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Overview
Jeuveau
JEUVEAU IS DESIGNED WITH PRECISION TO PUT CONTROL IN THE HANDS OF THE PROVIDER
- A precise, tight field of effect
- Fast-acting, long-lasting results
- Real-world patient satisfaction
Jeuveau is a modern neurotoxin providing:
Jeuveau is the latest FDA-approved 900-kDa neurotoxin designed with precision to effectively improve the appearance of moderate to severe glabellar lines.1,2
JEUVEAU OVERVIEW
IMPORTANT SAFETY INFORMATION FOR JEUVEAU® (prabotulinumtoxinA-xvfs)
WARNING: DISTANT SPREAD OF TOXIN EFFECT: The effects of all botulinum toxin products, including JEUVEAU, 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. JEUVEAU is not approved for the treatment of spasticity or any conditions other than glabellar lines.
CONTRAINDICATIONS
JEUVEAU is contraindicated in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, and in the presence of infection at the proposed injection site(s)
WARNINGS AND PRECAUTIONS
Spread of Toxin Effect
Postmarketing safety data from other approved botulinum toxins suggest that botulinum toxin effects may be observed beyond the site of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, blurred vision and breathing difficulties. 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 related to spread of toxin effects. In unapproved uses, including upper limb spasticity in children and approved indications, symptoms consistent with spread of toxin effect have been reported at doses comparable to or lower than the maximum recommended total dose. JEUVEAU is not approved for the treatment of spasticity or any conditions other than glabellar lines. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech or respiratory difficulties occur.
WARNINGS AND PRECAUTIONS
Lack of Interchangeability between Botulinum Toxin Products
The potency Units of JEUVEAU are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of JEUVEAU cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method.
Serious Adverse Reactions with Unapproved Use
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received botulinum toxin injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of botulinum toxin products to the site of injection and/or adjacent structures. In several of the cases, patients had pre-existing dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of botulinum toxin products.
Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported for botulinum toxin products, including anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such reactions occur with JEUVEAU, discontinue use of JEUVEAU and immediately institute appropriate medical therapy.
Cardiovascular System
There have been reports following administration of botulinum toxins of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.
Increased Risk of Clinically Significant Effects with Pre-existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) were excluded from the JEUVEAU clinical studies. Patients with neuromuscular disorders may be at increased risk of clinically significant effects, including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia and respiratory compromise from typical doses of JEUVEAU.
Dysphagia and Breathing Difficulties
Treatment with botulinum toxin products, including JEUVEAU, can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing. Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several months, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised. Patients treated with botulinum toxin products, including JEUVEAU, may require immediate medical attention should they develop problems with swallowing, speech or breathing.
Pre-existing Conditions at the Injection Site
Caution should be used when JEUVEAU is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s). Caution should be used when JEUVEAU treatment is used in patients who have marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin or when subjects do not respond to 20 Units of botulinum toxin (e.g. the inability to substantially lessen glabellar lines even by physically spreading them apart). Do not exceed the recommended dosage and frequency of administration of JEUVEAU.
Ophthalmic Adverse Reactions in Patients Treated with Botulinum Toxin Products
Dry eye has been reported with the use of botulinum toxin products in the treatment of glabellar lines. Reduced tear production, reduced blinking, and corneal disorders, may occur with use of botulinum toxins, including JEUVEAU. If symptoms of dry eye (e.g., eye irritation, photophobia, or visual changes) persist, consider referring patient to an ophthalmologist.
Human Albumin and Transmission of Viral Diseases
JEUVEAU contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is also considered extremely remote. No cases of transmission of viral diseases or CJD have ever been reported for albumin.
ADVERSE REACTIONS
The most frequently reported adverse reactions (≥ 1% and placebo) following injection of JEUVEAU were headache (12%), eyelid ptosis (2%), upper respiratory tract infection (3%), and white blood cell count increase (1%).
DRUG INTERACTIONS
No formal drug interaction studies have been conducted with JEUVEAU. The potential for certain drugs to potentiate the effects of JEUVEAU warrant consideration given the potential risks involved and should be used with caution, including: aminoglycosides or other agents interfering with neuromuscular transmission, anticholinergic drugs, botulinum neurotoxin products, and muscle relaxants.
USE IN SPECIFIC POPULATIONS
The limited available data on JEUVEAU use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. There are no data on the presence of JEUVEAU in human or animal milk, its effects on the breastfed infant, or its effects on milk production. Safety and effectiveness in pediatric patients have not been established.
INDICATION
JEUVEAU is an acetylcholine release inhibitor and a 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.
Please note that this information is not comprehensive. For more information about JEUVEAU, and to see the full Prescribing Information, including BOXED WARNING and Medication Guide, visit evolus.com.
