PDPN: painful diabetic peripheral neuropathy.
Not an actual patient.
Favorable safety profile1
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
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)
|General Disorders and Administration Site Conditions|
|Application site reactions|
|Application site pain||10||2|
|Injury, Poisoning and Procedural Complications|
|Musculoskeletal and Connective Tissue Disorders|
|Pain in extremity||11||6|
|Nervous System Disorders|
|Respiratory, Thoracic and Mediastinal Disorders|
|Upper respiratory symptoms|
|Upper respiratory tract infection||4||< 1|
Less common adverse reactions (<1%) with QUTENZA, observed during DPN clinical trials included: dizziness, dysesthesia, blister.
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: second-degree burn and scarring; accidental exposure (including eye pain, cough, eye and throat irritation).
The most common adverse reactions were transient and self-limited.1
QUTENZA has a favorable safety profile with no systemic drug-drug interactions
- QUTENZA can be used alone or in combination
Low risk for systemic side effects1
- QUTENZA is non-systemic
- QUTENZA is non-opioid
- QUTENZA has no contraindications
Low discontinuation rates1
- 1% of QUTENZA patients discontinued in clinical studies due to an adverse event
Patients may experience the following1:
- Pain at treatment site, which can be treated with a cooling pack or appropriate analgesic medication, if needed
- Transient increase in blood pressure
- Sensitivity to heat (eg, during showers, sunlight exposure, vigorous exercise) for a few days