WARNINGS AND PRECAUTIONS
Eye and Mucous Membrane Exposure
Do not apply Qutenza to the face or scalp to avoid risk of exposure to the eyes or mucous membranes.
Aerosolization of Capsaicin
Aerosolization of capsaicin can occur upon rapid removal of Qutenza patches. Therefore, remove Qutenza patches gently and slowly by rolling the adhesive side inward [see Dosage and Administration ].
If irritation of eyes or airways occurs, remove the affected individual from the vicinity of Qutenza. Flush eyes and mucous membranes with cool water.
Inhalation of airborne capsaicin can result in coughing or sneezing. Provide supportive medical care if shortness of breath develops.
Unintended Skin Exposure
If skin not intended to be treated comes in contact with Qutenza, 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.
Application Associated Pain
Even following use of a local anesthetic prior to administration of Qutenza, patients may experience substantial procedural pain. Prepare to treat acute pain during and following the application procedure with local cooling (such as an ice pack) and/or appropriate analgesic medication, such as opioids. Opioids may affect the ability to perform potentially hazardous activities such as driving or operating machinery.
Increase in Blood Pressure
In clinical trials, increases in blood pressure occurred during or shortly after exposure to Qutenza. The changes averaged less than 10 mm Hg, although some patients had greater increases and these changes lasted for approximately two hours after patch removal. Increases in blood pressure were unrelated to the pretreatment blood pressure but were related to treatment-related increases in pain. Monitor blood pressure periodically during the treatment and provide adequate support for treatment related pain.
Patients with unstable or poorly controlled hypertension, a recent history of cardiovascular or cerebrovascular events may be at an increased risk of adverse cardiovascular effects. Consider these factors prior to initiating Qutenza treatment.
USE IN SPECIFIC POPULATIONS
Teratogenic effects: Pregnancy Category B
There are no adequate and well-controlled studies evaluating Qutenza in pregnant women.
There was no evidence of fetal teratogenicity in embryofetal developmental toxicological studies conducted in pregnant rats and rabbits in which Qutenza patches (rats) or liquid (rabbits) were applied once daily for a 3 hour duration during the period of fetal organogenesis up to doses corresponding to an 11-fold (rat, 32 mg capsaicin patch/day) and 37-fold (rabbit, 260 mg capsaicin/day) margin over the maximum recommended human dose [MRHD] based on a Cmax exposure comparison.
In a peri- and post-natal reproduction toxicology study, pregnant female rats were treated with Qutenza patches at doses up to 32 mg capsaicin patch/rat/day applied once daily for a 3 hours duration during gestation and lactation (from gestation day 7 through day 28 postpartum). Analyses of milk samples on day 14 of the lactation period demonstrated measurable levels of capsaicin in the dam's milk at all dose levels. There were no effects on survival, growth, learning and memory tests (passive avoidance and water maze), sexual maturation, mating, pregnancy, and fetal development in the offspring of mothers treated with capsaicin up to 32 mg capsaicin patch/rat/day (corresponding to an 11-fold margin over the MRHD based on Cmax exposure).
Labor and Delivery
The effects of Qutenza on labor and delivery are unknown.
There are no adequate and well-controlled studies in nursing women. Studies in rat have demonstrated capsaicin is excreted into breast milk of this species. It is unknown whether capsaicin is excreted in human breast milk. Because Qutenza is administered as a single 60-minute application and capsaicin is rapidly cleared from the bloodstream [ see Clinical Pharmacology (12.3) ], mothers can reduce infant exposure by not breast-feeding after treatment on the day of treatment.
The safety and effectiveness of Qutenza in patients younger than 18 years of age have not been studied.
In controlled clinical studies of Qutenza in neuropathic pain associated with postherpetic neuralgia, 75% of patients were 65 years and older and 43% of patients were 75 years and older.
Safety and effectiveness were similar in geriatric patients and younger patients. No dose adjustments are required in geriatric patients.