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Complete Prescribing Information for COMBIVIR Tablets
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Important Safety Information for COMBIVIR



Possible Side Effects of COMBIVIR

It’s important to know that serious side effects can occur with COMBIVIR, such as a decrease in red and white blood cells and muscle damage. A buildup of lactic acid and an enlarged liver, including fatal cases, have been reported rarely with some HIV drugs, including nucleoside analogues.

For HIV-infected individuals, periodic blood tests are recommended. If certain changes occur in your laboratory results while you are taking COMBIVIR, particularly if you become anemic or if your white blood cell count falls too low, your medication may need to be adjusted; your doctor may prescribe EPIVIR plus RETROVIR separately in place of COMBIVIR.

Some patients infected with both hepatitis B virus (HBV) and HIV have worsening of hepatitis after stopping lamivudine (a component of COMBIVIR). Discuss any change in treatment with your doctor. If you have both HBV and HIV and stop treatment with COMBIVIR, you should be closely monitored by your doctor for at least several months.

Worsening of liver disease (sometimes resulting in death) has occurred in patients infected with both HIV and hepatitis C virus who are taking anti-HIV medicines and are also being treated for hepatitis C with interferon with or without ribavirin. If you are taking COMBIVIR as well as interferon with or without ribavirin and you experience side effects, be sure to tell your doctor.

When you start taking HIV medicines, your immune system may get stronger and could begin to fight infections that have been hidden in your body, such as pneumonia, herpes virus or tuberculosis. If you have new symptoms after starting your HIV medicines, be sure to talk with your doctor.

Changes in body fat may occur in some patients taking antiretroviral therapy. These changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the trunk. Loss of fat from the legs, arms and face may also occur. The cause and long-term health effects of these conditions are not known at this time.

In clinical studies of lamivudine plus zidovudine, side effects occurring in 5% or more of patients included: headache, upset stomach, weakness and fatigue, and nasal symptoms.

Tell your doctor promptly about any side effects or other unusual symptoms you may experience. Although it may make you healthier, COMBIVIR does not cure HIV.

More information about how to use COMBIVIR is available in the Frequently Asked Questions section.

 
   


COMBIVIR does not cure HIV infection/AIDS or prevent passing HIV to others.
COMBIVIR in combination with other HIV medicines is indicated for the treatment of HIV infection.


Complete Prescribing Information for COMBIVIR® (lamivudine/zidovudine) Tablets


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