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Non-Small Cell Lung Cancer
Important Safety Information
Prescribing Information
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NON-SMALL CELL LUNG CANCER

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

GEMZAR can suppress bone marrow function, which may cause low blood cell counts.

Lung Cancer
Lung cancer begins in the lungs, where cells multiply at a very fast rate to form "tumors" that invade and destroy normal tissue. These cancer cells sometimes spread from the lung(s) to other parts of the body. That process is known as "metastasis."

Approximately 350,000 people in the United States are living with lung cancer at any given time.1
Fortunately, the number of new lung cancer cases reported in recent years is going down due to less smoking, better diagnostic tools, and new treatment options. But lung cancer remains the second most common form of cancer diagnosed.1
In the United States, 80% to 85% of those diagnosed with lung cancer have non-small cell lung cancer.1

Two Categories of Lung Cancer
The two main categories of lung cancer are non-small cell lung cancer (also known by its initials as "NSCLC") and small cell lung cancer (SCLC). Please note that GEMZAR is not indicated for patients who have small cell lung cancer.

The difference between non-small cell and small cell lung cancer has to do with the kind of cancer cells, how quickly the cancer cells grow, and how each kind of cancer cell responds to treatment.

Your Non-Small Cell Lung Cancer Journey
Facing a diagnosis of non-small cell lung 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 is approved by the FDA in combination with cisplatin (another type of chemotherapy) for the first-line treatment of patients (for whom surgery is not possible) with locally advanced (stage IIIA or stage IIIB) or metastatic (stage IV or cancer that has spread) non-small cell lung cancer.

GEMZAR can suppress bone marrow function, which may cause low blood cell counts.

This section explores the different types of non-small cell lung cancer. Learn how GEMZAR can help treat a specific stage of first-line non-small lung cancer* when used in combination with cisplatin, another chemotherapy drug. You can also find information about side effects, and answers to frequently asked questions.

*Locally advanced, stage IIIA or stage IIIB, or metastatic non-small cell lung cancer.

Indications and Important Safety Information for GEMZAR

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

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

GEMZAR is approved by the FDA in combination with paclitaxel 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.

GEMZAR is approved by the FDA 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 can suppress bone marrow function, which may cause low blood cell counts.

GEMZAR may not be appropriate for some patients.

If you are allergic to GEMZAR, tell your doctor because you should not receive it.

GEMZAR given for longer than 60 minutes or more than once a week has caused increased side effects.

You should call your doctor right away if you have any symptoms of infection, such as a fever or chills. If you notice bleeding, unexplained bruising, or symptoms of anemia, contact your healthcare team, as these can be symptoms of low blood cell counts.

Serious lung problems, sometimes fatal, have been reported with GEMZAR. Tell your healthcare team if you develop breathing problems.

There have been reports of serious kidney or liver damage including failure with GEMZAR treatment, sometimes fatal. If you have had kidney or liver problems or impairment, please tell your healthcare team. GEMZAR may not be right for you.

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 tests and on your general condition.

If you think you are pregnant, are planning to become pregnant, or are nursing, please tell your healthcare team.

Patients who receive radiation therapy before, during, or after receiving GEMZAR may sometimes experience more side effects, especially at the site of the radiation.

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; diarrhea; rash; shortness of breath; muscle aches; blood in urine; hearing changes and numbness or tingling in your toes or fingers. These are not all of the side effects of GEMZAR. Lab work may identify additional side effects. If you have any side effect that bothers you or that does not go away, be sure to talk with your doctor. Call your healthcare team right away if you have fever or chills. These symptoms could mean you have an infection.

If you are pregnant, GEMZAR may cause fetal harm to your unborn baby. It is not known if GEMZAR passes into breast milk; because of the potential for serious side effects in nursing infants, discuss breast feeding and GEMZAR with your doctor. The safety and effectiveness of GEMZAR in children has not been established.

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.

SG25

Reference:

  1. The Wellness Community. Understanding Lung Cancer. Available at:
    http://www.thewellnesscommunity. org/education/lung/understanding.php. Accessed March 3, 2008.


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