WHAT IS METASTATIC RENAL CELL CARCINOMA (mRCC)?

Possible serious side effects

Everyone reacts differently to MVASI™ therapy. So, it's important to know what the side effects are. Although some people may have a life-threatening side effect, most do not. Your doctor will stop treatment if any serious side effects occur. Be sure to contact your health care team if there are any signs of these side effects.

Most serious side effects (not common, but sometimes fatal):

• GI perforation. A hole that develops in your stomach or intestine. Symptoms include pain in your abdomen, nausea, vomiting, constipation, or fever
• Wounds that don't heal. A cut made during surgery can be slow to heal or may not fully heal. MVASI™ should not be used for at least 28 days before or after surgery and until surgical wounds are fully healed
• Serious bleeding. This includes vomiting or coughing up blood; bleeding in the stomach, brain, or spinal cord; nosebleeds; and vaginal bleeding. If you recently coughed up blood or had serious bleeding, be sure to tell your doctor

Other possible serious side effects

• Abnormal passage in the body. This type of passage—known as a fistula—is an irregular connection from one part of the body to another and can sometimes be fatal
• Severe high blood pressure. Blood pressure that severely spikes or shows signs of affecting the brain. Blood pressure should be monitored every 2 to 3 weeks while on MVASI™ and after stopping treatment
• Kidney problems. These may be caused by too much protein in the urine and can sometimes be fatal
• Infusion reactions. These were uncommon with the first dose (less than 3% of patients). 0.2% of patients had severe reactions. Infusion reactions include high blood pressure or severe high blood pressure that may lead to stroke, trouble breathing, decreased oxygen in red blood cells, a serious allergic reaction, chest pain, headache, tremors, and excessive sweating. Your doctor or nurse will monitor you for signs of infusion reactions
• Severe stroke or heart problems. These may include blood clots, mini-stroke, heart attack, chest pain, and your heart may become too weak to pump blood to other parts of your body (congestive heart failure). These can sometimes be fatal
• Nervous system and vision problems. Signs include headache, seizure, high blood pressure, sluggishness, confusion, and blindness

Side effects seen most often

In clinical studies across different types of cancer, some patients experienced the following side effects:

• High blood pressure
• Too much protein in the urine
• Nosebleeds
• Rectal bleeding
• Back pain
• Headache
• Taste change
• Dry skin
• Inflammation of the skin
• Inflammation of the nose
• Watery eyes

MVASI™ is not for everyone

Talk to your doctor if you are:

• Undergoing surgery. MVASI™ should not be used for 28 days before or after surgery and until surgical wounds are fully healed
• Pregnant, think you are pregnant, planning to become pregnant, or breastfeeding. Data have shown that MVASI™ may harm your unborn baby. Use birth control while on MVASI™. If you stop MVASI™, you should keep using birth control for 6 months before trying to become pregnant. Taking MVASI™ could cause a woman’s ovaries to stop working and may impair her ability to have children. Breastfeeding while on MVASI™ may harm your baby and is therefore not recommended during and for 6 months after taking MVASI™

If you have any questions about your condition or treatment, talk to your doctor.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Amgen at 1-800-772-6436.

Please see full Product Information for additional Important Safety Information.