LEUPROLIDE ACETATE INJECTION DEPOT
(leuprolide acetate for depot suspension) 22.5 mg
LEUPROLIDE ACETATE INJECTION DEPOT (leuprolide acetate for depot suspension) 22.5 mg for 3-month administration (leuprolide acetate) is indicated for palliative treatment of advanced prostate cancer.1
Please see Important Safety Information below
| DETAILS |
|---|
| NDC1 | 69097-909-50 |
| STRENGTH1 | 22.5 mg |
| SELLING UNITS PER SHIPPING CASE | 80 |
| SHELF LIFE2 | 36 months from date of manufacture |
| STORAGE1 | Store at controlled room temperature at 20º-25ºC (68º-77ºF); excursions permitted between 15ºC and 30ºC (59ºC and 86ºF) [see USP Controlled Room Temperature] |
| STORAGE AFTER RECONSTITUTION1 | The suspension should be administered immediately after reconstitution |
| SELLING UNIT | 1 kit consisting of a LEUPROLIDE ACETATE INJECTION MIXJECT single-dose delivery system |
| ROUTE OF ADMINISTRATION | Intramuscular injection |
LEUPROLIDE ACETATE INJECTION DEPOT
(leuprolide acetate for depot suspension)
22.5 mg SELL SHEET
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PACKAGING INFORMATION
Dosing & Administration
The following instructions explain what comes in the kit and how health care providers should inject Leuprolide Acetate injection Depot 22.5 mg. This medication must be administered under the supervision of a physician.
LEUPROLIDE ACETATE INJECTION DEPOT is packaged in a commercial kit. Each kit contains:
- One vial containing 22.5 mg of leuprolide acetate as lyophilized microspheres
- One prefilled syringe containing 2 mL of mannitol for injection
- One MIXJECT transfer device including one needle
- Instructions for Use Leaflet
INSTRUCTIONS FOR USE VIDEO
LEUPROLIDE ACETATE
INJECTION DEPOT 22.5 mg
for 3 months administration, given as a single intramuscular injection every 12 weeks.
DOSAGE FORMS & STRENGTHS
FOR INJECTION
22.5 mg of leuprolide acetate in a single dose vial as a kit with a prefilled syringe containing diluent and a MIXJECT transfer device.
These highlights do not include all the information needed to use LEUPROLIDE ACETATE INJECTION DEPOT safely.
Please See the full prescribing information including the Instructions for Use. Please see the important Safety information below.
To enquire about ordering directly from Cipla, please fill out the below form or contact your wholesaler with your Order Entry numbers.
| WHOLESALER/DISTRIBUTOR ORDER ENTRY NUMBER |
|---|
| AMERISOURCEBERGEN | CARDINAL | MCKESSON | MORRIS & DICKSON |
| 10274981 | 5815139 | 2655967 | 190595 |
WANT TO LEARN MORE ABOUT
Leuprolide Acetate Injection Depot
(leuprolide acetate for depot suspension)
22.5 mg
WANT TO LEARN MORE ABOUT
leuprolide acetate injection depot
(leuprolide acetate for depot suspension)
22.5 mg
IMPORTANT SAFETY INFORMATION
Contraindications:
Hypersensitivity:
LEUPROLIDE ACETATE INJECTION DEPOT is contraindicated in individuals with known hypersensitivity to GnRH agonists or any of the excipients in LEUPROLIDE ACETATE INJECTION DEPOT. Anaphylactic reactions to GnRH agonists have been reported.
Warnings And Precautions:
Tumor Flare:
LEUPROLIDE ACETATE INJECTION DEPOT causes increases in serum levels of testosterone during the first weeks of treatment. Isolated cases of ureteral obstruction and spinal cord compression have been observed, which may contribute to paralysis with or without fatal complications. Transient worsening of symptoms may develop. Patients may experience a temporary increase in bone pain. Patients with metastatic vertebral lesions and/or with urinary tract obstruction should be closely observed.
Hyperglycemia and Diabetes:
Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Monitor blood glucose and/or glycosylated hemoglobin (HbA1c) periodically in patients receiving a GnRH.
Cardiovascular Diseases:
Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported, and should be evaluated carefully along with cardiovascular risk factors. Patients receiving a GnRH agonist should be monitored for symptoms and signs suggestive of development of cardiovascular disease and be managed accordingly.
Effect on QT/QTc Interval:
Androgen deprivation therapy may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy 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. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.
Convulsions:
Convulsions have been observed and should be managed accordingly.
Laboratory Tests:
Monitor serum levels of testosterone following injection of LEUPROLIDE ACETATE INJECTION DEPOT 22.5 mg for 3-month administration.
Embryo-Fetal Toxicity:
LEUPROLIDE ACETATE INJECTION 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.
Most common adverse events (incidences >10%) are hot flushes, upper respiratory infection, fatigue, diarrhea, pollakiuria, arthralgia, and injection site pain.
Use in Specific Populations:
Lactation: A decision should be made to discontinue breastfeeding or discontinue the LEUPROLIDE ACETATE INJECTION DEPOT.
Females and Males of Reproductive Potential:
LEUPROLIDE ACETATE INJECTION DEPOT may impair fertility in males of reproductive potential.
Pediatric Use:
The safety and effectiveness of LEUPROLIDE ACETATE INJECTION DEPOT in pediatric patients have not been established.
Geriatric Use:
Hot flushes occurred with equal frequency in those ≤ 65 years of age.
To report suspected adverse reactions, contact Cipla at 1-866-604-3268 or FDA at 1-800-FDA-1088 or fda.gov/medwatch.
Please see the accompanying full Prescribing Information for additional Important Safety Information.
References
1. Leuprolide Prescribing Information, Cipla, 2018
2. Data on file. CIP-REF-LEU-001. Warren, NJ: Cipla usa; 2022
Medical Information
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