Fyremadel (ganirelix acetate) injection

FYREMADEL® (ganirelix acetate) injection is used to prevent surges of luteinizing hormone (LH) in women undergoing controlled ovarian hyperstimulation. Premature surges in LH can cause ovulation to occur too early.¹

FYREMADEL has high antagonistic activity against naturally occurring gonadotropin-releasing hormone (GnRH) receptors.¹

FYREMADEL is rapidly absorbed following subcutaneous injection.¹

FYREMADEL comes in a convenient, ready-to-use, prefilled glass syringe, and does not require refrigeration.¹

Reference

1. FYREMADEL® (ganirelix acetate) injection. Prescribing Information. Ferring Pharmaceuticals Inc.

INDICATION AND IMPORTANT SAFETY INFORMATION

FYREMADEL® (ganirelix acetate) injection

INDICATION FOR USE

FYREMADEL® (ganirelix acetate) injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.

IMPORTANT SAFETY INFORMATION

Ganirelix acetate injection is contraindicated under the following conditions: Known hypersensitivity to ganirelix acetate or to any of its components, Known hypersensitivity to GnRH or any other GnRH analog, Known or suspected pregnancy.
Ganirelix acetate injection should be prescribed by physicians who are experienced in infertility treatment. Before starting treatment with ganirelix acetate, pregnancy must be excluded. Safe use of ganirelix acetate during pregnancy has not been established.
Special care should be taken in women with signs and symptoms of active allergic conditions.
Cases of hypersensitivity reactions, including anaphylactoid reactions, have been reported, as early as with the first dose, during postmarketing surveillance. In the absence of clinical experience, ganirelix acetate treatment is not advised in women with severe allergic conditions.
The packaging of this product contains natural rubber latex which may cause allergic reactions.
Most commonly reported adverse reactions (≥ 1%) reported in clinical trials were: Abdominal Pain (gynecological), Fetal Death, Headache, Ovarian Hyperstimulation Syndrome, Vaginal Bleeding, Injection Site Reaction, Nausea, Abdominal Pain (gastrointestinal).
During post marketing surveillance, rare cases of hypersensitivity reactions, including anaphylactoid reactions, have been reported, as early as with the first dose.
Major and minor congenital abnormalities have been reported in clinical follow-up studies of newborns of women administered ganirelix acetate injection. The causal relationship between these congenital anomalies and ganirelix acetate is unknown.

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Please see full Prescribing Information.

FYREMADEL® (ganirelix acetate) injection

INDICATION FOR USE

FYREMADEL® (ganirelix acetate) injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.

IMPORTANT SAFETY INFORMATION

Ganirelix acetate injection is contraindicated under the following conditions: Known hypersensitivity to ganirelix acetate or to any of its components, Known hypersensitivity to GnRH or any other GnRH analog, Known or suspected pregnancy.
Ganirelix acetate injection should be prescribed by physicians who are experienced in infertility treatment. Before starting treatment with ganirelix acetate, pregnancy must be excluded. Safe use of ganirelix acetate during pregnancy has not been established.