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Full Prescribing Information
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

How FIRMAGON® Is Given

FIRMAGON® is given as a series of subcutaneous (just below the skin) injections in your abdomen. The injected medicine forms a small mass, called a depot, which supplies your body with a continuous release of FIRMAGON® over 28 days.

First you will be given a starting dose of 2 injections (120 mg each), which will start to suppress testosterone fast. Then you will be given a maintenance dose of 1 injection per month (80 mg) until the end of your treatment.

The location of the injection in your abdomen will be changed slightly each time. The injection will be given by your doctor or nurse at the doctor's office, a hospital, or a clinic.

For 3 to 5 days after each of the first 2 injections, you might experience temporary redness, local swelling, and slight pain. If you have these symptoms after your first 2 treatments, taking a pain reliever such as acetaminophen or ibuprofen can help. These reactions are less likely with the monthly injections that follow.


If you miss an injection

You should receive your injection every month so FIRMAGON® can effectively keep your testosterone and prostate-specific antigen (PSA) levels low. If you cannot keep your appointment to receive the injection, be sure to call your health care provider to reschedule another injection date as soon as possible.

This is the best way to ensure control of prostate cancer. After each injection, always set up an appointment for your next injection.


Length of treatment

At certain times over the course of your treatment, your doctor will measure the level of PSA in your blood. The results of these tests will tell your doctor how well your treatment is working. Based on your test results, your doctor will decide on the length of your treatment.

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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.

The information on this Web site is provided for educational purposes only. While there may be information on this Web site related to certain medical conditions and their treatment, should a medical condition exist, promptly see your own physician or health care provider as the information on this Web site is not intended to take the place of advice from a physician or health care professional. Ferring does not offer personalized medical diagnosis or patient-specific treatment advice. The statements made by doctors on this Web site represent their own individual experiences and opinions and is not intended to be medical advice. Indeed, only your doctor or other health care professional, as a learned intermediary, can determine if a product described in this Web site is appropriate for you.

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