ado-TRASTUZUMAB INJ. (KADCYLA) WARNING: HEPATOTOXICITY, CARDIAC TOXICITY, EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning Do not substitute KADCYLA for or with trastuzumab. Hepatotoxicity, liver failure and death have occurred in KADCYLA-treated patients: Monitor hepatic function prior to initiation and prior to each dose. Institute dose modifications or permanently discontinue as appropriate. KADCYLA may lead to reductions in left ventricular ejection fraction (LVEF): Assess LVEF prior to initiation. Monitor and withhold dosing or discontinue as appropriate. Can cause fetal harm. Advise women of potential risk to the fetus. BEFORE USING THIS MEDICINE: Tell your doctor: TOP If you are PREGNANT. Tell your doctor if you are having any of the following conditions: TOP HEART CONDITION. * 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 * This medicine is given as an IV INFUSION at a constant rate over a period of time as recommended by manufacturer. * Patient should read specific "MEDICATION GUIDE" provided with this medicine before starting treatment and each time their prescription is renewed. * Follow manufacturer's directions to properly reconstitute. * To reconstitute, SWIRL, DO NOT SHAKE. * Do not administer medication IV concomitantly with any other medication through same site and or tubing. * PRESERVATIVE FREE formulation: Use immediately after reconstitution. * DO NOT MIX WITH DEXTROSE SOLUTIONS 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. * This medicine is CONTRAINDICATED for use during pregnancy. CALL YOUR DOCTOR IMMEDIATELY IF PREGNANT or intend to become pregnant. * Inform your doctor immediately if you experience respiratory symptoms such as shortness of breath, dry and nonproductive cough. * Notify doctor if symptoms of CHF occur (eg, difficult breathing, especially on exertion or lying down; night cough; swelling of the extremities). 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: Difficulty breathing; Swelling of the extremities; Swelling of feet or lower legs. Other Common Side Effects: TOP Generalized pain; Muscle weakness; Fever; Nausea; Chills; Joint pain; Unusual tiredness or weakness; Headache; Diarrhea; Cough; Vomiting; Infection; Stomach discomfort or pain; Back pain; Skin rash; Nasal congestion; Decreased appetite; Difficulty falling asleep; Dizziness; Inflammation of the pharynx; Burning pain, tingling, or numbness; Inflammation of the sinuses; Congestive heart failure; Depression; Urinary tract infection; Rapid heart rate; Anemia; Peripheral neuritis. 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