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Issue No. 3 | January 20, 2012

News and Features

FDA Updates Tenofovir Disoproxil Fumarate (Viread) Label with New Dosing and Formulation Information

“On January 18, 2012, the Viread (tenofovir disoproxil fumarate) labeling was updated to include dosing information in pediatric patients 2 to less than 18 years of age. An oral powder (40 mg per 1 gram of oral powder) formulation and 150 mg, 200 mg and 250 mg tablets were also approved to support dosing in pediatric patients. ... In addition the patient labeling was updated to include information on pediatric patients and instruction on how to prepare and give Viread oral powder.”

The updated label will be available soon at the FDA Web site.

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American Academy of Neurology Issues New Guidelines for Prescribing Antiepileptic Drugs to People Infected with HIV

“[The objective is to] develop guidelines for selection of antiepileptic drugs (AEDs) among people with HIV/AIDS. … The literature was systematically reviewed to assess the global burden of relevant comorbid entities, to determine the number of patients who potentially utilize AEDs and antiretroviral agents (ARVs), and to address AED-ARV interactions. … AED-ARV administration may be indicated in up to 55% of people taking ARVs. Patients receiving phenytoin may require a lopinavir/ritonavir dosage increase of ∼50% to maintain unchanged serum concentrations (Level C). Patients receiving valproic acid may require a zidovudine dosage reduction to maintain unchanged serum zidovudine concentrations (Level C). Coadministration of valproic acid and efavirenz may not require efavirenz dosage adjustment (Level C). Patients receiving ritonavir/atazanavir may require a lamotrigine dosage increase of ∼50% to maintain unchanged lamotrigine serum concentrations (Level C). Coadministration of raltegravir/atazanavir and lamotrigine may not require lamotrigine dosage adjustment (Level C). Coadministration of raltegravir and midazolam may not require midazolam dosage adjustment (Level C). Patients may be counseled that it is unclear whether dosage adjustment is necessary when other AEDs and ARVs are combined (Level U). It may be important to avoid enzyme-inducing AEDs in people on ARV regimens that include protease inhibitors or nonnucleoside reverse transcriptase inhibitors, as pharmacokinetic interactions may result in virologic failure, which has clinical implications for disease progression and development of ARV resistance. If such regimens are required for seizure control, patients may be monitored through pharmacokinetic assessments to ensure efficacy of the ARV regimen (Level C).”

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