Alerts & Corrections - AHFS Drug Information

Correction Notice: Alpelisib 10:00

1 June, 2022 AHFS

Alerts-Corrections

The Editors of AHFS Drug Information® (AHFS DI®) wish to inform you of an error in the alpelisib monograph 10:00.

In the AHFS monograph, the error appears under the subhead Breast Cancer, in Dosage and Administration: Dosage. (This is in the second column on page 870 of the printed edition of AHFS DI 2022®.) In the first sentence under this subhead, the statement should read:

“For use in combination with fulvestrant in the treatment of hormone receptor-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer in men and postmenopausal women with disease progression following endocrine therapy, the recommended adult dosage of alpelisib is 300 mg (two 150-mg tablets) once daily.”

In the AHFS Essentials monograph, this statement should read:

“Oral: 300 mg (two 150-mg tablets) once daily; use in combination with fulvestrant 500 mg by IM injection on days 1, 15, and 29 and then once monthly thereafter.”

Emergency Use Authorization (EUA) for bamlanivimab

12 November, 2020 AHFS

no responses

On November 9, 2020, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.

While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.

Bamlanivimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. A benefit of bamlanivimab treatment has not been shown in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

See the full announcement on the FDA website.

Emergency Use Authorization (EUA) for Convalescent Plasma

23 August, 2020 AHFS

COVID-19

no responses

On August 23, 2020, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19. Based on scientific evidence available, the FDA concluded, as outlined in its decision memorandum, this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.

This action follows the FDA’s extensive review of the science and data generated over the past several months stemming from efforts to facilitate emergency access to convalescent plasma for patients as clinical trials to definitively demonstrate safety and efficacy remain ongoing.

The EUA authorizes the distribution of COVID-19 convalescent plasma in the U.S. and its administration by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients with COVID-19.

Read the full announcement on the FDA’s website.

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