Important Safety Information for GEMZAR® (gemcitabine for injection)
What is the most important information that I should know about GEMZAR?
GEMZAR can suppress bone marrow function, which may cause low blood cell counts.
GEMZAR may not be appropriate for some patients.
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 (for example, feeling tired), 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 now have or have had in the past kidney or liver problems, 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.
Patients who receive radiation therapy before, during, or after receiving GEMZAR may sometimes experience more side effects, especially at the site of the radiation.
The safety and effectiveness of GEMZAR in children has not been established.
Who should not receive GEMZAR?
If you are allergic to GEMZAR, tell your doctor because you should not receive it.
What should I tell my doctor before receiving GEMZAR?
If you think you are pregnant, are planning to become pregnant, or are nursing, please tell your healthcare team. 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.
Tell your doctor if you are taking other medicines, including prescription and nonprescription medicines, vitamins, and herbal supplements.
What are the possible side effects of GEMZAR?
There is a risk of side effects associated with GEMZAR therapy.
Call your healthcare team right away if you have fever or chills. These symptoms could mean you have an infection.
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. Lab work may identify additional side effects.
These are not all the side effects of GEMZAR. Talk with your doctor, nurse, or pharmacist about any side effect that bothers you or that doesn’t go away.
How is GEMZAR given?
GEMZAR is given (injected) into a vein. The injection will last about 30 minutes.
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.
For more safety information about GEMZAR, please talk with your doctor, nurse, or pharmacist, see the full Prescribing Information, visit www.GEMZAR.com, or call 1-800-545-5979.
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