Medicine Information

Firmagon

Name: Firmagon
Brand: Firmagon
Rating: 4.5 (117 reviews)

Powder for solution for injection120 mgHormonal AntagonistsATC: L02BX02

Generic Name

Degarelix

Manufacturer

Ferring Pharmaceuticals

Country

Switzerland (origin), manufactured globally

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Price Details

Current market pricing information

Variant	Unit Price	Strip Price
firmagon 120 mg injection	৳ 27,642.00	N/A

Description

Overview of the medicine

Firmagon (degarelix) is an injectable medicine used to treat advanced prostate cancer. It works by blocking the effects of a natural hormone called gonadotropin-releasing hormone (GnRH), which reduces the amount of testosterone produced by the body.

Uses & Indications

Treatment of adult male patients with advanced hormone-dependent prostate cancer.

Dosage

Adults

The recommended starting dose is 240 mg administered as two subcutaneous injections of 120 mg each, followed by a maintenance dose of 80 mg administered as a single subcutaneous injection every month. The 120 mg injection is primarily for the loading dose.

Elderly

No dosage adjustment is necessary for elderly patients.

Renal_impairment

No dosage adjustment is necessary for patients with mild to moderate renal impairment. Caution should be exercised in patients with severe renal impairment due to lack of data.

How to Take

Firmagon is administered as a subcutaneous injection into the abdominal region. The injection sites should be rotated, and areas with pressure, like waistbands or tight clothing, or areas with previous irritation should be avoided. Do not administer intravenously.

Mechanism of Action

Degarelix is a selective GnRH receptor antagonist. It binds to GnRH receptors in the anterior pituitary gland, preventing the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) from the pituitary. This leads to a rapid and sustained suppression of testicular testosterone production, without the initial testosterone surge (flare) often seen with GnRH agonists.

Pharmacokinetics

Onset

Rapid testosterone suppression, reaching castration levels within 3 days.

Excretion

The main route of excretion for degarelix and its metabolites is via the faeces (approximately 65-80%), with a smaller portion excreted via urine (approximately 20-35%).

Half life

After a 240 mg loading dose, the mean terminal half-life is approximately 29-43 days. For subsequent monthly 80 mg doses, the half-life is around 29-68 days. For 120 mg, it falls within this range depending on single vs loading dose.

Absorption

Following subcutaneous injection, degarelix is absorbed slowly and sustainedly. Peak plasma concentrations are reached approximately 2 days after administration.

Metabolism

Degarelix is a peptide and is primarily metabolized by enzymatic hydrolysis into smaller peptide fragments, not via the cytochrome P450 system.

Side Effects

Contraindications

Hypersensitivity to the active substance degarelix or to any of the excipients.
Not indicated for women or pediatric patients.

Drug Interactions

Warfarin

Although not directly interacting, patients receiving anticoagulants should have their coagulation parameters closely monitored as injection site hematomas may occur.

QT Prolonging Drugs

Caution when co-administering with drugs known to prolong the QT interval (e.g., Class IA antiarrhythmics, Class III antiarrhythmics, methadone, moxifloxacin, antipsychotics). Periodic monitoring of ECG and electrolytes is recommended.

Storage

Store in a refrigerator (2°C to 8°C). Do not freeze. Keep the vial in the outer carton to protect from light. Once reconstituted, use immediately.

Overdose

There is no experience of overdose in clinical trials. In case of overdose, the patient should be treated symptomatically, and supportive measures should be initiated. Patients should be monitored for signs of injection site reactions and cardiovascular events.

Pregnancy & Lactation

Firmagon is not indicated for women and should not be used in pregnant or lactating women.

Frequently Asked Questions

Common questions about this medicine

Pack Sizes

1 vial of 120 mg powder + 1 pre-filled syringe of solvent (or similar configuration)

Shelf Life

Typically 2-3 years, check specific product labeling for exact duration.

Availability

Available in hospitals and specialized pharmacies

Approval Status

FDA approved, marketed globally

Patent Status

Patented by Ferring Pharmaceuticals

Clinical Trials

Degarelix has been evaluated in multiple large-scale clinical trials (e.g., CS21, CS21A) demonstrating its efficacy and safety in advanced prostate cancer, showing rapid testosterone suppression and comparable efficacy to GnRH agonists but without the initial testosterone flare.

Lab Monitoring

Serum testosterone levels (to ensure castration levels)
Prostate-specific antigen (PSA)
Liver function tests (transaminases)
Blood glucose levels
Electrolytes (especially potassium and magnesium if QT prolongation is a concern)
ECG (for QT interval prolongation)

Doctor Notes

Monitor testosterone and PSA levels regularly.
Assess cardiovascular risk factors and perform ECG monitoring if QT-prolonging drugs are co-administered.
Counsel patients on potential bone loss and recommend bone density screening for long-term therapy.
Educate patients about injection site reactions and other common side effects.

Patient Guidelines

Inform your doctor about all existing medical conditions and medications.
Report any severe injection site reactions or new symptoms promptly.
Do not stop treatment without consulting your doctor.
Be aware of potential side effects like hot flashes and fatigue.

Missed Dose Advice

If a maintenance dose is missed, it should be administered as soon as possible. Subsequent doses should then be administered monthly from the date of the last injection. Monitor testosterone levels to ensure they remain at castration levels.

Driving Precautions

Firmagon may cause fatigue or dizziness, which could impair the ability to drive or operate machinery. Patients should be cautious until they know how the medicine affects them.

Lifestyle Advice

Maintain a healthy lifestyle, including regular exercise and a balanced diet, to help manage potential side effects and overall health.
Monitor for cardiovascular risk factors and discuss with your doctor.
Consider bone density screenings due to potential bone loss with long-term use.