Local Reactions and Side Effects
There are 2 types of effects that may occur following treatment with FIRMAGON®:
Injection site reactions include:
- Pain
You may experience soreness or discomfort around the site. - Redness
You may notice some redness around the site. - Swelling
Your skin may puff up or bulge above the surrounding skin level, or there may be a lump where the medicine has gelled under your skin.
In clinical studies, all of these reactions were mild to moderate and usually went away within a few days, so you may expect the same. If you experience these reactions, pain relievers such as acetaminophen or ibuprofen can help. Please talk with your health care provider if you have any questions.
Common side effects:
These are usually mild to moderate in intensity.
- Hot flashes
- Flushing of the skin
Less frequent side effects include:
- Weight gain
- Increase in some liver enzymes
- Tiredness
- Hypertension
- Back and joint pain
- Chills
- Urinary tract infection
- Decreased sex drive and erectile dysfunction (impotence)
If you experience any of these or other possible side effects, and they bother you or do not go away, please tell your health care provider.
INDICATIONS AND USAGE
FIRMAGON® is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer.
IMPORTANT SAFETY INFORMATION
The most commonly observed adverse reactions during FIRMAGON® therapy included injection site reactions (e.g., pain, erythema, swelling or induration), hot flashes, increased weight, fatigue, and increases in serum levels of transaminases and gamma-glutamyltransferase (GGT). 99% of these observed adverse reactions were Grade 1 or 2 (mild to moderate). Specifically relating to the injection site adverse reactions, most were transient, of mild to moderate intensity, occurred primarily with the starting dose and led to few discontinuations (<1%). Grade 3 (severe) injection site reactions occurred in 2% or less of patients receiving FIRMAGON®.
FIRMAGON® is contraindicated in patients with known hypersensitivity to degarelix or to any of the product components. FIRMAGON® is not indicated in women or pediatric patients. Long-term androgen deprivation therapy prolongs the QT interval. Physicians should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, electrolyte abnormalities, or congestive heart failure and in patients taking Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications.
Please see the Full Prescribing Information. You can view or download it by clicking on the link in the right-hand column of the page.
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