Lupron Depot-6 Month 45mg Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Mechanism of Action
Lupron Depot-6 Month 45mg Indications
Indications
Treatment of advanced prostatic cancer.
Lupron Depot-6 Month 45mg Dosage and Administration
Adult
Children
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
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