hydroxyprogesterone caproate (Makena®)

OFFICE ADMINISTRATION / SELF ADMINISTRATION (With Proper Training) -  INTRAMUSCULAR INJECTION

Indications for Prior Authorization:

Preterm birth

  • To reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth

Limitation of use

  • Safety and efficacy have been demonstrated only in women with a prior spontaneous singleton preterm birth. Use is not intended for women with multiple gestations or other risk factors for preterm birth

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

  • Use is to reduce the risk of preterm birth in a patient with a history of preterm birth
  • Approvable under pharmacy benefit if patient is self-administering
  • Approvable under medical benefit if office administered

This Medication is Not Approvable for the following condition(s):

  • Any condition not listed above as an approved indication

Dosing:

Adult

  • Usual dosage
    • 250 mg administered intramuscularly (IM) once weekly (every 7 days). Begin treatment between 16 weeks, 0 days and 20 weeks, 6 days of gestation 
  • Duration of therapy
    • Continue administration once weekly until week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first

Pediatric (16 years and older)

  • Usual dosage
    • 250 mg administered intramuscularly (IM) once weekly (every 7 days). Begin treatment between 16 weeks, 0 days and 20 weeks, 6 days of gestation
  • Duration of therapy 
    • Continue administration once weekly until week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first

Younger than 16 years

  • Safety and effectiveness have not been established

 

Last review date: July 24, 2016