Side Effects

This section discusses the side effects associated with GEMZAR. 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.

General Considerations: Chemotherapy
GEMZAR in Combination with Paclitaxel

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 your blood cells, 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 in Combination with Paclitaxel
Most patients taking GEMZAR will have side effects. Sometimes it is not always possible to tell whether GEMZAR, paclitaxel, or the cancer itself is causing these side effects, but you should always tell your healthcare team about any side effects and especially if you are experiencing anything new.

Here we will talk about side effects associated with GEMZAR when used 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. The side effects described were experienced by at least 20 percent of the patients in the 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 white blood cell count (neutropenia/leukopenia)
  White blood cells help you fight infection. A low number of white blood cells is called neutropenia or leukopenia. You will most likely have a drop in your white blood cell count beginning several days after you receive GEMZAR therapy. About 7 out of 10 patients experienced a low white blood cell count.
  
  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 that help with a low white blood cell count.
• 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 69 percent of patients experienced anemia in a clinical trial of GEMZAR plus paclitaxel. There are medications available to help with anemia.
• Low platelet count (thrombocytopenia)
  Platelets help your blood clot. A lowered platelet count puts you at more risk for bleeding. 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. Of the patients who received GEMZAR in combination with paclitaxel, 26 percent had a low platelet count.
• Liver
  You will have regular blood tests prior to each treatment with GEMZAR to monitor how well your liver is functioning. These tests will be evaluated by your healthcare team prior to starting therapy, then periodically after.

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

• Hair loss (alopecia)
  Nine out of 10 patients in the study experienced hair loss. This was not permanent.
• Nerve damage (neuropathy)
  Of the patients receiving GEMZAR in combination with paclitaxel, 64 percent experienced some form of neuropathy. Symptoms of neuropathy may include weakness, pain, numbness, and tingling sensations, especially in the fingers and toes.
• Fatigue (tiredness)
  About 4 in 10 patients receiving GEMZAR in combination with paclitaxel had some degree of fatigue. If you experience fatigue, some ideas to counteract it include balancing your periods of activity with rest; increasing your fluid intake; and following a well-balanced diet with several small meals, rather than 3 large meals.
• Pain (arthralgia/myalgia)
  At least 33 percent of all patients who received GEMZAR in combination with paclitaxel complained of some type of pain, such as joint pain (arthralgia) or muscle pain (myalgia). Your healthcare team should be told about any pain you are having. They can help you manage it.
• Gastrointestinal upset
  Be sure to talk with your healthcare team if you notice one of the following or anything different about the way you feel.
  • Nausea and/or vomiting
    About half of the patients in the clinical trial with GEMZAR in combination with paclitaxel experienced some degree of nausea, and 3 in 10 patients experienced some degree of vomiting. It is important that you tell your healthcare team if you have nausea and vomiting. There are now many medications that can help prevent and/or treat nausea and/or vomiting.
  • Diarrhea
    About 1 in 5 patients on GEMZAR in combination with paclitaxel 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.
• Shortness of breath (dyspnea)
  If you experience shortness of breath, tell your healthcare team and they can suggest measures to lessen the occurrence of dyspnea.

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