Trastuzumab Solution for injection

What is this medicine?

TRASTUZUMAB (tras TOO zoo mab) is a monoclonal antibody. It is used to treat breast cancer and stomach cancer.

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

What should I tell my health care provider before I take this medicine?

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)

• lung or breathing disease, like asthma

• recent or ongoing radiation therapy

• an unusual or allergic reaction to trastuzumab, benzyl alcohol, or other medications, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This drug is given as an infusion into a vein. It is administered in a hospital or clinic by a specially trained health care professional.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

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 a dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

• doxorubicin

• warfarin

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 medicine?

Visit your doctor for checks on your progress. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

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. Try to avoid being around people who are sick.

You may experience fever, chills and shaking during your first infusion. These effects are usually mild and can be treated with other medicines. Report any side effects during the infusion to your health care professional. Fever and chills usually do not happen with later infusions.

Do not become pregnant while taking this medicine or for 7 months after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Women of child-bearing potential will need to have a negative pregnancy test before starting this medicine. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for 7 months after stopping it.

Women must use effective birth control with this medicine.

What side effects may I notice from receiving this medicine?

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

• breathing difficulties

• chest pain or palpitations

• cough

• dizziness or fainting

• fever or chills, sore throat

• skin rash, itching or hives

• swelling of the legs or ankles

• unusually weak or tired

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

• loss of appetite

• headache

• muscle aches

• nausea

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 medicine?

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