Mixing

Mixing

Follow the step-by-step instructions below, or watch the full mixing & administration training video.

Video: steps to administer ELIGARD

Step 1

Video: step 1

Pull out (do NOT unscrew) the short blue plunger rod with attached gray stopper from Syringe B. Discard both the blue plunger and attached gray stopper.

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

Step 2

Video: step 2

Unscrew and discard the clear cap from Syringe A. Remove and discard the gray rubber cap from Syringe B.

Step 3

Video: step 3

Join the two syringes together by pushing and gently screwing until secure. Be sure to not overtighten.

Step 4

Video: step 4

Inject the liquid contents of Syringe A into the leuprolide acetate powder of Syringe B.

Mix the product for 45 seconds by pushing the contents back and forth between both syringes to obtain a uniform suspension (This is a great time to set expectations for the injection with the patient).

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.

Step 5

Video: step 5

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.

Step 6

Video: step 6

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

Note: Do not attempt to remove small air bubbles that remain in the formulation – this is acceptable for subcutaneous injections.

Step 7

Video: step 7

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.

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

Note: Should the needle hub appear to be damaged, or leak, ELIGARD 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 and contact our Product support line at 1-844-4TOLMAR (1-844-486-5627) or tolmarproductsupport@tolmar.com.

IMPORTANT SAFETY INFORMATION

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ELIGARD®, (leuprolide acetate) for injectable suspension, is indicated for the palliative treatment of advanced prostate cancer.

ELIGARD is contraindicated in patients with hypersensitivity to GnRH, GnRH agonists, or any of the components of ELIGARD. Anaphylactic reactions to synthetic GnRH or GnRH agonists have been reported in the literature. Transient increase in serum levels of testosterone during treatment may result in worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment, including bone pain, neuropathy, hematuria, bladder outlet obstruction, ureteral obstruction, or spinal cord compression. Monitor patients at risk closely and manage as appropriate.

Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Monitor blood glucose level and manage according to current clinical practice. Increased risk of myocardial infarction, sudden cardiac death and stroke has also been reported with use of GnRH agonists in men. Monitor for cardiovascular disease and manage according to current clinical practice. Androgen deprivation therapy may prolong the QT/QTc interval. Consider risks and benefits. May cause fetal harm. Convulsions have been observed in patients taking leuprolide acetate with or without a history of predisposing factors. Manage convulsions according to current clinical practice.

ELIGARD may impair fertility in males of reproductive potential.

The most common injection site adverse events are transient burning and stinging, pain, bruising, and erythema. The most common systemic adverse events include mild to severe hot flashes/sweats, malaise and fatigue, weakness, myalgia, dizziness, clamminess, testicular atrophy, and gynecomastia. As with other GnRH agonists, other adverse reactions, including decreased bone density and rare cases of pituitary apoplexy have been reported.

See package insert for full prescribing and safety information.

Please see full Prescribing Information for ELIGARD and full Prescribing Information for ELIGARD with Pre-connected Syringe System.