INDICATIONS AND USAGE
LUPRON DEPOT 3.75 mg is indicated for management of endometriosis, including pain relief and reduction of endometriotic lesions. LUPRON DEPOT monthly with norethindrone acetate 5 mg daily is also indicated for initial management of endometriosis and for management of recurrence of symptoms. (Referalso to norethindrone acetate prescribing information for WARNINGS, PRECAUTIONS, CONTRAINDICATIONS and ADVERSE REACTIONS associated with norethindrone acetate). Duration of initial treatment or retreatment should be limited to 6 months.
Uterine Leiomyomata (Fibroids)
LUPRON DEPOT 3.75 mg concomitantly with iron therapy is indicated for the preoperative hematologic improvement of patients with anemia caused by uterine leiomyomata. The clinician may wish to consider a one-month trial period on iron alone inasmuch as some of the patients will respond to iron alone. (See Table 1.) LUPRON may be added if the response to iron alone is considered inadequate. Recommended duration of therapy with LUPRON DEPOT 3.75 mg is up to three months.
Experience with LUPRON DEPOT in females has been limited to women 18 years of age and older.
Table 1 PERCENT OF PATIENTS ACHIEVING HEMOGLOBIN ≥ 12 GM/DL
|Treatment Group||Week 4||Week 8||Week 12|
|LUPRON DEPOT 3.75 mg with Iron||41
||71P-Value < 0.001||79|
DOSAGE AND ADMINISTRATION
LUPRON DEPOT Must Be Administered Under The Supervision Of A Physician.
The recommended duration of treatment with LUPRON DEPOT 3.75 mg alone or in combination with norethindrone acetate is six months. The choice of LUPRON DEPOT alone or LUPRON DEPOT plus norethindrone acetate therapy for initial management of the symptoms and signs of endometriosis should be made by the health care professional in consultation with the patient and should take into consideration the risks and benefits of the addition of norethindrone to LUPRON DEPOT alone.
If the symptoms of endometriosis recur after a course of therapy, retreatment with a six-month course of LUPRON DEPOT monthly and norethindrone acetate 5 mg daily may be considered. Retreatment beyond this one six-month course cannot be recommended. It is recommended that bone density be assessed before retreatment begins to ensure that values are within normal limits. LUPRON DEPOT alone is not recommended for retreatment. If norethindrone acetate is contraindicated for the individual patient, then retreatment is not recommended.
An assessment of cardiovascular risk and management of risk factors such as cigarette smoking is recommended before beginning treatment with LUPRON DEPOT and norethindrone acetate.
Uterine Leiomyomata (Fibroids)
Recommended duration of therapy with LUPRON DEPOT 3.75 mg is up to 3 months. The symptoms associated with uterine leiomyomata will recur following discontinuation of therapy. If additional treatment with LUPRON DEPOT 3.75 mg is contemplated, bone density should be assessed prior to initiation of therapy to ensure that values are within normal limits.
The recommended dose of LUPRON DEPOT is 3.75 mg, incorporated in a depot formulation. The lyophilized microspheres are to be reconstituted and administered monthly as a single intramuscular injection. For optimal performance of the prefilled dual chamber syringe (PDS), read and follow the following instructions:
- The LUPRON DEPOT powder should be visually inspected and the syringe should NOT BE USED if clumping or caking is evident. A thin layer of powder on the wall of the syringe is considered normal. The diluent should appear clear.
- To prepare for injection, screw the white plunger into the end stopper until the stopper begins to turn.
- 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.
- Keep the syringe UPRIGHT. Gently mix the microspheres (powder) thoroughly to form a uniform suspension. The suspension will appear milky. If the powder adheres to the stopper or caking/clumping is present, tap the syringe with your finger to disperse. DO NOT USE if any of the powder has not gone into suspension.
- Hold the syringe UPRIGHT. With the opposite hand pull the needle cap upward without twisting.
- Keep the syringe UPRIGHT. Advance the plunger to expel the air from the syringe.
- 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.
- 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.
Each LUPRON DEPOT 3.75 mg kit (NDC 0074-3641-03) contains:
one prefilled dual-chamber syringe
two alcohol swabs
instructions for how to mix and administer
an information pamphlet for patients
a complete prescribing information enclosure
Each syringe contains sterile lyophilized microspheres, which is leuprolide incorporated in a biodegradable copolymer of lactic and glycolic acids. When mixed with diluent, LUPRON DEPOT 3.75 mg is administered as a single monthly IM injection.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]
U.S. Patent Nos. 4,652,441; 4,677,191; 4,728,721; 4,849,228; 4,917,893; 5,330,767; 5,476,663; 5,575,987; 5,631,020; 5,631,021; 5,716,640; 5,823,997; 5,980,488; and 6,036,976.
Other patents pending.
North Chicago, IL 60064
by Takeda Pharmaceutical Company Limited
Osaka, Japan 540-8645
™ - Trademark
® - Registered Trademark
Revised: October, 2008
©2008, Abbott Laboratories
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