Firmagon

Drug overview for FIRMAGON (degarelix acetate):

Generic name: DEGARELIX ACETATE (DEG-a-REL-ix)
Drug class: LHrH(GNrH) Antagonist, Pituitary Suppressant Agents
Therapeutic class: Antineoplastics

Degarelix acetate, a gonadotropin-releasing hormone (GnRH, luteinizing hormone-releasing hormone (LHRH), gonadorelin) antagonist, is used as an antineoplastic agent.

No enhanced Uses information available for this drug.

DRUG IMAGES

FIRMAGON 2 X 120 MG KIT
FIRMAGON 80 MG KIT
FIRMAGON 120 MG VIAL

The following indications for FIRMAGON (degarelix acetate) have been approved by the FDA:

Indications:
Advanced prostatic carcinoma

Professional Synonyms:
Advanced cancer of prostate gland
Advanced malignant neoplasm of prostate
Advanced prostate cancer
Advanced prostate malignancy
Advanced prostatic cancer

Dosing information for FIRMAGON
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
FIRMAGON 80 MG KIT	Maintenance	Adults inject 80 mg by subcutaneous route every 28 days in the abdomen rotating injection sites
FIRMAGON 120 MG VIAL	Maintenance	Adults inject 240 mg as 2 equally divided injections by subcutaneous route once in the abdomen using 2 separate injection sites
FIRMAGON 2 X 120 MG KIT	Maintenance	Adults inject 240 mg as 2 equally divided injections by subcutaneous route once in the abdomen using 2 separate injection sites

The following contraindication information is available for FIRMAGON (degarelix acetate):

Overview
Contraindicated
Severe
Moderate

Drug contraindication overview.

Known hypersensitivity to degarelix or any ingredient in the formulation. Degarelix is not indicated for use in women; the drug is contraindicated in women who are or may become pregnant. (See Fetal/Neonatal Morbidity and Mortality under Cautions: Warnings/Precautions and also see Pregnancy under Warnings/Precautions: Specific Populations, in Cautions.)

There are 0 contraindications.

There are 6 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Chronic heart failure
Congenital long QT syndrome
Hypokalemia
Hypomagnesemia
Pregnancy
Prolonged QT interval

There are 2 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Disease of liver
Osteopenia

The following adverse reaction information is available for FIRMAGON (degarelix acetate):

Overview
Severe
Less Severe

Adverse reaction overview.

Adverse effects reported in 5% or more of patients receiving degarelix in the open-label clinical study include injection site reactions (e.g., pain, erythema, swelling, induration, nodule), hot flashes, weight gain, increased transaminase and gamma-glutamyltransferase (gamma-glutamyltranspeptidase, GGT, GGTP) concentrations, hypertension, back pain, fatigue, chills, arthralgia, constipation, and urinary tract infection.

There are 4 severe adverse reactions.

More Frequent	Less Frequent
None.	Hypertension

Rare/Very Rare
Anaphylaxis Angioedema Osteopenia

There are 23 less severe adverse reactions.

More Frequent	Less Frequent
Abnormal hepatic function tests Fatigue Flushing Injection site sequelae Weight gain	Arthralgia Chills Constipation Diarrhea Dizziness Erectile dysfunction Fever General weakness Gynecomastia Headache disorder Hyperhidrosis Induration of skin Insomnia Nausea Night sweats Testicular atrophy Urinary tract infection

Rare/Very Rare
Urticaria

The following precautions are available for FIRMAGON (degarelix acetate):

Pediatric
Pregnant
Lactation
Geriatric

Safety and efficacy have not been established in pediatric patients.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Category X. (See Cautions: Contraindications and also see Fetal/Neonatal Morbidity and Mortality under Cautions: Warnings/Precautions.)

Not known whether degarelix is distributed into milk. Degarelix is not indicated for use in women. (See Cautions: Contraindications.)

In clinical studies of degarelix, approximately 82% of the patients were 65 years of age or older, and 42% were 75 years of age or older. No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out. (See Dosage and Administration: Special Populations.)

Advanced prostatic carcinoma
C61	Malignant neoplasm of prostate