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Firmagon Generic Name & Formulations
Legal Class
Rx
General Description
Degarelix 80mg/vial, 120mg/vial; pwd for SC inj after reconstitution.
Pharmacological Class
GnRH antagonist.
How Supplied
Treatment Initiation pack (120mg/vial)—2 (w. supplies); Treatment Maintenance pack (80mg/vial)—1 (w. supplies)
Manufacturer
Firmagon Indications
Indications
Advanced prostate cancer.
Firmagon Dosage and Administration
Adult
Give by SC inj in abdomen once every 28 days; avoid waist and rib areas. Two 120mg injections once, then one 80mg inj once every 28 days.
Children
Not established.
Firmagon Contraindications
Not Applicable
Firmagon Boxed Warnings
Not Applicable
Firmagon Warnings/Precautions
Warnings/Precautions
Congenital long QT syndrome. CHF. Correct electrolyte abnormalities. Monitor electrolytes and ECG periodically. Monitor serum PSA. Discontinue if serious hypersensitivity reaction occurs; do not rechallenge. Moderate or severe renal impairment (CrCl <50mL/min). Severe hepatic impairment. Embryo-fetal toxicity. Pregnancy. Nursing mothers: not recommended.
Firmagon Pharmacokinetics
See Literature
Firmagon Interactions
Interactions
Caution with concomitant drugs known to prolong the QT interval.
Firmagon Adverse Reactions
Adverse Reactions
Inj site reactions (eg, pain, erythema, swelling, induration), hot flashes, increased weight, fatigue, increased transaminases, increased gamma-glutamyltransferase; QT prolongation.
Firmagon Clinical Trials
See Literature
Firmagon Note
Not Applicable
Firmagon Patient Counseling
See Literature
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