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Neurogesx, Inc. Drugs
2.1 Special PrecautionsOnly physicians or health care professionals under the close supervision of a physician are to administer Qutenza. Use only nitrile gloves when handling Qutenza, and when cleaning capsaicin residue from the skin. Do not use latex gloves as they do not provide adequate protection. Immediately after use, dispose of used and unused patches, Cleansing Gel and other treatment materials in accordance with the local biomedical waste procedures. Use Qutenza only on dry, intact (unbroken) skin. Apply the Qutenza patch within 2 hours of opening the pouch.
The recommended dose of Qutenza is a single, 60-minute application of up to four patches.
Treatment with Qutenza may be repeated every three months or as warranted by the return of pain (not more frequently than every three months).
2.3 Instructions for Use
Put on nitrile gloves. Inspect the pouch. Do not use if the pouch has been torn or damaged.
The treatment area (painful area including areas of hypersensitivity and allodynia) must be identified by a physician and marked on the skin.
If necessary, clip hair (do not shave) in and around the identified treatment area to promote patch adherence.
Qutenza can be cut to match the size and the shape of the treatment area.
Gently wash the treatment area with mild soap and water and dry thoroughly.
Pre-treat with a topical anesthetic to reduce discomfort associated with the application of Qutenza.
Apply topical anesthetic to the entire treatment area and surrounding 1 to 2 cm, and keep the local anesthetic in place until the skin is anesthetized prior to the application of Qutenza patch.
Remove the topical anesthetic with a dry wipe. Gently wash the treatment area with mild soap and water and dry thoroughly.
Tear open the pouch along the three dashed lines, remove the Qutenza patch.
Inspect the Qutenza patch and identify the outer surface backing layer with the printing on one side and the capsaicin-containing adhesive on the other side. The adhesive side of the patch is covered by a clear, unprinted, diagonally-cut release liner.
Cut Qutenza before removing the protective release liner.
The diagonal cut in the release liner is to aid in its removal. Peel a small section of the release liner back, and place the adhesive side of the patch on the treatment area.
While you slowly peel back the release liner from under the patch with one hand, use your other hand to smooth the patch down on to the skin.
Once Qutenza is applied, leave in place for 60 minutes.
To ensure Qutenza maintains contact with the treatment area, a dressing, such as rolled gauze, may be used.
Instruct the patient not to touch the patch or treatment area.
Remove Qutenza patches by gently and slowly rolling them inward.
After removal of Qutenza, generously apply Cleansing Gel to the treatment area and leave on for at least one minute. Remove Cleansing Gel with a dry wipe and gently wash the area with mild soap and water and dry thoroughly.
Dispose of all treatment materials as described. [see Dosage and Administration (2.1)]
Inform the patient that the treated area may be sensitive for a few days to heat (e.g., hot showers/baths, direct sunlight, vigorous exercise).
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