"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...
DOSAGE AND ADMINISTRATION
- Only physicians or health care professionals under the close supervision of a physician are to administer Qutenza (capsaicin 8% patch) .
- 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 Cleansing Gel and other treatment materials in accordance with the local biomedical waste procedures.
- Use Qutenza (capsaicin 8% patch) only on dry, intact (unbroken) skin.
- Apply the Qutenza (capsaicin 8% patch) patch within 2 hours of opening the pouch.
The recommended dose of Qutenza (capsaicin 8% patch) is a single, 60-minute application of up to four patches.
Treatment with Qutenza (capsaicin 8% patch) may be repeated every three months or as warranted by the return of pain (not more frequently than every three months).
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 (capsaicin 8% patch) 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 (capsaicin 8% patch) .
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 (capsaicin 8% patch) 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 (capsaicin 8% patch) patch.
Inspect the Qutenza (capsaicin 8% patch) 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 (capsaicin 8% patch) 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 (capsaicin 8% patch) is applied, leave in place for 60 minutes.
To ensure Qutenza (capsaicin 8% patch) 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 (capsaicin 8% patch) patches by gently and slowly rolling them inward.
After removal of Qutenza (capsaicin 8% patch) , 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 in Section 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).
Dosage Forms And Strengths
Qutenza patch contains 8% capsaicin (640 mcg/cm2). Each patch contains a total of 179 mg of capsaicin.
Qutenza (capsaicin) 8% patch is a single-use patch stored in a sealed pouch (NDC 49685-920-00).
Each individual patch is printed with “capsaicin 8%”.
Cleansing Gel is provided in a 50 g tube.
Qutenza (capsaicin 8% patch) is available in the following presentations:
Carton of 1 patch and 50 g tube of Cleansing Gel (NDC 49685-920-01).
Carton of 2 patches and 50 g tube of Cleansing Gel (NDC 49685-920-02).
Store carton between 20° to 25°C (68° to 77°F). Excursions between 15°C and 30°C (59°F and 86°F) are allowed.
Keep the patch in the sealed pouch until immediately before use.
Handling and disposal
Qutenza contains capsaicin capable of producing severe irritation of eyes, skin, respiratory tract and mucous membranes. Do not dispense Qutenza (capsaicin 8% patch) to patients for self-administration. It is critical that health care professionals who administer Qutenza (capsaicin 8% patch) have completely familiarized themselves with proper dosing, handling, and disposal procedures before handling Qutenza to avoid accidental or inadvertent capsaicin exposure to themselves or others [see DOSAGE AND ADMINISTRATION].
- Do not touch Qutenza (capsaicin 8% patch) , treatment areas, and all used supplies or other materials placed in contact with the treatment area without wearing nitrile gloves.
- Wear nitrile gloves at all times while handling Qutenza (capsaicin 8% patch) and cleaning treatment areas. Do NOT use latex gloves.
- Do not hold Qutenza (capsaicin 8% patch) near eyes or mucous membranes.
- Immediately after use, dispose of used and unused patches, patch clippings, unused Cleansing Gel and associated treatment supplies in accordance with local biomedical waste procedures.
Manufactured for NeurogesX, Inc., San Mateo, CA 94404, USA by Lohmann Therapie-Systeme AG (LTS), Andernach, Germany. November 2009.
Last reviewed on RxList: 12/2/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Qutenza Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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