To report side effects associated with use of JEUVEAU, please call 1-877-EVOLUS1/ 1-877-386-5871. You are encouraged to report side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
practise with precision
Jeuveau® is 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.
Jeuveau is designed with precision to put control in the hands of provider.1
IMPORTANT SAFETY INFORMATION FOR JEUVEAU® (prabotulinumtoxinA-xvfs)
WARNING: DISTANT SPREAD OF TOXIN EFFECT: The effects of all botulinum toxin products, including JEUVEAU, 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. JEUVEAU is not approved for the treatment of spasticity or any conditions other than glabellar lines.
CONTRAINDICATIONS
JEUVEAU is contraindicated in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, and in the presence of infection at the proposed injection site(s)
WARNINGS AND PRECAUTIONS
Spread of Toxin Effect
Postmarketing safety data from other approved botulinum toxins suggest that botulinum toxin effects may be observed beyond the site of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, blurred vision and breathing difficulties. 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 related to spread of toxin effects. In unapproved uses, including upper limb spasticity in children and approved indications, symptoms consistent with spread of toxin effect have been reported at doses comparable to or lower than the maximum recommended total dose. JEUVEAU is not approved for the treatment of spasticity or any conditions other than glabellar lines. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech or respiratory difficulties occur.
WARNINGS AND PRECAUTIONS
Lack of Interchangeability between Botulinum Toxin Products
The potency Units of JEUVEAU are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of JEUVEAU cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method.
Serious Adverse Reactions with Unapproved Use
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received botulinum toxin injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of botulinum toxin products to the site of injection and/or adjacent structures. In several of the cases, patients had pre-existing dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of botulinum toxin products.
Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported for botulinum toxin products, including anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such reactions occur with JEUVEAU, discontinue use of JEUVEAU and immediately institute appropriate medical therapy.
Cardiovascular System
There have been reports following administration of botulinum toxins of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.
Increased Risk of Clinically Significant Effects with Pre-existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) were excluded from the JEUVEAU clinical studies. Patients with neuromuscular disorders may be at increased risk of clinically significant effects, including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia and respiratory compromise from typical doses of JEUVEAU.
Dysphagia and Breathing Difficulties
Treatment with botulinum toxin products, including JEUVEAU, can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing. Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several months, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised. Patients treated with botulinum toxin products, including JEUVEAU, may require immediate medical attention should they develop problems with swallowing, speech or breathing.
Pre-existing Conditions at the Injection Site
Caution should be used when JEUVEAU is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s). Caution should be used when JEUVEAU treatment is used in patients who have marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin or when subjects do not respond to 20 Units of botulinum toxin (e.g. the inability to substantially lessen glabellar lines even by physically spreading them apart). Do not exceed the recommended dosage and frequency of administration of JEUVEAU.
Ophthalmic Adverse Reactions in Patients Treated with Botulinum Toxin Products
Dry eye has been reported with the use of botulinum toxin products in the treatment of glabellar lines. Reduced tear production, reduced blinking, and corneal disorders, may occur with use of botulinum toxins, including JEUVEAU. If symptoms of dry eye (e.g., eye irritation, photophobia, or visual changes) persist, consider referring patient to an ophthalmologist.
Human Albumin and Transmission of Viral Diseases
JEUVEAU contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is also considered extremely remote. No cases of transmission of viral diseases or CJD have ever been reported for albumin.
ADVERSE REACTIONS
The most frequently reported adverse reactions (≥ 1% and placebo) following injection of JEUVEAU were headache (12%), eyelid ptosis (2%), upper respiratory tract infection (3%), and white blood cell count increase (1%).
DRUG INTERACTIONS
No formal drug interaction studies have been conducted with JEUVEAU. The potential for certain drugs to potentiate the effects of JEUVEAU warrant consideration given the potential risks involved and should be used with caution, including: aminoglycosides or other agents interfering with neuromuscular transmission, anticholinergic drugs, botulinum neurotoxin products, and muscle relaxants.
USE IN SPECIFIC POPULATIONS
The limited available data on JEUVEAU use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. There are no data on the presence of JEUVEAU in human or animal milk, its effects on the breastfed infant, or its effects on milk production. Safety and effectiveness in pediatric patients have not been established.
INDICATION
JEUVEAU is an acetylcholine release inhibitor and a 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.
Please note that this information is not comprehensive. For more information about JEUVEAU, and to see the full Prescribing Information, including BOXED WARNING and Medication Guide, visit evolus.com.
To report side effects associated with use of JEUVEAU, please call 1-877-EVOLUS1/ 1-877-386-5871. You are encouraged to report side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Dosing & Administration
900-kDa molecule
A proprietary purified botulinum toxin type A formulation produced from fermentation of Clostridium botulinum.2
100U vial
100 units of botulinum toxin type A neurotoxin complex, 0.5 mg human serum albumin, and 0.9 mg sodium chloride. Sterile, vacuum-dried without a preservative and stored at 2 °C to 8 °C.?
