Retsevmo Dosage/Direction for Use

Retsevmo therapy should be initiated and supervised by physicians experienced in the use of anti-cancer therapies.
RET testing: The presence of a RET gene fusion (NSCLC and non-medullary thyroid cancer) or mutation (MTC) should be confirmed by a validated test prior to initiation of treatment with Retsevmo.
Posology: The recommended dose of Retsevmo based on body weight is: Less than 50 kg: 120 mg twice daily; 50 kg or greater: 160 mg twice daily.
If a patient vomits or misses a dose, the patient should be instructed to take the next dose at its scheduled time; an additional dose should not be taken.
Treatment should be continued until disease progression or unacceptable toxicity.
The current selpercatinib dose should be reduced by 50% if co-administering with a strong CYP3A inhibitor. If the CYP3A inhibitor is discontinued, the selpercatinib dose should be increased (after 3-5 half-lives of the inhibitor) to the dose that was used before starting the inhibitor.
Dose adjustments: Management of some adverse reactions may require dose interruption and/or dose reduction. Retsevmo dose modifications are summarised in Table 6 and Table 7. (See Tables 6 and 7.)

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Click on icon to see table/diagram/image

Special populations: Elderly: No dose adjustment is required based on age (see Pharmacology: Pharmacokinetics under Actions).
No overall differences were observed in the treatment emergent adverse events or effectiveness of selpercatinib between patients who were ≥65 years of age and younger patients. Limited data are available in patients ≥75 years.
Renal impairment: Dose adjustment is not necessary in patients with mild, moderate or severe renal impairment. There are no data in patients with end stage renal disease, or in patients on dialysis (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: Close monitoring of patients with impaired hepatic function is important. No dose adjustment is required for patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment. Patients with severe (Child-Pugh class C) hepatic impairment should be dosed with 80 mg selpercatinib twice daily (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: Retsevmo should not be used in children aged less than 12 years.
There is no data in children or adolescents with RET fusion-positive NSCLC or thyroid cancer. Retsevmo is intended to be used from the age of 12 years for the treatment of patients with RET-mutant MTC (see Pharmacology: Pharmacodynamics under Actions). In RET-mutant MTC, there are very limited data available in children or adolescents aged less than 18 years. Patients should be dosed according to body weight (as previously mentioned). Based on results from a preclinical study (see Pharmacology: Toxicology: Preclinical safety data under Actions), open growth plates in adolescent patients should be monitored. Dose interruption or discontinuation should be considered based on the severity of any growth plate abnormalities and an individual risk-benefit assessment.
Method of administration: Retsevmo is for oral use.
The capsules should be swallowed whole (patients should not open, crush, or chew the capsule before swallowing) and can be taken with or without food.
Patients should take the doses at approximately the same time every day.
Retsevmo must be accompanied by a meal if used concomitantly with a proton pump inhibitor (see Interactions).
Retsevmo should be administered 2 hours before or 10 hours after H₂ receptor antagonists (see Interactions).