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.

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.

(Generic available)

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

SUBQ (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).

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.

Therapeutic Classification: hormones (gonadotropin-releasing hormone antagonist)

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)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	1 hr	unknown

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.

NDC Code

0548- Amphastar Pharmaceuticals, Inc.
- 0548-5001- Ganirelix Acetate
  - 0548-5001-00- 1 SYRINGE in 1 CARTON (0548-5001-00) / .5 mL in 1 SYRINGE

14403- Hybio Pharmaceutical Co., Ltd.
- 14403-0011-
  - 14403-0011-1- 10 BAG in 1 CANISTER (14403-0011-1) / 15 g in 1 BAG

14403- Hybio Pharmaceutical Co., Ltd.
- 14403-0011-
  - 14403-0011-2- 30 BAG in 1 CANISTER (14403-0011-2) / 10.5 g in 1 BAG

32861- Chengdu Shengnuo Biopharm Co. Ltd.
- 32861-0009-
  - 32861-0009-1- 1 kg in 1 BOTTLE (32861-0009-1)

35207- BCN PEPTIDES SA
- 35207-0010-
  35207-0010-5- 500 g in 1 BOTTLE (35207-0010-5)

42973- APICORE PHARMACEUTICALS PRIVATE LIMITED
- 42973-325-
  42973-325-00- 50 kg in 1 DRUM (42973-325-00)

55566- Ferring Pharmaceuticals Inc.
- 55566-1010- Fyremadel
  55566-1010-1- 1 BLISTER PACK in 1 CARTON (55566-1010-1) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE

59651- Aurobindo Pharma Limited
- 59651-592-
  - 59651-592-37- 1 kg in 1 BOTTLE, GLASS (59651-592-37)

60870- Aspen Oss B.V.
- 60870-0476-
  60870-0476-0- 30 g in 1 BOTTLE, GLASS (60870-0476-0)

65219- Fresenius Kabi USA, LLC
- 65219-028- Ganirelix Acetate
  65219-028-05- 1 SYRINGE, GLASS in 1 CARTON (65219-028-05) / 1 mL in 1 SYRINGE, GLASS

67184- Qilu Pharmaceutical Co., Ltd.
- 67184-0574- Ganirelix Acetate
  - 67184-0574-1- 1 BLISTER PACK in 1 CARTON (67184-0574-1) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS

68083- Gland Pharma Limited
- 68083-472- GANIRELIX ACETATE
  - 68083-472-01- 1 BLISTER PACK in 1 CARTON (68083-472-01) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS

70700- Xiromed LLC
- 70700-327- Ganirelix Acetate
  - 70700-327-98- 1 SYRINGE, GLASS in 1 CARTON (70700-327-98) / 1 mL in 1 SYRINGE, GLASS

70748- Lupin Pharmaceuticals, Inc.
- 70748-274- Ganirelix Acetate
  - 70748-274-01- 1 TRAY in 1 CARTON (70748-274-01) / 1 SYRINGE, GLASS in 1 TRAY / 1 mL in 1 SYRINGE, GLASS

71288- Meitheal Pharmaceuticals Inc.
- 71288-554- Ganirelix Acetate
  - 71288-554-80- 1 BLISTER PACK in 1 CARTON (71288-554-80) / 1 SYRINGE, GLASS in 1 BLISTER PACK / .5 mL in 1 SYRINGE, GLASS

78206- Organon LLC
- 78206-138- Ganirelix Acetate
  - 78206-138-01- 1 BLISTER PACK in 1 CARTON (78206-138-01) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS

78206- Organon LLC
- 78206-138- Ganirelix Acetate
  - 78206-138-02- 1 BLISTER PACK in 1 CARTON (78206-138-02) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS

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