Pertuzumab Injection

Brand Name(s): Perjeta^®

IMPORTANT WARNING:

Pertuzumab injection may cause serious or life-threatening heart problems, including heart failure. Tell your doctor if you have recently had a heart attack or if you have or ever had high blood pressure, heart failure, an abnormal heart rhythm, or heart disease. Your doctor will check your heart function before and during your treatment. If you experience any of the following symptoms, tell your doctor immediately: shortness of breath, cough, swelling of the ankles, legs, or face, rapid heartbeat, sudden weight gain, dizziness, or loss of consciousness.

Pertuzumab injection should not be used by women who are pregnant or who may become pregnant. There is a risk that pertuzumab will cause loss of the pregnancy or will cause the baby to be born with birth defects (physical problems that are present at birth). Tell your doctor if you are pregnant or plan to become pregnant. You will need to have a pregnancy test before you receive this medication. You should use effective birth control during treatment with pertuzumab injection 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 treatment with pertuzumab injection, or think you might be pregnant, call your doctor immediately.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests before and during your treatment to check your body's response to pertuzumab injection.

Talk to your doctor about the risk of treatment with pertuzumab injection.

WHY is this medicine prescribed?

Pertuzumab injection is used along with trastuzumab (Herceptin) and docetaxel (Taxotere) to treat a certain type of breast cancer that has spread to other parts of the body. It is also used before and after surgery along with trastuzumab (Herceptin) and other chemotherapy medications to treat certain types of early stage breast cancer. Pertuzumab injection 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?

Pertuzumab injection comes as a solution (liquid) to be injected into a vein over a 30 to 60 minutes by a doctor or nurse in a hospital or medical facility. It is usually given 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.

Pertuzumab injection may cause serious or possibly life-threatening reactions that may occur while the medication is being given and for a period of time afterwards. Your doctor or nurse will watch you carefully while you receive each dose of pertuzumab injection, and for at least one hour after your first dose and thirty minutes after later doses. Tell your doctor or nurse right away if you experience any of the following symptoms during or shortly after your infusion: shortness of breath, wheezing or noisy breathing, hoarseness, difficulty swallowing, hives, rash, itching, fever, chills, tiredness, headache, weakness, vomiting, unusual taste in the mouth, or muscle pain.

What SPECIAL PRECAUTIONS should I follow?

Before receiving pertuzumab injection,

• tell your doctor and pharmacist if you are allergic to pertuzumab injection, any other medications, or any of the ingredients in pertuzumab injection. Ask your doctor for a list of the ingredients.

• tell your doctor and pharmacist what other 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 ever been treated with chemotherapy or radiation therapy.

• tell your doctor if you are breastfeeding.

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 pertuzumab injection.

What SIDE EFFECTS can this medicine cause?

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

• nausea
• diarrhea
• decrease in appetite
• difficulty falling asleep or staying asleep
• pain, burning, numbness, or tingling in the hands or feet
• teary eyes
• pale or dry skin
• hair loss
• mouth sores

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

• sore throat, fever, chills, cough, and other signs of infection
• nausea; vomiting; loss of appetite; fatigue; rapid heartbeat; dark urine; decreased amount of urine; stomach pain; seizures; hallucinations; or muscle cramps and spasms

Talk to your doctor about the risks of taking this medication.

Pertuzumab injection may cause other side effects. Call your doctor if you have any unusual problems while 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).

What should I know about STORAGE and DISPOSAL of this medication?

Your healthcare provider will store your medication.

What OTHER INFORMATION should I know?

Your doctor will order a lab test before you begin your treatment to see whether your cancer can be treated with pertuzumab.

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.