Fyremadel

Drug overview for FYREMADEL (ganirelix acetate):

Generic name: ganirelix acetate (GAN-i-REL-ix AS-e-tate)
Drug class: LHrH(GNrH) Antagonist, Pituitary Suppressant Agents
Therapeutic class: Endocrine

Ganirelix acetate, a synthetic decapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH, luteinizing hormone-releasing hormone, gonadorelin), is a GnRH antagonist.

No enhanced Uses information available for this drug.

DRUG IMAGES

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The following indications for FYREMADEL (ganirelix acetate) have been approved by the FDA:

Indications:
Prevention of luteinizing hormone surge when undergoing controlled ovarian hyperstimulation

Professional Synonyms:
Prevention of LH surge in COH
Prophylaxis of luteinizing hormone surge when undergoing controlled ovarian hyperstimulation

Dosing information for FYREMADEL
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
FYREMADEL 250 MCG/0.5 ML SYR	Maintenance	Adults inject 0.5 milliliter (250 mcg) by subcutaneous route once daily

Generic dosing information for GANIRELIX ACETATE
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
GANIRELIX ACET 250 MCG/0.5 ML	Maintenance	Adults inject 0.5 milliliter (250 mcg) by subcutaneous route once daily

Contraindication List
Lactation
Pregnancy

The following adverse reaction information is available for FYREMADEL (ganirelix acetate):

Overview
Severe
Less Severe

Adverse reaction overview.

Adverse effects of ganirelix occurring in at least 1% of treated individuals include neutrophil count of 8.3/mm3 or greater, gynecologic abdominal pain, fetal death, headache, ovarian hyperstimulation syndrome, vaginal bleeding, injection site reactions, nausea, and GI abdominal pain.

There are 5 severe adverse reactions.

More Frequent	Less Frequent
None.	Ovarian hyperstimulation syndrome

Rare/Very Rare
Anaphylaxis Angioedema Facial edema Hypersensitivity drug reaction

There are 13 less severe adverse reactions.

More Frequent	Less Frequent
None.	Abnormal vaginal bleeding Acute abdominal pain Drug-induced hot flash Dyspnea Fatigue Headache disorder Injection site sequelae Nausea Pain Rhinitis Upper respiratory infection

Rare/Very Rare
Dizziness Urticaria

The following precautions are available for FYREMADEL (ganirelix acetate):

Pediatric
Pregnant
Lactation
Geriatric

Not indicated.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Category X. (See Users Guide.) May result in fetal loss due to antigonadotropic properties. (See Cautions: Contraindications and also Major Toxicities.)

It is unknown whether ganirelix is distributed in breast milk; use in nursing women is not recommended.

Clinical studies did not include sufficient numbers of geriatric adults 65 years of age or older.

Prevention of LH surge in ovarian hyperstimulation
Z31.83	Encounter for assisted reproductive fertility procedure cycle
Z31.89	Encounter for other procreative management