Rx Item-Eligard Ds 7.5MG KIT-KEEP REFRIG- by Tolmar Pharma USA , Clinical Information:
Generic Code And Description: 50363 Leuprolide Acetate Subcutaneous Syringe 7.5 Mg
Strength: 7.5 Mg (1 Month)
Dose Form: Syringe (Ea)
Product Category: : Rx Pharmaceuticals
Fine Line Class: 850085008510 All Rx Products
DEA Class: None Omp Family:
Drug Class: 68180800 Gonadotropins
10000000 Antineoplastic Agents
Active Ingredients: 2675 Leuprolide Acetate 74381536
Inactive Ingredients: Drug Class: Drug Class: 68180800 Gonadotropins
10000000 Antineoplastic Agent, OMP Family: , Temparature Zone: 30 Refrige./DoNot Freez, Unit Dose Indicator: NO, Item Size: , Brand Label Flag: BRAND , Storage Temperature Zone: 30 Refrige./DoNot Freez, Item Size Code: , Item Strength Code:7.5MG , Item Abbreviation: Eligard Ds , Generic Form: Syringe
These highlights do not include all the information needed to use ELIGARD® safely and effectively. See full prescribing information for ELIGARD®.
ELIGARD® (leuprolide acetate) for injectable suspension, for subcutaneous use
Initial U.S. Approval: 2002
RECENT MAJOR CHANGES
Dosage and Administration, Administration Procedure (2.2) 04/2019
Warnings and Precautions, Embryo-Fetal Toxicity (5.6) 02/2019
INDICATIONS AND USAGE
ELIGARD® is a gonadotropin releasing hormone (GnRH) agonist indicated for the palliative treatment of advanced prostate cancer (1)
DOSAGE AND ADMINISTRATION
7.5 mg subcutaneously every month (2)
22.5 mg subcutaneously every 3 months (2)
30 mg subcutaneously every 4 months (2)
45 mg subcutaneously every 6 months (2)
DOSAGE FORMS AND STRENGTHS
Injectable suspension: 7.5 mg (3)
Injectable suspension: 22.5 mg (3)
Injectable suspension: 30 mg (3)
Injectable suspension: 45 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to GnRH, GnRH agonist analogs or any of the components of ELIGARD® (4.1)
WARNINGS AND PRECAUTIONS
Tumor Flare: Transient increase in serum levels of testosterone during treatment may result in worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment, including bone pain, neuropathy, hematuria, bladder outlet obstruction, ureteral obstruction, or spinal cord compression. Monitor patients at risk closely and manage as appropriate. (5.1, 5.2)
Hyperglycemia and diabetes: Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH analogs. Monitor blood glucose level and manage according to current clinical practice. (5.3)
Cardiovascular diseases: Increased risk of myocardial infarction, sudden cardiac death and stroke has been reported in men. Monitor for cardiovascular disease and manage according to current clinical practice. (5.4)
Effect on QT/QTc Interval: Androgen deprivation therapy may prolong the QT interval. Consider risks and benefits. (5.5)
Embryo-Fetal Toxicity: May cause fetal harm. (5.6, 8.1)
Convulsions have been observed in patients with or without a history of predisposing factors. Manage convulsions according to the current clinical practice. (5.7)
ADVERSE REACTIONS
Most common adverse reactions in clinical studies (incidence ≥ 5%): Malaise, fatigue, hot flashes/sweats, and testicular atrophy. (6.1)
As with other GnRH agonists, other adverse reactions, including decreased bone density and rare cases of pituitary apoplexy have been reported. (6.1, 6.2)
To report SUSPECTED ADVERSE REACTIONS, contact Tolmar Pharmaceuticals, Inc. at 1-888-354-4273 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Females and males of reproductive potential: ELIGARD® may impair fertility. (8.3)
Safety and effectiveness in pediatric patients have not been established (8.4)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 4/2019
