"The US Food and Drug Administration (FDA) has approved 5-aminolevulinic acid (ALA; Ameluz, Biofrontera) gel in combination with the activating BF-RhodoLED photodynamic therapy (PDT) lamp for treatment of patients with actinic keratosis ("...
In a clinical study evaluating a 90 mg dose (30 mg in each of 3 subcutaneous sites), the adverse event profile was similar to that seen with 30 mg administered in a single subcutaneous site.
In another clinical study, a dose of 3.2 mg/kg administered intravenously (approximately 8 times the therapeutic dose for HAE) caused erythema, itching and hypotension in healthy subjects. No therapeutic intervention was necessary.
None.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/7/2015
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