What's in the vial?
Jeuveau is a proprietary botulinum neurotoxin formula, non-interchangeable with other neurotoxins.2,5
EVERY VIAL OF JEUVEAU COMES PACKED WITH PRECISION
DOSING & ADMINISTRATION
20U dose. 5 injection sites.
Proper dosing and administration is designed to help patients get the most out of the precision of Jeuveau.
- Place the lateral corrugator injections at least 1 cm above the bony supraorbital ridge?
- Avoid injection near the levator palpebrae superioris?
- Retreatment of Jeuveau should be administered no more frequently than every 3 months?
Additional considerations:
- The inferomedial and superior middle of each corrugator muscle
- One in the midline of the procerus muscle
0.1 mL (4 units) injected intramuscularly into 5 sites
Glabellar lines:
DOSING AND ADMINISTRATION2
5-POINT
INJECTION PATTERN?
IMPORTANT SAFETY INFORMATION FOR JEUVEAU® (prabotulinumtoxinA-xvfs)
WARNING: DISTANT SPREAD OF TOXIN EFFECT: The effects of all botulinum toxin products, including JEUVEAU, 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. JEUVEAU is not approved for the treatment of spasticity or any conditions other than glabellar lines.
CONTRAINDICATIONS
JEUVEAU is contraindicated in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, and in the presence of infection at the proposed injection site(s)
WARNINGS AND PRECAUTIONS
Spread of Toxin Effect
Postmarketing safety data from other approved botulinum toxins suggest that botulinum toxin effects may be observed beyond the site of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, blurred vision and breathing difficulties. 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 related to spread of toxin effects. In unapproved uses, including upper limb spasticity in children and approved indications, symptoms consistent with spread of toxin effect have been reported at doses comparable to or lower than the maximum recommended total dose. JEUVEAU is not approved for the treatment of spasticity or any conditions other than glabellar lines. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech or respiratory difficulties occur.
WARNINGS AND PRECAUTIONS
Lack of Interchangeability between Botulinum Toxin Products
The potency Units of JEUVEAU are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of JEUVEAU cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method.
Serious Adverse Reactions with Unapproved Use
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received botulinum toxin injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of botulinum toxin products to the site of injection and/or adjacent structures. In several of the cases, patients had pre-existing dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of botulinum toxin products.
Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported for botulinum toxin products, including anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such reactions occur with JEUVEAU, discontinue use of JEUVEAU and immediately institute appropriate medical therapy.
Cardiovascular System
There have been reports following administration of botulinum toxins of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.
Increased Risk of Clinically Significant Effects with Pre-existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) were excluded from the JEUVEAU clinical studies. Patients with neuromuscular disorders may be at increased risk of clinically significant effects, including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia and respiratory compromise from typical doses of JEUVEAU.
Dysphagia and Breathing Difficulties
Treatment with botulinum toxin products, including JEUVEAU, can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing. Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several months, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised. Patients treated with botulinum toxin products, including JEUVEAU, may require immediate medical attention should they develop problems with swallowing, speech or breathing.
Pre-existing Conditions at the Injection Site
Caution should be used when JEUVEAU is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s). Caution should be used when JEUVEAU treatment is used in patients who have marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin or when subjects do not respond to 20 Units of botulinum toxin (e.g. the inability to substantially lessen glabellar lines even by physically spreading them apart). Do not exceed the recommended dosage and frequency of administration of JEUVEAU.
Ophthalmic Adverse Reactions in Patients Treated with Botulinum Toxin Products
Dry eye has been reported with the use of botulinum toxin products in the treatment of glabellar lines. Reduced tear production, reduced blinking, and corneal disorders, may occur with use of botulinum toxins, including JEUVEAU. If symptoms of dry eye (e.g., eye irritation, photophobia, or visual changes) persist, consider referring patient to an ophthalmologist.
Human Albumin and Transmission of Viral Diseases
JEUVEAU contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is also considered extremely remote. No cases of transmission of viral diseases or CJD have ever been reported for albumin.
ADVERSE REACTIONS
The most frequently reported adverse reactions (≥ 1% and placebo) following injection of JEUVEAU were headache (12%), eyelid ptosis (2%), upper respiratory tract infection (3%), and white blood cell count increase (1%).
DRUG INTERACTIONS
No formal drug interaction studies have been conducted with JEUVEAU. The potential for certain drugs to potentiate the effects of JEUVEAU warrant consideration given the potential risks involved and should be used with caution, including: aminoglycosides or other agents interfering with neuromuscular transmission, anticholinergic drugs, botulinum neurotoxin products, and muscle relaxants.
