asfotase alfa (Strensiq®)

ORAL

Indications for Prior Authorization:

Hypophosphatasia

  • Treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP)

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

  • Treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP) AND
  • Chart notes must be included with the request

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

  • Any condition not listed above as an approved indication

Dosing and Duration of Therapy:

General dosing considerations
  • Round patient weight to the nearest kg when determining dose. Injection site reactions may limit the tolerability of the 6 times per week regimen
  • Adult: Not indicated for adult-onset hypophosphatasia
  • Pediatric
    • Juvenile-onset hypophosphatasia:   2 mg/kg 3 times weekly or 1 mg/kg 6 times weekly.
    • Perinatal/infantile-onset hypophosphatasia: Usual dosage is 2 mg/kg 3 times weekly or 1 mg/kg 6 times weekly.

Maximum dose

  • Juvenile-onset hypophosphatasia: There is no well-established maximum dose for the approved indication according to the prescribing information.
  • Perinatal/infantile-onset hypophosphatasia:  9 mg/kg per week according to the prescribing information.

Dosage adjustment:  

  • May increase dose up to 3 mg/kg 3 times weekly for lack of efficacy (eg, no improvement in respiratory status, growth, or radiographic findings).

Renal function impairment  

  • There are no dosage adjustments provided in the manufacturer's labeling.

Hepatic function impairment  

There are no dosage adjustments provided in the manufacturer's labeling.

Approval:  

One year


 

Last review date: July 24, 2016