Omacetaxine mepesuccinate (Synribo®)

OFFICE / SELF ADMINISTRATION (By Caregiver OR Patient with Proper Training) - SUBCUTANEOUS INJECTION

Indications for Prior Authorization:

Chronic myeloid leukemia

  • Treatment of chronic or accelerated phase chronic myeloid leukemia (CML) in adult patients with resistance and/or intolerance to 2 or more tyrosine kinase inhibitors (TKIs)
  • TKIs with this FDA indication include the following: 
    • Bosutinib (Bosulif®)
    • Dasatinib (Sprycel®)
    • Imatinib (Gleevec®)
    • Nilotinib (Tasigna®)
    • Ponatinib (Iclusiq®)

The following indications do not meet the criteria for use established by the Western Health Advantage Pharmacy and Therapeutics Committee:

  • Any other diagnosis not listed in the approved indications

All of the following must be met as a condition(s) for coverage:

Chronic or accelerated phase chronic myeloid leukemia (CML)

  • Treatment of chronic or accelerated phase chronic myeloid leukemia (CML) in adult patients AND
  • Patient is resistant and/or intolerant to 2 or more tyrosine kinase inhibitors (TKIs)

The drug is not covered for:

  • Any indication not listed in this policy

Dosing:

Maximum dose

  • There is no well-established maximum dose for the approved indication according to the prescribing information

General dosing consideration

  • Treatment cycles may be delayed and/or the number of days of dosing during the cycle reduced for hematologic toxicities (eg, neutropenia, thrombocytopenia)

Adult

  • Initial dosage: 1.25 mg/m2 subcutaneously twice daily for 14 consecutive days every 28 days, over a 28-day cycle. Repeat cycles every 28 days until patients achieve a hematologic response
  • Maintenance dosage: 1.25 mg/m2 subcutaneously twice daily for 7 consecutive days every 28 days, over a 28-day cycle
  • Dosage adjustment:
    • Hematologic toxicity: If a patient experiences grade 4 neutropenia (absolute neutrophil count [ANC] less than 0.5 × 109/L) or grade 3 thrombocytopenia (platelet counts less than 50 × 109/L) during a cycle, delay starting the next cycle until ANC is 1 × 109/L or higher and platelet count is 50 × 109/L or higher. For the next cycle, reduce the number of dosing days by 2 days (eg, to 12 or 5 days)
    • Nonhematologic toxicity: Manage other clinically significant nonhematologic toxicity symptomatically. Interrupt and/or delay omacetaxine until toxicity is resolved

Missed dose

  • If a dose is missed, skip that dose and resume with the next regularly scheduled dose. Do not administer 2 doses at the same time to make up for a missed dose

Pediatric

  • Safety and effectiveness have not been established

Renal function impairment

  • There is no dosage adjustment provided in the manufacturer's labeling (has not been studied)
  • Based on the minimal amount of unchanged drug excreted in the urine, dosage adjustment is not likely necessary

Hepatic function impairment

  • There is no dosage adjustment provided in the manufacturer's labeling (has not been studied)

Approval:

One year


 

Last review date: July 24, 2016