ALISERPATINIB

COMPOSITION
Selpercatinib………………………40mg
INDICATION

This product is a kinase inhibitor indicated:

  • For the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion.
  • For the treatment of advanced or metastatic medullary thyroid carcinoma (MTC) with a RET mutation in adults and children aged 12 and above who require systematic treatment.
  • For the treatment of advanced or metastatic thyroid cancer with a RET gene fusion in adults and children aged 12 and above who require systematic treatment and are difficult to treat with radioactive iodine (if radioactive iodine is applicable).

PACKAGING:
120 capsules /bottle.

Reg No: 11 L 1233/24
Download ALISERPATINIB Drug Registration Certificate

Brand name: ALISERPATINIB


Composition:
Each tablet contains:
Selpercatinib………………………40mg


Indications:

This product is a kinase inhibitor indicated:

  • For the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion.
  • For the treatment of advanced or metastatic medullary thyroid carcinoma (MTC) with a RET mutation in adults and children aged 12 and above who require systematic treatment.
  • For the treatment of advanced or metastatic thyroid cancer with a RET gene fusion in adults and children aged 12 and above who require systematic treatment and are difficult to treat with radioactive iodine (if radioactive iodine is applicable).

Dosage:

  • Based on body weight, the recommended dosage of Selpercatinib:
    • Less than 50 kg: 120 mg taken orally twice daily.
    • 50 kg or greater: 160 mg taken orally twice daily.

Continue treatment with Selpercatinib until disease progression or unacceptable toxicity.

  • Selpercatinib may be taken with or without food.

Contraindications:
Patients who are allergic to the active ingredients or any excipients of this product.


Warnings:

  • Hepatotoxicity: Suspend, reduce dosage, or permanently discontinue administration based on severity.
  • Interstitial Lung Disease (ILD)/Pneumonitis: Suspend, reduce dosage, or permanently discontinue administration based on severity.
  • QT Interval Prolongation: Suspend, reduced dosage, or permanently discontinue administration based on severity.
  • Tumor Lysis Syndrome: Closely monitor patients at risk and treat as clinically indicated.
  • Hypothyroidism: Monitor thyroid function before treatment with Selpercatinib and periodically during treatment.
  • Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the possible risk to a fetus and to use effective contraception.

Adverse Effects:
Edema, fatigue, hypertension, abdominal pain, constipation, decreased lymphocytes, elevated alanine aminotransferase (ALT), elevated aspartate aminotransferase (AST), rash, headache, nausea.


Dosage form: Blue capsules.


Expiry date: 24 months from the date of manufacture.


Packaging: 120 capsules/bottle.


Storage:

  • Protected from light, sealed in original packaging, and stored at 20℃- 25℃.
  • Keep out of reach of children.

DISCLAIMER

The information on this website about our medications is intended for general educational purposes only and should not be considered a substitute for professional medical advice, diagnosis, or treatment. Never disregard professional medical advice or delay seeking care because of something you have read on this website.

For your safety:

Do not self-diagnose or treat any medical condition based solely on the information on this website. If you have any questions or concerns about a medication, please talk to your doctor or pharmacist.