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Indication for LUPRON DEPOT-PED^® (leuprolide acetate for depot suspension)
Central Precocious Puberty
LUPRON DEPOT-PED^® (leuprolide acetate for depot suspension) 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 for the treatment of pediatric patients with central precocious puberty (CPP).

Important Safety Information for LUPRON DEPOT-PED
CONTRAINDICATIONS

Hypersensitivity to gonadotropin releasing hormone (GnRH), GnRH agonists, or any of the excipients in LUPRON DEPOT-PED. Anaphylactic reactions to synthetic GnRH or GnRH agonists have been reported.
Pregnancy: LUPRON DEPOT-PED may cause fetal harm.

WARNINGS AND PRECAUTIONS
Initial Rise of Gonadotropins and Sex Steroid Levels

During the early phase of therapy, gonadotropins and sex steroids may rise above baseline because of the initial stimulatory effect of the drug. Therefore, an increase in clinical signs and symptoms of puberty, including vaginal bleeding, may be observed during the first weeks of therapy or after subsequent doses.

Psychiatric Events

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

Convulsions

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.

ADVERSE REACTIONS

The most common (≥2%) adverse reactions in the 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, weight increased, headache, mood altered, 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.
The safety and effectiveness of LUPRON DEPOT-PED have not been established in pediatric patients less than 1 year old.
LUPRON DEPOT-PED must be administered by a healthcare professional

Please click here for full Prescribing Information.

References: 1. LUPRON DEPOT-PED [package insert]. North Chicago, IL: AbbVie Inc. 2. IMS Health, IMS National Prescription Audit, May 2018. 3. Lee PA, Neely EK, Fuqua J, et al. Efficacy of leuprolide acetate 1-month depot for central precocious puberty (CPP): Growth outcomes during a prospective, longitudinal study. Int J Pediatr Endocrinol. 2011;2011(1):7. doi:10.1186/1687-9856-2011-7