What are some key steps in evaluating children for early puberty?

Indication for LUPRON DEPOT-PED^® (leuprolide acetate for depot suspension)

LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg for 1-month and 11.25 mg and 30 mg for 3-month administration are indicated in the treatment of children with central precocious puberty (CPP).

CPP is defined as early onset of secondary sexual characteristics (generally earlier than 8 years of age in girls and 9 years of age in boys) associated with pubertal pituitary gonadotropin activation. It may show a significantly advanced bone age that can result in diminished adult height.

Prior to initiation of treatment, confirm diagnosis of CPP by testing luteinizing hormone (LH) and sex steroid levels, and assess bone age versus chronological age. Baseline evaluations should be done to rule out intracranial tumor, steroid secreting tumors, a chorionic gonadotropin secreting tumor, and congenital adrenal hyperplasia.

Important Safety Information for LUPRON DEPOT-PED

LUPRON DEPOT-PED is contraindicated in:

• Patients with hypersensitivity to GnRH, GnRH agonist, or any of the excipients. Anaphylactic reactions to GnRH agonists have been reported in the medical literature.
• Females who are or may become pregnant during treatment, as it may cause fetal harm.

During the early phase of therapy, gonadotropins and sex steroids rise above baseline because of the initial stimulatory effect of the drug. An increase in clinical signs and symptoms of puberty may be observed.

Psychiatric events have been reported in patients taking GnRH agonists, including LUPRON DEPOT-PED. Events include emotional lability, such as crying, irritability, impatience, anger, and aggression. Monitor for development or worsening of psychiatric symptoms during treatment.

Postmarketing reports of convulsions have been observed in patients receiving GnRH agonists, including LUPRON DEPOT-PED. These included patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions, such as bupropion and SSRIs. Convulsions have also been reported in patients in the absence of any of the conditions mentioned above.

Monitor adequate response with a GnRHa stimulation test, basal LH, or serum concentration of sex steroid levels:

• After 1-2 months of initiating therapy for 1-month formulations
• After 2-3 months of initiating therapy and at month 6 for 3-month formulations
• For both formulations, ensure adequate suppression with each dose change or as judged clinically appropriate. Measure for height and bone advancement every 6-12 months

Noncompliance with drug regimen or inadequate dosing may result in inadequate control of the pubertal process with gonadotropins and/or sex steroids increasing above prepubertal levels.

The most common adverse reactions with GnRH agonists including LUPRON DEPOT-PED are injection site reactions/pain including abscess, general pain, headache, emotional lability, and hot flushes/sweating. The most frequent adverse reactions (≥2%) in LUPRON DEPOT-PED clinical studies were:

• LUPRON DEPOT-PED 7.5 mg, 11.25 mg and 15 mg for 1-month administration: injection site reactions including abscess, emotional lability, acne/seborrhea, vaginitis/vaginal bleeding/vaginal discharge, pain, rash including erythema multiforme, headache, and vasodilation.
• LUPRON DEPOT-PED 11.25 mg, and 30 mg for 3-month administration: injection site pain, increased weight, headache, altered mood, and injection site swelling.

Diagnostic tests of pituitary gonadotropic and gonadal functions conducted during treatment and up to 6 months after discontinuation may be affected.

LUPRON DEPOT-PED must be administered under the supervision of a physician.

The use of LUPRON DEPOT-PED in children under 2 years of age is not recommended.

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