Qutenza Drug Information
Generic name: CAPSAICIN
Uses of Qutenza
is indicated in adults for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and for neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet. QUTENZA is a TRPV1 channel agonist indicated for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet.
Dosage & Administration of Qutenza
USE IN NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA(60-MINUTE APPLICATION TIME)
| USE IN NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY(30-MINUTE APPLICATION TIME ON THE FEET)
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Side Effects of Qutenza
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in clinical practice. Across all controlled and uncontrolled clinical trials, 2848 patients have received QUTENZA. A total of 924 patients received more than one treatment application and 732 patients were followed for 48 weeks or longer. A total of 590 DPN patients and 1112 PHN patients have received QUTENZA across all controlled and uncontrolled clinical trials.
Among patients treated with QUTENZA, 1% discontinued prematurely due to an adverse event. Most Common Adverse Reactions in all Controlled Clinical Trials In all controlled clinical trials, adverse reactions occurring in ≥5% of patients in the QUTENZA group and at an incidence at least 1% greater than in the control group were application site erythema, application site pain, and application site pruritus. The majority of application site reactions were transient and self-limited.
Transient increases in pain were commonly observed on the day of treatment in patients treated with QUTENZA. Pain increases occurring during QUTENZA application usually began to resolve after QUTENZA removal. On average, pain scores returned to baseline by the end of the treatment day and then remained at or below baseline levels. A majority of QUTENZA-treated patients in clinical trials had adverse reactions with a maximum intensity of "mild" or "moderate". Postherpetic Neuralgia (PHN) Table 1 summarizes all adverse reactions, regardless of causality, occurring in >1% of patients with PHN in the QUTENZA group for which the incidence was at least 1% greater than in the control group.
TABLE 1: Adverse Reaction Incidence (%) in Controlled Double-blind Trials in Postherpetic Neuralgia (Events in >1% of QUTENZA-treated Patients and at Least 1% Greater in the QUTENZA Group than in the Control Group) Body System Preferred Term QUTENZA 60 minutes (N=622) % Control 60 minutes (N=495) % General Disorders and Administration Site Conditions Application site erythema 63 54 Application site pain 42 21 Application site pruritus 6 4 Application site papules 6 3 Application site edema 4 1 Application site swelling 2 1 Application site dryness 2 1 Infections and Infestations Nasopharyngitis 4 2 Bronchitis 2 1 Sinusitis 3 1 Gastrointestinal Disorders Nausea 5 2 Vomiting 3 1 Skin and Subcutaneous Tissue Disorder Pruritus 2 < 1 Vascular Disorders Hypertension 2 1 Less common adverse reactions (<1%) with QUTENZA observed during PHN clinical trials included: palpitations, tachycardia, eye pruritus, application site reactions (such as urticaria, paresthesia, dermatitis, hyperesthesia). Neuropathic Pain Associated with Diabetic Peripheral Neuropathy (DPN) Table 2 summarizes all adverse reactions, regardless of causality, occurring in >1% of patients with DPN in the QUTENZA group for which the incidence was at least 1% greater than in the control group. TABLE 2: Adverse Reaction Incidence (%) in Double-blind Controlled Trials in Neuropathic Pain Associated with Diabetic Peripheral Neuropathy (Events in >1% of QUTENZA-treated Patients and at Least 1% Greater in the QUTENZA Group than in the Control Group) Body System Preferred Term QUTENZA 30 minutes (N=186) % Control 30 minutes (N=183) % General Disorders and Administration Site Conditions Application site reactions Burning sensation 14 3 Application site pain 10 2 Erythema 2 0 Injury, Poisoning and Procedural Complications Excoriation 2 0 Musculoskeletal and Connective Tissue Disorders Pain in extremity 11 6 Nervous System Disorders Headache 3 2 Respiratory, Thoracic and Mediastinal Disorders Upper respiratory symptoms Upper respiratory tract infection 4 < 1 Cough 2 < 1 Vascular Disorders Hypertension 2 < 1 Less common adverse reactions (<1%) with QUTENZA observed during DPN clinical trials included: dizziness, dysesthesia, blister.
