Qutenza^® (capsaicin) 8% patch

Indication: Qutenza^® (capsaicin) 8% patch is indicated for the management of neuropathic pain associated with postherpetic neuralgia.

IMPORTANT SAFETY INFORMATION

Only physicians or healthcare professionals under the close supervision of a physician are to administer Qutenza^®.

Contraindications: None.

Warnings and Precautions:

• Do not use on face or scalp.
• Aerosolization of capsaicin can occur and inhalation may result in coughing or sneezing.
• If skin not intended to be treated comes into contact with Qutenza^®, clean area using Cleansing Gel.
• Patients may experience substantial procedural pain. Prepare to treat pain with local cooling (such as a cold pack) and/or appropriate analgesic medication.
• Transient increases in blood pressure may occur during and shortly after the Qutenza^® treatment. In clinical trials, blood pressure changes were associated with treatment-related increases in pain. Monitor blood pressure and provide adequate 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.

Adverse Reactions: In clinical trials, serious adverse reactions included application-associated pain and increase in blood pressure. The most common adverse reactions (≥ 5% and greater than control) were application-site erythema, application-site pain, application-site pruritus, and application-site papules.

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