DrugindexOnline^{2nd edition}

Generic Name: Trastuzumab (traz-TOO-ze-mab)
Brand Name: Herceptin

Use of Herceptin may lead to serious heart problems, including heart failure. Your doctor may need to stop Herceptin if these problems occur. Patients who also use anthracyclines (eg, doxorubicin) and cyclophosphamide are more likely to develop heart problems. The use of Herceptin may also result in several other severe, rarely fatal, problems. Specifically, these are allergic reactions, intravenous (IV) dosing (infusion reaction), and lung disease (acute respiratory distress syndrome [ARDS]). These problems, if they occur, usually happen while the medicine is being given, or within 24 hours of the dose. The IV dose should be interrupted if you experience difficulty breathing or severe dizziness/very low blood pressure; consult your doctor or pharmacist immediately. The treatment may need to be stopped if severe allergic or lung problems occur; seek immediate medical attention.

Herceptin is used for:

Treating certain patients with metastatic breast cancer. It may be used in combination with paclitaxel to treat patients who have not received chemotherapy.

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

Do NOT use Herceptin if:

• you are allergic to any ingredient in Herceptin

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

Before using Herceptin :

Some medical conditions may interact with Herceptin . 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 breathing conditions (eg, asthma, emphysema), heart problems or disease, HIV, or lung disease or tumors
• if you have received radiation treatment

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

• Anthracyclines (eg, doxorubicin) and 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 Herceptin 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 Herceptin :

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

• Herceptin is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Herceptin at home, carefully follow the injection procedures taught to you by your health care provider.
• If Herceptin contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Herceptin , contact your doctor immediately.

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

Important safety information:

• Herceptin may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Herceptin . Using Herceptin alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Herceptin may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection including fever, sore throat, rashes, or chills.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Herceptin .
• Check with your doctor before receiving vaccinations.
• LAB TESTS may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Herceptin with caution in the ELDERLY because they may be more sensitive to its effects.
• This medicine is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Avoid becoming pregnant while taking Herceptin . If you think you may be pregnant, discuss with your doctor the benefits and risks of using Herceptin during pregnancy. Herceptin is excreted in breast milk. Do not breast-feed while taking Herceptin and for 6 months after the last dose.

Possible side effects of Herceptin :

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; diarrhea; dizziness; headache; muscle pain or weakness; runny nose; sinus pain; sleeplessness; stomach pain; trouble sleeping; unsteadiness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; dark urine or pale stools; fast heartbeat; fever and chills; hoarseness; nausea; pain, redness, or swelling at the injection site; persistent cough; personality changes; shortness of breath; sore throat; sudden onset of cold sweat; swelling of feet or ankles; unusual fatigue or weakness; upper respiratory tract infection; vision changes; vomiting; weakness; wheezing; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or 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/findyour.htm), or emergency room immediately.

Proper storage of Herceptin :

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

General information:

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