Pertuzumab (Intravenous route)
Cardiomyopathy: Pertuzumab administration can result in subclinical and clinical cardiac failure. Evaluate left ventricular function in all patients prior to and during treatment with pertuzumab. Discontinue pertuzumab treatment for a confirmed clinically significant decrease in left ventricular function. Embryo-fetal Toxicity: Exposure to pertuzumab can result in embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception .
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, docetaxel and trastuzumab, and only in patients with HER2-positive breast cancer. The HER2 protein is produced by some breast tumors. Pertuzumab interferes with the growth of this protein, which is eventually destroyed by the body. It is a monoclonal antibody.
Pertuzumab is also used as part of a complete treatment regimen for early breast cancer before surgery.
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:
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.
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.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pertuzumab injection in the elderly.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
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.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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:
A doctor or other trained health professional will give you this medicine while you are in a hospital or cancer treatment center. This medicine is given through a needle placed in a vein.
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 and for 6 months after the last dose of this medicine. 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. Anaphylaxis 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:
- More common
- Black, tarry stools
- burning, numbness, tingling, or painful sensations
- fast heartbeat
- 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
- More common
- Body aches or pain
- change in taste
- cracked lips
- decreased appetite
- dry skin
- ear congestion
- hair loss or thinning of the hair
- loosening of the fingernails
- loss of taste
- loss of voice
- nasal congestion
- redness or soreness around the fingernails
- runny nose
- watering of the eyes
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:
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:
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.
Last Updated: 11/4/2014