Trastuzumab Injection

IMPORTANT WARNING:

Trastuzumab injection 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 trastuzumab injection. 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 may cause serious or life-threatening reactions that may occur while the medication is being given or up to 24 hours afterward. Trastuzumab injection 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 trastuzumab injection. 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. Your doctor may need to slow down your infusion, or delay or stop your treatment if you experience these side effects.

Tell your doctor if you are pregnant or plan to become pregnant. Trastuzumab injection may harm your unborn baby. You should not becomepregnant while you are receiving trastuzumab injection. You may have to take a pregnancy test before starting treatment. 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 trastuzumab injection, 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 trastuzumab injection.

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

IMPORTANT NOTICE:

Trastuzumab injection, trastuzumab-anns injection, trastuzumab-dkst injection, trastuzumab-dttb injection, trastuzumab-pkrb injection, trastuzumab-qyyp injection, and trastuzumab-strf injection are biologic medications (medications made from living organisms). Trastuzumab-anns, trastuzumab-dkst, trastuzumab-dttb, trastuzumab-pkrb, and trastuzumab-qyyp are considered to be "biosimilar" to trastuzumab injection which means they work just as well and are just assafe to use as trastuzumab injection. Trastuzumab injection mentioned in the monograph below refers to anyof these 7 products.

WHY is this medicine prescribed?

Trastuzumab injection is used to treat certain types of breast and stomach cancers. Trastuzumab is in a class of medications called monoclonal antibodies. It works by stopping the growth of cancer cells.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Trastuzumab injection comes as a powder to be mixed with a liquid and injected slowly into a vein over 30 to 90 minutes. Trastuzumab injections are usually given by a doctor or nurse in a medical facility. Your doctor will tell you howoften you will receive trastuzumab injection. The schedule depends on the condition you haveand on how your body responds to the medication. The length of your treatment depends on how well your body responds to the medication and the side effects that you experience.

What SPECIAL PRECAUTIONS should I follow?

Before receiving trastuzumab injection,

• tell your doctor and pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• 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.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

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

What SIDE EFFECTS can this medicine cause?

Trastuzumab injection 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 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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.