USE IN SPECIFIC POPULATIONS
The limited available data on JEUVEAU use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. There are no data on the presence of JEUVEAU in human or animal milk, its effects on the breastfed infant, or its effects on milk production. Safety and effectiveness in pediatric patients have not been established.
INDICATION
JEUVEAU is an acetylcholine release inhibitor and a 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.
Please note that this information is not comprehensive. For more information about JEUVEAU, and to see the full Prescribing Information, including BOXED WARNING and Medication Guide, visit evolus.com.
To report side effects associated with use of JEUVEAU, please call 1-877-EVOLUS1/ 1-877-386-5871. You are encouraged to report side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Important Safety Information
-
- Kaminer MS, Cox SE, Fagien S, Kaufman J, Lupo M, Shamban A. Re-examining the optimal use of neuromodulators and the changing landscape: A consensus panel update. J Drugs Dermatol. 2020;19(4 suppl 1):s5-15.
- Jeuveau® [package insert]. Evolus, Inc; 2019.
- Rzany B. A multicenter, randomized, double-blind, placebo-controlled, single-dose, phase III, non-inferiority study comparing prabotulinumtoxinA and onabotulinumtoxinA for the treatment of moderate to severe glabellar lines in adult patients. Aesthet Surg J. 2020; 40(4):413-429.
- Jeuveau Experience Treatment (J.E.T.) Interim Data Report, 12/16/2019; Evolus, Inc.
- Brodsky MA, Swope DM, Grimes D. Diffusion of botulinum toxins. Tremor Other Hyperkinet Mov (N Y). Epub 2012.
- Kim CS, Song KY, Min KM, An YD, inventors; Daewoong Co, Ltd, assignee. Method for production of botulinum toxin. US patent 9,512,418 B2. December 6, 2016.
7. de Almeida AT, De Boulle K, Diffusion characteristics of botulinum neurotoxin products and their clinical significance in cosmetic applications. J Cosmet Laser Ther. 2007; 9(suppl 1): 17-22.
8. Data on file; CSR EV-001, BLA761085. Evolus, Inc., Newport Beach, CA.
9. Data on file; CSR EV-002, BLA761085. Evolus, Inc., Newport Beach, CA.
10. Beer K. Efficacy and safety of prabotulinumtoxinA for the treatment of glabellar lines in adult subjects: results from 2 identical phase Ill studies. Dermatol Surg. 2019;45(11):1381-1393.
11. Data on file; CSR EVB-003, BLA761085, Evolus, Inc., Newport Beach, CA.
12. Data on file; CSR EV-004, BLA761085. Evolus, Inc., Newport Beach, CA.
13. Data on file: CSR EV-006. BLA761085. Evolus. Inc.. Newbort Beach. CA.
REFERENCES
Patient Satisfation
In a clinical trial,
OF JEUVEAU PATIENTS RATED THEMSELVES AS IMPROVED OR MUCH IMPROVED AT DAY 30 (EVB-003).*3
* Based on the GAIS.
†JET Survey data collected 30 days after treatment, Oncepointing scale she extenteety inc on a 5-point rating scale.
In a survey of >9000 people treated with Jeuveau+4:
believed their results were natural-looking
were likely to recommend Jeuveau to a friend or a family member
PATIENT SATISFACTION
were satisfied with their overall treatment
Long after a single treatment, patients were satisfied with Jeuveau and eager to share the experience with their loved ones.4
JET SURVEY DATA:
PATIENT-REPORTED SATISFACTION WITH JEUVEAU*4
Month 4 (n=4725)
Month 5 (n=2782)
Overall satisfaction with Jeuveau
Likely to recommend to a friend or family member
83%
79%
76%
72%
Results are self-reported patient satisfaction, and may not be clinically significant.
* JET Survey data collected 120 and 150 days after treatment, December 2019 n=4725 |120 days]; n=2782 [150 days]; slightly to extremely satisfied on a 5-point rating scale; somewhat to extremely likely on a 5-point rating scale. † Slightly to extremely satisfied (Top 3 on a 5-point rating scale). ‡ Somewhat to extremely likely (Top 3 on a 5-point rating scale).
Patient satisfaction continues months after treatment
IMPORTANT SAFETY INFORMATION FOR JEUVEAU® (prabotulinumtoxinA-xvfs)
WARNING: DISTANT SPREAD OF TOXIN EFFECT: The effects of all botulinum toxin products, including JEUVEAU, 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. JEUVEAU is not approved for the treatment of spasticity or any conditions other than glabellar lines.
