Leep (225mg) 30 Tablets

Leep (225mg) 30 Tablets

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  • Manufacturer Winlet Pharmaceuticals (Pvt.) Ltd.
  • Generic Name Tepotinib

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Product Information

  • Description
  • Ingredients
  • Drug Class
  • Dosage Form
  • Uses
  • In case of Overdose
  • Missed Dose
  • How To Use
  • When Not to Use
  • Side Effects
  • Precautions & Warnings
  • Drug Interactions
  • Food Interactions
  • Storage/Disposal
  • Quick Tips, if any
  • Description

    Tepotinib is a selective tyrosine kinase inhibitor, primarily targeting the human epidermal growth factor receptor 2 (HER2). Its mechanism of action involves binding to the ATP-binding site of the HER2 receptor, thereby inhibiting its kinase activity. By blocking the activity of HER2, tepotinib prevents the activation of downstream signaling pathways that promote cell growth, proliferation, and survival. This inhibition leads to the suppression of tumor growth and progression in cancers that overexpress the HER2 protein. Specifically, tepotinib binds to the inactive or 'closed' conformation of the HER2 kinase domain, which results in a more potent and selective inhibition compared to other HER2-targeting agents. This mechanism contributes to its effectiveness in treating HER2-positive cancers, particularly non-small cell lung cancer (NSCLC) with specific HER2 mutations.

  • Ingredients

    Tepotinib
  • Drug Class

    Tepotinib is a kinase inhibitor.

  • Dosage Form

    Tablet

  • Uses

    The following are the uses of Tepotinib 225mg Tablet:

    • Used for treating non-small cell lung cancer (NSCLC) in adults.
    • Used for targeting specific mutations in the MET gene.
    • Used for shrinking tumors and controlling cancer growth.
    • Used as a second-line treatment option for advanced NSCLC.
    • Used in combination with other targeted therapies for enhanced effectiveness.
  • In case of Overdose

    In the case of an overdose of Tepotinib 225mg Tablet, it is important to seek medical assistance promptly. Overdose symptoms may include severe dizziness, fainting, or unusual tiredness. If you or someone you know has taken an excessive amount of this medication, contact a healthcare professional or poison control center immediately. They will provide guidance on the necessary steps to take, which may include monitoring vital signs and administering appropriate treatment to manage any adverse effects.

  • Missed Dose

    In the case of a missed dose of Tepotinib 225mg Tablet, it is important to take the medication as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed one. If you miss multiple doses, contact your healthcare provider for guidance, as they may advise you to restart the medication or provide alternative instructions. It is crucial to maintain a consistent medication routine for the best therapeutic outcome.

  • How To Use

    To take Tepotinib 225mg Tablet, swallow the tablet whole with a glass of water, preferably at the same time each day, following the dosage instructions provided by your doctor, typically taken on an empty stomach, at least one hour before or two hours after a meal.

  • When Not to Use

    Here is the list of conditions when Tepotinib 20mg Tablet should not be taken:

    • Should not be used in patients with a known hypersensitivity or allergy to tepotinib or any of its excipients.
    • Contraindicated in individuals with severe liver impairment.
    • Not recommended for patients with active or unstable severe lung disease (interstitial lung disease or ILD).
    • Should not be used in patients with a history of lung toxicity related to previous cancer treatments.
    • Contraindicated during pregnancy due to potential harm to the unborn baby.
    • Should not be used in women who are breastfeeding, as it may pass into breast milk.
    • Not suitable for individuals with a history of severe gastrointestinal perforation.
    • Should be avoided in patients with active or recent bleeding in the brain (intracranial hemorrhage).
    • Not recommended for individuals with uncontrolled high blood pressure.
    • Should not be used in patients with a history of severe skin reactions or toxic epidermal necrolysis (TEN).
  • Side Effects

    The side effects of Tepotinib 225mg Tablet may include:

    • Diarrhea
    • Nausea and vomiting
    • Fatigue
    • Skin reactions (rashes, itching)
    • Loss of appetite
    • Dry mouth
    • Changes in taste
    • Hair loss
  • Precautions & Warnings

    Following are the precautions and warnings for Tepotinib 225mg Tablet:

