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About GEMZAR
Important Safety Information
Prescribing Information
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Starting Chemotherapy

Until very recently, people diagnosed with cancer were nearly as worried about chemotherapy as they were about the disease. The good news is that chemotherapy treatments and supportive care are improving constantly, and chemotherapy now offers a wider, more effective range of drugs than ever before. Newer chemotherapy treatment has provided additional options for patients, including improvements in medications for managing side effects.

Seeking Support
Becoming a "self-advocate" is one way to approach your diagnosis and treatment. Being self-supportive requires that you understand what is best for you. You may want to consider spending some time figuring out your needs to determine how you would like to approach your treatment.

  • Keep a journal
    One way to familiarize yourself with your needs is through self-testing. Your experience with cancer is a very personal journey, and understanding your feelings is very important. Keeping a journal can provide a way for you to document this period in your life, record questions and thoughts, and express concerns about your cancer treatment. Getting familiar with your needs is a good first step in approaching your cancer therapy.
  • Ask for help
    As the primary supporter of your cause, you must determine when and from whom to ask for help. You may request that a friend or family member go with you to your first healthcare team appointments to help take notes, clarify information, and be a source of support. Your care partner does not have to be the same person all of the time, but should be someone who can help you gather and understand the large amount of information you will receive.

  • Build a support network
    Allow yourself to depend on others for a while. By building a network of support, your ability to take control of your life actually will be enhanced. Accept that people really do want to help you and that by accepting their help, you may both benefit. Acknowledging that you need assistance and identifying the specific tasks that need to be accomplished make it easier for others to help you. For example, keep a list of things that you need help with, such as shopping, cooking, laundry, childcare, and transportation. You may want to keep a calendar and encourage others to sign up with specific tasks.

  • Share your feelings
    You may want to consider sharing your diagnosis with others. You may want to consider talking with your employer or anyone else who may be affected directly by your disease or your treatment. You may find that an even stronger support system will be available to you when you begin to communicate with others.

  • Talk to other patients
    You also may consider talking to other cancer patients who have received treatment. Support groups meet regularly and can provide valuable information to you, your family, and others you care about. In the
    Support section you will find a list of groups that may be a good starting point in your search for support.
Healthcare Team Assessment Tool

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Choosing a Healthcare Team
Finding the best available healthcare is very important. Your primary care doctor will have an ongoing role in your cancer treatment and may refer you to an oncologist who is a specialist in cancer care. Your oncologist should be someone who listens carefully to your needs and concerns, relates to you with consideration and respect, and will work with you to select the cancer treatment that is right for you.

Getting a second opinion
Many people choose to seek a second opinion. If you feel that this is an option you would like to take, ask your primary care doctor or oncologist for help in referring you to another specialist. Taking a few days to meet with more than one healthcare professional may be appropriate and is a positive step toward taking control of your cancer therapy. Physicians understand that this is necessary for many newly diagnosed patients and should be supportive of your need to explore this option. After meeting with and talking to different physicians, you should feel free to move forward with the healthcare team who best fits your needs and will work with you to meet your goals.

Your healthcare team may also include:

Make sure that you communicate your needs as clearly as you can to everyone on your healthcare team so they can help you make the best decisions.
  • Oncology nurse
    The person who will give your chemotherapy treatments, help you understand your disease, and assist you in managing the symptoms of your disease and its treatment.
  • Dietitian
    Helps you with your nutritional needs.
  • Social worker
    Helps you with emotional support, financial concerns, and identifying other treatment resources
  • Oncology pharmacist
    Helps explain how you may be affected by the drugs used in your treatment, and will be able to answer your questions in a way that makes sense to you.

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Seeking More Information
A wealth of information is available to you. In addition to the Internet resources found in the
Support section, you will find that information is readily available from such places as libraries, bookstores, your healthcare team's office, community centers, and pharmaceutical companies. These materials can be found in various forms, such as pamphlets, booklets, on the Web, books, audiotapes, and videotapes.

Seek information in quantities that you can manage. We all feel overwhelmed when presented with too much information at one time. As you review information and think of questions, write them down and take them to your next appointment. You may want to make a special appointment with your healthcare team just for this. Before your appointment, discuss these questions with your care partner and give him or her a copy to review.

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Clinical Trials
One of the first decisions you may want to make is whether to participate in a clinical trial. It is important to make this decision prior to starting any treatment because you may not qualify for certain clinical trials if you have already received treatment for your cancer. If your doctor does not bring up this subject with you, you may want to ask him or her if participating in a clinical trial is an option for you.
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.

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