Give patients with PDPN of the feet a topical treatment with a favorable safety profile and no drug-drug interactions
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)
| 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.
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
Treatment flexibility
- 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