Postmarketing Experience
Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post approval use of QUTENZA: deep partial-thickness (second-degree) and full-thickness (third-degree) burns and scarring; accidental exposure (including eye pain, cough, eye and throat irritation) .
Warnings & Cautions for Qutenza
- Severe Irritation with Unintended Capsaicin Exposure: Capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin to the healthcare professional, patients, and others. (See Full Prescribing Information for detailed instructions on how to manage this risk. ( 2.1 , 5.1 ) Application-Associated Pain: Patients may experience substantial procedural pain and burning upon application of QUTENZA and following removal of QUTENZA. Prepare to treat acute pain during and following the application procedure with local cooling and/or appropriate analgesic medication. ( 5.2 ) Increase in Blood Pressure: Transient increases in blood pressure may occur with QUTENZA treatment. Monitor blood pressure during and following the treatment procedure. ( 5.3 ) Sensory Function: Reductions in sensory function, which were generally minor and temporary, have been reported following administration of QUTENZA. Assess for signs of sensory deterioration or loss prior to each application of QUTENZA. If sensory loss occurs, treatment should be reconsidered. ( 5.4 ) Severe Application Site Burns: Full-thickness (third-degree) and deep partial-thickness (second-degree) burns have been reported following administration of QUTENZA. Ensure that dosage and administration recommendations are followed. ( 5.5 ) 5.1 Severe Irritation with Unintended Capsaicin Exposure Unintended exposure to capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin in healthcare professionals, patients, and others. Ensure that the recommended procedures and protective measures are used when administering QUTENZA [see Dosage and Administration ( 2.1 )] . Eye and Mucous Membrane Exposure
- For healthcare professionals: ○ Wear nitrile gloves when administering QUTENZA and avoid unnecessary contact with items in the room, including items that the patient may later have contact with, such as horizontal surfaces and bedsheets. ○ Use of a face mask and protective glasses is advisable.
- Do not apply QUTENZA to the patient’s 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 QUTENZA or items exposed to capsaicin and then touching the eyes and mucous membranes.
- If irritation of eyes or mucous membranes occurs, flush eyes and mucous membranes with cool water. Remove the affected individual (healthcare professional or patient) from the vicinity of QUTENZA. Respiratory Tract Exposure Aerosolization of capsaicin can occur upon rapid removal of QUTENZA. Therefore, remove QUTENZA gently and slowly by rolling the adhesive side inward [see Dosage and Administration ( 2.1 , 2.3 )] . Inhalation of airborne capsaicin can result in coughing or sneezing. Administer QUTENZA in a well-ventilated treatment area. Provide supportive medical care if shortness of breath develops. If irritation of airways occurs, remove the affected individual (healthcare professional or patient) from the vicinity of QUTENZA. If respiratory irritation worsens or does not resolve, do not re-expose the affected healthcare professional or patient to QUTENZA [see Adverse Reactions ( 6.2 )] . Skin Exposure If skin not intended to be treated is exposed to 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. Thoroughly clean all areas that had contact with QUTENZA and properly dispose of QUTENZA, associated packaging, Cleansing Gel, gloves, and other treatment materials in accordance with local biomedical waste procedures [see Dosage and Administration ( 2.1 , 2.3 )] . 5.2 Application-Associated Pain Even following use of a local anesthetic prior to administration of QUTENZA, patients may experience substantial procedural pain and burning upon application of QUTENZA and following removal of QUTENZA. Prepare to treat acute pain during and following the application procedure with local cooling and/or appropriate analgesic medication. 5.3 Increase in Blood Pressure In clinical trials, transient 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 QUTENZA 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 and following the treatment procedure and provide adequate support for treatment-related pain. Patients with unstable or poorly controlled hypertension, or 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. 5.4 Sensory Function Reductions in sensory function have been reported following administration of QUTENZA. Decreases in sensory functions are generally minor and temporary (including to thermal and other harmful stimuli). All patients with pre-existing sensory deficits should be clinically assessed for signs of sensory deterioration or loss prior to each application of QUTENZA. If sensory deterioration or loss is detected or pre-existing sensory deficit worsens, continued use of QUTENZA treatment should be reconsidered. 5.5 Severe Application Site Burns Cases of full-thickness (third-degree) and deep partial-thickness (second-degree) burns have been reported following administration of QUTENZA. Cases of full-thickness (third-degree) burns, requiring hospitalization and skin grafting have been reported in patients who received QUTENZA for an unapproved indication and/or frequency of dosing at an application site where there had been prior skin trauma [see Adverse Reactions ( 6.2 )]. Ensure that dosage and administration recommendations are followed [see Dosage and Administration ( 2 )].
