DOSAGE AND ADMINISTRATION - LUPRON DEPOT–3 Month 22.5 mg
LUPRON DEPOT Must Be Administered Under The Supervision Of A Physician.
The recommended dose of LUPRON DEPOT–3 Month 22.5 mg to be administered is one
injection every three months
(84 days). Due to different release characteristics, a fractionaldose of this 3-month depot formulation is not equivalent to the same dose of the monthly
formulation and should not be given.
Incorporated in a depot formulation, the lyophilized microspheres are to be reconstituted
and administered every three months as a single intramuscular injection.
For optimalperformance of the prefilled dual chamber syringe (PDS), read and follow the following
instructions:
1. To prepare for injection, screw the white plunger into the end stopper until the stopper
begins to turn.
2. Hold the syringe UPRIGHT. Release the diluent by SLOWLY PUSHING (6 to 8
seconds) the plunger until the first stopper is at the blue line in the middle of the barrel.
3. Keep the syringe UPRIGHT. Gently mix the microspheres (particles) thoroughly to form
a uniform suspension. The suspension will appear milky.
4. Hold the syringe UPRIGHT. With the opposite hand pull the needle cap upward without
twisting.
5. Keep the syringe UPRIGHT. Advance the plunger to expel the air from the syringe.
LUPRON DEPOT - 3 Month 22.5 mg Package Insert Page 7 of 8
6. Inject the entire contents of the syringe intramuscularly at the time of reconstitution. The
suspension settles very quickly following reconstitution; therefore, LUPRON DEPOT
should be mixed and used immediately.
NOTE: Aspirated blood would be visible just below the luer lock connection if a blood vessel is
accidentally penetrated. If present, blood can be seen through the transparent LuproLoc™
safety device.
AFTER INJECTION
7. Withdraw the needle. Immediately activate the LuproLoc™ safety device by pushing the
arrow forward with the thumb or finger until the device is fully extended and a CLICK is
heard or felt.
Since the product does not contain a preservative, the suspension should be discarded if not
used immediately.
As with other drugs administered by injection, the injection site should be varied
periodically.
HOW SUPPLIED
LUPRON DEPOT–3 Month 22.5 mg is packaged as follows:
Kit with prefilled dual-chamber syringe NDC 0300-3346-01
Each syringe contains sterile lyophilized microspheres which is leuprolide acetate incorporated
in a biodegradable polymer of polylactic acid. When mixed with 1.5 mL of accompanying
diluent, LUPRON DEPOT–3 Month 22.5 mg is administered as a single IM injection
EVERYTHREE MONTHS (84 days).
An information pamphlet for patients is included with
the kit.
Store at 25°C (77°F); excursions permitted to 15-30°C
(59-86°F) [See USP Controlled Room Temperature]
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