May 20, 2013
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Gemzar

(gemcitabine)

DIN (Drug Identification Number)

02230309 GEMZAR 1GM/VIAL POWDER FOR SOLUTION
02230308 GEMZAR 200MG/VIAL POWDER FOR SOLUTION

What side effects are possible with Gemzar?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • constipation (mild)
  • diarrhea
  • flu-like symptoms (most commonly after the first dose of gemcitabine) including:
    • chills
    • cough
    • difficulty sleeping
    • feeling of illness
    • fever (not associated with infection)
    • headache
    • muscle pain
    • runny nose
    • sweating
    • weakness
  • nausea and vomiting (for less than 24 hours)
  • numbness or tingling of hands or feet
  • severe drowsiness
  • temporary hair loss (minimal)

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • high blood pressure
  • pain at site of injection
  • pinpoint-sized red spots on skin
  • severe constipation for 3 days that has not been relieved by laxatives
  • severe diarrhea (3 or more watery bowel movements per day lasting more than 24 hours)
  • skin rash
  • sores on mouth or lips
  • swelling of fingers, feet, or lower legs
  • unusual tiredness or weakness
  • vomiting lasting more than 24 hours after treatment

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • black, tarry stools or blood in stools or urine
  • fast or irregular heartbeat
  • pain in chest, arm, or back
  • peeling or blistering skin
  • pressure or squeezing in chest
  • shortness of breath
  • symptoms of anemia (i.e., shortness of breath, paleness, tiredness, fast heartrate, yellowing of the skin or eyes, dark urine)
  • symptoms of infection (i.e., fever, cough, chills, difficult or painful urination, pain in the side or lower back)
  • tightness in chest, or wheezing
  • unusual bleeding or bruising

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.





Are there any other precautions or warnings for Gemzar?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood clotting: This medication can reduce the number of platelet cells in the blood. Your doctor will monitor the number of platelets in your blood with regular blood tests while you are using this medication. Platelets help the blood to clot, and a shortage could make you bleed more easily. Tell your doctor of any signs that your blood is not clotting as quickly. Such symptoms may include black and tarry stools, nosebleeds, bleeding gums, blood in the urine, easy bruising, or cuts that won't stop bleeding.

Fever and flu-like symptoms: Gemcitabine can cause a fever and flu-like symptoms (chills, feeling unwell) that are not associated with an infection. Your doctor may prescribed acetaminophen to help treat this reaction.

Infection: As well as killing cancer cells, this medication can reduce the number of cells that fight infection in the body (white blood cells). Avoid contact with people who have contagious infections and tell your doctor if you begin to notice signs of an infection, such as fever or chills. Your doctor will monitor the number of white blood cells in your blood with regular blood tests while you are using this medication.

Kidney problems: Rarely, gemcitabine can cause a rapid breakdown of red blood cells that can be associated with kidney failure and may be fatal. Your doctor will monitor you for this while you are receiving this medication. People who have kidney problems should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver problems: People with liver problems (e.g., hepatitis, cirrhosis, alcoholism, cancer in the liver) should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: Gemcitabine should not be used during pregnancy. Effective birth control should be used while receiving this medication. Gemcitabine may harm the baby if used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if gemcitabine passes into breast milk. Women receiving gemcitabine should not breast-feed.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with Gemzar?

There may be an interaction between gemcitabine and any of the following:

  • acetylsalicylic acid (ASA)
  • bleomycin
  • denosumab
  • echinacea
  • leflunomide
  • natalizumab
  • other cancer medications
  • pimecrolimus
  • tacrolimus
  • vaccines
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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