New OTC Nasal Spray for Allergy Relief Granted FDA Approval
June 18, 2021 02:32pm
BioCryst Pharmaceuticals received approval on December 22, 2014, for Rapivab, an influenza virus neuraminidase inhibitor indicated for the treatment of acute uncomplicated influenza in patients 18 years or older who have been symptomatic for no more than 2 days.
Limitations of use: efficacy was based on clinical trials in which the predominant influenza virus type was influenza A; a limited number of subjects infected with influenza B virus were enrolled. Available information on influenza drug susceptibility patterns and treatment effects should be considered when deciding whether to use. Efficacy could not be established in patients with serious influenza requiring hospitalization.
Neuropsychiatric events: patients with influenza may be at an increased risk of hallucinations, delirium, and abnormal behavior early in their illness. Monitor for signs of abnormal behavior. The most common adverse reaction (incidence >2%) is diarrhea. (Serious skin/hypersensitivity reactions such as Stevens-Johnson syndrome and erythema multiforme have also occurred with Rapivab.)
Use of intranasal live attenuated influenza vaccine should be avoided 2 weeks before or 48 hours after administration of Rapivab, unless medically indicated. Rapivab should be used during pregnancy only if the benefit outweighs the risk. Caution should be exercised when administering Rapivab to a patient who is breastfeeding.
Source: Rapivab prescribing information.