Endometriosis: LUPRON DEPOT3 Month 11.25 mg is indicated for management of endometriosis, including pain relief and reduction of endometriotic lesions. LUPRON DEPOT with norethindrone acetate 5 mg daily is also indicated for initial management of endometriosis and for management of recurrence of symptoms. (Refer also 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 DEPOT3 Month 11.25 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, CLINICAL STUDIES section.) LUPRON may be added if the response to iron alone is considered inadequate. Recommended therapy is a single injection of LUPRON DEPOT3 Month 11.25 mg. This dosage form is indicated only for women for whom three months of hormonal suppression is deemed necessary.

Experience with LUPRON DEPOT3 Month 11.25 mg in females has been limited to women 18 years of age and older treated for no more than 6 months.

Endometriosis: The recommended duration of treatment with LUPRON DEPOT3 Month 11.25 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 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): The recommended dose of LUPRON DEPOT3 Month 11.25 mg is one injection. The symptoms associated with uterine leiomyomata will recur following discontinuation of therapy. If additional treatment with LUPRON DEPOT3 Month 11.25 mg is contemplated, bone density should be assessed prior to initiation of therapy to ensure that values are within normal limits.

Incorporated in a depot formulation, the lyophilized microspheres are to be reconstituted and administered as a single intramuscular injection. For optimal performance of the prefilled dual chamber syringe (PDS), read and follow the following instructions:

1. 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.

2. To prepare for injection, screw the white plunger into the end stopper until the stopper begins to turn.

3. 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.

4. 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.

5. Hold the syringe UPRIGHT. With the opposite hand pull the needle cap upward without twisting.

6. Keep the syringe UPRIGHT. Advance the plunger to expel the air from the syringe.

7. 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

8. 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.

LUPRON DEPOT3 Month 11.25 mg is packaged as follows:

Each syringe contains sterile lyophilized microspheres which are leuprolide acetate incorporated in a biodegradable polymer of polylactic acid. When mixed with 1.5 mL of the diluent, LUPRON DEPOT3 Month 11.25 mg is administered as a single IM injection EVERY THREE MONTHS.

Store at 25°C (77° F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]

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