METASTATIC BREAST CANCER

GEMZAR in combination with paclitaxel is approved by the FDA for the first-line treatment of patients with metastatic breast cancer after they have received another type of chemotherapy called an anthracycline, unless their medical condition did not allow them to receive an anthracycline.

Breast Cancer
Breast cancer happens when cells in the breast tissue divide and grow in an uncontrolled manner, becoming a cancerous ("malignant") tumor. About 20% of breast cancers start in the glands that produce milk, also called "lobules." About 80% start in the milk passages that connect the lobules and the nipple, called "ducts." Cancerous tumors in the breast usually grow very slowly. By the time one is large enough to be felt as a lump, it may have been growing for as long as ten years.¹

In 2007, about 178,000 women in the United States had invasive breast cancer.²

Fortunately, breast cancer death rates are going down, probably thanks to earlier diagnosis and improved treatment. But breast cancer is the most common cancer among women in the United States, other than skin cancer — and is the second leading cause of cancer death in women, after lung cancer. There is a 1 in 8 chance of a woman having invasive breast cancer some time during her life, while the chance of dying from breast cancer is about 1 in 35.²

Right now there are about 2.5 million breast cancer survivors in the United States.²

Two Types of Breast Cancer
There are two kinds of breast cancer, "invasive" breast cancer and "non-invasive" cancer.³ GEMZAR in combination with the chemotherapy drug paclitaxel is used to treat the metastatic, invasive form.

Your Metastatic Breast Cancer Journey
Facing a diagnosis of metastatic breast cancer is not easy. Like any person living with cancer, you are probably facing situations you never had to deal with before. And it is understandable if you are concerned about the new journey that lies ahead.

GEMZAR in combination with paclitaxel is approved by the Food and Drug Administration for the first-line treatment of patients with metastatic breast cancer after they have received another type of chemotherapy called an anthracycline, unless their medical condition did not allow them to receive an anthracycline.

This section explores the two types of breast cancer. Learn how GEMZAR can help treat metastatic breast cancer when used first-line in combination with paclitaxel, another chemotherapy drug. You can also find information about side effects, and answers to frequently asked questions.

Important Safety Information for GEMZAR (gemcitabine HCl for injection)

GEMZAR is indicated in combination with carboplatin (another type of chemotherapy) for the patient with ovarian cancer that has returned at least 6 months after the patient had finished platinum-based therapy.

GEMZAR is indicated in combination with cisplatin (another type of chemotherapy) for the first-line treatment of patients with locally advanced (Stage IIIA or Stage IIIB) or metastatic (Stage IV or cancer that has spread) non-small cell lung cancer for whom surgery is not possible.

GEMZAR is indicated as a single agent (given alone) as the first-line treatment for patients with locally advanced (Stage II or Stage III when surgery is not an option) or metastatic (Stage IV) adenocarcinoma of the pancreas. GEMZAR is also indicated for patients previously treated with 5-FU (another type of chemotherapy).

GEMZAR may not be appropriate for some patients.

If you are allergic to GEMZAR, tell your doctor you should not receive it. GEMZAR can suppress bone marrow function. There have been rare reports of serious kidney or liver toxicity with GEMZAR treatment, sometimes fatal. Serious lung toxicity has also been reported, sometimes fatal. If you think you are pregnant, are planning to become pregnant, or are nursing, please tell your healthcare team. GEMZAR may harm your unborn or nursing baby.

If you have had prior kidney or liver problems or impairment, please tell your healthcare professional. GEMZAR may not be right for you. GEMZAR has not been shown to work in children. Tell your doctor if you are taking other medicines, including prescription and nonprescription medicines, vitamins, or herbal supplements.

There is a risk of side effects associated with GEMZAR therapy. The most common side effects are low blood cell counts (red blood cells, white blood cells, and platelets); fever; infection; hair loss; tiredness; nausea, vomiting, constipation, and diarrhea; rash; shortness of breath; muscle aches; and numbness or tingling in your toes or fingers. These are not all of the side effects of GEMZAR. If you have any side effect that bothers you or that doesn't go away, be sure to talk with your healthcare professional. Call your healthcare professional right away if you have fever or chills. These symptoms could mean you have an infection.

You will have regular blood tests before and during your treatment with GEMZAR. Your doctor may adjust your dose of GEMZAR or delay your treatment based on the results of your blood test and on your general condition.

For more information about all of the side effects of GEMZAR, please talk with your healthcare team, see the full Prescribing Information, or call 1-800-545-5979.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

SG23

References:

National Cancer Institute. Cellular Classification of Breast Cancer. Available at:
http://www.cancer.gov/cancertopics/pdq/….
Accessed April 14, 2008.
American Cancer Society. How Many Women Get Breast Cancer? Available at: http://www.cancer.org/docroot/CRI/content/…. Accessed March 3, 2008.
Center for Disease Control. Common Kinds of Breast Cancer. Available at:
http://www.cdc.gov/cancer/breast/basic_info/. Accessed April 14, 2008.