Page 2: Health Product InfoWatch - January 2017

New health product safety information

The following topics have been selected to raise awareness and, in some cases, to stimulate reporting of similar adverse reactions.

Medication error alert

Eligard (leuprolide acetate): Reconstitution and administration errors and risk of lack of efficacy

Key points

  • Reconstitution and route of administration errors have been reported with Eligard which could compromise the clinical efficacy of the product.
  • Eligard must only be administered after reconstituting the leuprolide acetate component with the Atrigel Delivery System, following proper mixing procedures, in order to provide the continued sustained release of leuprolide.
  • Eligard must be administered via subcutaneous injection only.

Eligard (leuprolide acetate) is a gonadotropin-releasing hormone agonist. It is indicated for the palliative treatment of advanced prostate cancer (stage D2)Footnote 1 and has been marketed in Canada since 2003. Eligard is an extended release formulation of leuprolide acetate available as 1-month (7.5 mg), 3-month (22.5 mg), 4-month (30 mg) and 6-month (45 mg) subcutaneous injections to be administered by a healthcare professional.Footnote 1 The product is intended to provide sustained levels of leuprolide, over the respective dosing intervals, resulting in continuous testosterone suppression.

Health Canada has reviewed Canadian reports of handling errors involving incorrect reconstitution and route of administration with Eligard, which could compromise the clinical efficacy of the product.Footnote 2

Some of the errors reported with Eligard described inadequate mixing of the product. The product consists of 2 separate prefilled syringes. One syringe contains the active ingredient, leuprolide acetate powder, and the other contains the Atrigel Delivery System to reconstitute the product. In order to thoroughly mix the product, it must first be allowed to reach room temperature by removing from the refrigerator at least 30 minutes before mixing.Footnote 1 The two syringes must then be joined together and the contents pushed back and forth between syringes for approximately 45 seconds until uniform. Shaking will not provide adequate mixing of the product. Once mixed, Eligard must be administered within 30 minutes, as the viscosity of the reconstituted product increases with time. If not used within this timeframe, the reconstituted product should be discarded.

Other medication errors involved the administration of leuprolide acetate after reconstitution with a diluent other than the supplied Atrigel Delivery System. In certain cases, the leuprolide acetate powder was mixed with saline or sterile water. As leuprolide has an elimination half-life of approximately 3.6 hours when administered subcutaneously,Footnote 3 the sustained release and intended efficacy period of Eligard is compromised if the leuprolide acetate is not reconstituted with the Atrigel Delivery System.

Some medication errors also included cases of incorrect route of administration where the product was administered intramuscularly instead of by the intended subcutaneous route. Eligard is approved for subcutaneous administration only. The Canadian product monograph does not include information pertaining to either efficacy or clinical outcomes if administered via the intramuscular route.

The Warnings and Precautions and Dosage and Administration sections of the Canadian product monograph have recently been updated to include the risk of lack of clinical efficacy due to incorrect reconstitution or administration of Eligard. The package labels and educational materials have also been updated to highlight key information for healthcare professionals.

Healthcare professionals are reminded to consult the updated Eligard Canadian product monograph or the package insert for detailed mixing and administration procedure information. Healthcare professionals are also advised to consider additional testosterone level monitoring in cases of suspected or known handling errors with Eligard.

Did you know?

Other continuous sustained release leuprolide acetate injectable products authorized for sale in Canada require administration via the intramuscular route. Eligard must be administered via subcutaneous injection only.

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