Ado-Trastuzumab Emtansine for injection

What is this medication?

ADO-TRASTUZUMAB EMTANSINE (ADD oh traz TOO zuh mab em TAN zine) is a monoclonal antibody combined with chemotherapy. It is used to treat breast cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Kadcyla

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• heart disease
• heart failure
• infection (especially a virus infection such as chickenpox, cold sores, or herpes)
• liver disease
• lung or breathing disease, like asthma
• tingling of the fingers or toes, or other nerve disorder
• an unusual or allergic reaction to ado-trastuzumab emtansine, other medications, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medication?

This medicine may also interact with the following medications:

• atazanavir
• boceprevir
• clarithromycin
• delavirdine
• indinavir
• dalfopristin; quinupristin
• isoniazid, INH
• itraconazole
• ketoconazole
• nefazodone
• nelfinavir
• ritonavir
• telaprevir
• telithromycin
• tipranavir
• voriconazole

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your doctor for checks on your progress. This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

You may need blood work done while you are taking this medicine.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

Do not become pregnant while taking this medicine or for 7 months after stopping it, men with female partners should use contraception during treatment and for 4 months after the last dose. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Do not breast-feed an infant while taking this medicine or for 7 months after the last dose.

Men who have a partner who is pregnant or who is capable of becoming pregnant should use a condom during sexual activity while taking this medicine and for 4 months after stopping it. Men should inform their doctors if they wish to father a child. This medicine may lower sperm counts. Talk to your health care professional or pharmacist for more information.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• chest pain or palpitations
• fever or chills, sore throat
• general ill feeling or flu-like symptoms
• light-colored stools
• nausea, vomiting
• pain, tingling, numbness in the hands or feet
• signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose
• swelling of the legs or ankles
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• changes in taste
• constipation
• dizziness
• headache
• joint pain
• muscle pain
• trouble sleeping
• unusually weak or tired

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

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

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.