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Submitted URL: http://www.qutenzahcp.com/
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Submission: On September 13 via manual from US — Scanned from DE
Effective URL: https://qutenzahcp.com/
Submission: On September 13 via manual from US — Scanned from DE
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For US Healthcare Professionals * Patient Site * Important Safety Information * Prescribing Information * My QUTENZA Connect * DPN * PHN * Access & Savings * Request a Rep QUTENZA. For ongoing and sustained pain relief.1 QUTENZA FOR PAINFUL DPN OF THE FEET DPN: diabetic peripheral neuropathy. Not an actual patient. QUTENZA FOR NEUROPATHIC PAIN ASSOCIATED WITH PHN PHN: postherpetic neuralgia. Not an actual patient. Non-surgical1 * Topical treatment Treatment flexibility1 * Can be used alone or in combination * No known drug-drug interactions * No additional pill burden Low risk for systemic side effects1 * Localized * Non-systemic * Non-opioid * No contraindications Low discontinuation rates1 * 1% of QUTENZA patients discontinued in clinical studies due to an adverse event Resources and forms for your practice and patients View Resources Help your eligible patients save on their prescriptions for QUTENZA Learn More Request a representative today Request Today INDICATION QUTENZA® (capsaicin) 8% topical system is indicated in adults for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) or associated with diabetic peripheral neuropathy (DPN) of the feet. IMPORTANT SAFETY INFORMATION Do not dispense QUTENZA to patients for self‑administration or handling. Use only on dry, unbroken skin. Only physicians or healthcare professionals are to administer and handle QUTENZA, following the procedures in the label. Warnings and Precautions * Severe Irritation: Whether applied directly or transferred accidentally from other surfaces, capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin to the healthcare professional, patients, and others. Do not use near eyes or mucous membranes, including face and scalp. Take protective measures, including wearing nitrile gloves and not touching items or surfaces that the patient may also touch. Flush irritated mucous membranes or eyes with water and provide supportive medical care for shortness of breath. Remove affected individuals from the vicinity of QUTENZA. Do not re‑expose affected individuals to QUTENZA if respiratory irritation worsens or does not resolve. If skin not intended to be treated comes into contact with QUTENZA, apply Cleansing Gel and then wipe off with dry gauze. Thoroughly clean all areas and items exposed to QUTENZA and dispose of properly. Because aerosolization of capsaicin can occur with rapid removal, administer QUTENZA in a well‑ventilated area, and remove gently and slowly, rolling the adhesive side inward. * Application-Associated Pain: Patients may experience substantial procedural pain and burning upon application and following removal of QUTENZA. Prepare to treat acute pain during and following application with local cooling (e.g., ice pack) and/or appropriate analgesic medication. * Increase in Blood Pressure: Transient increases in blood pressure may occur with QUTENZA treatment. Monitor blood pressure during and following treatment procedure and provide support for treatment‑related pain. Patients with unstable or poorly controlled hypertension, or 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. * Sensory Function: Reductions in sensory function (generally minor and temporary) have been reported following administration of QUTENZA. All patients with sensory deficits should be assessed for signs of sensory deterioration or loss prior to each application of QUTENZA. If sensory loss occurs, treatment should be reconsidered. Adverse Reactions The most common adverse reactions (≥5% and > control group) in all controlled clinical trials are application site erythema, application site pain, and application site pruritus. To report SUSPECTED ADVERSE REACTIONS, contact Averitas Pharma, Inc. at 1‑877‑900‑6479 or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch. Please see full Prescribing Information. INDICATION QUTENZA® (capsaicin) 8% topical system is indicated in adults for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) or associated with diabetic peripheral neuropathy (DPN) of the feet. IMPORTANT SAFETY INFORMATION Do not dispense QUTENZA to patients for self‑administration or handling. Use only on dry, unbroken skin. Only physicians or healthcare professionals are to administer and handle QUTENZA, following the procedures in the label. Warnings and Precautions * Severe Irritation: Whether applied directly or transferred accidentally from other surfaces, capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin to the healthcare professional, patients, and others. Do not use near eyes or mucous membranes, including face and scalp. Take protective measures, including wearing nitrile gloves and not touching items or surfaces that the patient may also touch. Flush irritated mucous membranes or eyes with water and provide supportive medical care for shortness of breath. Remove affected individuals from the vicinity of QUTENZA. Do not re‑expose affected individuals to QUTENZA if respiratory irritation worsens or does not resolve. If skin not intended to be treated comes into contact with QUTENZA, apply Cleansing Gel and then wipe off with dry gauze. Thoroughly clean all areas and items exposed to QUTENZA and dispose of properly. Because aerosolization of capsaicin can occur with rapid removal, administer QUTENZA in a well‑ventilated area, and remove gently and slowly, rolling the adhesive side inward. * Application-Associated Pain: Patients may experience substantial procedural pain and burning upon application and following removal of QUTENZA. Prepare to treat acute pain during and following application with local cooling (e.g., ice pack) and/or appropriate analgesic medication. * Increase in Blood Pressure: Transient increases in blood pressure may occur with QUTENZA treatment. Monitor blood pressure during and following treatment procedure and provide support for treatment‑related pain. Patients with unstable or poorly controlled hypertension, or 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. * Sensory Function: Reductions in sensory function (generally minor and temporary) have been reported following administration of QUTENZA. All patients with sensory deficits should be assessed for signs of sensory deterioration or loss prior to each application of QUTENZA. If sensory loss occurs, treatment should be reconsidered. Adverse Reactions The most common adverse reactions (≥5% and > control group) in all controlled clinical trials are application site erythema, application site pain, and application site pruritus. To report SUSPECTED ADVERSE REACTIONS, contact Averitas Pharma, Inc. at 1‑877‑900‑6479 or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch. Please see full Prescribing Information. Carton with one topical system + Cleansing Gel: NDC #72512-928-01 Carton with two topical systems + Cleansing Gel: NDC #72512-929-01 Carton with four topical systems + Cleansing Gel: NDC #72512-930-01 Reference: 1.QUTENZA® [prescribing information]. Morristown, NJ: Averitas Pharma, Inc. * Privacy Statement * Terms of Use * Full Prescribing Information * AveritasPharma.com * Grunenthal.com QUTENZA® is a registered trademark of Averitas Pharma, Inc. © 2023 Averitas Pharma, Inc. All rights reserved. QZA-03-22-0029 v7.0 August 2023 Healthcare Professionals The information contained in this section of the site is intended for US Healthcare Professionals only. Click continue if you are a healthcare professional. ContinueCancel