Pronunciation:

per-TOOZ-ue-mab

Brand Names:

• Perjeta

Dosage Forms:

• Solution

Warnings:

Pertuzumab can result in subclinical and clinical cardiac failure manifesting as decreased left ventricular ejection fraction and congestive heart failure. Evaluate cardiac function prior to and during treatment. Discontinue pertuzumab treatment for a confirmed clinically significant decrease in left ventricular function. Exposure to pertuzumab can result in embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Pertuzumab injection is used to treat breast cancer that has spread to other parts of the body. It is used together with other cancer medicines (eg, docetaxel, trastuzumab) to treat patients with HER2-positive breast cancer. The HER2 protein is produced by some breast tumors. Pertuzumab is a monoclonal antibody that interferes with the growth of this protein, which is eventually destroyed by the body.

Pertuzumab is also used as part of a complete treatment regimen for early breast cancer before surgery and as an additional treatment for breast cancer that is at high risk for occurring again.

This medicine is to be given only by or under the immediate supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of pertuzumab injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pertuzumab injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bacillus of Calmette and Guerin Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Cholera Vaccine
• Daunorubicin
• Daunorubicin Citrate Liposome
• Daunorubicin Liposome
• Doxorubicin
• Ebola Zaire Vaccine, Live
• Epirubicin
• Idarubicin
• Influenza Virus Vaccine, Live
• Pirarubicin
• Pixantrone
• Rotavirus Vaccine, Live
• Valrubicin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Congestive heart failure—Use with caution. May make this condition worse.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A doctor or other trained health professional will give you this medicine while you are in a hospital or cancer treatment center. It is given through a needle placed into a vein. It is usually given once every 3 weeks.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects. Be sure to keep all appointments.

Your unborn baby could be harmed if you use this medicine while you are pregnant. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 7 months after the last dose. Tell your doctor right away if you think you have become pregnant.

This medicine may cause heart failure. Your doctor will test your heart before you start receiving pertuzumab. The test will be repeated every few months while you are receiving the medicine. Check with your doctor right away if you have chest pain, trouble breathing, rapid weight gain, or abnormal swelling in your ankles or legs. These could be symptoms of heart failure.

This medicine may cause a serious infusion reaction. This can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a fever, chills, chest pain, lightheadedness, dizziness, fainting, a headache, a rash, pain, nausea, vomiting, trouble breathing, or weakness within a few hours after the infusion.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you get the injection.

Cancer medicines can cause nausea or vomiting in most people, sometimes even after receiving medicines to prevent it. If this happens, ask your doctor or nurse about other ways to control these side effects.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools

burning, numbness, tingling, or painful sensations

chills

cough

fast heartbeat

fever

hives, itching, or rash

hoarseness

joint pain, stiffness, or swelling

lower back or side pain

painful or difficult urination

pale skin

redness of the skin

sore throat

swelling of the eyelids, face, lips, hands, or feet

tightness in the chest

troubled breathing or swallowing

ulcers, sores, or white spots in the mouth

unsteadiness or awkwardness

unusual bleeding or bruising

unusual tiredness or weakness

weakness in the arms, hands, legs, or feet

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Body aches or pain

change in taste

cracked lips

decreased appetite

diarrhea

dizziness

dry skin

ear congestion

hair loss or thinning of the hair

headache

loosening of the fingernails

loss of taste

loss of voice

nasal congestion

nausea

redness or soreness around the fingernails

runny nose

sneezing

vomiting

watering of the eyes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.