Ganirelix Acetate Injection is a gonadotropin-releasing hormone (GnRH) antagonist for the inhibition of premature luteinizing hormone (LH) surges for women undergoing controlled ovarian hyperstimulation.
Ganirelix Acetate Injection induces a rapid, reversible suppression of gonadotropin secretion.
The suppression of pituitary LH secretion by Ganirelix Acetate is more pronounced than that of follicle-stimulating hormone (FSH). An initial release of endogenous gonadotropins has not been detected with Ganirelix Acetate, which is consistent with an antagonist effect. Upon discontinuation of Ganirelix Acetate, pituitary LH and FSH levels are fully recovered within 48 hours.
Maximum serum concentrations reached approximately 1 hour after dosing.
A gonadotropin-releasing hormone (GnRH) antagonist available in a ready-to-use prefilled syringe
Mean duration of treatment: 5.4 days (range 2–14 days)a
No mixing required
Supplied in disposable, sterile, prefilled 1-mL glass syringes containing 250 mcg/0.5 mL of Ganirelix Acetate
Each Ganirelix Acetate sterile, prefilled syringe is affixed with a 27-gauge x 0.5-inch needle and is blister packed
Room temperature storage: 25°C (77°F)
Small injection volume: 0.5 mL for subcutaneous administration
(a) Results from a multicenter, open-label randomized study to assess the efficacy and safety of Ganirelix Acetate Injection in women undergoing controlled ovarian hyperstimulation (range 2–14 days).
Ganirelix Acetate Injection is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation.
Selected Safety Information
Contraindications
Ganirelix Acetate Injection is contraindicated in patients with a known hypersensitivity to Ganirelix Acetate or to any of its components including dry natural rubber/latex which may be contained in the rigid needle shield, known hypersensitivity to gonadotropin-releasing hormone (GnRH) or any other GnRH analogue, and in patients with known or suspected pregnancy.
Warnings and Precautions
Ganirelix Acetate Injection should be prescribed by physicians who are experienced in infertility treatment. Before starting treatment with Ganirelix Acetate, pregnancy must be excluded.
Special care should be taken in women with signs and symptoms of active allergic conditions. Cases of hypersensitivity reactions (both generalized and local), including anaphylaxis (including anaphylactic shock), angioedema and urticaria, have been reported with Ganirelix Acetate, as early as with the first dose, during post-marketing surveillance. If a hypersensitivity reaction is suspected, Ganirelix Acetate should be discontinued and appropriate treatment administered. In the absence of clinical experience, Ganirelix Acetate treatment is not advised in women with severe allergic conditions.
Prior to therapy with Ganirelix Acetate Injection, patients should be informed of the duration of treatment and the monitoring procedures that will be required.
The rigid needle shield of this product contain dry natural rubber/latex which comes into contact with this product and may cause allergic reactions.
Ganirelix Acetate should not be used by lactating women.
Adverse Reactions
The most common adverse events occurring in ≥1% of patients treated with Ganirelix Acetate Injection in clinical studies (N=794) include: abdominal pain (gynecological) (4.8%), fetal death (3.7%), headache (3.0%), ovarian hyperstimulation syndrome (OHSS) (2.4%), vaginal bleeding (1.8%), injection site reaction (1.1%), nausea (1.1%), and abdominal pain (gastrointestinal) (1.0%).
Before prescribing Ganirelix Acetate Injection, please read the accompanying Prescribing Information.
Ganirelix Acetate Injection is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation.
Ganirelix Acetate Injection is contraindicated in patients with a known hypersensitivity to Ganirelix Acetate or to any of its components including dry natural rubber/latex which may be contained in the rigid needle shield, known hypersensitivity to gonadotropin-releasing hormone (GnRH) or any other GnRH or any other GnRH analogue, and in patients with 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. Special care should be taken in women with signs and symptoms of active allergic conditions…
Indications
Ganirelix Acetate Injection is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation.
