Frågedatum: 2016-05-10
RELIS database 2016; id.nr. 24688, DRUGLINE
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Could Thyrogen powder for solution for injection be reconstituted with saline



Fråga: Could Thyrogen powder for solution for injection be reconstituted with saline (Natriumklorid Braun Infusionsvätska lösning 9 mg/ml) instead of water for injection (Sterilt vatten Braun spädningsvätska för parenteral användning) without risking adverse drug reactions?

Sammanfattning: Thyrogen powder for solution for injection has to be mixed with water for injection. The marketing authorisation holder does not recommend that the powder is mixed with saline due to the risk of getting an instable and hypertonic formulation, and also due to an increased risk of injection related reactions.

Svar: Thyrogen contains thyrotropin alfa (recombinant human thyroid stimulating hormone (rhTSH)), a heterodimeric glycoprotein produced by recombinant DNA technology. Thyrogen is indicated for use with serum thyroglobulin (Tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post-thyroidectomy patients maintained on hormone suppression therapy (THST). The recommended dose regimen is two doses of 0.9 mg thyrotropin alfa administered at a 24-hour interval by intramuscular injection only (1).

The marketing authorisation holder Sanofi Genzyme has not studied the stability of Thyrogen when mixed in solutions other than water for injection. Thyrogen needs to be mixed with water for injection for adequate solubilisation of the rhTSH protein. Also, by adding water for injection, the ionic strength and pH of the final solution are acceptable to provide stability for storage up to 24 hours in a refrigerator (2°C - 8°C), which has been formally demonstrated, and reported in the Summary of Product Characteristics (2). If Thyrogen is reconstituted with saline, the result would be a hypertonic formulation and this could cause an injection site reaction for the patient (2). Thyrogen : EPAR - Product Information Personal contact Genzyme Corp. Sanofi AB Medical Information, sanofi. Drugsafety. STO@sanofi.com

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