Firmagon SC Injection
Degarelix Acetate
80mg
Radiant Pharmaceutical Ltd.
| Pack size | 1's Pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 23,036.00 AED |
Available as:
Indications
Firmagon SC Injection is used for:
Hormone-dependent Advanced Prostate Carcinoma (Stage D)
Adult Dose
Subcutaneous
Hormone-dependent Advanced Prostate Carcinoma (Stage D)
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.
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
Moderate to severe renal (CrCl <50 mL/min) and severe hepatic impairment.
Hypersensitivity: Anaphylaxis, urticaria and angioedema have been reported. Discontinue Degarelix if a severe hypersensitivity reaction occurs and manage as clinically indicated
QT Interval Prolongation: Androgen deprivation therapy treatment with Degarelix may prolong the QT interval. Patient with congenital long QT syndrome, history of or risk factors for QT prolongation (e.g. cardiac failure, electrolyte imbalance) and CV disease.
Embryo-Fetal Toxicity: Degarelix can cause fetal harm.
MONITORING PARAMETERS
Monitor bone density.
Pregnancy-Lactation
Pregnancy & Lactation
Pregnancy
Safety and efficacy not established in women
Animal data
Based on findings in animal studies and mechanism of action, drug can cause fetal harm and loss of pregnancy when administered to a pregnant woman; there are no human data on use of drug in pregnant women to inform drug-associated risk; in animal developmental and reproductive toxicity studies in rats and rabbits, oral administration of degarelix during organogenesis caused embryo-fetal lethality and abortion as well as increased post-implantation loss and decreased number of live fetuses in animals at doses less than clinical loading dose based on body surface area; advise pregnant patients and females of reproductive potential of potential risk to fetus
Based on findings in animals and the mechanism of action, degarelix may impair fertility in males and females of reproductive potential
Lactation
Safety and efficacy not established in females; there are no data on presence of drug in human milk, effects on breastfed child, or on milk production; because many drugs are present in human milk and because of potential for serious adverse reactions in a breastfed child from therapy, a decision should be made whether to discontinue nursing or discontinue drug taking into account importance of drug to mother
Interactions
Increased risk of QT prolongation with class IA (e.g. disopyramide) or class III (e.g. amiodarone) antiarrhythmics, antipsychotics, methadone and moxifloxacin.
This drug is not a substrate for the human CYP450 system; degarelix is not an inducer or inhibitor of the CYP450 system in vitro; clinically significant CYP450 pharmacokinetic drug-drug interactions are unlikely.
Adverse Effects
Side effects of Degarelix Acetate :
>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 SC Injection manufactured by Radiant Pharmaceutical Ltd.. Its generic name is Degarelix Acetate. Firmagon is availble in Bangladesh.
Farmaco BD drug index information on Firmagon SC Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.