Qutenza

Do not use this medicine if you are allergic to chili peppers, or if you have ever had an allergic reaction to capsaicin topical.

Ask a doctor or pharmacist about using capsaicin topical if you have any allergies (especially to plants), or if you have a serious medical condition.

It is not known whether capsaicin topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether capsaicin topical passes into breast milk or if it could harm a nursing baby. Do not apply capsaicin topical to your breast area if you are breast-feeding a baby.

Do not use this medication on anyone younger than 18 years old without the advice of a doctor.

• It is used to ease muscle and joint aches and pain.
• It may be given to you for other reasons. Talk with the doctor.

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.

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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

There is no clinical experience with Qutenza overdose in humans.

There is no specific antidote for overdose with capsaicin. In case of suspected overdose, remove patches 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.

Qutenza (capsaicin) 8% patch 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 patch stored in a foil pouch. Each Qutenza patch is 14 cm x 20 cm (280 cm2) 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 patch 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 patch.

The empirical formula is C18H27NO3, 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:

The patch 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Adequate carcinogenicity studies have not been conducted with Qutenza or capsaicin.

Mutagenesis

Capsaicin was not mutagenic in the Ames, mouse micronucleus and chromosomal aberration in human peripheral blood lymphocytes assays. As with other catechol-containing compounds (e.g., dopamine), capsaicin showed a weak mutagenic response in the mouse lymphoma assay.

Impairment of Fertility

A fertility and reproductive toxicology study was conducted in rats with exposure to Qutenza patches daily for 3 hours/day beginning 28 days before cohabitation, through cohabitation and continuing through the day before sacrifice (approximately 49 days of treatment). The results revealed a statistically significant reduction in the number and percent of motile sperm. Sperm motility obtained from the vas deferens was reduced in all capsaicin treatment groups (16, 24 and 32 mg capsaicin patch/rat/day). Though a "no effect" level was not determined, dose levels used in the study correspond to a 13- to 28-fold exposure margin over the mean Cmax associated with the maximal human recommended dose. Sperm counts were reduced in the vas deferens or cauda epididymis in the 24 and 32 mg capsaicin patch/rat/day dose groups (79 and 69%, respectively) compared to the placebo patch treated control group; however, these reductions did not adversely affect fertility. As this animal model has a large excess of sperm generating capacity relative to the threshold necessary for fertilization, the lack of an effect on fertility in this species is of unknown significance for human risk assessment.

How Supplied

Qutenza (capsaicin) 8% patch is a single-use patch stored in a sealed pouch (NDC 49685-920-00).

Each individual patch is printed with "capsaicin 8%".

Cleansing Gel is provided in a 50 g tube.

Qutenza is available in the following presentations:

Carton of 1 patch and 50 g tube of Cleansing Gel

(NDC 49685-928-01).

Carton of 2 patches and 50 g tube of Cleansing Gel

(NDC 49685-928-02).

Storage

Store carton between 20° to 25°C (68° to 77°F). Excursions between 15°C and 30°C (59°F and 86°F) are allowed.

Keep the patch in the sealed pouch until immediately before use.

Handling and Disposal

Qutenza contains capsaicin capable of producing severe irritation of eyes, skin, respiratory tract and mucous membranes. Do not dispense Qutenza to patients for self-administration. It is critical that health care professionals who administer Qutenza have completely familiarized themselves with proper dosing, handling, and disposal procedures before handling Qutenza to avoid accidental or inadvertent capsaicin exposure to themselves or others [see Dosage and Administration (2)].

• Do not touch Qutenza, treatment areas, and all used supplies or other materials placed in contact with the treatment area without wearing nitrile gloves.
• Wear nitrile gloves at all times while handling Qutenza and cleaning treatment areas. Do NOT use latex gloves.
• Do not hold Qutenza near eyes or mucous membranes.
• Immediately after use, dispose of used and unused patches, patch clippings, unused Cleansing Gel and associated treatment supplies in accordance with local biomedical waste procedures.

Do not use Qutenza if you are allergic to chili peppers, or if you have ever had an allergic reaction to capsaicin topical.

Ask a doctor or pharmacist about using Qutenza if you have any allergies (especially to plants), or if you have a serious medical condition.

It is not known whether Qutenza will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether capsaicin topical passes into breast milk or if it could harm a nursing baby. Do not apply Qutenza to your breast area if you are breast-feeding a baby.

Do not use this medication on anyone younger than 18 years old without the advice of a doctor.

Use Qutenza exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Do not touch Qutenza, treatment areas, and all used supplies or other materials placed in contact with the treatment area without wearing nitrile gloves.

Do not take by mouth. This medicine is for use only on the skin.

Do not use Qutenza on open wounds or on sunburned, windburned, dry, chapped, or irritated skin. If this medicine gets in your eyes, nose, mouth, rectum, or vagina, rinse with water.

Make sure your skin is clean and dry before you apply the patch.

Pre-treat the area with a topical anesthetic to reduce discomfort associated with the application of Qutenza.

Apply topical anesthetic to the entire treatment area and surrounding 1 to 2 cm, and keep the local anesthetic in place until the skin is anesthetized prior to the application of a Qutenza patch.

Tear open the pouch along the three dashed lines and remove the patch.

Inspect the patch and identify the outer surface backing layer with the printing on one side and the capsaicin-containing adhesive on the other side. The adhesive side of the patch is covered by a clear, unprinted, diagonally-cut release liner.

Cut the patch before removing the protective release liner. The diagonal cut in the release liner is to aid in its removal. Peel a small section of the release liner back, and place the adhesive side of the patch on the treatment area.

While you slowly peel back the release liner from under the patch with one hand, use your other hand to smooth the patch down on to the skin.

Once the Qutenza patch is applied, leave in place for 60 minutes.

To keep the medication from getting on your hands when you apply it, use nitrile gloves. Wear nitrile gloves at all times while handling Qutenza and cleaning treatment areas.

Capsaicin can cause a burning sensation wherever it is applied. This sensation is usually mild and should gradually lessen over time with continued regular use of the medicine.

If the burning sensation is painful or causes significant discomfort, wash the treated skin area with soap and cool water. Get medical attention right away if you have severe burning, pain, swelling, or blistering.

Do not cover treated skin with a bandage or heating pad, which can increase the burning sensation. You may cover the skin with clothing.

Avoid taking a bath or shower within 1 hour before or after you apply capsaicin to your skin. Also avoid direct sunlight, swimming or vigorous exercise. Warm water or perspiration can increase the burning sensation caused by capsaicin.

Avoid getting Qutenza in your eyes or near your nose where you might inhale it. If it does get into any of these areas, rinse thoroughly with water.

Use only nitrile gloves when handling Qutenza, and when cleaning capsaicin residue from the skin. Do not use latex gloves as they do not provide adequate protection.

Also avoid getting this medication on contact lenses, dentures, and other items that come into contact with sensitive areas of your body.

For best results, keep using the medication as directed. Pain relief should occur gradually as the substance P in your body is decreased in the nerve cells.

Call your doctor if your pain does not improve after using this medication for 7 days, or if your symptoms get worse or get better and then come back in a few days.

Store Qutenza at room temperature away from moisture and heat, in a place where children and pets cannot get to it.

Usual Adult Dose for Postherpetic Neuralgia:

Up to 4 patches applied to intact, non-irritated, dry skin, and allowed to remain in place for 30 minutes for the feet and 60 minutes for other locations

Comments:
-Treatment may be repeated not more frequently than every three months.
-The patch should be applied by a physician or by a health care professional under the supervision of a physician.