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
Last review date: September 4, 2018