LUPRON DEPOT Powder for solution for injection Ref.[109539] Active ingredients: Leuprorelin

2.1 Important Use Information

LUPRON DEPOT 3.75 mg must be administered by a healthcare professional.

LUPRON DEPOT 3.75 mg for 1-month administration has different release characteristics than LUPRON 11.25 mg for 3-month administration and is dosed differently.

• Do not substitute LUPRON DEPOT 3.75 mg for LUPRON DEPOT 11.25 mg.
• Do not administer LUPRON DEPOT 3.75 mg more frequently than once a month.
• Do not give a fractional dose of the LUPRON DEPOT 11.25 mg 3-month formulation as it is not equivalent to a single dose of the LUPRON DEPOT 3.75 mg.
• Do not give a triple dose of the LUPRON DEPOT 3.75 mg, as it is not equivalent to a single dose of the LUPRON DEPOT 11.25 mg 3-month formulation.

Endometriosis

The initial and retreatment dosage regimens for LUPRON DEPOT 3.75 mg for the management of women with endometriosis are outlined in Table 1.

Table 1. LUPRON DEPOT 3.75 mg, Management of Endometriosis:

¹May use LUPRON DEPOT 3.75 mg with or without norethindrone acetate 5 mg tablet taken daily.
²Use LUPRON DEPOT 3.75 mg with norethindrone acetate for retreatment 5 mg tablet taken daily [see Warnings and Precautions (5.1)] and assess bone mineral density (BMD) prior to retreatment.
³Treatment should not exceed 12 months due to concerns about adverse impact on bone mineral density.

Fibroids

The recommended dosage of LUPRON DEPOT 3.75 mg is one IM injection every month for up to three months.

2.2 Reconstitution and Administration for Injection of LUPRON DEPOT

• Reconstitute and administer the lyophilized microsphere as a single IM injection as directed below. Visually inspect the drug product for particulate matter and discoloration prior to administration, whenever solution and container permit.
• Inject the LUPRON DEPOT 3.75 mg suspension immediately or discard if not used within two hours as the suspension does not contain a preservative.

1. Visually inspect the LUPRON DEPOT 3.75 mg powder. Do not use the syringe if clumping or caking is evident. A thin layer of powder on the wall of the syringe is considered normal prior to mixing with the diluent. The diluent should appear clear.

2. To prepare for injection, screw the white plunger into the end stopper until the stopper begins to turn (see Figure A and Figure B).

Figure A:

Figure B:

3. Hold the syringe UPRIGHT. Release the diluent by SLOWLY PUSHING the plunger for 6 to 8 seconds until the first middle stopper is at the blue line in the middle of the barrel (see Figure C).

Figure C:

4. Keep the syringe upright. Mix the microsphere powder thoroughly by gently shaking the syringe until the powder forms 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 (see Figure D).

Figure D:

5. Keep 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. The syringe is now ready for injection.

7. After cleaning the injection site with an alcohol swab, administer the IM injection by inserting the needle at a 90-degree angle into the gluteal area, anterior thigh, or deltoid. Injection sites should be alternated (see Figure E).

Figure E:

Note: If a blood vessel is accidentally penetrated, aspirated blood will be visible just below the luer lock (see Figure F) and can be seen through the transparent LuproLoc safety device. If blood is present, remove the needle immediately. Do not inject the medication.

Figure F:

8. Inject the entire contents of the syringe intramuscularly.

9. Withdraw the needle. Once the syringe has been withdrawn, immediately activate the LuproLoc safety device by pushing the arrow on the lock upward towards the needle tip with the thumb or finger, as illustrated, until the needle cover of the safety device over the needle is fully extended and a click is heard or felt (see Figure G).

Figure G:

10. Dispose of the syringe according to local regulations/procedures.

Store between 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].