Side Effects

This section takes a look at the side effects associated with GEMZAR. 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 can suppress bone marrow function, which may cause low blood cell counts.

General Considerations: Chemotherapy
GEMZAR in Combination with Cisplatin

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 in Combination with Cisplatin
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 the most frequent or serious side effects that patients with non-small cell lung cancer experienced in clinical trials.

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. Nine out of 10 patients experienced anemia in the clinical trials of GEMZAR plus cisplatin. There are medications available to help with anemia.
• 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. About 9 out of 10 patients who received GEMZAR plus cisplatin had a low white blood cell count. You may have a drop in your white blood cell count beginning several days after you receive GEMZAR plus cisplatin.
  
  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 low white blood cell counts. About 3 out of 10 patients in GEMZAR clinical trials did experience some kind of infection.
• Low platelet count (thrombocytopenia)
  85 percent of patients who received GEMZAR plus cisplatin had low platelets. A low platelet count is called 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 which reduce the risk of bleeding, such as 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) and renal (kidney) status
  You will have regular blood tests prior to each treatment with GEMZAR to measure how well your liver and kidneys are functioning. These tests will be evaluated by your healthcare team before starting therapy, then periodically after.

You will have regular blood tests before and during your treatment with GEMZAR. Your healthcare team may adjust your dose of GEMZAR or delay treatment based on the results of your blood test or your general condition.

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

• Gastrointestinal upset
  • Nausea and/or vomiting
    Of the patients in the clinical trial with GEMZAR in combination with cisplatin, 96 percent experienced some degree of nausea and/or 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.
  • Constipation
    Of the patients treated with GEMZAR plus cisplatin, 28 percent experienced constipation. Your healthcare team can help you treat your constipation. It is important that you talk with them before you take any over-the-counter laxatives or stool softeners.
  • Diarrhea
    Of the patients receiving GEMZAR plus cisplatin, 24 percent experienced diarrhea. It is important that you tell your healthcare team if you have diarrhea. They will tell you what to do to 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)
  Shortness of breath, or dyspnea, is a common side effect for patients with lung cancer, including those who are given GEMZAR plus cisplatin. If you experience shortness of breath, tell your healthcare team and they can suggest measures to lessen the occurrence of dyspnea.
• Mouth or lip sores (stomatitis)
  Two in 10 patients on GEMZAR plus cisplatin experienced redness or sores in their mouth or lips. These symptoms may happen a few days after GEMZAR treatment. Talk with your healthcare team about proper mouth and lip care.
• Numbness or tingling (paresthesia)
  About 4 out of 10 patients who received GEMZAR plus cisplatin reported some type of paresthesia, numbness, or tingling.
• Hair loss (alopecia)
  Nearly 8 of 10 patients experienced some hair loss. This was not permanent.
• Blood in urine (hematuria)
  Two in 10 patients taking GEMZAR plus cisplatin reported having blood in their urine.

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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.