Lupron Depot-6 Month 45mg Generic Name & Formulations
Legal Class
Rx
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
Palliative treatment of advanced prostatic carcinoma.
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, ureteral obstruction, spinal cord compression) may occur; monitor closely in metastatic vertebral lesions, urinary obstruction, hematuria. Monitor serum testosterone, PSA. Increased risk of diabetes, MI, sudden cardiac death, stroke; monitor blood glucose, HbA1c, and for signs/symptoms of CVD during therapy. Increased risk of convulsions in patients with history of seizures, epilepsy, cerebrovascular disorder, CNS anomalies or tumors. Risk of QT prolongation in long-term androgen deprivation therapy, congenital long QT syndrome, electrolyte abnormalities (correct and monitor), or CHF; consider monitoring ECGs. Instruct patient on correct self administration. Embryo-fetal toxicity. Pregnancy. Nursing mothers: not recommended.
Lupron Depot-6 Month 45mg Pharmacokinetics
Elimination
Half-life: ~3 hours.
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, hyperglycemia, convulsions, 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