DACARBAZINE INJ. (DTIC-DOME) BOXED WARNING It is recommended that Dacarbazine for Injection be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. 1. Hemopoietic depression is the most common toxicity with Dacarbazine for Injection 2. Hepatic necrosis has been reported 3. Studies have demonstrated this agent to have a carcinogenic and teratogenic effect when used in animals. 4. In treatment of each patient, the physician must weigh carefully the possibility of achieving therapeutic benefit against the risk of toxicity. HOW MEDICINE IS ADMINISTERED? TOP Use this medicine exactly as directed on the label, unless instructed differently by your doctor * This medicine is given as an IV INFUSION at a constant rate over a period of time as recommended by manufacturer. * Follow manufacturer's directions to properly reconstitute. * For best results, get the support of your friends and family. Enroll in a Stop-Smoking program. WARNINGS/PRECAUTIONS: TOP * Safety of use during pregnancy has not been established. This medicine SHOULD NOT BE USED DURING PREGNANCY unless benefit justifies potential risk to the fetus. CALL YOUR DOCTOR. * Notify doctor if there are symptoms that suggest BLEEDING, such as black tarry stools or "coffee ground" vomit. * AVOID sources of INFECTION. This medication weakens your body's immune system and increases your risk of infection. * It is important that your doctor monitors your BLOOD CELL COUNTS at regular intervals. * Hair loss from this medication should grow back after treatment ends. Stop taking this medicine and notify your doctor AS SOON AS POSSIBLE if you experience: Abnormal blood cell count; Abnormally low platelet count; Anemia. Other Common Side Effects: TOP Decreased appetite; Nausea; Vomiting; Baldness; Hot sensation and redness of face; Flu-like symptoms; Kidney function tests abnormalities; Liver problems; Feeling of general discomfort; Muscle pain; Increased sensitivity to sunlight; Skin rash; Diarrhea. Other Common Side Effects: If symptoms are mild but do not go away or are bothersome, check with your doctor. IF ANY OF THE ABOVE SIDE EFFECTS IS SEVERE, CALL YOUR DOCTOR IMMEDIATELY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This leaflet has been developed by CliniDATA Source, Inc. based primarily on labeling information provided by the manufacturer. The information does not cover all possible uses, actions, precautions, side effects, or interactions of this medicine. It is not intended as medical advice for individual patients. Copyright © CliniDATA Source, Inc. 03/14. All rights reserved