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Qutenza

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Qutenza

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Eye and Mucous Membrane Exposure

Do not apply Qutenza (capsaicin 8% patch) 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 (capsaicin 8% patch) patches. Therefore, remove Qutenza (capsaicin 8% patch) patches gently and slowly by rolling the adhesive side inward [see Instructions for Use].

If irritation of eyes or airways occurs, remove the affected individual from the vicinity of Qutenza (capsaicin 8% patch) . 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 (capsaicin 8% patch) , 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 and Increase in Blood Pressure

Even following use of a local anesthetic prior to administration of Qutenza (capsaicin 8% patch) , 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.

In clinical trials, increases in blood pressure occurred during or shortly after exposure to Qutenza (capsaicin 8% patch) . 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 (capsaicin 8% patch) treatment.

Nonclinical Toxicology

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 (capsaicin 8% patch) 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.

Use In Specific Populations

Pregnancy

Teratogenic effects: Pregnancy Category B

There are no adequate and well-controlled studies evaluating Qutenza (capsaicin 8% patch) in pregnant women.

There was no evidence of fetal teratogenicity in embryofetal developmental toxicological studies conducted in pregnant rats and rabbits in which Qutenza (capsaicin 8% patch) 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 (capsaicin 8% patch) on labor and delivery are unknown.

Nursing Mothers

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 Pharmacokinetics], mothers can reduce infant exposure by not breast-feeding after treatment on the day of treatment.

Pediatric Use

The safety and effectiveness of Qutenza (capsaicin 8% patch) in patients younger than 18 years of age have not been studied.

Geriatric Use

In controlled clinical studies of Qutenza (capsaicin 8% patch) 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.

Last reviewed on RxList: 12/2/2009
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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