Qutenza (capsaicin) 8% patch
Company:  Neurogesx, Inc.
Application No.: 022395
Approval Date: 11/16/2009

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• Approval Letter(s) (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Cross Discipline Team Leader Review (PDF)
• Printed Labeling (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
• Statistical Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF

INDICATIONS AND USAGE

• Qutenza is a TRPV1 channel agonist indicated for the management of neuropathic pain associated with postherpetic neuralgia (PHN). (1)

DOSAGE AND ADMINISTRATION

• Only physicians or health care professionals under the close supervision of a physician are to administer Qutenza. (2.1)
• Do not use Qutenza on broken skin. (2.1)
• Apply Qutenza to the most painful skin areas, using up to four patches. (2.2)
• Apply Qutenza for 60 minutes and repeat every 3 months or as warranted by the return of pain (not more frequently than every three months). (2.2)
• Use only nitrile (not latex) gloves when handling Qutenza and when cleaning treatment areas. (2.1)
• Before patch application, a physician must identify and mark the painful area, including areas of hypersensitivity and allodynia. (2.3)
• Apply a topical anesthetic before Qutenza application. (2.3)
• Apply Qutenza by placing on the skin while slowly removing the release liner from underneath. (2.3)
• Remove the Qutenza patches by gently and slowly rolling them inward. (2.3)
• After removal of Qutenza, apply Cleansing Gel for one minute and then remove it with a dry wipe. (2.3)
• Treat acute pain during and following the procedure with local cooling and/or analgesics. (5.4)
• Dispose of patches and other treatment materials immediately after use in accordance with local biomedical waste procedures. (2.1)
• The treated area may be sensitive for a few days to heat (e.g., hot showers/baths, direct sunlight, vigorous exercise). (2.3)

DOSAGE FORMS AND STRENGTHS

• Qutenza patch contains 8% capsaicin (640 mcg/cm2). Each patch contains a total of 179 mg of capsaicin. (3)

CONTRAINDICATIONS

• None

WARNINGS AND PRECAUTIONS

• Do not use near eyes or mucous membranes. (5.1)
• Inhalation of airborne capsaicin can result in coughing or sneezing. (5.2)
• If irritation of eyes or airway occurs, remove the affected individual from the vicinity of Qutenza and flush the mucous membranes or eyes with water. If skin not intended to be treated comes into contact with Qutenza, apply Cleansing Gel and then wipe off with dry gauze. (5.2, 5.3)
• Transient increases in blood pressure may occur in patients during and shortly after the Qutenza treatment. Monitor blood pressure during and following the treatment procedure. For those patients who require the use of opioids to treat pain during or following the procedure, their ability to perform potentially hazardous activities such as driving or operating machinery may be affected. (5.4, 5.5)

ADVERSE REACTIONS

The most common adverse reactions (≥ 5% and greater than control) are application site erythema, application site pain, application site pruritus and application site papules. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact NeurogesX at 1-877-900-NGSX (6479) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.