Perjeta Vial

GENERIC NAME(S): Pertuzumab

OTHER NAME(S): Perjeta Solution

WARNINGS:

Pertuzumab can cause serious (possibly fatal) harm to an unborn baby if used during pregnancy. It should only be used during pregnancy if the benefits outweigh these risks. It is important that men and women using this medication use reliable forms of birth control (such as condoms, birth control pills) while using this medication and for 7 months after treatment stops. If you become pregnant, think you may be pregnant, or cause a pregnancy, tell your doctor right away.

Who should not take Perjeta Vial?

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Uses

Uses

Pertuzumab is used with other medications to treat certain types of breast cancer that has spread to other parts of the body in patients who have not received treatment or chemotherapy. It is also used with other medications to treat early stage breast cancer in patients who will be having surgery to remove the cancer. The types of cancers pertuzumab is used to treat are tumors that produce more than the normal amount of a certain substance called HER2 protein.

This medication is called a monoclonal antibody. It works by attaching to the HER2 cancer cells and blocking them from dividing and growing. It may also destroy the cancer cells or signal the body (immune system) to destroy the cancer cells.

How to use Perjeta Vial

This medication is given by a health care professional. It is injected slowly into a vein as directed by your doctor, usually once every 3 weeks. Your first infusion will be given over 60 minutes.

The dosage, the speed of your injection, and the length of time you receive pertuzumab is based on your medical condition, other treatments you are taking, and your response to pertuzumab treatment.

A health care professional should watch you for at least 60 minutes after your first infusion is finished to make sure you do not have an infusion reaction (see also Side Effects section).

Use this medication regularly to get the most benefit from it. To help you remember, mark the days on the calendar when you need to receive the medication.

Side Effects

Side Effects

Diarrhea, nausea, vomiting, tiredness, and loss of appetite may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: swelling ankles/feet, trouble breathing, unusual tiredness, numbness/tingling of arms/legs.

Pertuzumab can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, tell your doctor right away if you develop any rash.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throat, cough).

This medication can sometimes cause a serious infusion (IV) reaction. Immediately tell your doctor if the following side effects occur while this drug is being given: chills, fever, headache, rash, vomiting, and weakness. Your doctor may decrease the speed of your injection.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Precautions

Before using pertuzumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: previous cancer treatments (including radiation therapy to the chest), heart disease, high blood pressure, previous severe reaction to monoclonal antibody treatment.

Pertuzumab can make you more likely to get infections or may worsen any current infection. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose). Wash your hands well to prevent the spread of infections.

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using pertuzumab. Pertuzumab may harm an unborn baby. See also Warning section.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug or for 7 months after the last dose. Consult your doctor before breast-feeding.

Interactions

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as heart exams, HER2 testing) should be done before you start using this medication and while you are using it. A pregnancy test should also be done before starting treatment. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule.

Storage

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.

Images
Perjeta 420 mg/14 mL (30 mg/mL) intravenous solution
Perjeta 420 mg/14 mL (30 mg/mL) intravenous solutioniconicon
Perjeta 420 mg/14 mL (30 mg/mL) intravenous solution

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Perjeta 420 mg/14 mL (30 mg/mL) intravenous solution
Perjeta 420 mg/14 mL (30 mg/mL) intravenous solution

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colorless
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This medicine is a colorless, clear, vial

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.