Qutenza

What is Qutenza?

• Qutenza (capsaicin) is a TRPV1 channel agonist used for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet.

Capsaicin V2

Capsaicin Formulae

What are the uses of this medicine?

• Qutenza (capsaicin) is used 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.

How does this medicine work?

• Capsaicin is an agonist for the transient receptor potential vanilloid 1 receptor (TRPV1), which is an ion channel-receptor complex expressed on nociceptive nerve fibers in the skin.

Topical administration of capsaicin causes an initial enhanced stimulation of the TRPV1-expressing cutaneous nociceptors that may be associated with painful sensations.

• This is followed by pain relief thought to be mediated by a reduction in TRPV1-expressing nociceptive nerve endings.
• Over the course of several months, there may be a gradual re-emergence of painful neuropathy thought to be due to TRPV1 nerve fiber reinnervation of the treated area.

What drug interactions can this medicine cause?

• No clinical drug interaction studies have been performed.

Is this medicine FDA approved?

• Initial U.S. Approval: 2009

How should this medicine be used?

Recommended dosage: Postherpetic neuralgia (PHN):

• Apply up to four topical systems for 60 minutes.

Diabetic peripheral neuropathy (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).

Administration:

• Only physicians or health care professionals under the close supervision of a physician 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As topical system contains 8% capsaicin (640 mcg per cm 2). Each topical systems contains a total of 179 mg of capsaicin.

This medicine is available in fallowing brand namesː

• QUTENZA

What side effects can this medication cause?

The most common side effects of this medicine include:

• application site erythema
• application site pain
• application site pruritus

What special precautions should I follow?

• 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.
• Wear nitrile gloves and avoid touching items or surfaces that the patient may later touch.
• If irritation of eyes or airway occurs, flush the mucous membranes or eyes with water and provide supportive medical care for shortness of breath. Remove the affected individual (healthcare professional or patient) from the vicinity of QUTENZA. Do not re-expose the affected individual 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.
• Patients may experience substantial procedural pain and burning upon application of QUTENZA and following removal of QUTENZA. Prepare to treat acute pain during and following the application procedure with local cooling (such as an ice pack) and/or appropriate analgesic medication.
• Transient increases in blood pressure may occur with QUTENZA treatment. Monitor blood pressure during and following the treatment procedure.
• Reductions in sensory function, which were 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.
• Inform patients that accidental exposure to capsaicin from touching QUTENZA or items exposed to capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin.
• Instruct patients not to touch their eyes and other unintended target area and that if irritation of eyes or airways occurs, or if any of the side effects become severe, to notify their doctor immediately.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• There is no clinical experience with QUTENZA overdose in humans.

Treatment of overdosage:

• There is no specific antidote for overdose with capsaicin.
• In case of suspected overdose, remove QUTENZA gently, apply Cleansing Gel for one minute, wipe off with dry gauze, and gently wash the area with soap and water.
• Use supportive measures and treat symptoms as clinically warranted.

Can this medicine be used in pregnancy?

• Capsaicin is negligibly absorbed systemically following topical administration of QUTENZA, and maternal use is not expected to result in the fetal exposure to QUTENZA.

Can this medicine be used in children?

• The safety and effectiveness of QUTENZA in patients younger than 18 years of age have not been studied.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• CAPSAICIN

Inactive ingredients:

• DIETHYLENE GLYCOL MONOETHYL ETHER
• DIMETHICONE
• ETHYLCELLULOSE, UNSPECIFIED

Who manufactures and distributes this medicine?

• Manufactured for Averitas Pharma, Inc., Morristown, NJ, USA
• Manufactured by Lohmann Therapie-Systeme AG (LTS), Andernach, Germany

What should I know about storage and disposal of this medication?

• Store carton between 20°C to 25°C (68°F to 77°F).
• Excursions between 15°C and 30°C (59°F and 86°F) are allowed.
• Keep QUTENZA in the sealed pouch until immediately before use.
• Unintended exposure to capsaicin can cause severe irritation of eyes, skin, respiratory tract, and mucous membranes.
• Wear nitrile (not latex) gloves while administering QUTENZA. Use of a face mask and protective glasses is advisable.
• Immediately after use, dispose of used and unused QUTENZA, QUTENZA clippings, associated packaging, Cleansing Gel, and all other potentially contaminated treatment supplies in accordance with local biomedical waste procedures.

• Dailymed label info on Qutenza
• FDA Qutenza

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