Diana Ernst, RPh

Most Recent Articles by Diana Ernst, RPh

Etravirine Indication Expanded to Include Younger HIV Patients

Etravirine Indication Expanded to Include Younger HIV Patients

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The approval of Intelence for this patient population was based on an open-label, single arm trial (N=20) which showed that the safety and efficacy of etravirine + an optimized background regimen (ritonavir-boosted protease inhibitor in combination with 1 or 2 NRTIs [N=14] and/or combination with an integrase inhibitor [N=7]) was comparable to that observed in adults.

FDA Strengthens Warnings for Fluoroquinolone Antibiotics

FDA Strengthens Warnings for Fluoroquinolone Antibiotics

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The labeling changes are based on a review of postmarketing adverse event reports found in the FDA Adverse Event Reporting System (FAERS) database and published medical literature.

Potential Significant Toxicity With Methotrexate, Trimethoprim-Sulfamethoxazole Combination

Potential Significant Toxicity With Methotrexate, Trimethoprim-Sulfamethoxazole Combination

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The case involved a 68-year-old female patient with rheumatoid arthritis on methotrexate 10mg weekly who presented to the emergency department with complaints of lethargy and weakness after being prescribed a 2-week course of TS for a bacterial skin infection.

NDA Submitted for Novel, Targeted Antibiotic Iclaprim

NDA Submitted for Novel, Targeted Antibiotic Iclaprim

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The NDA includes safety and efficacy data from two Phase 3 trials (REVIVE-1 and REVIVE-2; N=1190) which compared intravenous iclaprim to standard-of-care vancomycin in patients with ABSSSI.

HCV Guidelines Updated to Include Recommendations for Key Populations

HCV Guidelines Updated to Include Recommendations for Key Populations

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The guidelines were developed by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America.

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