QUTENZA is indicated for the management of neuropathic pain associated with postherpetic neuralgia.
DOSAGE AND ADMINISTRATION
Important Dosage And Administration Instructions
- Do not dispense QUTENZA to patients for self-administration or handling. Only physicians or health care professionals under the close supervision of a physician are to administer and handle QUTENZA.
- Unintended exposure to capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin in healthcare providers and others [see WARNINGS AND PRECAUTIONS].
- Because unintended exposure to capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin, when administering QUTENZA, it is important to follow these procedures:
- Administer QUTENZA in a well-ventilated treatment area.
- Wear only nitrile gloves when handling QUTENZA or any item that makes contact with QUTENZA, and when cleaning capsaicin residue from the skin. Do not use latex gloves as they do not provide adequate protection.
- Use of a face mask and protective glasses is advisable for healthcare providers.
- Keep QUTENZA in the sealed pouch until immediately before use.
- Use QUTENZA only on dry, intact (unbroken) skin.
- During administration, avoid unnecessary contact with any items in the room, including items that the patient may later have contact with, such as horizontal surfaces and bedsheets.
- Aerosolization of capsaicin can occur upon rapid removal of QUTENZA. Therefore, remove QUTENZA gently and slowly by rolling the adhesive side inward [see WARNINGS AND PRECAUTIONS].
- Immediately after use, clean all areas that had contact with QUTENZA and properly dispose of QUTENZA, associated packaging, Cleansing Gel, gloves, and other treatment materials in accordance with local biomedical waste procedures.
- If QUTENZA is cut, ensure unused pieces are properly disposed of.
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).
Instructions For Use
Administer QUTENZA in a well-ventilated treatment area.
Put on nitrile (not latex) gloves. Use of a face mask and protective glasses is advisable for healthcare providers.
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 QUTENZA 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.
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 QUTENZA is covered by a clear, unprinted, diagonally-cut release liner.
Cut QUTENZA before removing the protective release liner. Ensure that unused pieces do not make contact with other objects and are disposed of appropriately.
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 QUTENZA on the treatment area.
While you slowly peel back the release liner from under the QUTENZA with one hand, use your other hand to smooth QUTENZA 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. Remove the nitrile gloves after the application.
Instruct the patient not to touch QUTENZA or treatment area.
Put on nitrile (not latex) gloves. Remove QUTENZA by gently and slowly rolling 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. Dry thoroughly.
Dispose of all treatment materials as described. [see DOSAGE AND ADMINISTRATION]
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 per cm²). Each patch contains a total of 179 mg of capsaicin. Each patch is 14 cm x 20 cm (280 cm²) and consists of an adhesive side containing the active substance and an outer surface backing layer. The adhesive side is covered with a removable, clear, unprinted, diagonally cut, release liner. The outer surface of the backing layer is imprinted with “capsaicin 8%”.
Storage And Handling
QUTENZA (capsaicin) 8% patch is a single-use patch stored in a sealed pouch (NDC 72512-920-00).
Each patch is 14 cm x 20 cm (280 cm²) and consists of an adhesive side containing the active substance and an outer surface backing layer. The adhesive side is covered with a removable, clear, unprinted, diagonally cut, release liner. The outer surface of the backing layer is imprinted with “capsaicin 8%”.
Cleansing Gel is provided in a 50 g tube.
QUTENZA is available in the following presentations:
Carton of 1 patch and 50 g tube of Cleansing Gel (NDC 72512-928-01).
Carton of 2 patches and 50 g tube of Cleansing Gel (NDC 72512-929-01).
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 QUTENZA in the sealed pouch until immediately before use.
Handling And Disposal
Unintended exposure to capsaicin can cause severe irritation of eyes, skin, respiratory tract, and mucous membranes. Wear nitrile (not latex) gloves while administering QUTENZA. Use of a face mask and protective glasses is advisable. Immediately after use, dispose of used and unused QUTENZA, QUTENZA clippings, associated packaging, Cleansing Gel, and all other potentially contaminated treatment supplies in accordance with local biomedical waste procedures [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].
Manufactured for Averitas Pharma, Inc., Morristown, NJ 07960, USA by Lohmann Therapie-Systeme AG (LTS), Andernach, Germany. Revised: May 2020