Leuprolide Acetate
Injection Depot
(Leuprolide Acetate for Depot Suspension)
22.5 mg*
*Each syringe contains 22.5 mg
(provided as Leuprolide acetate)
WHOLESALER/DISTRIBUTOR ORDER ENTRY NUMBER
CENCORA
CARDINAL
MCKESSON
MORRIS & DICKSON
10274981
5815139
2655967
190595
To place your order, please contact your wholesaler.
Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059
Customer Service Tel.: 844-CIPLA US (844-247-5287)
Email: Cipla.CS@cipla.com
JUNE 2024 CUSAI-06212024-03
x
Convulsions: Convulsions have been observed and should
be managed accordingly.
x
Laboratory Tests: Monitor serum levels of testosterone
following injection of LEUPROLIDE ACETATE INJECTION
DEPOT 22.5 mg for 3-month administration.
x
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 the FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
www.ciplaleuprolide.com
DETAILS
NDC 1
69097-0909-50
STRENGTH1
22.5 mg
ROUTE OF ADMINISTRATION1
Intramuscular
SELLING UNIT
1 kit consisting of a LEUPROLIDE ACETATE INJECTION MIXJECT single-dose delivery system
STORAGE1
Store at controlled room temperature at 20º-25ºC (68º-77ºF)
SHELF LIFE2
36 months from date of manufacture
Please see www.ciplaleuprolide.com
or scan the QR code for full Prescribing
Information and Important Safety
Information.
HCPCS Code: J1954