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.