Leuprolidedosage

LUPRON DEPOT 11.25mg for 3-month administration, given by a healthcare provider as a single intramuscular injection. LUPRON DEPOT 11.25 mg has different release characteristics than LUPRON 3.75 mg and is dosed differently. Do not substitute LUPRON DEPOT 11.25 mg for LUPRON DEPOT 3.75 mg. Do not administer LUPRON DEPOT 11.25 mg more frequently than every 3 months. Do not give a fractional dose of the LUPRON DEPOT 11.25 mg, as it is not equivalent to the same dose of the LUPRON DEPOT 3.75 mg monthly formulation. Reconstitute LUPRON DEPOT 11.25 mg prior to use.

Endometriosis: LUPRON DEPOT 11.25 mg administered as a single intramuscular (IM) injection once every three months for up to two injections (6 months of therapy). LUPRON DEPOT may be administered alone or in combination with daily 5 mg tablet of norethindrone acetate (add-back). If endometriosis symptoms recur after initial course of therapy, retreatment for no more than six months may be considered but only with the addition of norethindrone acetate add-back therapy. Do not re-treat with LUPRON DEPOT 11.25 mg alone.

Fibroids: Recommended dose of LUPRON DEPOT 11.25 mg is one IM injection. Figure A img-128 plunger img-129 blue line img-0184 shake Injection site Figure F Figure G

2.1 Important

Use Information LUPRON DEPOT 11.25 mg must be administered by a healthcare professional. LUPRON DEPOT 11.25 mg for 3-month administration has different release characteristics than LUPRON 3.75 mg for 1-month administration and is dosed differently. Do not substitute LUPRON DEPOT 11.25 mg for LUPRON DEPOT 3.75 mg. Do not administer LUPRON DEPOT 11.25 mg more frequently than every 3 months. Do not give a fractional dose of the LUPRON DEPOT 11.25 mg, as it is not equivalent to the same dose of the LUPRON DEPOT 3.75 mg monthly formulation. Endometriosis The initial and retreatment dosage regimens for LUPRON DEPOT 11.25 mg for the management of women with endometriosis are outlined in Table 1. Table 1. LUPRON DEPOT 11.25 mg, Management of Endometriosis Treatment Phase LUPRON DEPOT 11.25 mg Dosing Maximum Treatment Duration Initial Treatment 1 11.25 mg IM every 3 months for 1 to 2 doses 6 months Retreatment 2 11.25 mg IM every 3 months for 1 to 2 doses 6 months 12 MONTHS 3 TOTAL TREATMENT DURATION 1 May use LUPRON DEPOT 11.25 mg with or without norethindrone acetate 5 mg tablet taken daily. 2 Use LUPRON DEPOT 11.25 mg with norethindrone acetate for retreatment 5 mg tablet taken daily and assess bone mineral density (BMD) prior to retreatment. 3 Treatment should not exceed 12 months due to concerns about adverse impact on bone mineral density. Fibroids The recommended dosage of LUPRON DEPOT 11.25 mg is one IM injection of 11.25 mg which provides a three-month treatment course.

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 11.25 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 11.25 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.