Central Precocious Puberty
LUPRON DEPOT-PED® (leuprolide acetate for depot suspension) 7.5 mg, 11.25 mg, and 15 mg for 1-month, 11.25 mg and 30 mg for 3-month, and 45 mg for 6-month administration are indicated for the treatment of pediatric patients with central precocious puberty (CPP).
Important Safety Information for LUPRON DEPOT-PED
- 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 or after subsequent doses, 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 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.
- 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.
Pseudotumor Cerebri (Idiopathic Intracranial Hypertension)
- Pseudotumor cerebri (idiopathic intracranial hypertension) have been reported in pediatric patients receiving GnRH agonists, including LUPRON DEPOT-PED. Monitor patients for signs and symptoms of pseudotumor cerebri, including headache, papilledema, blurred vision, diplopia, loss of vision, pain behind the eye or pain with eye movement, tinnitus, dizziness, and nausea.
- The most common (≥2%) adverse reactions in clinical studies with LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg for 1-month administration were: injection site reactions including abscess, emotional lability, acne/seborrhea, vaginitis/vaginal bleeding/vaginal discharge, pain, rash including erythema multiforme, headache, and vasodilation.
- The most common (≥2%) adverse reactions in clinical studies with LUPRON DEPOT-PED 11.25 mg and 30 mg for 3-month administration were: injection site pain, increased weight, headache, altered mood, and injection site swelling.
- The most common (≥4%) adverse reactions in clinical studies with LUPRON DEPOT-PED 45 mg for 6-month administration were: injection site reactions, headache, psychiatric events, abdominal pain, diarrhea, hemorrhage, nausea and vomiting, pyrexia, pruritus, pain in extremities, rash, back pain, ligament sprain, increased weight, fracture, breast tenderness, insomnia, chest pain, and hyperhidrosis.
- 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.