CONTRAINDICATIONS
JEUVEAU is contraindicated in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, and in the presence of infection at the proposed injection site(s)
WARNINGS AND PRECAUTIONS
Spread of Toxin Effect
Postmarketing safety data from other approved botulinum toxins suggest that botulinum toxin effects may be observed beyond the site of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, blurred vision and breathing difficulties. 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 related to spread of toxin effects. In unapproved uses, including upper limb spasticity in children and approved indications, symptoms consistent with spread of toxin effect have been reported at doses comparable to or lower than the maximum recommended total dose. JEUVEAU is not approved for the treatment of spasticity or any conditions other than glabellar lines. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech or respiratory difficulties occur.
WARNINGS AND PRECAUTIONS
Lack of Interchangeability between Botulinum Toxin Products
The potency Units of JEUVEAU are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of JEUVEAU cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method.
Serious Adverse Reactions with Unapproved Use
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received botulinum toxin injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of botulinum toxin products to the site of injection and/or adjacent structures. In several of the cases, patients had pre-existing dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of botulinum toxin products.
Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported for botulinum toxin products, including anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such reactions occur with JEUVEAU, discontinue use of JEUVEAU and immediately institute appropriate medical therapy.
Cardiovascular System
There have been reports following administration of botulinum toxins of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.
Increased Risk of Clinically Significant Effects with Pre-existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) were excluded from the JEUVEAU clinical studies. Patients with neuromuscular disorders may be at increased risk of clinically significant effects, including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia and respiratory compromise from typical doses of JEUVEAU.
Dysphagia and Breathing Difficulties
Treatment with botulinum toxin products, including JEUVEAU, can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing. Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several months, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised. Patients treated with botulinum toxin products, including JEUVEAU, may require immediate medical attention should they develop problems with swallowing, speech or breathing.
Pre-existing Conditions at the Injection Site
Caution should be used when JEUVEAU is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s). Caution should be used when JEUVEAU treatment is used in patients who have marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin or when subjects do not respond to 20 Units of botulinum toxin (e.g. the inability to substantially lessen glabellar lines even by physically spreading them apart). Do not exceed the recommended dosage and frequency of administration of JEUVEAU.
Ophthalmic Adverse Reactions in Patients Treated with Botulinum Toxin Products
Dry eye has been reported with the use of botulinum toxin products in the treatment of glabellar lines. Reduced tear production, reduced blinking, and corneal disorders, may occur with use of botulinum toxins, including JEUVEAU. If symptoms of dry eye (e.g., eye irritation, photophobia, or visual changes) persist, consider referring patient to an ophthalmologist.
Human Albumin and Transmission of Viral Diseases
JEUVEAU contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is also considered extremely remote. No cases of transmission of viral diseases or CJD have ever been reported for albumin.
ADVERSE REACTIONS
The most frequently reported adverse reactions (≥ 1% and placebo) following injection of JEUVEAU were headache (12%), eyelid ptosis (2%), upper respiratory tract infection (3%), and white blood cell count increase (1%).
DRUG INTERACTIONS
No formal drug interaction studies have been conducted with JEUVEAU. The potential for certain drugs to potentiate the effects of JEUVEAU warrant consideration given the potential risks involved and should be used with caution, including: aminoglycosides or other agents interfering with neuromuscular transmission, anticholinergic drugs, botulinum neurotoxin products, and muscle relaxants.
USE IN SPECIFIC POPULATIONS
The limited available data on JEUVEAU use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. There are no data on the presence of JEUVEAU in human or animal milk, its effects on the breastfed infant, or its effects on milk production. Safety and effectiveness in pediatric patients have not been established.
INDICATION
JEUVEAU is an acetylcholine release inhibitor and a 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.
Please note that this information is not comprehensive. For more information about JEUVEAU, and to see the full Prescribing Information, including BOXED WARNING and Medication Guide, visit evolus.com.
To report side effects associated with use of JEUVEAU, please call 1-877-EVOLUS1/ 1-877-386-5871. You are encouraged to report side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Injection Technique
INJECTION TECHNIQUE
Your injection technique is the difference between good and great results. Precise injection requires a thorough understanding of the functional anatomy and assessment.1
FUNCTIONAL ANATOMY
Injection technique should be determined by the specific muscles you are targeting.
PRECISION PUTS CONTROL IN THE HANDS OF THE PROVIDER
INJECTION TECHNIQUE
IMPORTANT SAFETY INFORMATION FOR JEUVEAU® (prabotulinumtoxinA-xvfs)
WARNING: DISTANT SPREAD OF TOXIN EFFECT: The effects of all botulinum toxin products, including JEUVEAU, 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. JEUVEAU is not approved for the treatment of spasticity or any conditions other than glabellar lines.