    • Tepotinib is intended for the treatment of specific types of non-small cell lung cancer (NSCLC) with a METex14 gene mutation, and should only be used in patients with this specific diagnosis.
    • Regular monitoring of liver function is crucial during treatment, as tepotinib can cause liver damage. Discontinuation or dose adjustments may be necessary if liver enzyme levels become elevated.
    • Patients with a history of lung disease or breathing problems should be closely monitored, as tepotinib may cause interstitial lung disease.
    • It can cause severe and life-threatening gastrointestinal perforation. Patients experiencing symptoms such as abdominal pain, nausea, or vomiting should seek immediate medical attention.
    • Tepotinib may cause severe and sometimes fatal vision loss. Patients should report any changes in vision to their healthcare provider immediately.
    • Patients should be aware of the risk of edema, including peripheral edema and ascites, and seek medical attention if they experience unexplained swelling.
    • This medication can cause severe embryo-fetal toxicity, and women should be advised not to become pregnant during treatment. Effective contraception should be used while taking tepotinib and for a period after treatment.
    • Tepotinib may cause serious cardiovascular events, including QT interval prolongation, which can lead to an increased risk of arrhythmias. Regular cardiac monitoring is recommended.
  • Drug Interactions

    Following are the drug interactions for Tepotinib 225mg Tablet:

    • Avoid combination with other medications that prolong the QT interval, such as certain antiarrhythmic drugs or antipsychotics, as this may increase the risk of serious heart rhythm problems.
    • Tepotinib may increase the concentration of drugs metabolized by CYP3A4 enzymes, including some statins, immunosuppressants, and certain antifungal medications. Dose adjustments may be required.
    • Concomitant use with strong CYP3A4 inhibitors can significantly increase tepotinib levels, potentially leading to increased side effects.
    • It may decrease the effectiveness of hormonal contraceptives, requiring additional contraceptive measures.
    • Drugs that increase gastric pH, such as proton pump inhibitors (PPIs), may reduce the absorption of tepotinib.
    • Caution is advised when using tepotinib with other medications that can cause liver toxicity, as this may increase the risk of liver-related side effects.
    • The effectiveness of tepotinib may be reduced when taken with certain anti-seizure medications that induce CYP3A4 enzymes.
  • Food Interactions

    Following are the food interactions for Tepotinib 225mg Tablet:

    • Grapefruit and grapefruit juice consumption should be avoided as they may influence the drug's metabolism, potentially leading to increased side effects and toxicity.
    • Alcohol intake should be minimized or avoided as it can potentially enhance the risk of liver-related adverse effects associated with Tepotinib.
    • High-fat meals might impact the absorption of Tepotinib, possibly reducing its effectiveness, so it's advisable to maintain a consistent dietary pattern.
    • Vitamin K-rich foods like leafy green vegetables may interact with the drug's anticoagulant properties, warranting monitoring of coagulation parameters.
    • Foods high in potassium, such as bananas and oranges, should be consumed with caution as Tepotinib may cause electrolyte imbalances.
    • Consuming excessive salt or sodium-rich foods might counteract the drug's ability to manage fluid retention, thus requiring dietary moderation.
    • Certain herbal supplements, particularly St. John's Wort, can affect the drug's metabolism and should be avoided without medical advice.
    • Always adhere to the dietary recommendations provided by your healthcare professional for the best treatment outcomes.
  • Storage/Disposal

    Tepotinib 225mg Tablets should be stored in a secure and dry location, preferably in a medicine cabinet or designated storage area, away from direct sunlight, moisture, and extreme temperatures. It is crucial to keep the tablets in their original packaging, ensuring the container is tightly sealed to maintain their integrity. When disposing of unused or expired tablets, it is important to follow local guidelines and regulations. Do not throw them in the trash or flush them down the toilet. Instead, contact your local pharmacy or healthcare facility to inquire about appropriate medication disposal programs or collection sites, ensuring the safe and environmentally friendly disposal of Tepotinib 225mg Tablets. Keep the medication out of children's reach to prevent accidental consumption, and always exercise caution when handling and storing this medication.

  • Quick Tips, if any

    Following are the quick tips for Tepotinib 225mg Tablet:

    • Ensure you take the medication exactly as prescribed by your doctor.
    • Maintain a consistent daily routine for taking the tablet to improve effectiveness.
    • Swallow the tablet whole with a glass of water; do not crush or chew.
    • Avoid consuming grapefruit or grapefruit juice while on this medication.
    • Inform your doctor about all medications and supplements you are taking.
    • Do not double the dose to make up for a missed one; continue with the next scheduled dose.
    • Regularly monitor your health and report any unusual symptoms to your healthcare provider.
    • Store the medication in a cool, dry place, away from direct sunlight and moisture.

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