FUEL LIFE, NOT CANCER

Important Safety Information and Usage

Who should NOT take ZOLADEX?

You should not take ZOLADEX if you are allergic to any of its ingredients or if you are allergic to medications that contain any of its ingredients or similar hormonal therapies.

You should not receive ZOLADEX if you are pregnant, or could become pregnant. Pregnancy must be excluded and nonhormonal contraception is to be used during ZOLADEX therapy.

What is the most important information I should know about ZOLADEX?

Serious side effects that may occur in both men and women taking ZOLADEX include:

• Tumor Flare Phenomenon (worsening tumor symptoms). Short-term worsening of tumor symptoms may occur in the first few weeks of therapy for men and women. This is due to the temporary increases in testosterone in men and estrogen in women. Rare cases of urinary tract blockage or spinal cord compression have been seen in men being treated for prostate cancer. Some cancer patients may also have increased bone pain during the first few weeks of ZOLADEX treatment.
• Abnormal Heart Rhythm. ZOLADEX may affect the electrical activity of your heart and could cause an irregular heartbeat. Your doctor should determine if the benefits of using ZOLADEX outweigh the risks, especially if you were born with a heart rhythm condition, have heart failure, abnormal blood tests or electrolytes, or take medications that may affect your heartbeat.
• Severe Skin Reactions. Severe skin reactions, which may be life-threatening or fatal, can be caused by ZOLADEX or drugs like ZOLADEX. Immediately contact your doctor or seek medical attention if you develop any signs or symptoms of a severe skin reaction, including fever or flu-like symptoms, blisters in the mouth, nose, throat, or eyes, severe rash or rash that continues to get worse, sores or blistering of the skin, or swollen lymph nodes.
• Injection Site Injury. Injuries at the injection site have been reported with ZOLADEX. This includes pain at the injection site, bleeding coming from a damaged blood vessel, and pooling of blood under the skin.
• Elevated Calcium Levels. Similar to other hormonal therapies, high calcium levels have occurred in some patients with prostate and breast cancer that has spread to the bones after starting treatment with ZOLADEX.

Serious side effects that may occur in women taking ZOLADEX include:

• Pregnancy and Breastfeeding. ZOLADEX may harm your unborn baby and may increase the risk of pregnancy loss. Pregnancy must be excluded and nonhormonal contraception is to be used during ZOLADEX therapy, and for at least 12 weeks after your last dose.
• Clinical Depression in Women. Depression may occur or worsen in women receiving medications such as ZOLADEX. Tell your doctor right away if you experience new or worsening mood changes or thoughts of harming yourself.

Serious side effects that may occur in men taking ZOLADEX include:

• Increased Blood Glucose and Diabetes. There is an increased risk for developing diabetes or worsening of glucose control if you already have diabetes while being treated with drugs like ZOLADEX.
• Increased Risk of Heart Disease. There is a small increased risk of heart attack, sudden cardiac death, and stroke during treatment with drugs like ZOLADEX.

What should I tell my doctor before receiving treatment with ZOLADEX?

Before starting ZOLADEX, tell your doctor:

• If you are allergic to ZOLADEX, any of its ingredients, or to any similar medications.
• If you are pregnant, plan to become pregnant, or are breastfeeding.
• If you have any unusual vaginal bleeding that has not been diagnosed by your doctor.
• About all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• About all your medical conditions.

What are the possible side effects of ZOLADEX?

The most common side effects of ZOLADEX that may occur in women and in men include:

• In women, the most common side effects are those resulting from reduction of estrogen. Those seen are hot flashes, headaches, sweating, acne, changes in mood or behavior, depression, decreased sex drive, vaginal irritation/dryness, change in breast size, skin flaking, and swelling in the arms and legs.
• In men, the most common side effects are those resulting from reduction of testosterone. Those seen are hot flashes, sexual dysfunction, decreased erections, and lower urinary tract symptoms.

These are not all of the possible side effects of ZOLADEX. Be sure to contact your doctor or healthcare team right away if you are worried about any side effects or have questions.