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FDA Approves Rituxan for Pemphigus Vulgaris

Genentech Web site; 2018 Jun 7

Genentech, a member of the Roche Group, has announced that the US Food and Drug Administration (FDA) has approved Rituxan (rituximab) for the treatment of adults with moderate-to-severe pemphigus vulgaris (PV), a rare, serious, potentially life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes. Rituxan is the first biologic therapy approved by the FDA for PV and the first major advancement in the treatment of the disease in >60 years. Genentech is headquartered in San Francisco, CA.

Dosage/administration: Rituxan should only be administered by a healthcare professional with appropriate medical support to manage any severe infusion reactions. The dose for PV is 2 1,000 mg intravenous infusions separated by 2 weeks in combination with a tapering course of glucocorticoids, then a 500 mg intravenous infusion at month 12 and every 6 months thereafter or based on clinical evaluation. Dose upon relapse is a 1,000 mg intravenous infusion with considerations to resume or increase the glucocorticoid dose based on clinical evaluation. Subsequent infusions may be no sooner than 16 weeks after the previous infusion. Methylprednisolone 100 mg intravenous or equivalent glucocorticoid is recommended 30 minutes prior to each infusion.

Adverse reactions: The most common adverse reactions for PV (≥15%) include infusion reactions and depression (other important adverse reactions include infections).

Citation:

FDA approves Genentech’s Rituxan (rituximab) for pemphigus vulgaris. [news release]. San Francisco, California: Genentech. June 7, 2018. https://www.gene.com/media/press-releases/14727/2018-06-07/fda-approves-genentechs-rituxan-rituxima. Accessed June 13, 2018.