Qutenza

capsaicin · KIT · Averitas Pharma Inc

No Recall History

Plain English

Qutenza is a kit containing capsaicin. Manufactured by Averitas Pharma Inc.

Key Facts

Brand Name: Qutenza
Generic Name: capsaicin
NDC Code (Product): 72512-930
Manufacturer: Averitas Pharma Inc
Dosage Form: KIT
Marketing Status
Application #: NDA022395
Marketing Start: 03/25/2021

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

application site pain490 reports

pain413 reports

drug ineffective340 reports

burning sensation312 reports

pain in extremity205 reports

fatigue153 reports

application site erythema137 reports

off label use137 reports

dyspnoea103 reports

insomnia101 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE 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. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Only physicians or health care professionals are to administer QUTENZA. ( 2.1 ) Administer QUTENZA in a well-ventilated treatment area. ( 2.1 ) Wear nitrile (not latex) gloves when handling QUTENZA and when cleaning treatment areas. ( 2.1 ) Use of a face mask and protective glasses is advisable for healthcare professionals. ( 2.1 ) Do not use QUTENZA on broken skin. ( 2.1 ) PHN: Apply up to four topical systems for 60 minutes. ( 2.2 ) DPN: Apply up to four topical systems for 30 minutes on the feet. ( 2.2 ) Repeat every 3 months or as warranted by the return of pain (not more frequently than every three months). ( 2.2 ) See Dosage and Administration, Instructions for Use, for detailed instructions on QUTENZA administration. ( 2.3 ) 2.1 Important Dosage and Administration Instructions Do not dispense QUTENZA to patients for self-administration or handling. Only physicians or healthcare professionals are to administer and handle QUTENZA. Unintended exposure to capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin in healthcare professionals, patients and others [see Warnings and Precautions ( 5.1 )] . Because unintend…

Contraindications

4 CONTRAINDICATIONS None. None

Drug Interactions

7 DRUG INTERACTIONS 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.

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Severe Irritation Due to Accidental Exposure of Eyes, Skin, Respiratory Tract, and Mucous Membranes [see Warning and Precautions ( 5.1 )] Application-Associated Pain [see Warnings and Precautions ( 5.2 )] Increase in Blood Pressure [see Warnings and Precautions ( 5.3 )] Sensory Function Reduction [see Warning and Precautions ( 5.4 )] Severe Application Site Burns [see Warning and Precautions ( 5.5 )] The most common adverse reactions (≥5% and greater than control) in all controlled clinical trials are application site erythema, application site pain, and application site pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Averitas Pharma at 1-877-900-6479 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 patient…

Frequently Asked Questions

What is Qutenza used for?

Qutenza contains capsaicin. It is a kit taken as directed. Consult your doctor for specific uses.

Is Qutenza a controlled substance?

Qutenza is not classified as a controlled substance by the DEA.

What is the generic name for Qutenza?

The generic name for Qutenza is capsaicin. There are 12 other brand versions of capsaicin.

What is the NDC code for Qutenza ?

The NDC (National Drug Code) for Qutenza is 72512-930, listed by Averitas Pharma Inc.

Product NDC

72512-930

Package NDC

72512-930-01

Other Capsaicin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)