VALGANCICLOVIR ORAL (VALCYTE) BOXED WARNINGS: WARNING: HEMATOLOGIC TOXICITY, CARCINOGENICITY, TERATOGENICITY, AND IMPAIRMENT OF FERTILITY See full prescribing information for complete boxed warning. • Clinical toxicity of Valcyte, which is metabolized to ganciclovir, includes granulocytopenia, anemia, and thrombocytopenia. • In animal studies, ganciclovir was carcinogenic, teratogenic, and caused aspermatogenesis BEFORE USING THIS MEDICINE: Tell your doctor if you are having any of the following conditions: TOP KIDNEY DISEASE; ANEMIA. * Inform your Doctor or Pharmacist if you are allergic to any prescription or non-prescription medicine; taking other medicines or have other medical problems; pregnant, planning a pregnancy, or breastfeeding. * Check with your Doctor, Pharmacists, or Nurse if information in this leaflet causes you special concern or if you want additional information about your medicine and its use. HOW MEDICINE IS ADMINISTERED? TOP Use this medicine exactly as directed on the label, unless instructed differently by your doctor * Take this medicine WITH food, a meal, or a snack. Do not take on an empty stomach. * Swallow TABLETS whole; DO NOT cut, crush or chew. Take with plenty of water or other appropriate fluids. * WASH hands immediately after using medication. * Use this medicine for the full prescribed treatment period. * This medicine is NOT A CURE. Patients need long-term management. * DO NOT EXCEED recommended dosage; excessive use may lead to adverse effects or loss of effectiveness. Do not adjust the dose unless instructed. WARNINGS/PRECAUTIONS: TOP * STOP TAKING MEDICINE & GET EMERGENCY HELP IMMEDIATELY IF A HYPERSENSITIVITY OR ANAPHYLACTIC REACTION occurs: (see symptoms below):- * shortness of breath, fast or irregular breathing, fever, joint pain, fast pulse, lightheadedness or fainting, swelling of face, hives, & itching. * 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. * This medicine may cause drowsiness, dizziness, or blurred vision. DO NOT drive or operate machines until you know how you react to this medicine. * Women of childbearing potential should use effective CONTRACEPTION during treatment. * MEN should practice barrier CONTRACEPTIVE methods DURING AND for 3 MONTHS FOLLOWING treatment. * This medicine may cause INFERTILITY. * Notify your doctor if signs of INFECTION develops (eg, fever, sore throat, chills, or unusual bruising or bleeding). * It is important that you keep your follow-up appointments with your doctor. * It is important that your doctor monitors your BLOOD CELL COUNTS at regular intervals. * This medicine may cause BLOOD PROBLEMS resulting in certain infections, slow healing, and gum bleeding. Be careful when toothbrushing and flossing. * The results of some MEDICAL or LAB tests may be affected by this medicine. Inform the doctor in charge that you are taking this medicine. * Regular follow-up visits to your OPHTHALMOLOGIST (eye doctor) are necessary to monitor visual problems. * Because of INTERACTIONS, report the use of any other prescription or nonprescription medicines, including natural/herbal remedies, to your doctor. ADVERSE REACTIONS: Stop taking this medicine and get emergency help IMMEDIATELY if you experience: Shortness of breath, fast or irregular breathing, fever, joint pain, fast pulse, lightheadedness or fainting, swelling of face, hives, & itching. Stop taking this medicine and notify your doctor AS SOON AS POSSIBLE if you experience: Confusion; Infection; Jerkings of face, trunk, or extremities; Unusual bleeding or bruising; Visual disturbances; Burning pain, tingling, or numbness; Fever. Other Common Side Effects: TOP Feeling uncoordinated; Dizziness; Fertility impairment; Sedation; Stomach discomfort or pain; Difficulty falling asleep; Vomiting; Headache; Nausea; 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