Percanib

Selpercatinib

Composition: Each capsule contains Selpercatinib INN 80mg.


Indications

• RET Fusion-Positive Non-Small Cell Lung Cancer: Selpercatinib is 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, as detected by an FDA-approved test.

• RET-Mutant Medullary Thyroid Cancer: Selpercatinib is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

• RET Fusion-Positive Thyroid Cancer: Selpercatinib is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

• Other RET Fusion-Positive Solid Tumors: Selpercatinib is indicated for the treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

Dosage and Administration: The recommended dosage of Selpercatinib based on body weight is: i) Less than 50 kg: 120mg, ii) 50 kg or greater: 160mg. It may be taken with or without food unless coadministered with a proton pump inhibitor. It should be taken orally twice daily (approximately every 12 hours) until disease progression or unacceptable toxicity, should swallow the capsules whole, should not crush or chew the capsules. If vomiting occurs after its administration, should not take an additional dose and continue to the next scheduled time for the next dose.

Use in pregnancy and lactation: It can cause fetal harm when administered to a pregnant woman. There are no available data on Selpercatinib use in pregnant women to inform drug- associated risk. Pregnant women should be advised of the potential risk to a fetus. Lactation: There are no data on the presence of Selpercatinib or its metabolites in human milk or on their effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed children, women should be advised not to breastfeed during treatment with Selpercatinib and for 1 week after the final dose.

Packing: Each box contains 120 capsules in a container.

Prescribing Description

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