Generic Name and Formulations:
Leuprolide acetate 11.25mg, 30mg; per kit; depot susp for IM inj; preservative-free.
Central precocious puberty.
<2yrs: not recommended. ≥2yrs: 11.25mg or 30mg as a single IM inj once every 3 months. If inadequate response, consider other alternative treatments.
Confirm diagnosis. Monitor for psychiatric symptoms. History of seizures/epilepsy, cerebrovascular disorders, CNS anomalies or tumors: risk of convulsions. Monitor hormonal effects after 1–2 months of starting therapy, with dose changes and during treatment. Depot 3-Month: monitor at months 2–3, month 6 and as needed thereafter. Measure height and bone age velocity every 6–12 months. Exclude pregnancy before treatment. Nursing mothers: not recommended.
Caution with concomitant drugs that are associated with convulsions (eg, bupropion, SSRIs).
Transient exacerbation of symptoms, inj site reactions, pain, headache, emotional lability, hot flushes/sweating, acne/seborrhea, rash, vaginitis, vaginal discharge, syncope, GI upset, gynecomastia, weight increased, mood altered; convulsions.
Depot-PED kit—1 (prefilled dual-chamber syringe w. diluent); Depot-PED 3 Month kit—1 (prefilled dual-chamber syringe w. diluent)
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