TRIPTODUR (triptorelin extended-release)

TRIPTODUR (triptorelin extended-release)

OFFICE ADMINISTRATION

Indication(s) for Prior Authorization:

• Indicated for the treatment of pediatric patients 2 years and older with central precocious puberty (CPP)

Patients must meet the following criteria for the indication(s) above:

• Prescribed by specialist (pediatric endocrinologist), AND
• Pediatric patient at least 2 years of age and older, AND
• Chart note documentation confirms central precocius puberty (idiopathic or neurogenic) with onset of secondary sexual characteristics earlier than 8 years of age in females and 9 years of age in males, AND
• Clinical diagnosis confirmed prior to initiation of therapy using the following parameters:
  • Pubertal response to a GnRH stimulation test
  • Bone age advanced one year beyond the chronological age, AND
• Should be discontinued at the appropriate age of onset of puberty

Dosing:

• Must be administered under the supervision of a physician
• Given as single 22.5 mg IM injection once every 24 weeks
• Monitor response with LH levels after a GnRH or GnRH agonist stimulation test, basal LH, or serum concentration of sex steroid levels beginning 1-2 months following initiation of therapy, during therapy as necessary to confirm maintenance of efficacy, and with each subsequent dose
• Measure height every 3-6 months and monitor bone age periodically

Approval:

• One year
• Discontinue therapy at appropriate age of onet of puberty