ga-ni-RELL-ix

Therapeutic Classification: hormones (gonadotropin-releasing hormone antagonist)

• As a component of infertility regimens (with recombinant follicle stimulating hormone [FSH], and human chorionic gonadotropin) to inhibit premature luteinizing hormone (LH) surges in patients undergoing controlled ovarian hyperstimulation.

• Induces a rapid, reversible suppression of gonadotropin (FSH and LH) secretion, which suppresses surges in LH. Ganirelix is a gonadotropin-releasing hormone antagonist.

• Suppression of LH surges increases the implantation and pregnancy rates in patients undergoing in vitro fertilization.

Absorption: Well absorbed following SUBQ administration.

Distribution: Well distributed to extravascular tissues.

Metabolism/Excretion: Metabolized to two primary metabolites; 18% excreted unchanged in urine.

Half-life: 16 hr.

(blood levels)

Contraindicated in:

• Hypersensitivity to ganirelix, gonadotropin releasing hormone or any of its analogs
• OB: Pregnancy (may cause fetal harm)
• Lactation: Lactation.

Use Cautiously in:

• None noted.

GI: abdominal pain, nausea.

GU: pelvic pain, OVARIAN HYPERSTIMULATION SYNDROME, vaginal bleeding.

Local: injection site reactions.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS).

Drug-Drug:

• None reported.

• SC (Adults): 250 mcg once daily during the mid-to-late follicular phase of menstrual cycle after initiating FSH on day 2 or 3 of cycle. Treatment should be continued daily until day of administration of human chorionic gonadotropin (when adequate follicular response achieved).

(Generic available)

• Solution for injection (prefilled syringes): 250 mcg/0.5 mL;

• Assess for latex allergy; packaging contains latex.

• Assess patient for pregnancy prior to therapy. Therapy should not be initiated if patient is pregnant.May cause elevated neutrophil counts and decreased hematocrit and total bilirubin concentrations.

• SC: Administer via SUBQ injection only.

• Instruct patient on correct technique for SUBQ injection, and care and disposal of equipment. Most convenient sites are in the abdomen around the navel and in the upper thigh.
• Advise patient to notify health care professional immediately if signs and symptoms of ovarian hyperstimulation syndrome (abdominal pain, abdominal bloating or increased waist size, nausea, vomiting, diarrhea, tenderness in area of ovaries, rapid weight gain of >2.2 pounds in 24 hr, blood clots, decreased urination, shortness of breath, tight or enlarged abdomen) occur.
• Advise female patient of reproductive potential to notify health care professional if pregnancy is suspected.

• Successful in vitro fertilization procedure.

Orgalutran

NDC Code^*

• 0052- Organon USA Inc.
  • 0052-0301- Ganirelix Acetate
    • 0052-0301-51- 1 BLISTER PACK in 1 CARTON (0052-0301-51) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS

• 0052- Organon USA Inc.
  • 0052-0301- Ganirelix Acetate
    • 0052-0301-81- 1 BLISTER PACK in 1 CARTON (0052-0301-81) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS

• 55566- FERRING PHARMACEUTICALS INC.
  • 55566-1000- Ganirelix Acetate
    • 55566-1000-1- 1 BLISTER PACK in 1 CARTON (55566-1000-1) > 1 SYRINGE in 1 BLISTER PACK >.5 mL in 1 SYRINGE

• 62756- Sun Pharmaceutical Industries, Inc.
  • 62756-072- Ganirelix Acetate
    • 62756-072-40- 1 BLISTER PACK in 1 CARTON (62756-072-40) > 1 SYRINGE in 1 BLISTER PACK >.5 mL in 1 SYRINGE