FIRMAGON
Degarelix · KIT · Ferring Pharmaceuticals Inc.
Firmagon (degarelix) is an injectable medication used to treat advanced prostate cancer by lowering testosterone levels in the body. It comes as a kit that your doctor will administer according to their prescribed treatment plan.
Key Facts
- Brand Name
- FIRMAGON
- Generic Name
- Degarelix
- NDC Code (Product)
55566-8403- Manufacturer
- Ferring Pharmaceuticals Inc.
- Dosage Form
- KIT
- Marketing Status
- Application #
- NDA022201
- Marketing Start
- 03/02/2009
Recall History
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE FIRMAGON ® is indicated for treatment of patients with advanced prostate cancer. FIRMAGON is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION FIRMAGON is for subcutaneous use only Starting Dosage: 240 mg given as two injections of 120 mg each ( 2.1 ) Maintenance Dosage: 80 mg administered as a single injection every 28 days ( 2.1 ) 2.1 Dosing information FIRMAGON is administered as a subcutaneous injection in the abdominal region only at the dosages in Table 1 below. Table 1: FIRMAGON Recommended Dosages Starting Dosage Maintenance Dosage – Administered once every 28 days 240 mg given as two subcutaneous injections of 120 mg at a concentration of 40 mg/mL The first maintenance dose should be given 28 days after the starting dose. 80 mg given as one subcutaneous injection at a concentration of 20 mg/mL 2.2 Reconstitution and Administration Instructions FIRMAGON is to be administered by a healthcare professional only . Before administering FIRMAGON read the Instructions for reconstitution and administration carefully. As with other drugs administered by subcutaneous injection, the injection site should vary periodically. Injections should be given only in areas of the abdomen that will not be exposed to pressure, e.g., not close to waistband or belt nor close to the ribs. FIRMAGON is supplied as…
Contraindications
4 CONTRAINDICATIONS FIRMAGON is contraindicated in patients with history of severe hypersensitivity to degarelix or to any of the product components [see Warnings and Precautions (5.1) ] . Patients with history of severe hypersensitivity reactions to degarelix or to any of the product components ( 4 )
Drug Interactions
7 DRUG INTERACTIONS No drug-drug interaction studies were conducted. Degarelix is not a substrate for the human CYP450 system. Degarelix is not an inducer or inhibitor of the CYP450 system in vitro . Therefore, clinically significant CYP450 pharmacokinetic drug-drug interactions are unlikely.
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (≥10%) are injection site reactions (e.g., pain, erythema, swelling or induration), hot flashes, and increases in serum levels of transaminases and gamma-glutamyltransferase (GGT) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ferring at 1-888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. FIRMAGON was studied in a randomized, open-label trial in which patients with prostate cancer were randomized to receive FIRMAGON (subcutaneous) or leuprolide (intramuscular) monthly for 12 months [see Clinical Studies (14) ] . The most common adverse reactions (≥10%) during FIRMAGON therapy are injection site reactions (e.g., pain, erythema, swelling or induration), hot flashes, and increases in serum levels of transaminases and gamma-glutamyltransferase (GGT). The majority of the adverse reactions were Grade 1 or 2, wit…
Frequently Asked Questions
What is FIRMAGON used for?
Firmagon (degarelix) is an injectable medication used to treat advanced prostate cancer by lowering testosterone levels in the body. It comes as a kit that your doctor will administer according to their prescribed treatment plan.
Is FIRMAGON a controlled substance?
FIRMAGON is not classified as a controlled substance by the DEA.
What is the generic name for FIRMAGON?
The generic name for FIRMAGON is Degarelix. There are no other listed brand versions of Degarelix.
What is the NDC code for FIRMAGON ?
The NDC (National Drug Code) for FIRMAGON is 55566-8403, listed by Ferring Pharmaceuticals Inc..
Other FIRMAGON Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)