Selcaxen 40 mg (Selpercatinib)

COMPOSITION
SELCAXEN capsule: Each capsule contains Selpercatinib INN 40 mg.

INDICATION ANDUSAGE
Metastatic RET Fusion-PositiveNon-Small Cell Lung Cancer
Selpercatinib is indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer(NSCLC).
This indication is approved under accelerated approva 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-Mutant Medullary Thyroid Cancer
Selpercatinib is indicated for the treatment of adult ano pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullarythyroio cancer(MTC) who require systemic therapy.
This indication is approved under accelerated approva based on overall response rate and duration o response.Continued approval for this indication may be contingent upon verificationand descriptionof 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 RET fusion-positivethyroic cancer who require systemic therapyandwho are radioactive iodine-refractoryif radioactive iodine is appropriate).
This indication is approved under accelerated approva 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).
DOSAGE AND ADMINISTRATION PatientSelection
Select patients for treatment with Selpercatinib baseo on the presence of a RET genefusion(NSCLC O thvroid cancer)or specificRETgenemutation(MTC)in tumor specimens or plasma.An FDA-approved test for the detection of RET gene fusions and RET gene mutations is not currently available.Important Administration Instructions
SELPERCATINIB may be taken with or without food unless co-administrated with a proton pumpinhibitor
(PPI).
Recommended Dosage
The recommended dosage of Selpercatinib based on body weight is:
·Less than 50 kg:120mg50 kg or greater:160 mg
Take Selpercatinib orally twice daily(approximately every 12 hours) until disease progression or unaccept- able toxicity.

Swallow the capsules whole.Do not crush or chew the capsules.
Do not take a missed dose unless it is morethan 6hours until next scheduled dose

If vomiting occurs after Selpercatinib administrationdo not take an additional dose and continue tothe next scheduled time for the next dose

Dosage Modifications for Concomitant Use of Acid-Re ducing Agents
Avoid concomitant use of a PPI，ahistamine-2(H2) receptor antagonist or a locallyacting antacid with Selpercatinib.If concomitant use cannot beavoided:·Take Selpercatinib with food whenco-administerec with a PPI.
·Take Selpercatinib 2 hours before or 10 hours after administration of an H2receptor antagonist
●Take Selpercatinib 2 hours before or 2 hours after administration of a locally-acting antacid
Dosage Modifications for AdverseReactions
The recommended dose reductions for adverse reactions are provided in Table 1) Dosage Modifications for Adverse Reactions
The recommended dose reductions for adverse reactions are provided in Table 1.
Table 1:Recommended Selpercatinib Dose Reductions for Adverse Reactions
Dose Reduction Patients Weighing Less Than 50 kg Patients Weighing50 kg or Greater
First 80 mg orally twice daily 120 mg orally twice daily
Second 40 mg orally twice daily 80 mg orally twice daily
Third 40 mg orally once daily 40 mg orally twice daily
Permanently discontinue Selpercatinib in patients unable to tolerate three dose reductions.The recommended dosage modifications for adverse reactions are provided in Table 2.
Dosage Modifications for Concomitant Use of Strong and Moderate CYP3AInhibitors

Avoid concomitant use of strong and moderateCYP3A inhibitors with Selpercatinib If concomitant use ofa strong or moderate CYP3A inhibitor cannot be avoided reduce the Selpercatinib dose asrecommended.After the inhibitor has been discontinuedfor3to5elimination half-lives,resume Selpercatinib at the dose taken prior to initiating the CYP3A inhibitor.
Table 2:Recommended Selpercatinib Dosage for Concomitant Use ofStrong andModerateCYP3A Inhibitors
Recommended Selpercatinib Dosage
Current Selpercatinib Dosage Moderate CYP3A Strong CYP3A
Inhibitor Inhibitor
120 mg orally twice daily 80 mg orally 40 mg orally
twice daily twice daily
160 mg orally twice daily 120 mg orally 80 mg orally
twice daily twice daily
Dosage Modification for Severe HepaticImpairment

Reduce the recommended dosage of Selpercatinibfor patients with severe hepaticimpairmentas recommended in Table 4.
Table 3:Recommended Selpercatinib Dosage for Severe Hepatic Impairment
Current Selpercatinib Dosage Recommended Selpercatinib Dosage
120 mg orally twice daily 80mg orally twice daily
160 mg orally twice daily 80 mg orally twice daily