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Eligard Dosage

Generic name: LEUPROLIDE ACETATE 7.5mg in 0.25mL;
Dosage form: injectable suspension

Medically reviewed by Drugs.com. Last updated on Mar 26, 2020.

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 every
month

1 injection every
3 months

1 injection every
4 months

1 injection every
6 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 1-1Figure 1-2 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

2. Pull out (do not unscrew) the short blue plunger rod with attached gray stopper from Syringe B and discard.

Figure 3

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

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

Figure-6

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

Figure-7

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

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.

2.2 Administration Procedure

Figure 2-2-1

1. Select an injection site on the abdomen, upper buttocks, or another location with adequate amounts of subcutaneous tissue that does not have excessive pigment, nodules, lesions, or hair and hasn’t recently been used.

2. Cleanse the injection-site area with an alcohol swab (not enclosed).

3. Using the thumb and forefinger, grab and bunch the area of skin around the injection site.

Figure 2-2-2

4. Using your dominant hand, insert the needle quickly at a 90° angle to the skin surface. The depth of penetration will depend on the amount and fullness of the subcutaneous tissue and the length of the needle. After the needle is inserted, release the skin.

5. Inject the drug using a slow, steady push and press down on the plunger until the syringe is empty.

6. Withdraw the needle quickly at the same 90° angle used for insertion.

Figure-7Figure 7-2

7. Immediately following the withdrawal of the needle, activate the safety shield using a finger/thumb or flat surface and push until it completely covers the needle tip and locks into place.

Figure-2-8-8Figure 2-8-9

8. An audible and tactile “click” verifies a locked position.

9. Check to confirm the safety sheath is fully engaged. Discard all components safely in an appropriate biohazard container.


Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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