ganirelix

REMS

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.

Action ⬆ ⬇

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

Therapeutic effects:

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

Pharmacokinetics ⬆ ⬇

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.

Time/Action Profile ⬆ ⬇

(blood levels)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	1 hr	unknown

Contraind./Precautions ⬆ ⬇

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.

Adv. Reactions/Side Effects ⬆ ⬇

GI: abdominal pain, nausea

GU: pelvic pain, OVARIAN HYPERSTIMULATION SYNDROME, vaginal bleeding

Local: injection site reactions

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

None reported.

Route/Dosage ⬆ ⬇

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).

Availability ⬆ ⬇

(Generic available)

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

Assessment ⬆ ⬇

Assess for latex allergy; packaging contains latex.

Lab Test Considerations:

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.

Implementation ⬆ ⬇

SC: Administer via SUBQ injection only.

Patient/Family Teaching ⬆ ⬇

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.

Evaluation/Desired Outcomes ⬆ ⬇

Successful in vitro fertilization procedure.

Canadian Brand Names ⬆ ⬇

Code ⬆

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

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