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QUTENZA(capsaicin) 8% patch
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use QUTENZA safely and effectively. See full prescribing information for QUTENZA.
QUTENZA ® (capsaicin) 8% patch
Initial U.S. Approval: 2009
INDICATIONS AND USAGE
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Qutenza is a TRPV1 channel agonist indicated for the management of neuropathic pain associated with postherpetic neuralgia (PHN). (1)
DOSAGE AND ADMINISTRATION
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Only physicians or health care professionals under the close supervision of a physician are to administer Qutenza. (2.1)
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Do not use Qutenza on broken skin. (2.1)
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Apply Qutenza to the most painful skin areas, using up to four patches. (2.2)
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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)
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Use only nitrile (not latex) gloves when handling Qutenza and when cleaning treatment areas. (2.1)
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Before patch application, a physician must identify and mark the painful area, including areas of hypersensitivity and allodynia. (2.3)
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Apply a topical anesthetic before Qutenza application. (2.3)
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Apply Qutenza by placing on the skin while slowly removing the release liner from underneath. (2.3)
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Remove the Qutenza patches by gently and slowly rolling them inward. (2.3)
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After removal of Qutenza, apply Cleansing Gel for one minute and then remove it with a dry wipe. (2.3)
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Treat acute pain during and following the procedure with local cooling and/or analgesics. (5.4)
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Dispose of patches and other treatment materials immediately after use in accordance with local biomedical waste procedures. (2.1)
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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
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Qutenza patch contains 8% capsaicin (640 mcg/cm2). Each patch contains a total of 179 mg of capsaicin. (3)
WARNINGS AND PRECAUTIONS
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Do not use near eyes or mucous membranes. (5.1)
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Inhalation of airborne capsaicin can result in coughing or sneezing. (5.2)
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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)
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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.
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 11/2009
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
Qutenza is indicated for the management of neuropathic pain associated with postherpetic neuralgia.
2 DOSAGE AND ADMINISTRATION
2.1 Special Precautions
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Only physicians or health care professionals under the close supervision of a physician are to administer Qutenza.
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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.
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Immediately after use, dispose of used and unused patches, Cleansing Gel and other treatment materials in accordance with the local biomedical waste procedures.
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Use Qutenza only on dry, intact (unbroken) skin.
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Apply the Qutenza patch within 2 hours of opening the pouch.
2.2 Dosing
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
Prepare
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).
3 DOSAGE FORMS AND STRENGTHS
Qutenza patch contains 8% capsaicin (640 mcg/cm2). Each patch contains a total of 179 mg of capsaicin.
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Eye and Mucous Membrane Exposure
Do not apply Qutenza to the face or scalp to avoid risk of exposure to the eyes or mucous membranes.
5.2 Aerosolization of Capsaicin
Aerosolization of capsaicin can occur upon rapid removal of Qutenza patches. Therefore, remove Qutenza patches gently and slowly by rolling the adhesive side inward [see Dosage and Administration (2.3)].
If irritation of eyes or airways occurs, remove the affected individual from the vicinity of Qutenza. Flush eyes and mucous membranes with cool water.
Inhalation of airborne capsaicin can result in coughing or sneezing. Provide supportive medical care if shortness of breath develops.
5.3 Unintended Skin Exposure
If skin not intended to be treated comes in contact with Qutenza, apply Cleansing Gel for one minute and wipe off with dry gauze. After the Cleansing Gel has been wiped off, wash the area with soap and water.
5.4 Application Associated Pain
Even following use of a local anesthetic prior to administration of Qutenza, patients may experience substantial procedural pain. Prepare to treat acute pain during and following the application procedure with local cooling (such as an ice pack) and/or appropriate analgesic medication, such as opioids. Opioids may affect the ability to perform potentially hazardous activities such as driving or operating machinery.
5.5 Increase in Blood Pressure
In clinical trials, increases in blood pressure occurred during or shortly after exposure to Qutenza. The changes averaged less than 10 mm Hg, although some patients had greater increases and these changes lasted for approximately two hours after patch removal. Increases in blood pressure were unrelated to the pretreatment blood pressure but were related to treatment-related increases in pain. Monitor blood pressure periodically during the treatment and provide adequate support for treatment related pain.
Patients with unstable or poorly controlled hypertension, a recent history of cardiovascular or cerebrovascular events may be at an increased risk of adverse cardiovascular effects. Consider these factors prior to initiating Qutenza treatment.
6 ADVERSE REACTIONS
The following serious adverse reactions are discussed elsewhere in the labeling:
Application-Associated Pain [see Warnings and Precautions (5.4)]
Increase in Blood Pressure [see Warnings and Precautions (5.5)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in clinical practice.
Across all controlled and uncontrolled trials, more than 1,600 patients have received Qutenza. A total of 394 patients received more than one treatment application and 274 patients were followed for 48 weeks or longer.
In controlled clinical studies, 98% of patients completed ≥ 90% of the intended patch application duration. Among patients treated with Qutenza, 1% discontinued prematurely due to an adverse event.
Controlled Clinical Studies
Common Adverse Reactions
Adverse reactions occurring in ≥ 5% of patients in the Qutenza group and at an incidence greater than in the control group were application site erythema, application site pain, application site pruritus and application site papules.
Table 1 summarizes all adverse reactions, regardless of causality, occurring in ≥ 1% of patients with postherpetic neuralgia in the Qutenza group for which the incidence was greater than in the control group. The majority of application site reactions were transient and self-limited. Transient increases in pain were commonly observed on the day of treatment in patients treated with Qutenza. Pain increases occurring during patch application usually began to resolve after patch removal. On average, pain scores returned to baseline by the end of the treatment day and then remained at or |
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