July 26, 2016
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Eligard

"Prostate cancer often has no early symptoms and usually grows very slowly. More than half of prostate cancers remain localized to the prostate and don’t become life-threatening. They can be treated with surgery or radiation, and in some "...

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Eligard




Indications
Dosage
How Supplied

INDICATIONS

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

DOSAGE AND ADMINISTRATION

As with other similar agents, the use of gloves is recommended during mixing and administration.

ELIGARD® is administered s ubcutaneous ly 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 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 Procedure

IMPORTANT: Allow the product to reach room temperature before mixing. Once mixed, the product must be administered within 30 minutes or it should be discarded.

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

ELIGARD® is packaged in two thermoformed trays. Each carton contains:

  • One sterile syringe (Syringe A) pre-filled with the ATRIGEL Delivery System
  • One sterile syringe (Syringe B) pre-filled with leuprolide acetate powder
  • One long white plunger rod for use with Syringe B
  • One sterile needle or One sterile safety needle
  • Desiccant pack(s)

1. On a clean field, open all of the packages and remove the contents. Discard the desiccant pack(s).

Figure 1 and 2

Blue and white plungers - Illustration

2. Pull out the short blue plunger rod with attached grey s topper from Syringe B and discard (Figure 1). Twist the long, white replacement plunger rod into the gray primary stopper remaining in Syringe B (Figure 2).

Figure 3 and 4

Removing caps from the syringes - Illustration

3. Unscrew and discard the clear cap from Syringe A (Figure 3). Remove and discard the gray rubber cap from Syringe B (Figure 4).

Figure 5

Join the two syringes together - Illustration

4. Join the two syringes together by pushing and twisting until secure (Figure 5).

Figure 6

Thoroughly mix the product - Illustration

5. Inject the liquid contents of Syringe A into Syringe B that contains the leuprolide acetate powder. Thoroughly mix the product for approximately 45 seconds by pushing the contents back and forth between both syringes to obtain a uniform suspension (Figure 6). 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). Pleas e Note: Product must be mixed as described; shaking will NOT provide adequate mixing of the product.

Figure 7

Unscrew Syringe A to decouple the syringes while continuing to push down on the Syringe A plunger - Illustration

6. After mixing, 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. Unscrew Syringe A to decouple the syringes while continuing to push down on the Syringe A plunger (Figure 7). Note: Small air bubbles will remain in the formulation – this is acceptable.

Figure 8,9 and 10

Attaching the needle cartridge to the end of Syringe B - Illustration

[Applies to ELIGARD® single use kit of a two syringe-mixing system with sterile needle]

7. Hold Syringe B vertically. Remove and discard the cap on the bottom of the sterile needle cartridge by twisting it (Figure 8). Attach the needle cartridge to the end of Syringe B (Figure 9) by pushing in and turning the needle until it is firmly seated. Do not overtwist the needle onto the syringe because the thread may become stripped. Pull off the clear needle cartridge cover prior to administration (Figure 10).

Figure 11,12 and 13

Securing the needle to the end of Syringe - Illustration

[Applies to ELIGARD® single use kit of a two syringe-mixing system with sterile safety needle]

8. Hold Syringe B vertically. Open the sterile safety needle package by peeling back the paper tab and remove the safety needle (Figure 11). Secure the needle to the end of Syringe B by holding the protective needle sheath and twisting the syringe clockwise to fully seat the needle (Figure 12). Do not over twist the needle onto the syringe because the thread may become stripped. Remove the protective needle sheath prior to administration (Figure 13).

Administration Procedure

IMPORTANT: Allow the product to reach room temperature before mixing. Once mixed, the product must be administered within 30 minutes or it should be discarded.

1. Choose 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. Since you can vary the injection site for subcutaneous injections, choose an area that hasn't recently been used.

2. Cleanse the injection-site area with an alcohol swab.

3. Using the thumb and forefinger of your non-dominant hand, grab and bunch the area of skin around the injection site.

Figure 13a

Grab and bunch the area of skin around the injection site -  Illustration

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 with your nondominant hand.

Figure 13b

Insert the needle quickly at a 90° angle to the skin surface - Illustration

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

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

Figure 14, 15, 16 and 17

Activating the safety shield on the needle - Illustration

[Step 7 only applies to ELIGARD® single use kit of a two syringe-mixing system with sterile safety needle]

7. Immediately following the withdrawal of the needle, activate the safety shield on the needle by using a thumb (Figure 14) or finger (Figure 15) or a flat surface (Figure 16) to push the safety shield forward until it completely covers the needle tip and locks into place. An audible and tactile “click” verifies a locked position for the safety shield (Figure 17).

8. Discard all components safely in an appropriate biohazard container.

HOW SUPPLIED

Dosage Forms And Strengths

ELIGARD® is an injectable suspension of leuprolide acetate available in a single use kit. The kit consists of a two-syringe mixing system, a sterile needle or a sterile safety needle (Table 2), a silica gel desiccant pouch to control moisture uptake, and a package insert for constitution and administration procedures. Each syringe is individually packaged. One contains the ATRIGEL Delivery System and the other contains leuprolide acetate powder. When constituted, ELIGARD® is administered as a single dose.

Table 2: ELIGARD® Needle specifications

ELIGARD® formulation Sterile needle Sterile safety needle
Gauge Length Gauge Length
7.5 mg 20-gauge ½-inch 20- gauge 5/8-inch
22.5 mg 20-gauge ½-inch gauge 5/8-inch
30 mg 20-gauge 5/8-inch 20- gauge 5/8-inch
45 mg 18-gauge 5/8-inch 18- gauge 5/8-inch

Storage And Handling

ELIGARD® is available in a single use kit of a two syringe-mixing system with a sterile needle in the following strengths:

ELIGARD® 7.5 mg – NDC 62935-752-75
ELIGARD® 22.5 mg – NDC 62935-222-05
ELIGARD® 30 mg – NDC 62935-302-30
ELIGARD® 45 mg – NDC 62935-452-45

ELIGARD® is available in a single use kit of a two syringe-mixing system with a sterile safety needle in the following strengths:

ELIGARD® 7.5 mg – NDC 62935-753-75
ELIGARD® 22.5 mg – NDC 62935-223-05
ELIGARD® 30 mg – NDC 62935-303-30
ELIGARD® 45 mg – NDC 62935-453-45

Storage

Store at 2 - 8 °C (35.6 - 46.4 °F)

Once outside the refrigerator this product may be stored in its original packaging at room temperature 15 – 30 °C (59 – 86 °F) for up to eight weeks prior to mixing and administration.

Manufactured by: TOLMAR Inc., Fort Collins, CO 80526. for: TOLMAR Therapeutics, Inc. Fort Collins, CO 80526. Distributed by: TOLMAR Pharmaceuticals, Inc., Fort Collins, CO 80526. Revised: Feb 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/25/2016

Indications
Dosage
How Supplied

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