Botulinum toxin

Jeuveau

100 UNITS injectableÉtats-UnisCommercialiséAutorisé le 1 févr. 2019

Contenu en anglais

Indications

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 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 ( 1 )

Contre-indications

Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation ( 4.1 )
Infection at the injection site ( 4.2 )

4.1Known Hypersensitivity to Botulinum Toxin

JEUVEAU is contraindicated in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation [ See Warnings and Precautions ( 5.4 ) ].

4.2Infection at the Injection Site(s)

JEUVEAU is contraindicated in the presence of infection at the proposed injection site(s).

Mises en garde et précautions d’emploi

Potency Units of JEUVEAU are not interchangeable with other preparations of botulinum toxin products ( 5.2 , 11 )
Spread of toxin effects; swallowing and breathing difficulties can lead to death. Seek immediate medical attention if respiratory, speech, or swallowing difficulties occur ( 5.2 , 5.7 )
Potential serious adverse reactions after JEUVEAU injections for unapproved uses ( 5.3 )
Adverse event reports have been received involving the cardiovascular system, some with fatal outcomes. Use caution when administering to patients with pre-existing cardiovascular disease ( 5.5 )

Indications

Contre-indications

Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation ( 4.1 )
Infection at the injection site ( 4.2 )

4.1Known Hypersensitivity to Botulinum Toxin

JEUVEAU is contraindicated in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation [ See Warnings and Precautions ( 5.4 ) ].

4.2Infection at the Injection Site(s)

JEUVEAU is contraindicated in the presence of infection at the proposed injection site(s).

Mises en garde et précautions d’emploi

Potency Units of JEUVEAU are not interchangeable with other preparations of botulinum toxin products ( 5.2 , 11 )
Spread of toxin effects; swallowing and breathing difficulties can lead to death. Seek immediate medical attention if respiratory, speech, or swallowing difficulties occur ( 5.2 , 5.7 )
Potential serious adverse reactions after JEUVEAU injections for unapproved uses ( 5.3 )
Adverse event reports have been received involving the cardiovascular system, some with fatal outcomes. Use caution when administering to patients with pre-existing cardiovascular disease ( 5.5 )

Effets indésirables

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

Spread of Toxin Effects [ see Warnings and Precautions ( 5.1 ) ]
Hypersensitivity [ see Contraindications ( 4.1 ) and Warnings and Precautions ( 5.4 ) ]
Dysphagia and Breathing Difficulties [ See Warnings and Precautions ( 5.7 ) ] The most common adverse reactions are headache (12%), eyelid ptosis (2%), upper respiratory tract infection (3%), and increased white blood cell count (1%) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Evolus at [1-877-386-5871] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In general, most adverse reactions occur within the first week following injection of JEUVEAU and while generally transient, may have a duration of several months or longer.

Localized pain, infection, inflammation, tenderness, swelling, erythema, and/or bleeding/bruising may be associated with the injection. Needle-related pain and/or anxiety may result in vasovagal responses, including syncope and hypotension, which may require appropriate medical therapy. Local weakness of the injected muscle(s) represents the expected pharmacological action of botulinum toxin. However, weakness of nearby muscles may also occur due to spread of toxin effect [ see Warnings and Precautions ( 5.1 ) ].

Glabellar Lines The adverse reactions below reflect exposure to JEUVEAU in the treatment of glabellar lines in placebo-controlled trials [ See Clinical Studies ( 14 ) ]. Table 2. Adverse Reactions Reported at Higher Frequency (≥1%) in the JEUVEAU Group Compared to the Placebo Group JEUVEAU EV-001, EV-002 N=492 n (%) PLACEBO EV-001, EV-002, N=162 n (%) Headache 57 (12%) 21 (13%) Eyelid Ptosis 8 (2%) 0 (0%) Upper Respiratory Tract Infection 13 (3%) 1 (1%) White blood cell count increase 6 (1%) 0 (0%) Two multi-center, open label, 1-year repeat dose safety trials, EV-004 [NCT02184988] and EV-006 [NCT02428608], were also conducted with JEUVEAU.

Both trials evaluated repeat treatments of 20 units of JEUVEAU, up to a maximum total of 80 units, for the treatment of moderate to severe glabellar lines in adult subjects. Of the 922 subjects enrolled, the median number of treatments was three. The adverse events profile was similar to that reported in single dose trials.

6.2 Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease.

For these reasons, comparison of the incidence of antibodies to prabotulinumtoxinA-xvfs in the studies described below, with the incidence of antibodies in other studies, or to other products may be misleading. Treatment with botulinum toxins may result in the formation of antibodies that may reduce the effectiveness of subsequent treatments by inactivating biological activity of the toxin. Among 1,414 subjects treated with prabotulinumtoxinA-xvfs, 2 subjects were found to have pre-existing antibodies and 2 subjects had treatment-emergent antibodies.

Jeuveau

Indications

Contre-indications

4.1Known Hypersensitivity to Botulinum Toxin

4.2Infection at the Injection Site(s)

Mises en garde et précautions d’emploi

Deux médicaments dans une même question ?

Jeuveau

Indications

Contre-indications

4.1Known Hypersensitivity to Botulinum Toxin

4.2Infection at the Injection Site(s)

Mises en garde et précautions d’emploi

Deux médicaments dans une même question ?

5.1Spread of Toxin Effect

5.3Serious Adverse Reactions with Unapproved Use

5.4Hypersensitivity Reactions

5.5Cardiovascular System

5.6Increased Risk of Clinically Significant Effects with Pre-Existing Neuromuscular Disorders Individuals

5.7Dysphagia and Breathing Difficulties Treatment

5.8Pre-existing Conditions at the Injection Site

5.9Ophthalmic Adverse Reactions in Patients Treated with Botulinum Toxin Products

5.10Human Albumin and Transmission of Viral Diseases

Interactions

Grossesse et allaitement

8.1Pregnancy Risk Summary

Effets indésirables

6.1Clinical Trials Experience

Dans d’autres pays

Conditionnements

Documents

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