Trastuzumab

Trastuzumab is used for:

Treating breast cancer in certain patients. It may be used with other medicines.

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

Do NOT use Trastuzumab if:

• you are allergic to any ingredient in Trastuzumab

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

Before using Trastuzumab :

Some medical conditions may interact with Trastuzumab . 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 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 Trastuzumab
• if you have a history of breathing or lung problems, heart problems, high blood pressure, chronic infections, or low red or white blood cell counts
• if you have received radiation treatment

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

• Anthracyclines (eg, doxorubicin) or antineoplastic agents (eg, cyclophosphamide) because the risk of heart problems may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Trastuzumab 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 Trastuzumab :

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

• Trastuzumab is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Trastuzumab at home, a health care provider will teach you how to use it. Be sure you understand how to use Trastuzumab . Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Trastuzumab if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Trastuzumab , contact your doctor right away.

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

Important safety information:

• Trastuzumab may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Trastuzumab with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Trastuzumab 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 like fever, sore throat, rash, or chills.
• Tell your doctor or dentist that you take Trastuzumab before you receive any medical or dental care, emergency care, or surgery.
• Talk with your doctor before you receive any vaccine.
• If you are able to become pregnant, you must use an effective form of contraception while you use Trastuzumab and for at least 6 months after you stop.
• Lab tests, including heart function and HER2 protein testing, may be performed while you use Trastuzumab . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Trastuzumab with caution in the ELDERLY; they may be more sensitive to its effects, especially heart problems.
• Trastuzumab should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Trastuzumab may cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Trastuzumab while you are pregnant. It is not known if Trastuzumab is found in breast milk. Do not breast-feed while taking Trastuzumab .

Possible side effects of Trastuzumab :

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:

Abnormal skin sensations; back pain; cough; diarrhea; dizziness; headache; loss of appetite; muscle, bone, or joint pain; nose, sinus, or throat inflammation; runny nose; stomach pain; trouble sleeping.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); change in the amount of urine produced; chest pain; difficult or painful urination; fainting; fast or irregular heartbeat; fever and chills; mood or mental changes (eg, depression); nausea; new or worsening shortness of breath; pain, redness, or swelling at the injection site; persistent cough; severe or persistent dizziness, lightheadedness, or headache; skin infection (eg, skin discharge, redness, swelling, or warmth); sore throat; sudden unexplained weight gain; swelling of feet or ankles; unusual fatigue or weakness; vomiting; 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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

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

Trastuzumab is usually handled and stored by a health care provider. If you are using Trastuzumab at home, store Trastuzumab as directed by your pharmacist or health care provider. Keep Trastuzumab out of the reach of children and away from pets.

General information:

• If you have any questions about Trastuzumab , please talk with your doctor, pharmacist, or other health care provider.
• Trastuzumab 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.

This information is a summary only. It does not contain all information about Trastuzumab . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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