Approved November 16, 2009

CAPSAICIN
(FDA Category 3S)

QUTENZA(TM) (Neurogesx, Inc) is a neuropeptide-active agent that affects the synthesis, storage, transport, and release of substance P.

DOSING INFORMATION: Apply up to 4 patches as a single 60-minute application every 3 months as needed. Do not apply more frequently than every 3 months.

PHARMACOKINETICS: Capsaicin patch provides a transient, low systemic exposure in approximately one-third of patients after a 60-minute application with the greatest exposure (4.6 ng/mL) occurring immediately after patch removal. Capsaicin concentrations are below the limit of quantitation 3 to 6 hours after patch removal.

CAUTIONS: Avoid the use near eyes or mucous membranes. Coughing or sneezing may occur if airborne capsaicin is inhaled. Blood pressure elevations, which are temporary, may occur. Adverse events include application site reactions. Nitrile, not latex, gloves should be used when handling the patch and cleaning the treated areas.

FDA APPROVED INDICATIONS: Capsaicin patch is approved for the management of neuropathic pain associated with postherpetic neuralgia.