capsaicin transdermal (Rx, OTC)

>10%

Qutenza (PHN)

• Transient increased pain at application site (63%)
• Application site erythema (42%)

Qutenza transdermal patch (DPN)

• Burning sensation at application site (14%)
• Pain in extremity (11%)

1-10%

Qutenza (PHN)

• Papules at application site (6%)
• Pruritus at application site (6%)
• Nausea (5%)
• Application site edema (4%)
• Nasopharyngitis (4%)
• Vomiting (3%)
• Sinusitis (3%)
• Pruritus (2%)
• Bronchitis (2%)
• Hypertension (2%)
• Application site swelling (2%)
• Skin dryness at application site (2%)

Qutenza transdermal patch (DPN)

• Pain at application site (10%)
• Upper respiratory tract infection (4%)
• Headache (3%)
• Excoriation (2%)
• Erythema at application site (2%)
• Cough (2%)
• Hypertension (2%)

<1%

Qutenza (PHN)

• Palpitations
• Tachycardia
• Eye pruritus
• Application site reactions (ie, urticaria, paresthesia, dermatitis, hyperesthesia)

Qutenza (DPN)

• Dizziness
• Dysesthesia
• Blister

Postmarketing Reports

Second-degree burn and scarring; accidental exposure (including eye pain, cough, eye and throat irritation)

Sensory function reduction

Contraindications

Hypersensitivity

Cautions

Monitor for at least 1 hour after patch application because of risk for increased blood pressure

Remove patch gently to avoid aerosolization (airborne capsaicin can result in coughing or sneezing)

Treated area may be sensitive to heat for several days (eg, hot water, direct sunlight, vigorous exercise)

Substantial procedural pain and burning upon application and following patch removal have occurred; prepare to treat acute pain during and following application procedure with local cooling (such as an ice pack) and/or appropriate analgesic medication

Transient increases in blood pressure may occur with treatment; monitor blood pressure during and following treatment procedure

Reductions in sensory function have been reported following administration; if sensory deterioration or loss is detected or pre-existing sensory deficit worsens, reconsider continuing treatment

Severe irritation with unintended capsaicin exposure

• In healthcare professionals, patients, and others; ensure that recommended procedures and protective measures are used when administering medication

• Do not apply to the 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 patch or items exposed to capsaicin and then touching the eyes and mucous membrane
• Wear nitrile gloves and avoid touching items or surfaces that the patient may later touch

• Use of a face mask and protective glasses is advisable

• Inhalation of airborne capsaicin can result in coughing or sneezing; if irritation of eyes or airway occurs, remove affected individual (health professional or patient) from vicinity and flush mucous membranes or eyes with cool water
• If skin not intended to be treated comes into contact with medication, apply cleansing gel and then wipe off with dry gauze
• Thoroughly clean all areas and items exposed to medication and dispose of properly

• Respiratory tract exposure

  • Aerosolization of capsaicin can occur upon rapid removal of the patch
  • Remove patch gently and slowly by rolling adhesive side inward
  • Inhalation of airborne capsaicin can result in coughing or sneezing
  • Administer patch in a well-ventilated treatment area; provide supportive medical care if shortness of breath develops
  • If irritation of airways occurs, remove affected individual (healthcare professional or patient) from vicinity of the patch
  • If respiratory irritation worsens or does not resolve, do not re-expose affected healthcare professional or patient to the patch

Pregnancy

Capsaicin is negligibly absorbed systemically following topical administration, and maternal use is not expected to result in fetal exposure

Animal data

• No evidence of malformations observed when capsaicin was topically administered daily to pregnant rats and rabbits during organogenesis at doses of up to 11- and 37-times, respectively, the maximum recommended human dose (MRHD) at 716 mg capsaicin per day (4 patches containing 179 mg/patch)

Lactation

Negligible systemic absorption following topical administration

Breastfeeding is not expected to result in infant exposure

To minimize potential direct exposure to the breast infant, avoid applying directing to the nipple or areola

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Transient receptor potential vanilloid-1 (TRPV1) agonist; topical application causes initial TRPV1 stimulation that may cause pain, followed by pain relief by reduction in TRPV1-expressing nociceptive nerve endings

Absorption

Qutenza

• Systemic absorption negligible
• Peak plasma concentration: Transient, low (<5 ng/mL) systemic exposure in one-third of patients following 60-min application; 4.6 ng/mL was highest level detected

Elimination

Qutenza

• Half-life: 1.64 hr

Transdermal Administration (Qutenza)

Do not dispense to patients for self-administration or handling

Only physicians or healthcare professionals under the close supervision of a physician are to administer and handle patch

Administer in a well-ventilated treatment area

Use nitrile gloves during application process; do not use latex gloves as they do not provide adequate protection

Use of a face mask and protective glasses recommended

Keep patch in sealed pouch until immediately before use

Use only on dry, intact (unbroken) skin

DPN: Carefully examine feet before each application to detect skin lesions related to underlying neuropathy or vascular insufficiency

During administration, avoid unnecessary contact with any items in the room, including items that the patient may later have contact with, such as horizontal surfaces and bedsheets

Patch removal

• Gently remove and slowly roll them inward (avoid aerosolization)
• Cleanse skin by generously applying cleansing gel (supplied with patch) to affected area, leave on for at least 1 minute, then remove with dry wipe and gently wash area with mild soap and water
• Immediately after use, clean all areas that had contact with drug and properly dispose patch
• If patch is cut, ensure unused pieces are disposed properly

Storage

Store carton between 20-25ºC (68-77ºF), excursions to 15-30ºC (59-86ºF)

Keep in the sealed pouch until immediately before use