Give patients with painful DPN of the feet a topical treatment with a favorable safety profile and no drug-drug interactions

DPN: diabetic peripheral neuropathy.
Not an actual patient.

Angle Shape

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)

Body System
Preferred Term
QUTENZA
30 minutes
(N=186)
%
Control
30 minutes
(N=183)
%
General Disorders and Administration Site Conditions
Application site reactions
Burning sensation143
Application site pain102
Erythema20
Injury, Poisoning and Procedural Complications
Excoriation20
Musculoskeletal and Connective Tissue Disorders
Pain in extremity116
Nervous System Disorders
Headache32
Respiratory, Thoracic and Mediastinal Disorders
Upper respiratory symptoms
Upper respiratory tract infection4< 1
Cough2< 1
Vascular Disorders
Hypertension2< 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

No drug-drug interactions

Treatment flexibility

  • QUTENZA can be used alone or in combination
Low risk for systemic side effects

Low risk for systemic side effects1

  • QUTENZA is non-systemic
  • QUTENZA is non-opioid
  • QUTENZA has no contraindications
Low discontinuation rates

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