Lupron Depot® for Endometriosis: Dosing and Administration

Dosing and Administration of Lupron Depot

For endometriosis Lupron Depot comes in two convenient doses:

3.75 mg – monthly injections
11.25 mg – injection every 3 months

The recommended duration of treatment alone or in combination with norethindrone acetate is up to 6 months.

Administration of Lupron Depot

Lupron Depot must be administered under the supervision of a physician. For all formulations of Lupron Depot, the lyophilized microspheres are to be reconstituted and administered as follows.

Preparing for Injection

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.

Injection

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

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.

Read safety information for Lupron Depot

Important Safety and Other Information

Side effects are generally those related to hypoestrogenism, including vasomotor flushes, headaches, and vaginal dryness. After 6 months of therapy with Lupron Depot 3.75 mg, vertebral bone density decreased by an average of 3.2% compared with the pretreatment value. Lupron Depot is indicated for the management of endometriosis, including pain relief and reduction of endometriotic lesions. Individual results may vary. Please see the full Prescribing Information for Lupron Depot 3.75 mg and -3 Month 11.25 mg dosage forms, and the Patient Product Information for the 3.75 mg and -3 Month 11.25 mg dosage forms.

The most commonly reported side effects of Lupron Depot plus norethindrone acetate 5 mg daily are vasomotor flushes, headache, nausea/vomiting, depression/emotional lability, and asthenia. In addition, Lupron Depot plus norethindrone acetate-treated patients had significantly decreased HDL levels and significantly increased LDL/HDL ratios. After treatment, mean serum lipid levels in patients with follow-up data returned to pretreatment values. Norethindrone acetate should be used with caution in women with cardiovascular risk factors including lipid abnormalities and cigarette smoking. Please refer to the norethindrone acetate prescribing information for warnings, precautions, contraindications and adverse reactions. Lupron Depot is indicated for the 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. Duration of initial treatment or retreatment should be limited to 6 months. Individual results may vary. Please see the full Prescribing Information for Lupron Depot 3.75 mg and -3 Month 11.25 mg dosage forms, and the Patient Product Information for the 3.75 mg and -3 Month 11.25 mg dosage forms.

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