Qutenza
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Qutenza is indicated for the management of neuropathic pain associated with postherpetic neuralgia.
History
There is currently no drug history available for this drug.
Other Information
Qutenza (capsaicin) 8% patch contains capsaicin in a localized dermal delivery system. The capsaicin in Qutenza is a synthetic equivalent of the naturally occurring compound found in chili peppers. Capsaicin is soluble in alcohol, acetone, and ethyl acetate and very slightly soluble in water.
Qutenza is a single-use patch stored in a foil pouch. Each Qutenza patch is 14 cm x 20 cm (280 cm2) and consists of a polyester backing film coated with a drug-containing silicone adhesive mixture, and covered with a removable polyester release liner.
The backing film is imprinted with "capsaicin 8%". Each Qutenza patch contains a total of 179 mg of capsaicin (8% in adhesive, 80 mg per gram of adhesive) or 640 micrograms (mcg) of capsaicin per square cm of patch.
The empirical formula is C18H27NO3, with a molecular weight of 305.42. The chemical compound capsaicin [(E)-8-methyl-N-vanillyl-6-nonenamide] is an activating ligand for transient receptor potential vanilloid 1 receptor (TRPV1) and it has the following structure:
| FIGURE 1: Structural Formula of Capsaicin |
The patch contains the following inactive ingredients: diethylene glycol monoethyl ether, dimethicone, ethyl cellulose, polyester film, silicone adhesive and white ink.
Qutenza is supplied with a Cleansing Gel which is used to remove residual capsaicin from the skin after treatment. Cleansing Gel consists of the following ingredients: butylated hydroxyanisole, carbomer copolymer, edetate disodium, polyethylene glycol, purified water, and sodium hydroxide.
Sources
Qutenza Manufacturers
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Neurogesx, Inc.
![Qutenza (Capsaicin) Kit [Neurogesx, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Qutenza | Neurogesx, Inc.
2.1 Special Precautions Only 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. 2.2 DosingThe 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 UsePrepare
Put on nitrile gloves. Inspect the pouch. Do not use if the pouch has been torn or damaged.
Identify
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.
Anesthetize
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.
Apply
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
Remove Qutenza patches by gently and slowly rolling them inward.
Cleanse
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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Acorda Therapeutics, Inc.
Qutenza | Acorda Therapeutics, Inc.
2.1 Special Precautions Only 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. 2.2 DosingThe 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 UsePrepare
Put on nitrile gloves. Inspect the pouch. Do not use if the pouch has been torn or damaged.
Identify
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.
Anesthetize
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.
Apply
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
Remove Qutenza patches by gently and slowly rolling them inward.
Cleanse
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).
![Qutenza (Capsaicin) Kit [Acorda Therapeutics, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ab5a8fa3-2eb2-44fd-bf9b-a1ac114e0c9b&name=qutenza-11.jpg)
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