Eligard (Leuprolide Acetate) - Indications and Dosage

INDICATIONS AND USAGE

ELIGARD^® 7.5 mg is indicated for the palliative treatment of advanced prostate cancer.

DOSAGE AND ADMINISTRATION

The recommended dose of ELIGARD^® 7.5 mg is one injection every month. The injection delivers 7.5 mg of leuprolide acetate, incorporated in a polymer formulation. It is administered subcutaneously and provides continuous release of leuprolide for one month.

Once mixed, ELIGARD^® 7.5 mg should be discarded if not administered within 30 minutes.

As with other drugs administered by subcutaneous injection, the injection site should vary periodically. The specific injection location chosen should be an area with sufficient soft or loose subcutaneous tissue. In clinical trials, the injection was administered in the upper- or mid-abdominal area. Avoid areas with brawny or fibrous subcutaneous tissue or locations that could be rubbed or compressed (i.e., with a belt or clothing waistband).

MIXING AND ADMINISTRATION PROCEDURE

IMPORTANT:    Allow the product to reach room temperature before using. Once mixed, the product must be administered within 30 minutes.

Follow the instructions as directed to ensure proper preparation of ELIGARD^® 7.5 mg prior to administration:

ELIGARD^® 7.5 mg is packaged in a pouch that contains two smaller pouches (Figure 3), a needle cartridge and a desiccant pack (Figure 4). Syringe A pouch contains the sterile Syringe A pre-filled with the ATRIGEL^® polymer system and a long white replacement plunger rod (Figure 5). Syringe B pouch contains the sterile Syringe B pre-filled with leuprolide acetate powder (Figure 6).

1. On a clean field, open all of the pouches and remove the contents. Discard the desiccant pack.
   
   
2. Pull out the blue-tipped short plunger rod and attached stopper from Syringe B and discard (Figure 7). Gently insert the long, white replacement plunger rod into the gray primary stopper remaining in Syringe B by twisting it in place (Figure 8).
   
   
3. Unscrew the clear cap from Syringe A (Figure 9). Remove the gray rubber cap from Syringe B (Figure 10).
   
4. Join the two syringes together by pushing in and twisting until secure (Figure 11).
   
5. Inject the liquid contents of Syringe A into Syringe B containing the leuprolide acetate. Thoroughly mix the product by pushing the contents of both syringes back and forth between syringes (approximately 45 seconds) to obtain a uniform suspension (Figure 12). When thoroughly mixed, the suspension will appear a light tan to tan color. Please note: Product must be mixed as described; shaking will not provide adequate mixing of the product.
   
6. Hold the syringes vertically with Syringe B on the bottom. The syringes should remain securely coupled. Draw the entire mixed product into Syringe B (short, wide syringe) by depressing the Syringe A plunger and slightly withdrawing the Syringe B plunger. Uncouple Syringe A while continuing to push down on the Syringe A plunger (Figure 13). Please note: Small air bubbles will remain in the formulation--this is acceptable.
   
   
   
7. Hold Syringe B upright. Remove the pink cap on the bottom of the sterile needle cartridge by twisting it (Figure 14). Attach the needle cartridge to the end of Syringe B (Figure 15) by pushing in and turning the needle until it is firmly seated. Do not twist the needle onto the syringe until it is stripped. Pull off the clear needle cartridge cover prior to administration (Figure 16).
8. Choose an injection site on the abdomen, upper buttocks, or anywhere with adequate amounts of subcutaneous tissue that does not have excessive pigment, nodules, lesions, or hair. Since you can vary the injection site with a subcutaneous injection, choose an area that hasn't recently been used.
9. Cleanse the injection-site area with an alcohol swab.⁴
   
10. Using the thumb and forefinger of your nondominant hand, grab and bunch the area of skin around the injection site.⁴
    
11. Using your dominant hand, insert the needle quickly. The approximate angle you use will depend on the amount and fullness of the subcutaneous tissue and the length of the needle.⁴
    
12. After the needle is inserted, release the skin with your nondominant hand.⁴
13. Inject the drug using a slow, steady push. Press down on the plunger until the syringe is empty. ⁴
14. Withdraw the needle quickly at the same angle used for insertion.⁴
15. Gently massage the injection area with a cotton ball or gauze pad. ⁴
16. Discard all components safely in an appropriate biohazard container.
17. Remove your gloves and wash your hands. Document both the procedure and the patient's response to the injection.

HOW SUPPLIED

ELIGARD^® 7.5 mg is available in a single use kit. The kit consists of a two-syringe mixing system, a 20-gauge half-inch needle, a silicone desiccant pouch to control moisture uptake, and package insert for constitution and administration procedures. Each syringe is individually packaged. One contains the ATRIGEL^® Delivery System and the other contains leuprolide acetate. When constituted, ELIGARD^® 7.5 mg is administered as a single dose.

(NDC 0024-0793-75)

Rx only

Store at 2-8 °C (36-46 °F)

Sanofi-Synthelabo

Manufactured for Sanofi-Synthelabo Inc.

New York, NY 10016

by Atrix Laboratories, Inc.

Fort Collins, CO 80525

1. Sennello LT et al. Single-dose pharmacokinetics of leuprolide in humans following intravenous and subcutaneous administration. J Pharm Sci 1986; 75(2): 158-160.
2. MacLeod TL et. al. Anaphylactic reaction to synthetic luteinizing hormone releasing hormone. Fertil Steril 1987 Sept; 48(3): 500-502.
3. Hatano T et. al. Incidence of bone fracture in patients receiving luteinizing hormone-releasing hormone agonists for prostate cancer. BJU International 2000 86: 449-452.
4. National Institutes of Health. Giving a subcutaneous injection. Bethesda, MD; 2002.

04295 Rev 5 7/03                   Revised July 2003

Copyright, Sanofi-Synthelabo Inc. 1996, 2003

                                                         ESS-3D