Investigator Sponsored Trials

Company

Investigator Sponsored Trials

Revance is committed to supporting Investigator Sponsored Trials (ISTs) developed and sponsored by independent investigators to further explore and understand the risks, benefits, and potential new opportunities and indications to address unmet patient needs in therapeutic areas of interest to us.

Investigator Sponsored Trials

We encourage researchers dedicated to the drug and/or medical device development processes to apply for IST support via our web portal.

In order to be considered for company support, the research must seek to address important clinical and/or non-clinical objectives while following rigorous scientific designs and respecting the privacy and safety of all enrolled patients and in alignment with good clinical practice.

Revance will consider providing support for both clinical and non-clinical studies. We will consider applications for both financial and in-kind (drug/device/biologic product) support, but studies must be conducted without any direction from Revance. Approved applications must culminate in a completed study and a supporting publication. Approved investigators will also be required to enter into a formal, written agreement with Revance outlining the scope of the support and requiring compliance with applicable local laws and regulations.

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APPLY FOR REVANCE INVESTIGATOR SPONSORED TRIAL SUPPORT

You may also contact Revance Medical Affairs at medicalaffairs@revance.com to discuss preliminary ideas or ask additional questions.

IMPORTANT SAFETY INFORMATION for DAXXIFY® (daxibotulinumtoxinA-Ianm) for injection

Indications

(daxibotulinumtoxinA-lanm) injection is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients and for the treatment of cervical dystonia in adults.

WARNING: DISTANT SPREAD OF TOXIN EFFECT The effects of DAXXIFY® and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. DAXXIFY® is not approved for the treatment of spasticity or any conditions other than cervical dystonia and glabellar lines.

IMPORTANT SAFETY INFORMATION

Contraindications

DAXXIFY® contraindications include hypersensitivity to any botulinum toxin preparation or any of the components in the formulation and infection at the injection site(s).

Warnings and Precautions

Please refer to Boxed Warning for Distant Spread of Toxin Effect.

The potency Units of DAXXIFY® are not interchangeable with other preparations of other botulinum toxin products. Recommended dose and frequency of administration should not be exceeded. Patients should seek immediate medical attention if respiratory, speech or swallowing difficulties occur. Use caution when administering to patients with pre-existing cardiovascular disease. Concomitant neuromuscular disorders may exacerbate clinical effects of treatment.

Adverse Reactions

The most commonly observed adverse reactions are:

Glabellar lines (≥1%) were headache (6%), eyelid ptosis (2%) and facial paresis (1%).

Cervical Dystonia (≥5%): headache (9%), injection site pain (8%), injection site erythema (6%), muscular weakness (5%), and upper respiratory tract infection (5%).

Drug Interactions

Co-administration of DAXXIFY® and aminoglycoside antibiotics, anticholinergic agents or any other agents interfering with neuromuscular transmission or muscle relaxants should only be performed with caution as the effect of DAXXIFY® may be potentiated. The effect of administering different botulinum neurotoxins during course of treatment with DAXXIFY® is unknown.

Use in Specific Populations

DAXXIFY® is not recommended for use in children or pregnant women.

Please see DAXXIFY® full Prescribing Information, including Boxed Warning and Medication Guide.

To report side effects associated with DAXXIFY®, please visit safety.revance.com, or call 1-877-373-8669. You may also report side effects to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch

DAXI-004726

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RHA® and RHA Redensity® are registered trademarks of TEOXANE SA, manufactured in Switzerland. The TEOXANE RHA® Collection is exclusively distributed by Revance®. All other trademarks are the property of their respective owners.
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SOCIAL MEDIA COMMUNITY GUIDELINES PRIVACY POLICY TERMS OF USE
WARNING: DISTANT SPREAD OF TOXIN EFFECT The effects of DAXXIFY® and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. DAXXIFY® is not approved for the treatment of spasticity or any conditions other than cervical dystonia and glabellar lines.