Indication
LUPRON DEPOT® (leuprolide acetate for depot suspension) 7.5 mg for 1-month, 22.5 mg for 3-month, 30 mg for 4-month, and 45 mg for 6-month administration are indicated for the treatment of advanced prostate cancer.
Important Safety Information
- LUPRON DEPOT is contraindicated in patients with hypersensitivity to GnRH agonists or any of the excipients in LUPRON DEPOT.
- LUPRON DEPOT causes an initial increase in serum testosterone (~50% above baseline) during the first few weeks of treatment. This initial increase can cause:
- Worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment, including bone pain, neuropathy, hematuria, or bladder outlet obstruction.
- Spinal cord compression may contribute to paralysis with or without fatal complications.
- Monitor patients for tumor flare symptoms during the first few weeks of treatment. Closely monitor patients with metastatic vertebral lesions and/or with urinary tract obstruction for new or worsening symptoms.
- The use of GnRH agonists may lead to an increased risk of metabolic changes, such as hyperglycemia, diabetes, hyperlipidemia, and non-alcoholic fatty liver disease. Monitor for signs and symptoms of metabolic syndrome including lipids, blood glucose level, and/or HbA1c and manage according to current treatment guidelines.
- An increased risk of myocardial infarction, sudden cardiac death, and stroke has been reported in association with the use of GnRH agonists in men, although the risk appears low. Evaluate the risks carefully, including cardiovascular risk factors, when determining prostate cancer treatment. Patients receiving a GnRH agonist should be monitored for signs and symptoms of cardiovascular disease and managed appropriately.
- Androgen deprivation therapy (ADT) may prolong the QT/QTc interval. Consideration should be given to whether the benefits of ADT outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval. Correct electrolyte abnormalities and consider periodic monitoring of electrocardiograms and electrolytes.
- Postmarketing reports of convulsions have been observed in patients on leuprolide acetate therapy, including patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications associated with convulsions, such as bupropion and SSRIs. Convulsions have also been reported in the absence of any of the conditions mentioned above.
- Periodic monitoring of serum testosterone and PSA levels is recommended.
- Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), occurred in patients treated with LUPRON DEPOT, including cases with visceral involvement and/or requiring skin grafts. Monitor and advise patients of the signs and symptoms of SCARs. Interrupt LUPRON DEPOT if signs or symptoms of a SCAR develop. Permanently discontinue if a SCAR is confirmed.
- LUPRON DEPOT may cause fetal harm when administered to a pregnant woman. Advise pregnant patients and females of reproductive potential of the potential risk to the fetus.
- LUPRON DEPOT may impair fertility in males of reproductive potential.
- In controlled clinical trials of advanced prostatic cancer patients receiving LUPRON DEPOT, the following adverse events occurred in >10% of patients:
- LUPRON DEPOT 7.5 mg for 1-month administration: hot flashes/sweats, general pain, edema, urinary disorders, GI disorders, and respiratory disorders.
- LUPRON DEPOT 22.5 mg for 3-month administration: hot flashes/sweats, general pain, testicular atrophy, GI disorders, urinary disorders, injection site reactions, and joint disorders.
- LUPRON DEPOT 30 mg for 4-month administration: hot flashes/sweats, injection site reactions, general pain, edema, urinary disorders, joint disorders, GI disorders, asthenia, flu syndrome, skin reactions, and headache.
- LUPRON DEPOT 45 mg for 6-month administration: hot flush/flushing, upper respiratory tract infection/influenza-like illness, injection site pain/discomfort, and fatigue/lethargy.
US-LUPR-240148
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Reference
LUPRON DEPOT [package insert]. North Chicago, IL: AbbVie Inc; 2019.