Trastuzumab injection, trastuzumab-anns injection, trastuzumab-dkst injection, trastuzumab-dttb, trastuzumab-pkrb, and trastuzumab-qyyp injection are biologic medications (medications made from living organisms). Biosimilar trastuzumab-anns injection, trastuzumab-dkst injection, trastuzumab-dttb, trastuzumab-pkrb, and trastuzumab-qyyp injection are highly similar to trastuzumab injection and work the same way as trastuzumab injection in the body. Therefore, the term trastuzumab injection products will be used to represent these medications in this discussion.

Trastuzumab injection products may cause serious or life-threatening heart problems. Tell your doctor if you have or have ever had heart disease. Your doctor will order tests before and during your treatment to see if your heart is working well enough for you to safely receive a trastuzumab injection product. Tell your doctor and pharmacist if you are being treated with radiation therapy to your chest or anthracycline medications for cancer such as daunorubicin (Cerubidine, in Vyxeos), doxorubicin (Doxil), epirubicin (Ellence), and idarubicin (Idamycin). If you experience any of the following symptoms, call your doctor immediately: cough; shortness of breath; swelling of the arms, hands, feet, ankles or lower legs; weight gain (more than 5 pounds [about 2.3 kilograms] in 24 hours); dizziness; loss of consciousness; or fast, irregular, or pounding heartbeat.

Trastuzumab injection products may cause serious or life-threatening reactions that may occur while the medication is being given or up to 24 hours afterward. Trastuzumab injection products may also cause severe lung damage. Tell your doctor if you have or have ever had lung disease or if you have a tumor in your lungs, especially if it has caused you to have difficulty breathing. Your doctor will watch you carefully when you receive a trastuzumab injection product so that your treatment can be interrupted if you experience a serious reaction. If you have any of the following symptoms, tell your doctor immediately: fever, chills, nausea, vomiting, pain, headache, dizziness, weakness, rash, hives, itching, tightening of the throat; or difficulty breathing or swallowing.

Tell your doctor if you are pregnant or plan to become pregnant. Trastuzumab injection products may harm your unborn baby. You should use birth control to prevent pregnancy during your treatment and for 7 months after your final dose. Talk to your doctor about birth control methods that will work for you. If you become pregnant during your treatment with a trastuzumab injection product, call your doctor immediately.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body’s response to a trastuzumab injection product.

Talk to your doctor about the risks of receiving a trastuzumab injection product.

Trastuzumab injection products are used with other medications or after other medications have been used to treat a certain type of breast cancer that has spread to other parts of the body. Trastuzumab injection products are also used during and after treatment with other medications to decrease the chance that a certain type of breast cancer will return. Trastuzumab injection products are also used with other medications to treat certain types of stomach cancer that have spread to other parts of the body. Trastuzumab is in a class of medications called monoclonal antibodies. It works by stopping the growth of cancer cells.

Trastuzumab injection products come as a powder to be mixed with a liquid and infused (injected slowly) into a vein over 30 to 90 minutes. Trastuzumab injection products are usually given by a doctor or nurse in a hospital or medical facility. When a trastuzumab injection product is used to treat breast cancer that has spread, it is usually given once a week. When a trastuzumab injection product is used to prevent the return of breast cancer, it is usually given once a week during treatment with other chemotherapy medications, and then once every 3 weeks after treatment with the other medications is completed for up to 52 weeks. When a trastuzumab injection product is used to treat stomach cancer, it is usually given once every 3 weeks. The length of your treatment depends on how well your body responds to the medication and the side effects that you experience.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving a trastuzumab injection product,

• tell your doctor and pharmacist if you are allergic to trastuzumab, trastuzumab-anns, trastuzumab-dkst, trastuzumab-dttb, trastuzumab-pkrb, trastuzumab-qyyp medications made from Chinese hamster ovary cell protein, any other medications, benzyl alcohol, or any of the ingredients in trastuzumab injection products. Ask your pharmacist if you are not sure if a medication you are allergic to is made from Chinese hamster ovary cell protein or contains benzyl alcohol.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or any other medical condition.
• tell your doctor if you are breast-feeding.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving a trastuzumab injection product.

Unless your doctor tells you otherwise, continue your normal diet.

Call your doctor right away if you are unable to keep an appointment to receive a dose of a trastuzumab injection product.

Trastuzumab injection products may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• constipation
• stomach pain
• heartburn
• loss of appetite
• back, bone, joint, or muscle pain
• difficulty falling asleep or staying asleep
• hot flashes
• numbness, burning, or tingling in the arms, hands, feet, or legs
• changes in the appearance of nails
• acne
• depression

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• sore throat, fever, chills, difficulty urinating, pain when urinating, and other signs of infection
• nosebleeds and other unusual bruising or bleeding
• excessive tiredness
• pale skin
• nausea; vomiting; loss of appetite; fatigue; rapid heart beat; dark urine; decreased amount of urine; stomach pain; seizures; hallucinations; or muscle cramps and spasms

Trastuzumab injection products may cause other side effects. Call your doctor if you have any unusual problems while you are receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Your doctor may order certain lab tests to check your body’s response to trastuzumab injection products.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Herceptin^® (trastuzumab)
• Herzuma^® (trastuzumab-pkrb)
• Kanjinti^® (trastuzumab-anns)
• Ogivri^® (trastuzumab-dkst)
• Onturzant^® (trastuzumab-dttb)
• Trazimera^®(trastuzumab-qyyp)