Brand Name
Firmagon
Generic Name
Degarelix
View Brand Information FDA approval date: March 02, 2009
Form: Kit
What is Firmagon (Degarelix)?
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.
Approved To Treat
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Brand Information
FIRMAGON (Degarelix)
1INDICATIONS AND USAGE
FIRMAGON
2DOSAGE FORMS AND STRENGTHS
For injection:
- FIRMAGON (240 mg): Two single-dose vials each delivering 120 mg of degarelix in a white to off-white lyophilized powder for reconstitution supplied with diluent in two prefilled syringes.
- FIRMAGON (80 mg): One single-dose vial delivering 80 mg of degarelix in a white to off-white lyophilized powder for reconstitution supplied with diluent in one prefilled syringe.
3CONTRAINDICATIONS
FIRMAGON is contraindicated in patients with history of severe hypersensitivity to degarelix or to any of the product components
4DRUG 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
5OVERDOSAGE
There have been no reports of overdose with FIRMAGON. In the case of overdose, however, discontinue FIRMAGON, treat the patient symptomatically, and institute supportive measures.
6DESCRIPTION
FIRMAGON is a sterile lyophilized powder for injection containing degarelix (as the acetate) and mannitol. Degarelix is a synthetic linear decapeptide amide containing seven unnatural amino acids, five of which are D-amino acids. The acetate salt of degarelix is a white to off-white amorphous powder of low density as obtained after lyophilization.
The chemical name of degarelix is D-Alaninamide,
Degarelix acetate has the following structural formula:
FIRMAGON is available in two packaging configurations:
- Starting Dose: Two vial carton with each vial delivering 120 mg of degarelix (equivalent to the median value of 126 mg degarelix acetate). Each 120 mg dose contains 150 mg mannitol.
- Maintenance Dose: One-vial carton delivering 80 mg of degarelix (equivalent to the median value of 84 mg degarelix acetate). Each 80 mg dose contains 200 mg mannitol.
7CLINICAL STUDIES
The safety and efficacy of FIRMAGON were evaluated in an open-label, multi-center, randomized, parallel-group study (NCT00295750) in patients with prostate cancer. A total of 620 patients were randomized to receive one of two FIRMAGON dosing regimens or leuprolide for one year:
- FIRMAGON at a starting dose of 240 mg (40 mg/mL) followed by monthly doses of 80 mg (20 mg/mL) subcutaneously,
- leuprolide 7.5 mg intramuscularly monthly.
- FIRMAGON at a starting dose of 240 mg (40 mg/mL) followed by monthly doses of 160 mg (40 mg/mL) subcutaneously.
FIRMAGON is not approved for use with monthly doses of 160 mg (40 mg/mL) subcutaneously.
Serum levels of testosterone were measured at screening, on Day 0, 1, 3, 7, 14, and 28 in the first month, and then monthly until the end of the study.
The clinical trial population (n=610) across all treatment arms had an overall median age of approximately 73 (range 50 to 98). The ethnic/racial distribution was 84% white, 6% black and 10% others. Disease stage was distributed approximately as follows: 20% metastatic, 29% locally advanced (T3/T4 Nx M0 or N1 M0), 31% localized (T1 or T2 N0 M0) and 20% classified as other (including patients whose disease metastatic status could not be determined definitively - or patients with PSA relapse after primary curative therapy). In addition, the median testosterone baseline value across treatment arms was approximately 400 ng/dL.
The primary objective was to demonstrate that FIRMAGON is effective achieving and maintaining testosterone suppression to castration levels (T ≤ 50 ng/dL) during 12 months of treatment. The results are shown in Table 3.
Percentage changes in testosterone from baseline to Day 28 (median with interquartile ranges) are shown in Figure 2 and the percentages of patients who attained the medical castration of testosterone ≤ 50 ng/dL are summarized in Table 4.
In the clinical trial, PSA levels were monitored as a secondary endpoint. PSA levels were lowered by 64% two weeks after administration of FIRMAGON, 85% after one month, 95% after three months, and remained suppressed throughout the one year of treatment. These PSA results should be interpreted with caution because of the heterogeneity of the patient population studied. No evidence has shown that the rapidity of PSA decline is related to a clinical benefit.
8HOW SUPPLIED/STORAGE AND HANDLING
FIRMAGON is available as:
- NDC 55566-8403-1, Starting dose – One carton contains:
- NDC 55566-8303-1, Maintenance dose – One carton contains:
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
10Patient Information
FIRMAGON (FIRM-uh-gahn)
What is FIRMAGON?
FIRMAGON is a prescription medicine used in the treatment of advanced prostate cancer.
Who should not receive FIRMAGON?
Do not receive FIRMAGON if you are allergic to degarelix or any ingredient in FIRMAGON. See the end of this leaflet for a complete list of ingredients in FIRMAGON.
Talk to your healthcare provider before receiving FIRMAGON if you have any of these conditions.
Before receiving FIRMAGON, tell your healthcare provider about all your medical conditions, including if you:
- have any heart problems including a condition called long QT syndrome.
- have problems with blood levels such as sodium, potassium, calcium, and magnesium
- have kidney or liver problems
- are pregnant or plan to become pregnant. FIRMAGON can cause harm to your unborn baby and loss of pregnancy (miscarriage)
- are breastfeeding or plan to breastfeed. It is not known if FIRMAGON passes into your breast milk. You and your healthcare provider should decide if you will receive FIRMAGON or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
How will I receive FIRMAGON?
You will receive an injection of FIRMAGON from your healthcare provider.
- The injection site will always be in the stomach (abdominal area). The injection site will change within the stomach area each time you receive a dose of FIRMAGON.
- Two injections are given as a first dose. The following monthly doses are one injection.
- Do not rub or scratch the injection site. Make sure your injection site is free of any pressure from belts, waistbands or other types of clothing.
- Always set up an appointment for your next injection.
What are the possible side effects of FIRMAGON?
FIRMAGON can cause serious side effects, including:
- Serious allergic reactions. Get medical help right away if you get any of these symptoms:
- Disorder of the heart's electrical activity. Your healthcare provider may do tests during treatment with FIRMAGON to check your heart for a condition called long QT syndrome.
The common side effects of FIRMAGON include:
Other side effects include decreased sex drive and erectile function problems.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of FIRMAGON.
Medicines are sometimes prescribed for conditions that are not mentioned in a Patient Information leaflet. Do not use FIRMAGON for a condition for which it was not prescribed. Do not give FIRMAGON to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about FIRMAGON that is written for health professionals.
What are the ingredients in FIRMAGON?
Active ingredient: degarelix (as acetate)
Inactive ingredient: mannitol
MANUFACTURED FOR:
FERRING PHARMACEUTICALS INC., PARSIPPANY, NJ 07054
For more information, go to www.FIRMAGON.com or call 1-888-337-7464.
This Patient Information has been approved by the U.S. Food and Drug Administration.
02/2020
11PRINCIPAL DISPLAY PANEL - 240 mg Kit Carton
NDC 55566-8403-1
FERRING
FIRMAGON
*240 mg dose administered from
For single use subcutaneous injection only
Kit contents:
Starting Dose
12PRINCIPAL DISPLAY PANEL - 80 mg Kit Carton
NDC 55566-8303-1
FERRING
FIRMAGON
For single use subcutaneous injection only
Kit contents:
Maintenance Dose (28 Days)
