Firmagon Infusion
Degarelix
80mg
Ferring GmbH
| Pack size | 1 Glass Vial (Dry Powder )+ 1 Solvent Vial (6ml) + Kit |
|---|---|
| Dispensing mode | POM |
| Source | GERMANY |
| Agent | PHARMATRADE |
| Retail Price | 1114.50 AED |
Available as:
Indications
Firmagon Infusion is used for:
Hormone-dependent Advanced Prostate Carcinoma (Stage D)
Adult Dose
Subcutaneous
Advanced prostate cancer
Adult: Loading dose: As 40 mg/mL solution: 240 mg (given as 2 separate injections of 120 mg). Maintenance: As 20 mg/mL solution: 80 mg once every 28 days, starting 28 days after the initial dose. Doses are administered in the abdominal area.
Hepatic Impairment
Mild-to-moderate: Dose adjustment not necessary
Severe: Safety and efficacy not established; use caution
Child Dose
Renal Dose
Renal Impairment
>50 mL/min: Dose adjustment not necessary
<50 mL/min: Use caution
Administration
Initiation pack contains 2 vials each with 120 mg per vial & 6 mL sterile water for injection diluent
Withdraw 3 mL of sterile water for injection diluent (supplied) & add to 1 of the 2 vials, swirl to mix - keep vial vertical at all times, do not shake
Inject SC in abdomen within 1 hour of reconstitution
Repeat for 2nd injection and use different injection site
Maintenance pack contains 1 vial of 80 mg per vial & 4.2 mL sterile water for injection diluent
Use 4.2 mL to reconstitute, withdraw 4 mL for dose of 80 mg
Contra Indications
Hypersensitivity. Pregnancy and lactation.
Precautions
Patient with congenital long QT syndrome, history of or risk factors for QT prolongation (e.g. cardiac failure, electrolyte imbalance) and CV disease; diabetes, risk factors for low BMD. Moderate to severe renal (CrCl <50 mL/min) and severe hepatic impairment.
Lactation: excretion in milk unknown/not recommended
Pregnancy-Lactation
Pregnancy Category: X
Lactation: excretion in milk unknown/not recommended
Interactions
Increased risk of QT prolongation with class IA (e.g. disopyramide) or class III (e.g. amiodarone) antiarrhythmics, antipsychotics, methadone and moxifloxacin.
Adverse Effects
Side effects of Degarelix :
>10%
Hot flashes (26%)
Injection site erythema (17%)
Injection site pain (28%)
Weight gain (11%)
Elevated liver enzymes (10%)
1-10% (selected)
Arthralgia
Back pain
Fatigue
HTN
Injection site induration/swelling
Mechanism of Action
Degarelix, a synthetic decapeptide, reversibly and competitively binds to gonadotropin-releasing hormone (GnRH) receptors in the anterior pituitary gland, thereby decreasing secretion of luteinising hormone (LH) and follicle stimulating hormone (FSH), and subsequently reducing testicular androgen synthesis.
Note
Firmagon 80mg Infusion manufactured by Ferring GmbH. Its generic name is Degarelix. Firmagon is availble in United Arab Emirates.
Farmaco UAE drug index information on Firmagon Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.