Advanced Recurrent Ovarian Cancer Side Effects - Gemzar.com (gemcitabine HCl for injection)

Side Effects

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

General Considerations: Chemotherapy
GEMZAR in Combination with Carboplatin

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 Carboplatin
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 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 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. Nine in 10 patients on GEMZAR with carboplatin had a lowered white blood cell count. You will likely have a drop in your white blood cell count beginning several days after you receive GEMZAR with carboplatin.

During this time, you are more likely to develop an infection, and you 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 red blood cell count (anemia)
Red blood cells help transport oxygen from your lungs to the 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. Nearly 9 in 10 patients experienced anemia in the clinical trial of GEMZAR with carboplatin. Your healthcare team may prescribe 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. About 8 in 10 patients who received GEMZAR with carboplatin had a low platelet count.

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

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 7 of 10 patients in the clinical trial with GEMZAR in combination with carboplatin experienced some degree of nausea, and about half 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 4 patients on GEMZAR in combination with carboplatin 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.
- Constipation
  Of the patients on GEMZAR in combination with carboplatin, 42 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.
Hair loss (alopecia)
About half of the patients in the study experienced hair loss. This was not permanent.
Fatigue (tiredness)
About 4 in 10 patients receiving GEMZAR in combination with carboplatin 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).
Nerve damage (neuropathy)
Three out of 10 patients receiving GEMZAR in combination with carboplatin experienced some form of neuropathy. Symptoms of neuropathy may include weakness, pain, a tingling sensation, or numbness and tingling, especially in the toes and fingertips.
Mouth, lip or throat sores (stomatitis, pharyngitis)
Of the patients receiving GEMZAR and carboplatin, 22 percent experienced redness or sores in their mouth, lips, or throat. These symptoms may happen a few days after GEMZAR treatment. Talk with your healthcare team about proper mouth, lip, and throat care.

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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.

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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