CONTRAINDICATIONS
JEUVEAU is contraindicated in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, and in the presence of infection at the proposed injection site(s)
WARNINGS AND PRECAUTIONS
Spread of Toxin Effect
Postmarketing safety data from other approved botulinum toxins suggest that botulinum toxin effects may be observed beyond the site of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, blurred vision and breathing difficulties. 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 related to spread of toxin effects. In unapproved uses, including upper limb spasticity in children and approved indications, symptoms consistent with spread of toxin effect have been reported at doses comparable to or lower than the maximum recommended total dose. JEUVEAU is not approved for the treatment of spasticity or any conditions other than glabellar lines. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech or respiratory difficulties occur.
WARNINGS AND PRECAUTIONS
Lack of Interchangeability between Botulinum Toxin Products
The potency Units of JEUVEAU are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of JEUVEAU cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method.
Serious Adverse Reactions with Unapproved Use
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received botulinum toxin injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of botulinum toxin products to the site of injection and/or adjacent structures. In several of the cases, patients had pre-existing dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of botulinum toxin products.
Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported for botulinum toxin products, including anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such reactions occur with JEUVEAU, discontinue use of JEUVEAU and immediately institute appropriate medical therapy.
Cardiovascular System
There have been reports following administration of botulinum toxins of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.
Increased Risk of Clinically Significant Effects with Pre-existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) were excluded from the JEUVEAU clinical studies. Patients with neuromuscular disorders may be at increased risk of clinically significant effects, including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia and respiratory compromise from typical doses of JEUVEAU.
Dysphagia and Breathing Difficulties
Treatment with botulinum toxin products, including JEUVEAU, can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing. Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several months, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised. Patients treated with botulinum toxin products, including JEUVEAU, may require immediate medical attention should they develop problems with swallowing, speech or breathing.
Pre-existing Conditions at the Injection Site
Caution should be used when JEUVEAU is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s). Caution should be used when JEUVEAU treatment is used in patients who have marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin or when subjects do not respond to 20 Units of botulinum toxin (e.g. the inability to substantially lessen glabellar lines even by physically spreading them apart). Do not exceed the recommended dosage and frequency of administration of JEUVEAU.
Ophthalmic Adverse Reactions in Patients Treated with Botulinum Toxin Products
Dry eye has been reported with the use of botulinum toxin products in the treatment of glabellar lines. Reduced tear production, reduced blinking, and corneal disorders, may occur with use of botulinum toxins, including JEUVEAU. If symptoms of dry eye (e.g., eye irritation, photophobia, or visual changes) persist, consider referring patient to an ophthalmologist.
Human Albumin and Transmission of Viral Diseases
JEUVEAU contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is also considered extremely remote. No cases of transmission of viral diseases or CJD have ever been reported for albumin.
ADVERSE REACTIONS
The most frequently reported adverse reactions (≥ 1% and placebo) following injection of JEUVEAU were headache (12%), eyelid ptosis (2%), upper respiratory tract infection (3%), and white blood cell count increase (1%).
DRUG INTERACTIONS
No formal drug interaction studies have been conducted with JEUVEAU. The potential for certain drugs to potentiate the effects of JEUVEAU warrant consideration given the potential risks involved and should be used with caution, including: aminoglycosides or other agents interfering with neuromuscular transmission, anticholinergic drugs, botulinum neurotoxin products, and muscle relaxants.
USE IN SPECIFIC POPULATIONS
The limited available data on JEUVEAU use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. There are no data on the presence of JEUVEAU in human or animal milk, its effects on the breastfed infant, or its effects on milk production. Safety and effectiveness in pediatric patients have not been established.
INDICATION
JEUVEAU is an acetylcholine release inhibitor and a 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.
Please note that this information is not comprehensive. For more information about JEUVEAU, and to see the full Prescribing Information, including BOXED WARNING and Medication Guide, visit evolus.com.
To report side effects associated with use of JEUVEAU, please call 1-877-EVOLUS1/ 1-877-386-5871. You are encouraged to report side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Experts agree that clinicians should reevaluate their technique when implementing precise products like Jeuveau.1
Traditional techniques1
- Injection depth is rarely discussed
- Superficial injections may not achieve the desired outcome
Injection technique with Jeuveau
- Precise injection requires a thorough understanding and assessment of the functional anatomy1
- Intramuscular injection technique is recommended2
RETHINK INJECTION TECHNIQUE WITH JEUVEAU
Precision
Every botulinum neurotoxin is unique and non-interchangeable.2,5 Jeuveau is a precise neurotoxin developed through modern manufacturing using proprietary Hi-Pure Technology™. 1,6
A tight field of effect puts control in the hands of the provider to drive consistent outcomes through intramuscular injection.'
