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Kadcyla intravenous

GENERIC NAME(S): ADO-TRASTUZUMAB EMTANSINE

WARNINGS:

Ado-trastuzumab emtansine has rarely caused very serious (possibly fatal) liver disease. Get medical help right away if you develop symptoms of liver disease, including persistent nausea, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.

Ado-trastuzumab emtansine may lead to serious heart problems, including heart failure. Past use of certain other anti-cancer drugs (including anthracyclines such as doxorubicin) may increase your risk of heart problems. Tell your doctor right away if you have any symptoms of heart failure, including swelling ankles/feet, trouble breathing, unusual tiredness, sudden unexplained weight gain.

Ado-trastuzumab emtansine can cause serious (possibly fatal) harm to an unborn baby if used during pregnancy. Discuss reliable forms of birth control with your doctor.

Do not substitute trastuzumab for ado-trastuzumab emtansine.

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Uses

Ado-trastuzumab emtansine is used alone to treat certain types of breast cancer. This medication is used to treat tumors that produce more than the normal amount of a certain substance called HER2 protein.

This medication is called a monoclonal antibody and microtubule inhibitor conjugate. Ado-trastuzumab emtansine works by attaching to the HER2 cancer cells and blocking them from dividing and growing. It may also destroy the cancer cells or signal the body (immune system) to destroy the cancer cells.

How to use Kadcyla intravenous

See also Warning and Side Effects sections.

Ado-trastuzumab emtansine may also be called trastuzumab emtansine. However, ado-trastuzumab emtansine is not the same as trastuzumab. Do not substitute trastuzumab for ado-trastuzumab emtansine.

This medication is given by slow injection into a vein by a health care professional. It is given as directed by your doctor, usually once every 3 weeks. Your first infusion will be given over at least 90 minutes.

The dosage, the speed of your injection, and the length of time you receive ado-trastuzumab emtansine is based on your body weight, medical condition, and response to treatment.

To get the most benefit from this medication, do not miss any doses. To help you remember, mark the days on the calendar when you need to receive the medication.

Your doctor may prescribe other medications (such as acetaminophen, diphenhydramine) for you to take before the start of your treatment to help prevent serious side effects.

Side Effects

See also Warning section.

Diarrhea, redness/irritation at the injection site, dizziness, muscle/joint/back pain, stomach/abdominal pain, constipation, trouble sleeping, nausea, vomiting, mouth sores, dry mouth, changes in taste, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: bone pain, increased coughing, swelling of the hands/ankles/feet, unusual tiredness, severe headache, tingling/numbness (such as in the hands, feet, leg), mental/mood changes, fast/pounding heartbeat, muscle cramps, easy bruising/bleeding.

This drug has caused very serious (rarely fatal) bleeding. Get medical help right away if you develop symptoms of very serious bleeding, including: weakness on one side of the body, slurred speech, vision changes, confusion, severe stomach/abdominal pain, trouble breathing, vomit that is bloody or looks like coffee grounds, black/tarry stool.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throat, cough).

This medication can sometimes cause a serious infusion reaction with serious lung problems. Immediately tell your doctor of the following side effects that occur while this drug is being given or within 24 hours after your treatment is finished, such as chills, fever, flushing, wheezing, shortness of breath, nausea, headache, dizziness, fainting, rash, and weakness.

Ado-trastuzumab emtansine can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, tell your doctor immediately if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

See also Warning section.

Before taking ado-trastuzumab emtansine, tell your doctor or pharmacist if you are allergic to it; or to other mouse protein medications; or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: previous cancer treatments (including radiation therapy to the chest), current infection, heart disease, high blood pressure, lung problems, previous severe reaction to monoclonal antibody treatment, liver disease (including a rare liver condition called nodular regenerative hyperplasia).

Ado-trastuzumab emtansine can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially heart problems (such as heart failure).

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Women of childbearing age should discuss the use of reliable forms of birth control with their doctors while using this medication and for 6 months after treatment has stopped. A pregnancy test should be done before starting treatment. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug or for 6 months after the last dose. Consult your doctor before breast-feeding.

Interactions

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of ado-trastuzumab emtansine from your body, which may affect how ado-trastuzumab emtansine works. Examples include azole antifungals (such as itraconazole, ketoconazole), clarithromycin, HIV protease inhibitors (such as atazanavir, ritonavir), nefazodone, telithromycin, among others.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as heart exams, platelet counts, liver function, bilirubin level) should be performed before you start treatment, and periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule.

Storage

Not applicable. This medication is given in a clinic or hospital and will not be stored at home.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Information last revised July 2014. Copyright(c) 2014 First Databank, Inc.

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KADCYLA 160 MG VIAL
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KADCYLA 160 MG VIAL
KADCYLA 160 MG VIAL

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This medicine is a colorless, clear vial.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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