Retevmo (selpercatinib): Cancer Treatment Warnings

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What is the dosage for Retevmo?

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. 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).

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. 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 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 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
QT Interval Prolongation Grade 3
  • Withhold Retevmo until recovery to baseline or Grade 0 or 1.
  • Resume at a reduced dose.
Grade 4
Hemorrhagic Events 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 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.

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.

Table 2: 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].

Table 3: 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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