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FDA Approved Changes to the Sustiva Label

September 7, 2016

FDA recently approved changes to the SUSTIVA (efavirenz) product labeling to include a new Warnings and Precautions regarding QTc prolongation. The following main changes to the product labeling were made:

The following sub-section was added in the WARNINGS AND PRECAUTIONS section.

  • 5.2 QTc Prolongation: QTc prolongation has been observed with the use of efavirenz [see Drug Interactions (7.3, 7.4) and Clinical Pharmacology (12.2)]. Consider alternatives to SUSTIVA when co-administered with a drug with a known risk of Torsade de Pointes or when administered to patients at higher risk of Torsade de Pointes.

The following new sub-section was added in the DRUG INTERACTIONS section.

  • 7.3 QT Prolonging Drugs: There is limited information available on the potential for a pharmacodynamic interaction between SUSTIVA and drugs that prolong the QTc interval. QTc prolongation has been observed with the use of efavirenz [see Clinical Pharmacology (12.2)]. Consider alternatives to SUSTIVA when co-administered with a drug with a known risk of Torsade de Pointes.
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Revisions were made in Table 5 and subsection 7.5 for Drugs Without Clinically Significant Interactions with SUSTIVA.

  • Specifically the clinical comment for Anti-infective: Clarithromycin now states: Consider alternatives to macrolide antibiotics because of the risk of QT interval prolongation. Likewise for Antimalarials: Artemether/lumefantrine the clinical comment states: Consider alternatives to artemether/lumefantrine because of the risk of QT interval prolongation.

The following new sub-section was added in the Clinical Pharmacology section.

  • 12.2 Pharmacodynamics-Cardiac Electrophysiology: The effect of SUSTIVA on the QTc interval was evaluated in an open-label, positive and placebo controlled, fixed single sequence 3-period, 3-treatment crossover QT study in 58 healthy subjects enriched for CYP2B6 polymorphisms. The mean Cmax of efavirenz in subjects with CYP2B6 *6/*6 genotype following the administration of 600 mg daily dose for 14 days was 2.25-fold the mean Cmax observed in subjects with CYP2B6 *1/*1 genotype. A positive relationship between efavirenz concentration and QTc prolongation was observed. Based on the concentration-QTc relationship, the mean QTc prolongation and its upper bound 90% confidence interval are 8.7 ms and 11.3 ms in subjects with CYP2B6*6/*6 genotype following the administration of 600 mg daily dose for 14 days [see Warnings and Precautions (5.2)].

You can view the updated label at Drugs@fda or DailyMed.




This article was provided by U.S. Food and Drug Administration. Visit the FDA's website to find out more about their activities and publications.
 

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