JEUVEAU IS A PRECISE PRODUCT WITH A TIGHT FIELD OF EFFECTS
PRECISION
IMPORTANT SAFETY INFORMATION FOR JEUVEAU® (prabotulinumtoxinA-xvfs)
WARNING: DISTANT SPREAD OF TOXIN EFFECT: The effects of all botulinum toxin products, including JEUVEAU, 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. JEUVEAU is not approved for the treatment of spasticity or any conditions other than glabellar lines.
CONTRAINDICATIONS
JEUVEAU is contraindicated in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, and in the presence of infection at the proposed injection site(s)
WARNINGS AND PRECAUTIONS
Spread of Toxin Effect
Postmarketing safety data from other approved botulinum toxins suggest that botulinum toxin effects may be observed beyond the site of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, blurred vision and breathing difficulties. 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 related to spread of toxin effects. In unapproved uses, including upper limb spasticity in children and approved indications, symptoms consistent with spread of toxin effect have been reported at doses comparable to or lower than the maximum recommended total dose. JEUVEAU is not approved for the treatment of spasticity or any conditions other than glabellar lines. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech or respiratory difficulties occur.
WARNINGS AND PRECAUTIONS
Lack of Interchangeability between Botulinum Toxin Products
The potency Units of JEUVEAU are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of JEUVEAU cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method.
Serious Adverse Reactions with Unapproved Use
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received botulinum toxin injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of botulinum toxin products to the site of injection and/or adjacent structures. In several of the cases, patients had pre-existing dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of botulinum toxin products.
Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported for botulinum toxin products, including anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such reactions occur with JEUVEAU, discontinue use of JEUVEAU and immediately institute appropriate medical therapy.
Cardiovascular System
There have been reports following administration of botulinum toxins of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.
Increased Risk of Clinically Significant Effects with Pre-existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) were excluded from the JEUVEAU clinical studies. Patients with neuromuscular disorders may be at increased risk of clinically significant effects, including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia and respiratory compromise from typical doses of JEUVEAU.
Dysphagia and Breathing Difficulties
Treatment with botulinum toxin products, including JEUVEAU, can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing. Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several months, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised. Patients treated with botulinum toxin products, including JEUVEAU, may require immediate medical attention should they develop problems with swallowing, speech or breathing.
Pre-existing Conditions at the Injection Site
Caution should be used when JEUVEAU is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s). Caution should be used when JEUVEAU treatment is used in patients who have marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin or when subjects do not respond to 20 Units of botulinum toxin (e.g. the inability to substantially lessen glabellar lines even by physically spreading them apart). Do not exceed the recommended dosage and frequency of administration of JEUVEAU.
Ophthalmic Adverse Reactions in Patients Treated with Botulinum Toxin Products
Dry eye has been reported with the use of botulinum toxin products in the treatment of glabellar lines. Reduced tear production, reduced blinking, and corneal disorders, may occur with use of botulinum toxins, including JEUVEAU. If symptoms of dry eye (e.g., eye irritation, photophobia, or visual changes) persist, consider referring patient to an ophthalmologist.
Human Albumin and Transmission of Viral Diseases
JEUVEAU contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is also considered extremely remote. No cases of transmission of viral diseases or CJD have ever been reported for albumin.
ADVERSE REACTIONS
The most frequently reported adverse reactions (≥ 1% and placebo) following injection of JEUVEAU were headache (12%), eyelid ptosis (2%), upper respiratory tract infection (3%), and white blood cell count increase (1%).
DRUG INTERACTIONS
No formal drug interaction studies have been conducted with JEUVEAU. The potential for certain drugs to potentiate the effects of JEUVEAU warrant consideration given the potential risks involved and should be used with caution, including: aminoglycosides or other agents interfering with neuromuscular transmission, anticholinergic drugs, botulinum neurotoxin products, and muscle relaxants.
USE IN SPECIFIC POPULATIONS
The limited available data on JEUVEAU use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. There are no data on the presence of JEUVEAU in human or animal milk, its effects on the breastfed infant, or its effects on milk production. Safety and effectiveness in pediatric patients have not been established.
INDICATION
JEUVEAU is an acetylcholine release inhibitor and a 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.
Please note that this information is not comprehensive. For more information about JEUVEAU, and to see the full Prescribing Information, including BOXED WARNING and Medication Guide, visit evolus.com.
