How GEMZAR Can Help

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

The FDA approved GEMZAR based upon the results of a clinical study comparing GEMZAR in combination with carboplatin to the use of carboplatin alone in more than 300 patients with ovarian cancer which had returned at least 6 months after the patients finished platinum-based therapy.¹ In this study, the women who were given the combination of GEMZAR with carboplatin experienced almost 3 months longer from the time they started therapy until their tumor advanced or progressed than did the women who were given carboplatin alone (8.6 months versus 5.8 months).¹ The study also demonstrated that 47% of the women who received GEMZAR with carboplatin had their tumors shrink as compared to 31% of the women who received carboplatin alone.¹ However, no significant difference in survival benefit was found.¹

How Is GEMZAR Given?
GEMZAR should be given only by a qualified healthcare professional.

The GEMZAR Treatment Cycle
GEMZAR for the treatment of recurrent ovarian cancer is usually given twice in a 21-day treatment cycle (on Day 1 and Day 8). This means that on your first day of treatment, you will receive GEMZAR in combination with another drug — carboplatin, the platinum agent. During your next week of treatment, you will receive GEMZAR alone.

Each treatment cycle usually includes a week when you receive no medication at all — this rest week is a normal part of your treatment.

Your healthcare team will give GEMZAR by mixing it into a solution and giving it through a needle into a vein — a process called intravenous infusion (or "IV"). This will take about 30 minutes. Any other drugs given with GEMZAR will generally be given by IV either before or after you receive GEMZAR.

Blood Tests and Dosing
You will have regular blood tests before and during your treatment with GEMZAR plus the chemotherapy drug carboplatin to determine how well your body is tolerating the therapy. You and your healthcare team will then usually decide whether you should continue treatment or change how much GEMZAR you receive, based on the results of these tests and the benefits and side effects you have experienced so far.

Your healthcare team may ask you to return for follow-up visits after you receive GEMZAR therapy, so they can keep track of how you are doing.

Managing Therapy: Important Things To Know
Before you begin your treatment with GEMZAR, it is important for you to do some things to help manage your treatment. If you are unsure about any of the following, be sure to ask your healthcare team. This information is very important for you to achieve the best results possible throughout your course of therapy.

As noted earlier, GEMZAR should be given as a 30-minute infusion. If it is given over a period of time longer than 60 minutes, and more frequently than weekly, you may experience additional side effects.
If you have liver or kidney problems, be sure to tell this to your healthcare team. Your dose of GEMZAR may have to be changed, or GEMZAR may not be right for you.
If you think you are pregnant, are planning to be pregnant, or are nursing, please tell your healthcare team. GEMZAR may harm your unborn or nursing baby. Tell your doctor if you are taking other medicines, including prescription or nonprescription medicines, vitamins, or herbal supplements.
Please check with your healthcare team if your doctor prescribes GEMZAR with radiation therapy. The safe and effective use of GEMZAR with radiation has not been determined.
Please use the therapy calendar to help keep track of your treatment plan. You may also want to use it to keep track of your appointments, side effects, or information you want to communicate to your healthcare team.
There is additional important information on the safety profile and side effects of GEMZAR therapy that you must be aware of. Please see the Important Safety Information for GEMZAR.

Reference:

GEMZAR (gemcitabine HCl for injection) package insert, May 2004. Eli Lilly and Company.

About GEMZAR

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 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.

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).

Important Safety Information

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 be 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 complete Prescribing Information, or call 1-800-545-5979.

SG22