Details for: GEMCITABINE INJECTION

In clinical studies of gemcitabine hydrochloride, side effects were generally manageable. Side effects significant enough to cause your treatment to be stopped occurred in about 10% of all patients. Less than 1% of patients stopped therapy due to any one side effect. Most side effects were reversible and can be managed by either a delay in your treatment, a reduction of the dose of chemotherapy or both. Therefore, it is important for you to know about common side effects and for you to communicate any suspected side effects to your doctor.

You should discuss possible side effects with your doctor before beginning Gemcitabine Injection therapy and at any time you think you may be experiencing a side effect. For a list of possible side effects see the Call Your Doctor or Nurse If You Experience section and Serious Side Effects table below.

In clinical studies of gemcitabine hydrochloride, the most common reason for dosage adjustments was low blood counts. About two thirds of patients had low blood counts. In about one fourth of patients, decreases in blood counts were severe. For more information speak with your doctor and see section below on Low Blood Counts.

Shortness of breath may develop or worsen during treatment due to disease progression or in rare cases, due to a direct effect of the drug. If this occurs, patients should inform their treating doctor immediately of the developing or worsening of shortness of breath.

Nausea and vomiting were the most common side effects in clinical studies of gemcitabine hydrochloride. About two thirds of patients experienced nausea and vomiting, which were usually mild to moderate. Other common side effects included fever, swelling, rash, and flu-like symptoms.

In rare cases, gemcitabine hydrochloride may affect your liver, especially if you have liver metastases (spreading of cancer) or medical history of hepatitis (inflammation of the liver), alcoholism or liver cirrhosis (liver disease). Follow your doctor’s instructions on having periodic blood work to check your liver.

In rare cases, gemcitabine hydrochloride may affect your kidney, especially if your kidney function is not normal. Follow your doctor’s instructions on having periodic blood work to check your kidneys.

Low Blood Counts:
Chemotherapy drugs often affect the blood cells, which means that temporary changes in their counts may occur. These effects may be more common in patients older than 65 and in women. Blood tests will be done before each dose of Gemcitabine Hydrochloride for Injection to monitor your blood counts.

If your doctor notices changes in your blood counts, follow their advice, which may include:

White Blood Count:

• if your white blood count becomes low, you may have trouble fighting infections.
• stay out of crowds and away from people with colds or other illnesses.
• call your doctor if you develop a temperature over 38°C.
• ensure regular mouth care to reduce chance of infection.

Red Blood Count:

• if your red blood count becomes low, you may feel tired or weak. If it becomes too low, your doctor may recommend a red blood cell transfusion.
• rest as much as you need to.
• try to eat a well-balanced diet.

Platelet Count:

• if your platelet count becomes low, your blood may not clot as fast as usual, and bleeding or bruising may occur. Sometimes a blood transfusion is given if platelet counts drop very low.
• try to avoid getting cuts, bumps, or bruises (for example avoid contact sport and using a razor).
• since acetylsalicylic acid can affect your platelets, you should avoid taking acetylsalicylic acid while you are receiving chemotherapy, unless your doctor advises otherwise.

Call Your Doctor or Nurse If You Experience:

• any unusual bruising or bleeding.
• any pain around an infusion site.
• a sore mouth or throat.
• prolonged or uncomfortable swelling.
• severe diarrhea, meaning three or more watery bowel movements per day, lasting more than 24 hours.
• severe constipation for three days that has not been relieved by laxatives.
• numbness or tingling in your hands or feet.
• vomiting for more than 24 hours after your treatment.
• any changes in your skin, especially rash or potential allergic skin reactions.
• headache with confusion, and/or seizures (fits), and/or changes in vision.
• see also Serious Side Effects table below.