Lupron Depot-6 Month 45mg

— THERAPEUTIC CATEGORIES —
  • Prostate and other male cancers

Lupron Depot-6 Month 45mg Generic Name & Formulations

General Description

Leuprolide acetate 45mg; depot susp for IM inj; preservative-free.

Pharmacological Class

GnRH analogue.

How Supplied

Depot kit—1 (prefilled dual-chamber syringe w. supplies)

Manufacturer

Mechanism of Action

Leuprolide acetate, a GnRH agonist, acts as an inhibitor of gonadotropin secretion. Animal studies indicate that following an initial stimulation, continuous administration of leuprolide acetate results in suppression of ovarian and testicular steroidogenesis.

Lupron Depot-6 Month 45mg Indications

Indications

Treatment of advanced prostatic cancer.

Lupron Depot-6 Month 45mg Dosage and Administration

Adult

Give as single IM inj into gluteal area, anterior thigh or deltoid; rotate inj sites. 45mg once every 6 months (24 weeks). Do not split doses.

Children

Not applicable.

Lupron Depot-6 Month 45mg Contraindications

Not Applicable

Lupron Depot-6 Month 45mg Boxed Warnings

Not Applicable

Lupron Depot-6 Month 45mg Warnings/Precautions

Warnings/Precautions

Initial worsening of signs/symptoms (eg, bone pain, neuropathy, hematuria, or bladder outlet obstruction) may occur during the first few weeks. Monitor for tumor flare symptoms. Patients with metastatic vertebral lesions and/or urinary tract obstruction; monitor closely for new/worsening symptoms. Monitor serum testosterone, PSA. Metabolic syndrome (hyperglycemia, diabetes, hyperlipidemia). Increased risk of MI, sudden cardiac death, stroke. Monitor serum lipids, blood glucose, HbA1c, and for signs/symptoms of CVD during therapy. Increased risk of convulsions in those with history of seizures, epilepsy, cerebrovascular disorder, CNS anomalies or tumors. Risk for QT prolongation in those with congenital long QT syndrome, electrolyte abnormalities (correct and monitor), or CHF; consider monitoring ECGs. Monitor for severe cutaneous adverse reactions (including SJS/TEN, DRESS, AGEP); interrupt if suspected and permanently discontinue if confirmed or for other Grade 4 skin reactions. Instruct patient on correct self administration. Embryo-fetal toxicity. Pregnancy. Nursing mothers: not recommended.

Lupron Depot-6 Month 45mg Pharmacokinetics

Absorption

Mean plasma concentration (Lupron Depot 7.5mg): 20 ng/mL at 4 hours and 0.36 ng/mL at 4 weeks; (Lupron Depot 22.5mg): 48 ng/mL at 4 hours and 0.67 ng/mL at 12 weeks; (Lupron Depot 30mg): 59.3 ng/mL at 4 hours and 0.30 ng/mL at 16 weeks; (Lupron Depot 45mg): 6.7 ng/mL at 2 hours and 0.07 ng/mL at 24 weeks.

Distribution

Mean steady-state volume of distribution: 27 L. Plasma protein bound: 43–49%.

Elimination

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

Lupron Depot-6 Month 45mg Interactions

Interactions

Concomitant antiarrhythmics may prolong the QT interval. Risk of seizures with concomitant SSRIs, bupropion, others.

Lupron Depot-6 Month 45mg Adverse Reactions

Adverse Reactions

Hot flashes/sweats, pain, GI disorders, edema, respiratory disorder, urinary disorders, inj site reaction, joint disorders, testicular atrophy, asthenia, flu syndrome, headache, skin reaction, fatigue; tumor flare, non-alcoholic fatty liver disease, cirrhosis, hypersensitivity.

Lupron Depot-6 Month 45mg Clinical Trials

See Literature

Lupron Depot-6 Month 45mg Note

Not Applicable

Lupron Depot-6 Month 45mg Patient Counseling

See Literature