About SUPPRELIN® LA -
Rate of Bone Maturation

Efficacy assessments of secondary endpoints

The mean bone age (BA) to chronological age (CA) ratio was reduced through the third year of therapy1

Study design: A multicenter, open-label study evaluating the effectiveness and safety of a 50 mg histrelin subcutaneous implant in children with CPP. The initial duration of treatment was 12 months (plus a 1-month follow-up period) with the possibility of rolling over into multiple 12-month extension phases.  Patients continued to receive a new implant at the end of each 12-month period until the patient no longer required hormone suppression. Of 36 children who enrolled in the study, 14 completed 36 months of therapy.

Reference:
1. Data on file, DOF-SP-03. Endo Pharmaceuticals; 2009.

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Indication

SUPPRELIN® LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP).

Important Safety Information

  • SUPPRELIN LA is contraindicated in women who are or may become pregnant, and in patients who are hypersensitive to GnRH or GnRH agonist analogs. Safety and effectiveness in pediatric patients under the age of 2 years has not been established.

  • SUPPRELIN LA, like other GnRH agonists, initially causes a transient increase in serum concentrations of estradiol in females and testosterone in both sexes during the first week of treatment, with worsening or onset of new symptoms during this period. Within 4 weeks of therapy, gonadal steroid suppression occurs and manifestations of puberty decrease.

  • Implant insertion and removal is a surgical procedure and should utilize aseptic technique. Careful adherence to the recommended insertion and removal procedures is recommended. On occasion, localizing and/or removal of implant products have been difficult and imaging techniques were used, including ultrasound, CT, or MRI (this implant is not radiopaque).

  • Rare events of spontaneous extrusion have been observed in clinical trials.

  • LH, FSH and estradiol or testosterone should be monitored at 1 month post implantation then every 6 months. Every 6-12 months, height and bone age should also be assessed.

  • In clinical trials, the most common adverse reactions involved the implant site and included bruising, pain, soreness, erythema and swelling.

Please see the accompanying full Prescribing Information.