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Important Safety Information | Full Prescribing Information

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PLEASE SEE IMPORTANT SAFETY INFORMATION AND FULL PRESCRIBING INFORMATION

INDICATION

PRODUCT® (capsaicin) 8% topical system is indicated in adults for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and for neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet.

IMPORTANT SAFETY INFORMATION

Do not dispense PRODUCT to patients for self-administration or handling. Only physicians or healthcare professionals under the close supervision of a physician are to administer and handle PRODUCT.

When administering PRODUCT, it is important to follow the procedures in the Important Dosage and Administration Instructions in the US Prescribing Information.

In patients treated for neuropathic pain associated with diabetic peripheral neuropathy of the feet, a careful examination of the feet should be undertaken prior to each application of PRODUCT to detect skin lesions related to underlying neuropathy or vascular insufficiency.

Contraindications

None

Warnings and Precautions

Unintended exposure to capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin in healthcare professionals, patients, and others. Healthcare professionals should ensure that the recommended procedures and protective measures are used when administering PRODUCT.
For healthcare professionals, wear nitrile gloves when administering PRODUCT and avoid unnecessary contact with items in the room, including items that the patient may later have contact with, such as horizontal surfaces and bedsheets.
Do not apply PRODUCT to the patient’s face, eyes, mouth, nose, or scalp to avoid risk of exposure to eyes or mucous membranes. Accidental exposure to the eyes and mucous membranes can occur from touching PRODUCT, or items exposed to capsaicin, and then touching the eyes and mucous membranes. If irritation of eyes or mucous membranes occurs, flush eyes and mucous membranes with cool water. Remove the affected individual (healthcare professional or patient) from the vicinity of PRODUCT.
Aerosolization of capsaicin can occur upon rapid removal of PRODUCT. Therefore, remove PRODUCT gently and slowly by rolling the adhesive side inward. Inhalation of airborne capsaicin can result in coughing or sneezing. Administer PRODUCT in a well-ventilated treatment area. Provide supportive medical care if shortness of breath develops. If irritation of airways occurs, remove the affected individual from the vicinity of PRODUCT. If respiratory irritation worsens or does not resolve, do not re-expose the affected healthcare professional or patient to PRODUCT.
If skin not intended to be treated is exposed to PRODUCT, 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.
Patients may experience substantial procedural pain and burning upon application and following removal of PRODUCT. Prepare to treat acute pain during and following the application procedure with local cooling (such as a cold pack) and/or appropriate analgesic medication.
Transient increases in blood pressure may occur during and shortly after PRODUCT treatment. 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 PRODUCT treatment.
Reductions in sensory function have been reported following administration of PRODUCT. Decreases in sensory function are generally minor and temporary. All patients with pre-existing sensory deficits should be clinically assessed for signs of sensory deterioration or loss prior to each application of PRODUCT. If sensory deterioration or loss is detected, or pre-existing sensory deficit worsens, continued use of PRODUCT treatment should be reconsidered.

Adverse Reactions

In all controlled clinical trials, adverse reactions occurring in ≥5% of patients in the PRODUCT group, and at an incidence at least 1% greater than in the control group, were application site erythema, application site pain, and application site pruritus.

Adverse Event Reporting

Physicians, other healthcare professionals, and patients are encouraged to voluntarily report adverse events involving drugs or medical devices. To make a report you can:

In the US, visit www.fda.gov/medwatch or call 1-800-FDA-1088; or
For PRODUCT, you may also call 1-877-900-6479 and select option 1, or press zero on your keypad to talk to an operator to direct your call.

Please see full Prescribing Information.