ADVERTISEMENT
QUTENZA® (capsaicin) 8% topical system
QUTENZA (capsaicin) 8% topical system 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.
Averitas Pharma
Averitas Pharma
Our company was formed in 2018, as the US commercial subsidiary of The Grünenthal Group. Grünenthal is a multinational pharmaceutical company headquartered in Germany, with a presence in more than 30 countries across Europe, Latin America, and the USA. For more than 70 years, Grünenthal has been a global leader in the research and development of therapeutics for pain, gout, and inflammation. Now, Averitas becomes a new chapter in the company’s global growth.
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
QUTENZA Combines a Unique Mechanism of Action (MOA) and Matrix System Technology1-4
PATENTED TECHNOLOGY1,4,5
The matrix system technology uniquely and rapidly delivers concentrated capsaicin at the source of the pain.
References
1. National Center for Biotechnology Information. PubChem Patent Summary for US-8821920-B2: Therapeutic patch for transdermal delivery of capsaicin. PubChem website. https://pubchem.ncbi.nlm.nih.gov/patent/US-8821920-B2. Accessed January 18, 2022.
2. Anand P, Privitera R, Donatien P, et al. Reversing painful and non-painful diabetic neuropathy with the capsaicin 8% patch: clinical evidence for pain relief and restoration of function via nerve fiber regeneration. Front Neurol. 2022;13:998904.
3. Simpson DM, Robinson-Papp J, Van J, et al. Capsaicin 8% patch in painful diabetic peripheral neuropathy: a randomized, double-blind, placebo-controlled study. J Pain. 2017;18(1):42-53.
4. QUTENZA® [prescribing information]. Morristown, NJ: Averitas Pharma, Inc.
5. Wohlrab J, Neubert RH, Heskamp ML, Michael J. Cutaneous drug delivery of capsaicin after in vitro administration of the 8% capsaicin dermal patch system. Skin Pharmacol Physiol. 2015;28(2):65-74.
QUTENZA can provide up to 3 months of relief from painful DPN of the feet with a non-systemic treatment. Treat early with QUTENZA, alone or in combination with systemic treatments.1
Reference
1.QUTENZA® [prescribing information]. Morristown, NJ: Averitas Pharma, Inc.
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 under close supervision of a physician 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 (eg, 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.
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.
Capsaicin 8%
• Only physicians or health care professionals are to administer QUTENZA.
• Administer QUTENZA in a well-ventilated treatment area.
• Wear nitrile (not latex) gloves when handling QUTENZA and when cleaning treatment areas.
• Use of a face mask and protective glasses is advisable for healthcare professionals.
• Do not use QUTENZA on broken skin.
• PHN: Apply up to four topical systems for 60 minutes.
• DPN: Apply up to four topical systems for 30 minutes on the feet.
• Repeat every 3 months or as warranted by the return of pain (not more frequently than every three months).
• See Dosage and Administration, Instructions for Use, for detailed instructions on QUTENZA administration.
