Description
Pertuzumab injection is used in combination with other cancer medicines (eg, trastuzumab, docetaxel) to treat HER2-positive metastatic (cancer that has spread) breast cancer in patients who have not received an anti-HER2 treatment for metastatic breast cancer. This medicine is also used with other cancer medicines (eg, trastuzumab) as a neoadjuvant treatment (before surgery) of HER2-positive, locally advanced (cancer that has spread to areas near the breast), inflammatory (swelling), or early stage breast cancer (tumor is greater than 2 centimeters in diameter or node positive) as part of a complete treatment plan for early breast cancer. It is also used as an adjuvant treatment (after surgery) of HER2-positive early breast cancer that has a high risk of coming back. Your doctor will test for the presence of the HER2 protein or HER2 gene. HER2 protein is produced by some tumors.
Pertuzumab is a monoclonal antibody. It interferes with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal body cells may also be affected by pertuzumab, other effects will also occur. Some of these may be serious and must be reported to your doctor.
This medicine is to be given only by or under the immediate supervision of your doctor.
This product is available in the following dosage forms:
- Solution
Before Using
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.
Pediatric
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.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pertuzumab injection in the elderly. However, elderly patients are more likely to have unwanted effects (eg, anemia, decreased appetite or weight, nerve problems, weakness), which may require caution in patients receiving this medicine.
Breastfeeding
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.
Drug Interactions
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, Live
- 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 or
- Heart rhythm problems—Use with caution. May make these conditions worse.
Proper Use
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 in a medical facility. It is given through an IV catheter that is placed into one of your veins. The medicine must be given slowly, so the IV will have to stay in place for at least 30 to 90 minutes. This medicine is usually given once every 3 weeks.
Precautions
It is very important that your doctor check your progress closely while receiving the medicine and at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.
Receiving this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. 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. If you think you have become pregnant while receiving the medicine, tell your doctor right away.
This medicine may cause heart failure. Your doctor will test your heart before and during treatment. 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 serious infusion reactions, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have blurred vision, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, facial swelling, fever or chills, headache, nausea or vomiting, skin rash, sweating, trouble breathing, or unusual tiredness or weakness.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require 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.
Side Effects
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
- bladder pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody or cloudy urine
- body aches or pain
- burning, numbness, tingling, or painful sensations
- chest tightness
- chills
- cough
- difficult, burning, or painful urination
- ear congestion
- fast heartbeat
- feeling of warmth
- fever
- frequent urge to urinate
- headache
- hives, itching, or rash
- hoarseness
- joint pain, stiffness, or swelling
- loss of voice
- lower back or side pain
- pale skin
- rapid weight gain
- redness of the face, neck, arms and occasionally, upper chest
- redness of the skin
- sneezing
- sore throat
- stuffy or runny nose
- sudden sweating
- swelling of the eyelids, face, lips, hands, or feet
- tingling of the hands or feet
- trouble breathing or swallowing
- ulcers, sores, or white spots in the mouth
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- 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
- Acid or sour stomach
- belching
- bloody nose
- change in taste
- cracked lips
- decreased appetite
- diarrhea
- dizziness
- dry skin
- hair loss or thinning of the hair
- heartburn
- indigestion
- lack or loss of strength
- loosening of the fingernails
- loss of taste
- muscle or joint pain
- nausea
- redness or soreness around the fingernails
- stomach discomfort, upset, or pain
- trouble sleeping
- 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.
DRG-20075621
