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Metastatic Breast Cancer
Important Safety Information
Prescribing Information
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Frequently Asked Questions

As a metastatic breast cancer patient or caregiver, you must have many questions — as well you should, since the disease and its treatment is so complex.

Below are several frequently asked questions. We hope that the responses provided can ease some of your concerns, and encourage conversations with your healthcare team.

So please click on a question you'd like answered from the list below.

Why me?

"Why me?" is a question most people diagnosed with cancer ask themselves. Although lifestyle decisions such as smoking and alcohol intake can increase the risk for metastatic breast cancer, the disease can strike any woman at any time.

But you are not alone in this journey. In 2007, about 178,480 women in the United States had invasive breast cancer, and over 2.5 million women are survivors of the disease.1

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How does GEMZAR fight metastatic breast cancer?

GEMZAR is a chemotherapy drug used to treat certain kinds of cancer, such as metastatic breast cancer. The scientific (or generic) name for GEMZAR is gemcitabine HCl (for injection). Chemotherapy consists of treatment with one or more anticancer drugs that kill cancer cells. GEMZAR works by stopping the process that cells use to divide and repair themselves, leading to cell death.

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

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What is the history of GEMZAR in treating metastatic breast cancer?

In 2004, GEMZAR received the indication for first-line metastatic breast cancer based on a large clinical trial of 529 patients, which revealed that GEMZAR combined with paclitaxel works better than paclitaxel alone.

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How is GEMZAR given?

GEMZAR should be administered only by a qualified healthcare professional. GEMZAR therapy for the treatment of metastatic breast cancer is usually given twice in a 21-day treatment cycle. During treatment with GEMZAR therapy, you will receive GEMZAR and paclitaxel on Day 1 of the first week. At the next week's therapy (Day 8), you will likely 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 doctor or nurse will give you GEMZAR by mixing it into a solution and giving it through a needle into a vein — called intravenous infusion (IV). This will take about 30 minutes. Any other drugs given with GEMZAR will generally be given by IV either before or after GEMZAR. You will have regular blood tests before and during your treatment with GEMZAR plus paclitaxel. You and your doctor will usually decide before each treatment whether you should continue treatment or change dose based on what benefits you have received from previous treatment and what side effects you may have experienced. Your doctor may ask you to return for follow-up visits after you receive GEMZAR therapy, so he or she can monitor how you are doing.

If you have questions about how GEMZAR is given, please be sure to discuss them with your healthcare team.

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What are the common side effects?

Side effects you and your healthcare team should monitor include: low white blood cell count (neutropenia/leukopenia); low red blood cell count (anemia); low platelet count (thrombocytopenia); and liver.

Some additional side effects you'll want to monitor include: hair loss (alopecia); nerve damage (neuropathy); fatigue (tiredness); pain (arthralgia/myalgia); gastrointestinal upset, including nausea and/or vomiting and diarrhea; and shortness of breath.

For more information about side effects please click here.

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When should I call my healthcare team?

You are probably attuned to changes in your body now more than ever. You must never take these changes for granted. According to The American Cancer Society, as a person living with cancer, you should alert your healthcare team right away if you notice any changes in your body or experience any of the following symptoms during your chemotherapy treatment2:

  • A fever of 100.5°F or greater
  • Bleeding or unexplained bruising
  • A rash or allergic reaction such as swelling or severe itching or wheezing
  • Intense chills
  • Pain or soreness at the chemotherapy injection site or catheter site
  • Unusual pain including intense headaches
  • Shortness of breath
  • Prolonged diarrhea or vomiting
  • Bloody stool or blood in your urine

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How can I find help to pay for my treatment?

"PatientOne" is the Lilly Oncology program that addresses financial, access, and claim issues for patients who are candidates for GEMZAR. Patients that can be helped include:

Call 1-866-4PatOne and let us know what you need. Live specialists are available Monday-Friday, 9 am-7 pm ET.

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Learn more about GEMZAR and other treatment options.

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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