Firmagon Warnings and Precautions

Tell your healthcare provider if you have heart disease, liver disease, or osteoporosis before using Firmagon. Other precautions for safely using this medicine include warnings of potential allergic reactions and drug interactions. This medicine can also cause other complications, such as potentially life-threatening heart rhythms and a decrease in bone density.

• Heart disease, such as heart failure or a heart problem known as congenital long QT syndrome
• An abnormal heart rhythm (arrhythmia)
• A history of an abnormal electrocardiogram (ECG)
• Electrolyte imbalances in your blood, such as low or high calcium, sodium, potassium, or magnesium
• Liver disease, such as hepatitis, cirrhosis, or liver failure
• Kidney disease, such as kidney failure (renal failure)
• Osteoporosis
• Any allergies, including to foods, dyes, or preservatives.

• Pregnant or thinking of becoming pregnant
• Breastfeeding.

• Firmagon may cause a potentially life-threatening problem with the heart rhythm known as QT prolongation. This can be dangerous, especially in people who have heart problems or arrhythmias (abnormal heartbeats) or in people who are taking other medications that also cause QT prolongation (see Firmagon Drug Interactions).

• Liver disease may decrease the level of Firmagon in your bloodstream. If you have liver disease, your healthcare provider may choose to monitor your testosterone levels once a month at the beginning of treatment, and then every other month after testosterone levels are sufficiently low.

• Your healthcare provider will need to monitor your hormone levels and prostate-specific antigen (PSA) levels during treatment to monitor how well Firmagon is working to treat your cancer. Make sure to keep all of your healthcare appointments.

• The kidneys help remove Firmagon from the body. If your kidneys are not functioning properly, the drug may accumulate in your bloodstream, which could cause problems. Your healthcare provider may choose to monitor you more closely if you have moderate or severe kidney disease.

• Medications that decrease testosterone levels, including Firmagon, can cause bone loss. This could lead to osteoporosis and bone fractures. Talk to your healthcare provider about ways you can decrease your risk for osteoporosis while using this medication.

• Firmagon may react with several other medicines (see Firmagon Drug Interactions for more information).

• It is unknown if Firmagon passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to receiving the drug (see Firmagon and Breastfeeding).

• Firmagon is a pregnancy Category X medication. It should not be used in women who are pregnant or who may become pregnant (see Firmagon and Pregnancy).