Generic Name: trastuzumab (tras-TOOZ-ue-mab)
Brand Name: Herceptin
Use of trastuzumab may lead to serious heart problems, including heart failure. The risk may be greater in patients who use certain other medicines, such as anthracyclines (eg, doxorubicin) or cyclophosphamide, with trastuzumab. Your doctor will perform heart function tests before you start trastuzumab and periodically while you use it. Contact your doctor right away if you develop signs of heart problems, such as chest pain; irregular heartbeat; persistent cough; shortness of breath; sudden, unexplained weight gain; or swelling of the hands, ankles, or feet.
Some patients have experienced serious and sometimes fatal infusion reactions and lung problems with trastuzumab. This usually occurred during administration of the medicine or within 24 hours after the dose. Tell your doctor right away if you develop swelling of the mouth, face, lips, tongue, or throat; fainting; rash; severe dizziness or light-headedness; new or worsening shortness of breath or trouble breathing; unusual hoarseness; or wheezing.
Trastuzumab may cause serious harm to the fetus if used during pregnancy. If you are able to become pregnant, you must use an effective form of birth control while you use trastuzumab and for at least 6 months after you stop using it. If you have questions about effective birth control, talk with your doctor. If you think you may be pregnant, contact your doctor right away.
Trastuzumab is used for:
Treating certain types of breast cancer alone or in combination with other medicines. It is also used in combination with other medicines to treat certain types of stomach or esophagus cancer in certain patients.
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 or to Chinese hamster ovary (CHO) cell proteins
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 able to become pregnant
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances, including benzyl alcohol
- 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 (eg, heart attack, heart failure, irregular heartbeat), high blood pressure, kidney problems, chronic infections, or bone marrow problems (eg, low red or white blood cell counts, low platelet counts)
- if you have had previous treatment with a certain type of chemotherapy called an anthracycline (eg, doxorubicin) or 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 given as an injection at your doctor's office, hospital, or clinic. Ask your doctor, nurse, or pharmacist any questions that you may have about trastuzumab.
- 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 away from 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.
- Some patients may experience an infusion reaction with trastuzumab. This usually happens while receiving the medicine or within 24 hours after a dose. Symptoms may include chills, fever, diarrhea, dizziness, headache, pain (sometimes at tumor sites), nausea, and vomiting. Your doctor may prescribe other medicines (eg, acetaminophen, diphenhydramine) to help treat or reduce the risk of these effects. Tell your doctor if you notice these or other unusual effects while you use trastuzumab.
- A more severe infusion reaction may sometimes occur with trastuzumab. Tell your doctor right away if you notice fainting; new or worsening shortness of breath; trouble breathing; rash; swelling of the mouth, face, lips, tongue, or throat; severe dizziness or light-headedness; unusual hoarseness; weakness; or wheezing.
- Trastuzumab may cause serious and sometimes fatal lung problems. Discuss any questions or concerns with your doctor. Tell your doctor right away if you experience chest pain or new or worsening cough, shortness of breath, or trouble breathing.
- Trastuzumab may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Tell your doctor or dentist that you take trastuzumab before you receive any medical or dental care, emergency care, or surgery.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking trastuzumab. Talk with your doctor before you receive any vaccine.
- If you are able to become pregnant, you must use an effective form of birth control while you use trastuzumab and for at least 6 months after you stop using it. If you have questions about effective birth control, talk with your doctor.
- Lab tests, including heart function, 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 be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Trastuzumab may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor right away. It is not known if trastuzumab is found in breast milk. Do not breast-feed while using 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:
Seek medical attention right away if any of these SEVERE side effects occur:
Back, bone, or joint pain; change in taste; constipation; diarrhea; dizziness; fingernail or toenail changes; headache; loss of appetite; mild fever or chills; mild muscle pain; nausea; nose, sinus, or throat irritation; runny or stuffy nose; stomach pain or upset; tiredness; trouble sleeping; vomiting; weight loss.
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); burning, numbness, or tingling sensation; calf or leg pain, redness, swelling, or tenderness; change in the amount of urine produced; chest pain; depression; difficult or painful urination; fainting; fast or irregular heartbeat; muscle pain, weakness, or cramping; new or worsening cough, shortness of breath, or trouble breathing; pain, redness, or swelling at the injection site; pain, swelling, or sores of the mouth or tongue; severe or persistent dizziness, light-headedness, or headache; severe or persistent nausea, vomiting, or diarrhea; skin infection (eg, skin discharge, redness, swelling, or warmth); sudden, unexplained weight gain (eg, more than 5 pounds in 24 hours); swelling of the hands, ankles, or feet; symptoms of infection (eg, severe or persistent fever, chills, sore throat); unusual bruising or bleeding (eg, nosebleed); unusual tiredness or 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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of trastuzumab:
Trastuzumab is handled and stored by a health care provider. Keep trastuzumab out of the reach of children and away from pets.
- 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take trastuzumab or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about trastuzumab. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to trastuzumab. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using trastuzumab.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.