Side Effects

This section takes a look at the side effects associated with GEMZAR. 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).

General Considerations: Chemotherapy
GEMZAR Used as a Single Agent

General Considerations: Chemotherapy
Side effects are different depending on the type of cancer you have and the combination of drugs given. Side effects may also be different from patient to patient and from treatment to treatment.

Side effects from chemotherapy should be monitored both by you and your physician. Signs and symptoms such as fatigue, nausea, and vomiting are a few examples. Another group of side effects, such as those that change measured values in your blood, are monitored through regular blood tests, but also through patients experiencing signs and symptoms.

Side effects could be serious if not treated. Though a few side effects can be permanent, many are temporary and go away after treatment dose is reduced or stopped.

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GEMZAR Used as a Single Agent
Most patients taking GEMZAR will have side effects. Sometimes it is not always possible to tell whether GEMZAR or the cancer itself is causing these side effects, but you should always tell your healthcare team if you are experiencing anything new.

Here we will talk about side effects that were experienced by at least 20 percent of the patients in the comparative clinical trial.

Side effects that you and your healthcare team should monitor:

You will have regular blood tests before and during your treatment with GEMZAR that will monitor you for the following side effects. You may also have symptoms that you should tell your healthcare team about.

• Low red blood cell count (anemia)
  Red blood cells help transport oxygen from your lungs to other parts of your body. A low red blood cell count is called anemia. If your red blood cell count is low, you may feel tired, get tired easily, appear pale, and become short of breath. About 7 out of 10 patients experienced anemia in the clinical trials of GEMZAR as a single agent. There are medications available to help with anemia.
• Low white blood cell count (leukopenia/neutropenia)
  White blood cells help you fight infection. A low number of white blood cells is called neutropenia or leukopenia. Seven out of 10 patients who received GEMZAR had a low white blood cell count. You will likely have a drop in your white blood cell count beginning several days after you receive GEMZAR therapy.
  
  During this time, you are more likely to develop an infection, and should avoid crowds and those with colds. You should call your healthcare team right away if you have any signs of infection, such as a temperature over 100.5°F or chills. There are medications to help with a low white blood cell count.
• Low platelet count (thrombocytopenia)
  Platelets help your blood clot. A lowered platelet count puts you at more risk for bleeding. Almost half of the patients who received GEMZAR as a single agent experienced some degree of thrombocytopenia. If your healthcare team tells you that you have a low platelet count, you will be asked to take some precautions, including avoiding injury, using stool softeners, using soft-bristle toothbrushes, etc. It is important that you call your healthcare team if you see any signs of bleeding, such as bruising or blood in your stool.
• Hepatic (liver)
  Seven out of 10 patients who received GEMZAR had changes in their liver function tests. These blood tests are a normal part of therapy and allow your healthcare team to monitor how your liver is functioning during therapy. Be sure to talk with your healthcare team if you notice anything different about the way you feel.

Here are some additional side effects you will want to monitor:

• Nausea and/or vomiting
  Of the patients taking GEMZAR, 64 percent experienced some amount of nausea and/or vomiting. It is important that you tell your healthcare team if you have nausea or vomiting. There are now many medications available that can help prevent and/or treat nausea and/or vomiting.
• Fever
  Fever can be the first sign of infection, but it may also be a result of chemotherapy without infection. About 3 in 10 patients taking GEMZAR experienced fever. There are medications that may reduce a fever that can be given along with chemotherapy. If you have a fever of 100.5°F or higher, you should call your healthcare team right away.
• Rash
  Of the patients taking GEMZAR, 24 percent experienced a rash.
• Diarrhea
  About 24 percent of the patients on GEMZAR experienced diarrhea. Again, it is important that you tell your healthcare team if you have diarrhea. They will tell you what to do to help manage it, including increasing your fluid intake and avoiding high-fiber foods. It is very important that you talk with your healthcare team before you take any over-the-counter diarrhea medicines.

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