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Retevmo Dosage

Medically reviewed by Drugs.com. Last updated on Jan 28, 2021.

Generic name: selpercatinib 40mg
Dosage form: capsule

Patient Selection

Select patients for treatment with RETEVMO based on the presence of a RET gene fusion (NSCLC or thyroid cancer) or specific RET gene mutation (MTC) in tumor specimens or plasma [see Clinical Studies (14)]. An FDA-approved test for the detection of RET gene fusions and RET gene mutations is not currently available.

Important Administration Instructions

RETEVMO may be taken with or without food unless coadministrated with a proton pump inhibitor (PPI) [see Dosage and Administration (2.4), Clinical Pharmacology (12.3)].

Recommended Dosage

The recommended dosage of RETEVMO based on body weight is:

  • Less than 50 kg: 120 mg
  • 50 kg or greater: 160 mg

Take RETEVMO orally twice daily (approximately every 12 hours) until disease progression or unacceptable toxicity.

Swallow the capsules whole. Do not crush or chew the capsules.

Do not take a missed dose unless it is more than 6 hours until next scheduled dose.

If vomiting occurs after RETEVMO administration, do not take an additional dose and continue to the next scheduled time for the next dose.

Dosage Modifications for Concomitant Use of Acid-Reducing Agents

Avoid concomitant use of a PPI, a histamine-2 (H2) receptor antagonist, or a locally-acting antacid with RETEVMO [see Drug Interactions (7.1)]. If concomitant use cannot be avoided:

  • Take RETEVMO with food when coadministered with a PPI.
  • Take RETEVMO 2 hours before or 10 hours after administration of an H2 receptor antagonist.
  • Take RETEVMO 2 hours before or 2 hours after administration of a locally-acting antacid.

Dosage Modifications for Adverse Reactions

The recommended dose reductions for adverse reactions are provided in Table 1.

Table 1: Recommended RETEVMO Dose Reductions for Adverse Reactions
Dose Reduction Patients Weighing
Less Than 50 kg
Patients Weighing
50 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 RETEVMO in patients unable to tolerate three dose reductions.

The recommended dosage modifications for adverse reactions are provided in Table 2.

Table 2: Recommended RETEVMO Dosage Modifications for Adverse Reactions
Adverse Reaction Severity Dosage Modification
Hepatotoxicity
[see Warnings and Precautions (5.1)]
Grade 3
or
Grade 4
  • Withhold RETEVMO and monitor AST/ALT once weekly until resolution to Grade 1 or baseline.
  • Resume at reduced dose by 2 dose levels and monitor AST and ALT once weekly until 4 weeks after reaching dose taken prior to the onset of Grade 3 or 4 increased AST or ALT.
  • Increase dose by 1 dose level after a minimum of 2 weeks without recurrence and then increase to dose taken prior to the onset of Grade 3 or 4 increased AST or ALT after a minimum of 4 weeks without recurrence.
Hypertension
[see Warnings and Precautions (5.2)]
Grade 3
  • Withhold RETEVMO for Grade 3 hypertension that persists despite optimal antihypertensive therapy. Resume at a reduced dose when hypertension is controlled.
Grade 4
  • Discontinue RETEVMO.
QT Interval Prolongation
[see Warnings and Precautions (5.3)]
Grade 3
  • Withhold RETEVMO until recovery to baseline or Grade 0 or 1.
  • Resume at a reduced dose.
Grade 4
  • Discontinue RETEVMO
Hemorrhagic Events
[see Warnings and Precautions (5.4)]
Grade 3
or
Grade 4
  • Withhold RETEVMO until recovery to baseline or Grade 0 or 1.
  • Discontinue RETEVMO for severe or life-threatening hemorrhagic events.
Hypersensitivity Reactions
[see Warnings and Precautions (5.5)]
All Grades
  • Withhold RETEVMO until resolution of the event. Initiate corticosteroids.
  • Resume at a reduced dose by 3 dose levels while continuing corticosteroids.
  • Increase dose by 1 dose level each week until the dose taken prior to the onset of hypersensitivity is reached, then taper corticosteroids.
Other Adverse Reactions
[see Adverse Reactions (6.1)]
Grade 3
or
Grade 4
  • Withhold RETEVMO until recovery to baseline or Grade 0 or 1.
  • Resume at a reduced dose.

Dosage Modifications for Concomitant Use of Strong and Moderate CYP3A Inhibitors

Avoid concomitant use of strong and moderate CYP3A inhibitors with RETEVMO. If concomitant use of a strong or moderate CYP3A inhibitor cannot be avoided, reduce the RETEVMO dose as recommended in Table 3. After the inhibitor has been discontinued for 3 to 5 elimination half-lives, resume RETEVMO at the dose taken prior to initiating the CYP3A inhibitor [see Drug Interactions (7.1)].

Table 3: Recommended RETEVMO Dosage for Concomitant Use of Strong and Moderate CYP3A Inhibitors
Current RETEVMO Dosage Recommended RETEVMO Dosage
Moderate CYP3A Inhibitor Strong CYP3A Inhibitor
120 mg orally twice daily 80 mg orally twice daily 40 mg orally twice daily
160 mg orally twice daily 120 mg orally twice daily 80 mg orally twice daily

Dosage Modification for Severe Hepatic Impairment

Reduce the recommended dosage of RETEVMO for patients with severe hepatic impairment as recommended in Table 4 [see Use in Specific Populations (8.7)].

Table 4: Recommended RETEVMO Dosage for Severe Hepatic Impairment
Current RETEVMO Dosage Recommended RETEVMO Dosage
120 mg orally twice daily 80 mg orally twice daily
160 mg orally twice daily 80 mg orally twice daily

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