Pertuzumab

Pertuzumab is a prescription medication used with other medications to treat a certain type of breast cancer that has spread to other areas of the body. Pertuzumab is also approved for use as a complete treatment regimen for patients with early stage breast cancer before surgery.

Pertuzumab is specifically designed to treat people with HER2-positive breast cancer. Pertuzumab belongs to a class of medications called monoclonal antibodies. It works by inhibiting the growth and spread of cancer cells.

Breast cancer is a cancer that forms in the cells of the breasts. Some women have (HER2+) breast cancer. (HER2+) stands for Human Epidermal growth factor receptor 2 positive. (HER2) is a special protein found on breast cancer cells that controls cancer growth and spread.

Pertuzumab is approved for treatment of HER2 positive breast cancer, because it is specifically designed to target the HER2 protein. By binding to the HER2 protein, pertuzumab prevents the growth of cancer cells.

HER2 testing is done to see whether treatment with pertuzumab will likely be effective in treating breast cancer. If testing is not done, treatment with this medication may not be an effective treatment.

Pertuzumab is a prescription medicine for use along with trastuzumab and docetaxel (chemotherapy) to treat breast cancer that has spread to different parts of the body. Pertuzumab has been shown to work only in people with HER2-positive breast cancer, and people who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.

Pertuzumab is also approved for use as a complete treatment regimen for patients with early stage breast cancer before surgery. It is intended for patients with HER2-positive, locally advanced, inflammatory or early stage breast cancer who are at high risk of having their cancer return or spread, or of dying from the disease.

Pertuzumab may be found in some form under the following brand names:

• Perjeta

Serious side effects can occur. See "Pertuzumab Precautions" section.

The most common side effects of pertuzumab when given with trastuzumab and docetaxel (chemotherapy) are:

• Diarrhea
• Hair loss
• Low levels of white blood cells with or without a fever
• Upset stomach
• Fatigue
• Rash
• Damage to the nerves (numbness, tingling, pain in hands/feet)

This is not a complete list of pertuzumab side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

No pertuzumab drug interactions have been identified, however, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with pertuzumab including the following:

• Most Serious Side Effect: Receiving pertuzumab during pregnancy can result in the death of an unborn baby and birth defects.
  • If you are exposed to pertuzumab during pregnancy, you are encouraged to enroll in the MotHER Pregnancy Registry by contacting 1 (800) 690-6720.
• Other possible side effects of pertuzumab therapy include:
  • Heart problems: Pertuzumab can result in heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure). Your doctor may run tests to monitor your heart function before and during treatment with pertuzumab.
  • Infusion-related reactions: Pertuzumab is a medicine that is delivered into a vein through a needle. This process can cause reactions known as infusion-related reactions. The most common infusion-related reactions when receiving pertuzumab, trastuzumab, and docetaxel (chemotherapy) were fatigue, loss of taste, allergic reactions, muscle pain, and vomiting.
  • Severe allergic reactions: Some people receiving pertuzumab may have severe allergic reactions, called hypersensitivity reactions or anaphylaxis. This reaction may be severe, may happen quickly, and may affect many areas of the body.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of pertuzumab there are no specific foods that you must exclude from your diet when receiving pertuzumab.

Before receiving pertuzumab, tell your doctor if you:

• are allergic to pertuzumab or any other medicines
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed
• have heart disease

Tell your doctor what prescription medicines you take as well as non-prescription medicines, vitamin, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Pertuzumab falls into category D. There are no adequate studies in pregnant women. However, in animal studies, pregnant animals were given this medication and their babies suffered developmental problems and death. 

Receiving pertuzumab during pregnancy can result in the death of an unborn baby and birth defects.

• If you are exposed to pertuzumab during pregnancy, you are encouraged to enroll in the MotHER Pregnancy Registry by contacting 1 (800) 690-6720.
• It is important that you use effective birth control while receiving pertuzumab and for 6 months after the last dose.

It is not known if pertuzumab crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using pertuzumab.

Pertuzumab comes as a solution to administer slowly into a vein (intravenous infusion). Pertuzumab is administered by a doctor or nurse in a medical office, infusion center, or hospital. This medicine is usually given once every 3 weeks.

It should take 60 minutes for you to receive your first dose of pertuzumab. A doctor or nurse will watch you closely to see how your body reacts to this medicine. If you do not have any serious problems when you receive your first dose of pertuzumab, it will usually take 30 to 60 minutes for you to receive each of your remaining doses of the medication.

Pertuzumab comes as a solution to administer slowly into a vein (intravenous infusion).

The initial dose of pertuzumab is 840 mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by 420 mg administered as a 30 to 60 minute intravenous infusion.

For metastatic breast cancer, Perjeta (pertuzumab) is injected every 3 weeks. 

For treatment for early stage breast cancer before surgery, Perjeta (pertuzumab) is injected every 3 weeks for 3 to 6 cycles. 

Pertuzumab is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.

Keep all of your medical and laboratory appointments. If you miss a scheduled dose, contact your doctor right away.

WARNING:  EMBRYO-FETAL TOXICITY