ELIGARD

ELIGARD- leuprolide acetate
TOLMAR PHARMACEUTICALS INC.

1 INDICATIONS AND USAGE

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

2 DOSAGE AND ADMINISTRATION

ELIGARD® is administered subcutaneously and provides continuous release of leuprolide acetate over a one-, three-, four-, or six-month treatment period (Table 1). The injection delivers the dose of leuprolide acetate incorporated in a polymer formulation.

Table 1. ELIGARD® Recommended Dosing

Dosage

7.5 mg

22.5 mg

30 mg

45 mg

Recommended dose

1 injection everymonth

1 injection every3 months

1 injection every4 months

1 injection every6 months

As with other drugs administered by subcutaneous injection, the injection site should vary periodically. The specific injection location should be an area with sufficient soft or loose subcutaneous tissue. In clinical trials, the injections were 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).

2.1 Mixing Procedure

Use aseptic technique throughout the procedure. As with other similar agents, the use of gloves is recommended during mixing and administration.1 Allow the product to reach room temperature before mixing. Once mixed, the product must be administered within 30 minutes or it should be discarded.

  • ELIGARD® is packaged in a carton containing two thermoformed trays and this package insert:

Table 2: Contents of the Two Trays in the ELIGARD® Carton

Syringe A Tray

Syringe B Tray

Syringe A pre-filled with the ATRIGEL® Delivery System

Syringe B pre-filled with the leuprolide acetate powder

Long white plunger rod

Safety needle

Desiccant pack

Desiccant pack

Follow the detailed instructions below to ensure correct preparation of ELIGARD® prior to administration:

Figure 1-1
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Figure 1-2
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1. On a clean field, open both trays by tearing off the foil from the corners and removing the contents. Discard the desiccant pack(s). Open the safety needle package by peeling back the paper tab.
Figure 2
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2. Pull out (do not unscrew) the short blue plunger rod with attached gray stopper from Syringe B and discard.

Figure 3
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3. Gently screw the white plunger rod into the remaining gray stopper in Syringe B.

Figure 4

4. Unscrew and discard the clear cap from Syringe A.

Figure-5
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5. Remove and discard the gray rubber cap from Syringe B.

Figure-6
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6. Join the two syringes together by pushing and gently screwing until secure.

Figure-7
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7. Inject the liquid contents of Syringe A into the leuprolide acetate powder contained in Syringe B. Thoroughly mix the product for approximately 45 seconds by pushing the contents back and forth between both syringes to obtain a uniform suspension. When thoroughly mixed, the suspension will appear light tan to tan (ELIGARD® 7.5 mg) or colorless to pale yellow (ELIGARD® 22.5 mg, 30 mg and 45 mg). Note: Product must be mixed as described; shaking will NOT provide adequate mixing.

Figure-8

8. After mixing, hold the syringes vertically (upright) with Syringe B (short, wide syringe) on the bottom. The syringes should remain securely coupled. Draw all of the mixed product into Syringe B by depressing the Syringe A plunger and slightly withdrawing the Syringe B plunger.

Figure-9

9. Unscrew Syringe A to decouple the syringes while continuing to push down on the Syringe A plunger. Note: Small air bubbles will remain in the formulation – this is acceptable.

step 10
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10. Continue to hold Syringe B upright with the open end at the top. Hold back the white plunger on Syringe B to prevent loss of the product and attach the safety needle cartridge. Gently screw clockwise with approximately a three-quarter turn until the needle is secure. Do not overtighten, as the hub may become damaged resulting in leakage of the product during injection. The safety sheath may also be damaged if the needle is screwed with too much force.

Figure11

11. (1) Move the safety sheath away from the needle and towards the syringe and (2) pull off the clear needle cartridge cover immediately prior to administration.

Note: Should the needle hub appear to be damaged, or leak, the product should NOT be used. The damaged needle should NOT be replaced and the product should NOT be injected. In the event of damage to the needle hub, use a new replacement ELIGARD® carton.

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