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Ganirelix Acetate Injection Ganirelix Acetate Injection

Dosing

Dosing resources for patients

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General dosing information

  • After initiating follicle-stimulating hormone (FSH) therapy on Day 2 or 3 of the cycle, Ganirelix Acetate Injection 250 mcg may be administered subcutaneously once daily during the mid to late portion of the follicular phase. By taking advantage of endogenous pituitary FSH secretion, the requirement for exogenously administered FSH may be reduced.
  • Treatment with Ganirelix Acetate should be continued daily until the day of human chorionic gonadotropin (hCG) administration. When a sufficient number of follicles of adequate size are present, as assessed by ultrasound, final maturation of follicles is induced by administering hCG.
  • The administration of hCG should be withheld in cases where the ovaries are abnormally enlarged on the last day of FSH therapy to reduce the chance of developing OHSS (ovarian hyperstimulation syndrome).

Directions for using Ganirelix Acetate Injection

  1. Ganirelix Acetate Injection is supplied in a sterile, prefilled syringe and is intended for SUBCUTANEOUS administration only.
  2. Wash hands thoroughly with soap and water.
  3. The most convenient sites for SUBCUTANEOUS injection are in the abdomen around the navel or upper thigh.
  4. The injection site should be swabbed with a disinfectant to remove any surface bacteria. Clean about 2 inches around the point where the needle will be inserted and let the disinfectant dry for at least 1 minute before proceeding.
  5. With syringe held upward, remove needle cover.
  6. Pinch up a large area of skin between the finger and thumb. Vary the injection site a little with each injection.
  7. The needle should be inserted at the base of the pinched-up skin at an angle of 45–90° to the skin surface.
  8. When the needle is correctly positioned, it will be difficult to draw back on the plunger. If any blood is drawn into the syringe, the needle tip has penetrated a vein or artery. If this happens, withdraw the needle slightly and reposition the needle without removing it from the skin. Alternatively, remove the needle and use a new, sterile, prefilled syringe. Cover the injection site with a swab containing disinfectant and apply pressure; the site should stop bleeding within 1 or 2 minutes.
  9. Once the needle is correctly placed, depress the plunger slowly and steadily, so the solution is correctly injected and the skin is not damaged.
  10. Pull the syringe out quickly and apply pressure to the site with a swab containing disinfectant.
  11. Use the sterile, prefilled syringe only once and dispose of it properly.
Clinical Data

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.

Indications

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Indications:

Ganirelix Acetate Injection is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation.

Selected Safety Information +

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Selected Safety Information:

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…