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Kadcyla

Generic Name: ado-trastuzumab (Ado tras-TOOZ-ue-mab)
Brand Name: Kadcyla

Severe and sometimes fatal liver problems may occur with the use of Kadcyla. Tell your doctor if you have a history of liver problems. Your doctor may need to check your liver function before you start Kadcyla and while you are taking it. Be sure to keep all doctor and lab appointments. Contact your doctor right away if you develop dark urine, pale stools, severe stomach pain, severe tiredness or weakness, unusual itching, or yellowing of the eyes or skin.

Use of Kadcyla may lead to serious heart problems, including heart failure. Your doctor will perform heart function tests before you start Kadcyla and periodically while you use it. Contact your doctor right away if you develop signs of heart problems, such as chest pain; irregular heartbeat; persistent cough; shortness of breath; sudden, unexplained weight gain; or swelling of the hands, ankles, or feet.

Kadcyla may cause serious harm to the fetus if used during pregnancy. If you are able to become pregnant, you must use an effective form of birth control while you use Kadcyla and for at least 6 months after you stop using it. If you have questions about effective birth control, talk with your doctor. If you think you may be pregnant, contact your doctor right away.


Kadcyla is used for:

Treating certain types of breast cancer.

Kadcyla is a monoclonal antibody. It works by targeting certain tumor cells and stopping them from growing and reproducing.

Do NOT use Kadcyla if:

  • you are allergic to any ingredient in Kadcyla
  • you are taking trastuzumab

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Kadcyla:

Some medical conditions may interact with Kadcyla. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have had a reaction (eg, rash; hives; itching; difficult breathing; shortness of breath; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing) to a previous dose of Kadcyla, or to trastuzumab
  • if you have a history of breathing or lung problems, heart problems (eg, heart attack, heart failure, irregular heartbeat), high blood pressure, liver problems, chronic infections, or bone marrow problems (eg, low red or white blood cell counts, low platelet counts)

Some MEDICINES MAY INTERACT with Kadcyla. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Azole antifungals (eg, itraconazole, ketoconazole, voriconazole), clarithromycin, cobicistat, nefazodone, protease inhibitors (eg, boceprevir, ritonavir), or telithromycin because they may increase the risk of Kadcyla's side effects
  • Anticoagulants (eg, warfarin) or antiplatelet medicines (eg, clopidogrel) because the risk of bleeding may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Kadcyla may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Kadcyla:

Use Kadcyla as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Kadcyla is given as an injection at your doctor's office, hospital, or clinic. Ask your doctor, nurse, or pharmacist any questions that you may have about Kadcyla.
  • If you miss a dose of Kadcyla, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Kadcyla.

Important safety information:

  • Kadcyla may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Kadcyla with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Kadcyla may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection such as fever, sore throat, rash, or chills.
  • Some patients may experience an infusion reaction with Kadcyla. This usually happens while receiving the medicine or within 24 hours after a dose. Symptoms may include chills, fever, flushing, fainting, fast heartbeat, dizziness, shortness of breath, or wheezing. Tell your doctor if you notice these or other unusual effects while you use Kadcyla.
  • Kadcyla may cause serious and sometimes fatal lung problems. Discuss any questions or concerns with your doctor. Tell your doctor right away if you experience chest pain or new or worsening cough, shortness of breath, or trouble breathing.
  • Kadcyla may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Discuss any questions or concerns with your doctor.
  • Severe and sometimes fatal bleeding problems have happened with Kadcyla. Call your doctor right away if you have symptoms of bleeding (eg, vomiting blood or vomit that looks like coffee grounds; coughing up blood; blood in the urine; black, tarry, or bloody stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is severe or that you cannot stop.
  • Tell your doctor or dentist that you take Kadcyla before you receive any medical or dental care, emergency care, or surgery.
  • If you are able to become pregnant, you must use an effective form of birth control while you use Kadcyla and for at least 6 months after you stop using it. If you have questions about effective birth control, talk with your doctor.
  • Lab tests, including heart function, liver function, and complete blood cell counts, may be performed while you use Kadcyla. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Kadcyla should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Kadcyla may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor right away. It is not known if Kadcyla is found in breast milk. Do not breast-feed while using Kadcyla.

Possible side effects of Kadcyla:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Change in taste; constipation; diarrhea; dizziness; dry mouth; headache; mild bone, joint, or muscle pain; mild fever or chills; nausea; stomach pain or upset; tiredness; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); burning, numbness, or tingling; chest pain; decreased coordination; difficult, frequent, or painful urination; fainting; fast or irregular heartbeat; muscle pain, weakness, or cramping; new or worsening cough, shortness of breath or trouble breathing; pain, redness, or swelling at the injection site; pain, swelling, or sores of the mouth or tongue; severe or persistent dizziness, light-headedness, or headache; severe or persistent nausea, vomiting, or diarrhea; skin infection (eg, skin discharge, redness, swelling, or warmth); sudden, unexplained weight gain (eg, more than 5 pounds in 24 hours); swelling of the hands, ankles, or feet; symptoms of infection (eg, severe or persistent fever, chills, sore throat); symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe stomach pain, yellowing of the skin or eyes); unusual tiredness or weakness; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Kadcyla:

Kadcyla is handled and stored by a health care provider. You will not store it at home. Keep all medicines out of the reach of children and away from pets.

General information:

  • If you have any questions about Kadcyla, please talk with your doctor, pharmacist, or other health care provider.
  • Kadcyla is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Kadcyla or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Kadcyla. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Kadcyla. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Kadcyla.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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