Lupron Depot-ped

— THERAPEUTIC DISORDERS TREATED —
  • Pituitary disorders

Lupron Depot-ped Generic Name & Formulations

General Description

Leuprolide acetate 7.5mg, 11.25mg or 15mg; per kit; depot susp for IM inj; preservative-free.

Pharmacological Class

GnRH analogue.

How Supplied

Depot-PED kit—1 (prefilled dual-chamber syringe w. diluent, supplies); Depot-PED 3 Month kit—1 (prefilled dual-chamber syringe w. diluent, supplies)

Manufacturer

Lupron Depot-ped Indications

Indications

Central precocious puberty.

Lupron Depot-ped Dosage and Administration

Adult

Not applicable.

Children

<1yr: not established. ≥1yrs: Individualize. Give by single IM inj once a month into the gluteal area, anterior thigh, or shoulder; rotate inj sites. ≤25kg: 7.5mg; 25–37.5kg: 11.25mg; >37.5kg: 15mg; if inadequate response with starting dose, may increase to next available higher dose. Also, dose may be adjusted with changes in body weight.

Lupron Depot-ped Contraindications

Contraindications

Pregnancy.

Lupron Depot-ped Boxed Warnings

Not Applicable

Lupron Depot-ped Warnings/Precautions

Warnings/Precautions

Must be administered by a healthcare professional. Initial transient rise in gonadotropins and sex steroids may result in increased signs/symptoms of puberty. Monitor LH and sex steroid levels at 1–2 months after treatment initiation, with dose changes, and as clinically indicated; for Depot 3-Month: monitor at months 2–3, month 6 and as needed thereafter. Measure height and bone age velocity every 6–12 months. Monitor for pseudotumor cerebri or psychiatric symptoms. History of seizures/epilepsy, cerebrovascular disorders, CNS anomalies or tumors: risk of convulsions. Exclude pregnancy prior to initiation. Advise females of reproductive potential to use non-hormonal method of contraception during treatment. Nursing mothers.

Lupron Depot-ped Pharmacokinetics

See Literature

Lupron Depot-ped Interactions

Interactions

Caution with concomitant drugs that are associated with convulsions (eg, bupropion, SSRIs).

Lupron Depot-ped Adverse Reactions

Adverse Reactions

Transient exacerbation of symptoms, inj site reactions, pain, headache, emotional lability, acne/seborrhea, rash, vaginitis, vaginal discharge, syncope, GI upset, gynecomastia, weight increased, mood altered.

Lupron Depot-ped Clinical Trials

See Literature

Lupron Depot-ped Note

Not Applicable

Lupron Depot-ped Patient Counseling

See Literature