To report side effects associated with use of JEUVEAU, please call 1-877-EVOLUS1/ 1-877-386-5871. You are encouraged to report side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Jeuveau is developed in a state-of-art facility using proprietary Hi-Pure TechnologyTM, resulting in > 95% purity6
Manufacturing processes contribute to distinct diffusion profiles7,8
*Purity specification of the botulinum toxin
PRECISION STARTS WITH MODERN MANUFACTURING
Larger diffusion areas may hinder accurate localization of the clinical effect of neurotoxins, increasing the risk of adverse events in the treated area7
LOW RATES OF EYELID PTOSIS WITH JEUVEAU ADVERSE EVENTS OBSERVED IN EV-001 AND EV-0029,10
Phase 3 randomized, multicenter, double-blind, placebo-controlled US trials
Jeuveau
Placebo
Overall
Treatment - related
2%
1%
(8/492)
(5/492)
0%
0%
(3/162)
(0/162)
PRECISION DRIVES CONSISTENT & SAFE OUTCOMES
Clinically Proven Efficacy & Safety
Through the Transparency Clinical Program, Jeuveau was clinically proven to temporarily improve moderate to severe glabellar lines in adults.2,11
- Two phase 3 US trials9,10
- The largest head-to-head aesthetic EU/Canadian phase 3 trial vs Botox Cosmetic12
- Two long - term safety studies13,14
THE PRECISION OF JEUVEAU DELIVERS PROVEN RESULTS
CLINICALLY PROVEN EFFICACY & SAFETY
Jeuveau met the primary endpoint by achieving statistically significant improvements in the appearance of glabellar lines vs placebo.11
Proportion of subjects achieving a ≥2-point composite GLS improvement at maximum frown (investigator and subject agree at day 30 vs placebo?-11
EV-001 and EV-002 were phase 3 randomized, multicenter, double-blind, placebo-controlled US trials designed to assess the superiority of Jeuveau vs placebo in the treatment of moderate to severe glabellar lines in adults
- Subjects were randomized 3:1 to receive 20U Jeuveau or placebo
- Primary endpoint was proportion of subjects achieving a>=2-point composite GLS improvement at maximum frown (investigator and subject agree) at day 30 vs placebo
THE DATA IS CLEAR: JEUVEAU DELIVERS RESULTS
Jeuveau patients at maximum frown (results may vary)
Patient 1
Patient 2
In EV-001 (n=330) and EV-002 (n=324), patients with ≥2-point composite GLS improvement at day 30 (primary endpoint): 68% and 70% Jeuveau vs 1% placebo (P‹0.001); day 150 (secondary endpoint): 4.6% and 4.6% Jeuveau vs 0% placebo (P=0.041 and P=0.047). Patients with ≥l-point improvement investigator assessment at day 2 (exploratory endpoint): 46% and 56% vs 8% and 17% placebo. Patients with ≥l-point improvement subject assessment at day 2 (exploratory endpoint): 50% and 47% vs 15% and 18% placebo
Comparisons against placebo after day 30 or based on a 1-point improvement may not be clinically meaningful.
THE DATA IS CLEAR: JEUVEAU DELIVERS RESULTS YOU CAN SEE
ADVERSE EVENTS OBSERVED IN EV-001 AND EV-002
Jeuveau demonstrated no serious drug-related adverse events in clinical trials?
ADVERSE EVENTS
Adverse reactions reported at ≥1% in the Jeuveau group compared with the placebo group (EV-001 and EV-002)?
Jeuveau
N=492, %
Placebo
N=162, %
Headache
Eyelid Ptosis
Upper Respiratory Tract Infection
White Blood Cell Count Increase
12%
2%
3%
1%
13%
0%
1%
0%
THE DATA IS CLEAR: JEUVEAU DEMONSTRATED A PROVEN SAFETY PROFILE
Jeuveau met the primary endpoint and demonstrated non-inferiority vs Botox Cosmetic3
EVB-003 (N=540) was a phase 3, EU/Canadian, randomized, multicenter double-blind, active- and placebo-controlled, single-dose study designed to assess non-inferiority of Jeuveau vs Botox Cosmetic in the treatment of moderate to severe glabellar lines in adults.
- Subjects randomized 5:5:1 to receive 20U Jeuveau, 20U Botox Cosmetic, or placebo
- Primary endpoint was proportion of Jeuveau subjects with GLS score of 0 or 1 at maximum frown on day 30 by investigator assessment vs Botox Cosmetic
HEAD-TO-HEAD: JEUVEAU vs BOTOX COSMETIC
In the largest head-to-head phase 3 study in glabellar lines, Jeuveau demonstrated substantially similar results vs Botox Cosmetic (EVB-003 non-inferiority study).
GAIS=Global Aesthetic Improvement Scale.
§Assessments based on the 5-point GAIS:
2= much improved
I=improved
0=no change
-1=worse
-2=mush worse
EXPLORATORY ENDPOINT3
Investigator Assessment: GLS ≥1-point improvement at maximum frown
HEAD-TO-HEAD: JEUVEAU vs BOTOX COSMETIC
ADVERSE EVENTS OBSERVED IN EVB-003
ADVERSE EVENTS3
All adverse events with frequency ≥5% in either Jeuveau or Botox Cosmetic groups
Placebo
N=49, %
Botox Cosmetic
N=246, %
Jeuveau
N=245, %