatment. Mantedanib should be used with caution in patients with liver disease, and it is not recommended for those with moderate to severe liver impairment; dosage adjustments may be needed for mild cases. It may increase the risk of blood clots. It is also advisable to avoid alcohol, as its interaction with Mantedanib is not fully known. This medicine is not recommended for children under 18 years. Smoking can decrease the blood levels of this medication, so inform your doctor if you smoke or have recently quit.

What happens if a dose of Mantedanib 150mg Capsule is missed?

If you miss a dose of Mantedanib 150mg Capsule, you should simply skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the one you missed, as this can increase the risk of side effects.

How should Mantedanib 150mg Capsule be stored?

Mantedanib 150mg Capsules should be stored in a cool and dry place, away from direct sunlight and moisture. The storage temperature typically ranges below 25°C or below 30°C. Keep the capsules in their original packaging and out of the reach and sight of children and pets.