Drug Interactions with Qutenza
No clinical drug interaction studies have been performed. Data from in vitro cytochrome P450 inhibition and induction studies show that capsaicin does not inhibit or induce liver cytochrome P450 enzymes at concentrations which far exceed those measured in blood samples. Therefore, interactions with systemic medicinal products are unlikely.
Pregnancy Safety for Qutenza
Pregnancy Risk Summary Capsaicin is negligibly absorbed systemically following topical administration of QUTENZA, and maternal use is not expected to result in the fetal exposure to QUTENZA. In animal reproductive studies, no evidence of malformations were observed when capsaicin was administered daily by the topical route to pregnant rats and rabbits during the period of organogenesis at doses of up to 11- and 37-times, respectively, the maximum recommended human dose (MRHD) of QUTENZA at 716 mg capsaicin per day (4 topical systems containing 179 mg/topical system). In a peri- and postnatal development study, no adverse effects were observed when capsaicin was administered daily by the topical route to rats during implantation to weaning at doses of up to 11-times the MRHD (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data There was no evidence of fetal malformations in embryofetal developmental toxicological studies conducted in pregnant rats and rabbits in which QUTENZA (rats) or capsaicin liquid (rabbits) were applied once daily for a 3-hour duration during the period of fetal organogenesis at doses up to 11-times (rat, 32 mg QUTENZA /day) and 37-times (rabbit, 260 mg capsaicin/day) the MRHD based on a C max exposure comparison. In a peri- and postnatal reproduction toxicology study, pregnant female rats were treated with QUTENZA at doses up to 32 mg QUTENZA/rat/day applied once daily for a 3-hour duration during gestation and lactation (from Gestation Day 7 through Lactation Day 20). 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 QUTENZA /rat/day (11-times the MRHD based on C max exposure).
Pediatric Use of Qutenza
Pediatric Use The safety and effectiveness of QUTENZA in patients younger than 18 years of age have not been studied.
Overdosage Information for Qutenza
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 QUTENZA 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.
Clinical Studies of Qutenza
Postherpetic Neuralgia
The efficacy of QUTENZA was established in two 12-week, double-blind, randomized, dose-controlled, multicenter clinical trials. These studies enrolled patients with postherpetic neuralgia (PHN) persisting for at least 6 months following healing of herpes zoster rash and a baseline score of 3-9 on an 11-point Numerical Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (worst possible pain). QUTENZA and a control topical system were each applied as a single, 60-minute application. The control used in these studies looked similar to QUTENZA but contained a low concentration of the active ingredient, capsaicin (3.2 mcg/cm 2, 0.04% w/w), to retain blinding regarding the known application site reactions of capsaicin (such as burning and erythema). The baseline mean pain score across the 2 studies was approximately 6.0. Patients who entered the study on stable doses of pain-control medications were required to keep dosing stable throughout the duration of the study.
Approximately half of the patients were taking concomitant medications, including anticonvulsants, non-SSRI antidepressants, or opioids for their PHN at study entry. Prior to application, a topical anesthetic was applied to the treatment area for 60 minutes. Patients were permitted to use local cooling and additional analgesic medications for treatment-related discomfort as needed through Day 5. Patients recorded their pain daily in a diary.
PHN Study 1: In this 12-week study, the QUTENZA group demonstrated a greater reduction in pain compared to the control group during the primary assessment at Week 8. The percent change in average pain from baseline to Week 8 was -18% (±2%) for the low-dose control and -29% (±2%) for QUTENZA. For various degrees of improvement in pain from baseline to study endpoint, Figure 2 shows the fraction of patients achieving that degree of improvement. The figure is cumulative, so that patients whose change from baseline is, for example, 50%, are also included at every level of improvement below 50%. Patients who did not complete the study through Week 12 or who showed no improvement at Week 12 were assigned 0% improvement. Some patients experienced a decrease in pain as early as Week 1, which persisted throughout the study.
