Most Recent Articles by Diana Ernst, RPh
Reports of pump failure, dosing errors, as well as other possible safety issues have prompted the Agency to issue the alert to make prescribers aware of the dangers associated with using medications not approved for intrathecal use.
Oralair is indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen specific IgE antibodies for any of the 5 grass species contained in this product.
The approval was based on data from the KEYNOTE-224 study, a single-arm trial in patients with HCC who had disease progression on or after sorafenib or were intolerant to sorafenib; had measurable disease; and Child-Pugh class A liver impairment.
The labeling now states that a caregiver may disintegrate the Nityr tablet in an oral syringe up to 24 hours before administration.