Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection

IMPORTANT WARNING:

Pertuzumab, trastuzumab, and hyaluronidase-zzxf 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 pertuzumab, trastuzumab, and hyaluronidase-zzxf injection. Tell your doctor and pharmacist if you are being treated with anthracycline medications for cancer such as daunorubicin (Cerubidine), doxorubicin (Doxil), epirubicin (Ellence), and idarubicin (Idamycin) at this time or within 7 months after receiving pertuzumab, trastuzumab, and hyaluronidase-zzxf injection. If you experience any of the following symptoms, call your doctor immediately: cough; shortness of breath; swelling of the face, 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.

Tell your doctor if you are pregnant or plan to become pregnant. Pertuzumab, trastuzumab, and hyaluronidase-zzxf injection may harm your unborn baby. There is a risk that it will cause the baby to be born with birth defects (physical problems that are present at birth). You will need to have a pregnancy test prior to starting treatment and 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 pertuzumab, trastuzumab, and hyaluronidase-zzxf injection, call your doctor immediately.

Pertuzumab, trastuzumab, and hyaluronidase-zzxf injection may also cause severe lung damage or an allergic reaction. Tell your doctor if you have or have ever had lung disease or if you have a tumor in your lungs, especially if you usually have difficulty breathing at rest. Your doctor will watch you carefully when you receive pertuzumab, trastuzumab, and hyaluronidase-zzxf injection 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: difficulty breathing or shortness of breath.

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, trastuzumab, and hyaluronidase-zzxf.

Talk to your doctor about the risks of receiving pertuzumab, trastuzumab, and hyaluronidase-zzxf.

WHY is this medicine prescribed?

The combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf is used in combination with chemotherapy to treat certain types of early breast cancer that has spread to nearby tissues. It is also used to treat a certain type of early breast cancer to decrease the chance that a certain type of breast cancer will return. The combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf is also used with docetaxel (Taxotere) to treat certain types of breast cancer that has spread to other parts of the body. Pertuzumab and trastuzumab are in a class of medications called monoclonal antibodies. They work by stopping the growth of cancer cells. Hyaluronidase is an endoglycosidase. It helps to keep pertuzumab and trastuzumab in the body longer so that these medications will have a greater effect.

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, trastuzumab, and hyaluronidase-zzxf injection comes as a liquid to be injected subcutaneously (under the skin). Pertuzumab, trastuzumab, and hyaluronidase-zzxf injection is given by a doctor or nurse in a hospital or medical facility. It is usually given into the thigh over 5 to 8 minutes once every 3 weeks. The length of your treatment will depend on the condition that you have and how well your body responds to treatment.

A doctor or nurse will watch you closely while you are receiving the medication and for 15-30 minutes afterwards to be sure you are not having a serious reaction to it. Tell your doctor or nurse immediately if you experience any of the following symptoms: fever; chills; nausea; vomiting; diarrhea; rash; hives; itching; swelling of the face, eyes, mouth, throat, tongue, or lips; difficulty breathing or swallowing; or chest pain.

Your doctor may temporarily or permanently stop your treatment. This depends on how well the medication works for you and the side effects you experience. Be sure to tell your doctor how you are feeling during your treatment with pertuzumab, trastuzumab, and hyaluronidase-zzxf.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving pertuzumab, trastuzumab, and hyaluronidase-zzxf injection,

• tell your doctor and pharmacist if you are allergic to pertuzumab, trastuzumab, hyaluronidase, any other medications, or any of the ingredients in pertuzumab, trastuzumab, and hyaluronidase injection. Ask your pharmacist 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 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 pertuzumab, trastuzumab, and hyaluronidase-zzxf injection.

What SIDE EFFECTS can this medicine cause?

Pertuzumab, trastuzumab, and hyaluronidase-zzxf may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• hair loss
• dry skin
• heartburn
• stomach pain
• changes in the appearance of nails
• mouth ulcers
• hemorrhoids
• weight loss
• loss of appetite
• changes in taste
• numbness, burning, or tingling in the arms, hands, feet, or legs
• arm, leg, back, bone, joint, or muscle pain
• muscle spasms
• pain or redness in the area where the medication was injected
• difficulty falling asleep or staying asleep
• dry eyes or tearing
• hot flashes

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

• sore throat, fever, cough, chills, difficult or painful urination, and other signs of infection
• nosebleeds or other unusual bruising or bleeding
• excessive tiredness or pale skin
• rash with blisters on hands and feet

Pertuzumab, trastuzumab, and hyaluronidase-zzxf 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 do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Ask your pharmacist any questions you have about pertuzumab, trastuzumab, and hyaluronidase-zzxf injection.

Your doctor will order a lab test before you begin your treatment to see whether your cancer can be treated with pertuzumab, trastuzumab, and hyaluronidase-zzxf.

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.