Selected Safety Information
Contraindications
Ganirelix Acetate Injection is contraindicated in patients with a known hypersensitivity to Ganirelix Acetate or to any of its components including dry natural rubber/latex which may be contained in the rigid needle shield, known hypersensitivity to gonadotropin-releasing hormone (GnRH) or any other GnRH analogue, and in patients with known or suspected pregnancy.
Warnings and Precautions
Ganirelix Acetate Injection should be prescribed by physicians who are experienced in infertility treatment. Before starting treatment with Ganirelix Acetate, pregnancy must be excluded.
Special care should be taken in women with signs and symptoms of active allergic conditions. Cases of hypersensitivity reactions (both generalized and local), including anaphylaxis (including anaphylactic shock), angioedema and urticaria, have been reported with Ganirelix Acetate, as early as with the first dose, during post-marketing surveillance. If a hypersensitivity reaction is suspected, Ganirelix Acetate should be discontinued and appropriate treatment administered. In the absence of clinical experience, Ganirelix Acetate treatment is not advised in women with severe allergic conditions.
Prior to therapy with Ganirelix Acetate Injection, patients should be informed of the duration of treatment and the monitoring procedures that will be required.
The rigid needle shield of this product contain dry natural rubber/latex which comes into contact with this product and may cause allergic reactions.
Ganirelix Acetate should not be used by lactating women.
Adverse Reactions
The most common adverse events occurring in ≥1% of patients treated with Ganirelix Acetate Injection in clinical studies (N=794) include: abdominal pain (gynecological) (4.8%), fetal death (3.7%), headache (3.0%), ovarian hyperstimulation syndrome (OHSS) (2.4%), vaginal bleeding (1.8%), injection site reaction (1.1%), nausea (1.1%), and abdominal pain (gastrointestinal) (1.0%).
Before prescribing Ganirelix Acetate Injection, please read the accompanying Prescribing Information.
Indications and Selected Safety Information
Indications
Ganirelix Acetate Injection is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation.
Selected Safety Information
Contraindications
Ganirelix Acetate Injection is contraindicated in patients with a known hypersensitivity to Ganirelix Acetate or to any of its components including dry natural rubber/latex which may be contained in the rigid needle shield, known hypersensitivity to gonadotropin-releasing hormone (GnRH) or any other GnRH analogue, and in patients with known or suspected pregnancy.
Warnings and Precautions
Ganirelix Acetate Injection should be prescribed by physicians who are experienced in infertility treatment. Before starting treatment with Ganirelix Acetate, pregnancy must be excluded.
Special care should be taken in women with signs and symptoms of active allergic conditions. Cases of hypersensitivity reactions (both generalized and local), including anaphylaxis (including anaphylactic shock), angioedema and urticaria, have been reported with Ganirelix Acetate, as early as with the first dose, during post-marketing surveillance. If a hypersensitivity reaction is suspected, Ganirelix Acetate should be discontinued and appropriate treatment administered. In the absence of clinical experience, Ganirelix Acetate treatment is not advised in women with severe allergic conditions.
Prior to therapy with Ganirelix Acetate Injection, patients should be informed of the duration of treatment and the monitoring procedures that will be required.
The rigid needle shield of this product contain dry natural rubber/latex which comes into contact with this product and may cause allergic reactions.
Ganirelix Acetate should not be used by lactating women.
Adverse Reactions
The most common adverse events occurring in ≥1% of patients treated with Ganirelix Acetate Injection in clinical studies (N=794) include: abdominal pain (gynecological) (4.8%), fetal death (3.7%), headache (3.0%), ovarian hyperstimulation syndrome (OHSS) (2.4%), vaginal bleeding (1.8%), injection site reaction (1.1%), nausea (1.1%), and abdominal pain (gastrointestinal) (1.0%).
Before prescribing Ganirelix Acetate Injection, please read the accompanying Prescribing Information.
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