The proportion of patients experiencing ≥30% reduction in pain intensity from baseline for each week through Week 12 is shown in Figure 3. FIGURE 2: Patients Achieving Various Percentages of Reduction in Pain Intensity at Week 12 – Study 1 FIGURE 3: Weekly Proportion of Patients Achieving ≥30% Pain Intensity Reduction – Study 1* PHN Study 2: In this 12-week study, the QUTENZA group demonstrated a greater reduction in pain compared to the control group during the primary assessment at Week 8. The percent change in average pain from baseline to Week 8 was -26% (±2%) for the low-dose control and -33% (±2%) for QUTENZA. For various degrees of improvement in pain from baseline to study endpoint, Figure 4 shows the fraction of patients achieving that degree of improvement. The figure is cumulative, so that patients whose change from baseline is, for example, 50%, are also included at every level of improvement below 50%. Patients who did not complete the study through Week 12 or who showed no improvement at Week 12 were assigned 0% improvement. Some patients experienced a decrease in pain as early as Week 1, which persisted throughout the study.
The proportion of patients achieving ≥30% reduction in pain intensity from baseline for each week through Week 12 is shown in Figure 5. FIGURE 4: Patients Achieving Various Percentages of Reduction in Pain Intensity at Week 12 – Study 2 FIGURE 5: Weekly Proportion of Patients Achieving ≥ 30% Pain Intensity Reduction – Study 2* Figure 2 Figure 3 Figure 4 Figure 5
Neuropathic Pain Associated with Diabetic Peripheral Neuropathy
The efficacy of QUTENZA was established in one 12-week, double-blind, randomized, placebo-controlled, multicenter study. This study enrolled patients with neuropathic pain associated with diabetic peripheral neuropathy (DPN) diagnosed at least 1 year prior to screening and an average pain score of ≥ 4 over the baseline period on an 11-point Numerical Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (worst possible pain). QUTENZA and placebo were each applied as a single, 30-minute application. The placebo used in this study was similar to QUTENZA but did not contain an active ingredient.
The baseline mean pain score in this study was 6.51 (SD 1.45) and was similar in both groups. Patients who entered the study on stable doses of pain-control medications were required to keep dosing stable throughout the duration of the study. Use of opioid medication other than short-acting rescue medication was not allowed during the study.
Concomitant medications for neuropathic pain associated with DPN were taken during the study by 47.2% of the patients and included anticonvulsants and non-SSRI antidepressants. Prior to application, a topical anesthetic was applied to the treatment area for 60 minutes. Patients were permitted to use local cooling and additional analgesic medications for treatment-related discomfort as needed through Day 5. Patients recorded their pain daily.
In this 12-week study, the percent change in average pain from baseline to Week 12 was higher in the QUTENZA group compared to the placebo group. The percent change in average pain from baseline to Week 12 was -22% (±3%) for placebo and -30% (±3%) for QUTENZA. The least-squares mean change was -1.92 on the 11-point NPRS scale for QUTENZA, vs -1.37 for placebo, a least-squares mean difference of -0.56 (95% CI -0.98, -0.14). For various degrees of improvement in pain from baseline to study endpoint, Figure 6 shows the fraction of patients achieving that degree of improvement. The figure is cumulative, so that patients whose change from baseline is, for example, 50%, are also included at every level of improvement below 50%. Patients who did not complete the study through Week 12 or who showed no improvement at Week 12 were assigned 0% improvement.
The proportion of patients experiencing ≥30% reduction in pain intensity from baseline for each week through Week 12 is shown in Figure 7. FIGURE 6: Patients Achieving Various Percentages of Reduction in Pain Intensity at Week 12 FIGURE 7: Weekly Proportion of Patients Achieving ≥30% Pain Intensity Reduction* figure-6 figure-7
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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