Branded Products Eligard

ELIGARD^® (leuprolide acetate for injectable suspension)

ELIGARD^® is a prescription drug, given by injection, for the management of advanced prostate cancer. It is designed to deliver leuprolide acetate at a controlled rate over a 1-, 3-, 4-, or 6-month therapeutic period. This product is a type of hormonal therapy known as “luteinizing hormone-releasing hormone” (LHRH) agonist and ELIGARD is the only LHRH agonist with the controlled-release ATRIGEL^® Delivery System. ELIGARD is also the only drug of its kind administered directly under the skin. ELIGARD is marketed in four single-dose strengths:

• ELIGARD 7.5 mg: 1 month of therapy
• ELIGARD 22.5 mg: 3 months of therapy
• ELIGARD 30 mg: 4 months of therapy
• ELIGARD 45 mg: 6 months of therapy 

ELIGARD^® (leuprolide acetate for injectable suspension) is a prescription drug, given by injection, for the management of advanced prostate cancer. However, there is no known cure for advanced prostate cancer.

IMPORTANT SAFETY INFORMATION
ELIGARD (leuprolide acetate for injectable suspension) is a medicine for managing advanced prostate cancer. It is not a cure for advanced prostate cancer.

ELIGARD should not be used by anyone who is allergic to any drug that is in the same class as ELIGARD, or anyone who is allergic to any of the ingredients in ELIGARD.

Please see Full Prescribing Information for additional important safety information

ELIGARD is a global product, marketed worldwide.

Latin America Tecnofarma

Asia

Middle East, North Africa

South Korea

South Africa

To learn more about ELIGARD, please visit the official ELIGARD website.

Important Safety Information for ELIGARD (leuprolide acetate for injectable suspension)

ELIGARD^® is a medicine for the treatment of advanced prostate cancer. It works by reducing the amount of testosterone in the blood. It is not a cure.

ELIGARD should not be used by anyone who is allergic to any of the ingredients in ELIGARD or to any medicines that reduce testosterone the same way. ELIGARD should not be used by women who are pregnant or may become pregnant. ELIGARD can cause pregnancy loss or harm to an unborn baby if used in pregnant women.

Severe and possibly life-threatening reactions called anaphylaxis have occurred in people receiving ELIGARD.

Increased risk of heart attack, sudden death due to heart problems and stroke have also been reported in men taking ELIGARD. ELIGARD may also affect electrical activity in the heart that can cause an irregular heartbeat. Your doctor will monitor you for heart conditions.

Elevated blood sugar and an increased risk of developing diabetes have been reported in men receiving ELIGARD. Your doctor will monitor blood sugar levels.

ELIGARD causes an increase in testosterone during the first few weeks of therapy and some men may experience new or worsening symptoms of prostate cancer e.g., bone pain, urinary symptoms, or nerve problems such as numbness, during this period. If your cancer has spread to the urinary tract or spine, urinary blockage or pressure on the spine that can lead to paralysis may occur. Your doctor will discuss with you the benefits and risks of taking ELIGARD.

The most common injection site reactions are transient burning and stinging, pain, bruising, and redness. The most common side effects include hot flashes/sweats, fatigue, weakness, muscle pain, dizziness, clamminess, testicular shrinkage, decreased erections and enlargement of breasts. Other side effects, including thinning of bones thatmay lead to fracture, and rare but serious problems with the pituitary gland in the brain, have been reported with ELIGARD. See package insert for full Prescribing and Safety Information.