Qutenza

What is Qutenza used for?

Qutenza is a prescription medicine that is used to ease muscle and joint aches and pain. Qutenza may be given to you for other reasons.

Description

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.

QUTENZA is a single-use topical system stored in a foil pouch. Each QUTENZA is 14 cm x 20 cm (280 cm 2) and consists of a polyester backing film coated with a drug-containing silicone adhesive mixture and covered with a removable polyester release liner.

The backing film is imprinted with “capsaicin 8%”. Each QUTENZA contains a total of 179 mg of capsaicin (8% in adhesive, 80 mg per gram of adhesive) or 640 micrograms (mcg) of capsaicin per square cm of topical system.

The empirical formula is C 18H 27NO 3, with a molecular weight of 305.42. The chemical compound capsaicin [(E)-8-methyl-N-vanillyl-6-nonenamide] is an activating ligand for transient receptor potential vanilloid 1 receptor (TRPV1) and it has the following structure:

FIGURE 1: Structural Formula of Capsaicin

QUTENZA contains the following inactive ingredients: diethylene glycol monoethyl ether, dimethicone, ethyl cellulose, polyester film, silicone adhesive, and white ink.

QUTENZA is supplied with a Cleansing Gel which is used to remove residual capsaicin from the skin after treatment. Cleansing Gel consists of the following ingredients: butylated hydroxyanisole, carbomer copolymer, edetate disodium, polyethylene glycol, purified water, and sodium hydroxide.

Mechanism of Action

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 [see Clinical Pharmacology ( 12.2)] . 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.

Before taking Qutenza, tell your doctor:

• If you are allergic to Qutenza; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are using another drug like this one. If you are not sure, ask your doctor or pharmacist.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Qutenza with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Qutenza?

• Tell all of your health care providers that you take Qutenza. This includes your doctors, nurses, pharmacists, and dentists.
• Do not use coverings (bandages, dressings) unless told to do so by the doctor.
• Avoid use of heat sources (such as sunlamps, tanning beds, heating pads, electric blankets, heat lamps, saunas, hot tubs, heated waterbeds). Avoid long, hot baths or sunbathing. Your temperature may rise and cause too much drug to pass into your body.
• Take Qutenza off of the skin if very bad burning or itching happens.
• This medicine may cause harm if chewed or swallowed. This includes used patches. If Qutenza has been put in the mouth, call a doctor or poison control center right away.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Qutenza best taken?

Use Qutenza as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Your doctor will put on.
• Do not touch the patch while it is on your skin.

What do I do if I miss a dose?

• If you use Qutenza on a regular basis, put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses or extra doses.
• Many times Qutenza is used on an as needed basis. Do not use more often than told by the doctor.

What are the side effects of Qutenza that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.

What are some other side effects of Qutenza?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Burning or stinging feeling. Most of the time, this will go away after a few days.
• Skin irritation.
• Pain where it was placed.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Qutenza?

• If you need to store Qutenza at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PRINCIPAL DISPLAY PANEL – CARTON LABEL (1 TOPICAL SYSTEM)

• NDC 72512-928-011
• One single-use topical system (179 mg capsaicin)One single-use 50 g tube of Cleansing Gel
• Qutenza ® (capsaicin) 8% topical system
• Rx only. For topical use only.

PRINCIPAL DISPLAY PANEL – CARTON LABEL (2 TOPICAL SYSTEMS)