FDA approves EPZICOM( ith continued treatment with EPZICOM Z...),Health

ith continued treatment with EPZICOM, ZIAGEN or TRIZIVIR, but generally resolve following permanent discontinuation of EPZICOM, ZIAGEN or TRIZIVIR. Patients experiencing these symptoms should stop taking EPZICOM, ZIAGEN or TRIZIVIR and contact a physician immediately.

Patients experiencing this reaction must not take EPZICOM, ZIAGEN or TRIZIVIR again as restarting the drug after a hypersensitivity reaction has resulted in cases of life-threatening and fatal reactions. When therapy with EPZICOM, ZIAGEN or TRIZIVIR has been discontinued and reinitiation of therapy is under consideration, the reason for discontinuation should be evaluated to ensure that the patient did not have a hypersensitivity reaction. A Medication Guide and Warning Card for EPZICOM, ZIAGEN or TRIZIVIR must be provided by pharmacists to patients with each new and refilled prescription in order to provide further information to the patient on this drug. EPIVIR (a medicine in EPZICOM) in combination with other antiretroviral agents is indicated for the treatment of HIV infection. Patients with HIV or coinfected with HIV and hepatitis B should only receive the recommended HIV dosage of EPIVIR (300mg/day) and not EPIVIR-HBV(R) (100mg/day). EPIVIR has not been adequately studied for treatment of chronic hepatitis B in patients coinfected with hepatitis B and HIV. Clinical and laboratory exacerbations of hepatitis B have occurred after discontinuation of EPIVIR and may be severe in patients with decompensated liver disease.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including ZIAGEN, EPIVIR and other antiretrovirals.

Redistribution/accumulation of body fat has been observed in patients receiving antiretroviral therapy. The causal relationship, mechanism and long-term consequences of these events are currently unknown.

EPZICOM
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Contact: Annie Noland
anoland@pcipr.com
Public Communications Inc.
2-Aug-2004

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