LUPRON DEPOT-PED Dosage & Rx Info

Lupron Depot-ped Generic Name & Formulations

Legal Class

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)

Manufacturer

AbbVie

Mechanism of Action

Leuprolide acetate, a GnRH agonist, acts as a potent inhibitor of gonadotropin secretion (LH and follicle stimulating hormone (FSH)) when given continuously in therapeutic doses.

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 clinically indicated; for Depot 6-Month: monitor at months 5–6, and as clinically indicated. 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

Absorption

Lupron Depot-PED 1-Month

Mean peak plasma concentration: ~20ng/mL at 4 hours then declined to 0.36ng/mL at 4 weeks.
Mean trough plasma levels: 0.77±0.033 (7.5mg); 1.25±1.06 (11.25mg); 1.59±0.65 (15mg).

Lupron Depot-PED 3-Month

Mean peak plasma concentration: 19.1ng/mL (11.25mg) and 52.5ng/mL (30mg) at 1 hour then declined to 0.08ng/mL (11.25mg) and 0.25ng/mL (30mg) at 2 weeks.

Lupron Depot-PED 6-Month

Mean peak plasma concentration: 15.7ng/mL (45mg) at 1 hour then declined to 0.03ng/mL at 24 weeks.

Distribution

Mean steady-state volume of distribution: 27 L.
43% to 49% human plasma protein bound in vitro.

Elimination

Renal.
Half-life: ~3 hours.
Mean systemic clearance: 7.6 L/h.

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; also for Depot-PED 6-Month: psychiatric events, abdominal pain, diarrhea, hemorrhage, pyrexia, nausea/vomiting, ligament sprain, fracture, breast tenderness, insomnia, hyperhidrosis.

Lupron Depot-ped Clinical Trials

See Literature

Lupron Depot-ped Note