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| MED WATCH: EMTRICITABINE
(Emtriva) |
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(Return
to page 17) |
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By William Palumbo, MS,
RD, CDN
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Brand Name:
Emtriva
Therapeutic Category:
nucleoside reverse transcriptase inhibitor, NRTI
Indications And
Usage: The Food
and Drug Administration approved this antiviral for HIV Infection in
2003. It is a nucleoside reverse transcriptase inhibitor. Emtricitabine
is indicated, in combination with other
antiretroviral agents, for the treatment of HIV-1 infection in adults.
This indication is based on analyses of plasma HIV-1 RNA levels and CD4
T-cell counts from controlled studies of 48 weeks duration in antiretroviral-
naive patients and antiretroviral- treatment-experienced patients who were
virologically suppressed on an HIV treatment regimen. In antiretroviral-
treatment-experienced patients, the use of emtricitabine may be considered
for adults with HIV strains that are expected to be susceptible to emtricitabine
as assessed by genotypic or phenotypic testing.
Contraindications:
Emtricitabine is contraindicated in those patients with previously demonstrated
hypersensitivity to any of the components of the products. |
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Warnings:Lactic
Acidosis/Severe Hepatomegaly with Steatosis- Lactic acidosis and severe
hepatomegaly with steatosis, including fatal cases, have been reported
with the use of nucleoside, analogues alone or in combination,
including
emtricitabine and other antiretrovirals. A majority of these cases
have been in women. Obesity and prolonged nucleoside exposure may be risk
factors. However, cases have also been reported in patients with no known
risk factors. Treatment with emtricitabine should be suspended in any patient
who develops clinical or laboratory findings suggestive of lactic acidosis
or pronounced hepatotoxicity (which may include hepatomegaly and steatosis
even in the absence of marked transaminase elevations). Post Treatment
Exacerbation of Hepatitis- It is recommended that all patients with
HIV be tested for the presence of chronic hepatitis B virus (HBV) before
initiating antiretroviral therapy. Emtricitabine is not indicated for the
treatment of chronic HBV infection and the safety and efficacy of emtricitabine
have not been established in patients co-infected with HBV and HIV. Exacerbation
of hepatitis B has been reported in patients after the discontinuation
of emtricitabine. Patients co-infected with HIV and HBV should be closely
monitored with both clinical and laboratory follow-up for at least several
months after stopping treatment. |
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Precautions:
Patients With Impaired Renal Function- Emtricitabine is principally
eliminated by the kidney. Fat Redistribution- Redistribution/accumulation
of body fat including central obesity, dorsocervical fat enlargement (buffalo
hump), peripheral wasting, facial wasting, breast enlargement, and "cushingoid
appearance" have been observed in those patients receiving antiretroviral
therapy. The mechanism and long-term consequences of these events are unknown.
A causal relationship has not been established.
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