Jeuveau

JEUVEAU- botulinum toxin type a powder
Evolus, Inc.

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. [See Warnings and Precautions (5.1) ]

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

2.1 Instructions for Safe Use

The potency Units of JEUVEAU (prabotulinumtoxinA-xvfs) for injection 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 [see Warnings and Precautions (5.2) and Description (11)].

Retreatment of JEUVEAU should be administered no more frequently than every three months. Consideration of the cumulative dose is necessary when treating adult patients with JEUVEAU for glabellar lines if other botulinum toxin products are or have been used to treat other indications approved for those products.

The safe and effective use of JEUVEAU depends upon proper storage of the product, selection of the correct dose, and proper reconstitution and administration techniques. Physicians administering JEUVEAU must understand the relevant neuromuscular and/or orbital anatomy of the area involved and any alterations to the anatomy due to prior surgical procedures [see Warnings and Precautions (5.4) ].

2.2 Preparation and Dilution Technique

JEUVEAU is supplied in a single-dose 100 Unit vial. Prior to intramuscular injection, reconstitute each vacuum-dried vial of JEUVEAU with only sterile, preservative-free 0.9% Sodium Chloride Injection, USP to obtain a reconstituted solution at a concentration of 4 Units/0.1 mL and a total treatment dose of 20 Units in 0.5 mL (see Table 1). Slowly inject the diluent into the vial. Discard the vial if a vacuum does not pull the diluent into the vial. Dispose of any unused saline. Gently mix JEUVEAU with 0.9% Sodium Chloride Injection USP by rotating the vial. JEUVEAU should be administered within 24 hours after reconstitution. During this time period, unused reconstituted JEUVEAU should be stored in a refrigerator between 2° to 8°C (36°F to 46°F) in the original carton to protect from light for up to 24 hours until time of use. Do not freeze reconstituted JEUVEAU. JEUVEAU vials are for single-dose only. After reconstitution, JEUVEAU should be used for only one injection session and for only one patient. Discard any remaining solution after administration.

Table 1. Dilution Instructions for JEUVEAU Vials (100 Units)
*
Preservative-free 0.9% Sodium Chloride Injection, USP

Diluent * Added to 100 Unit Vial

Resulting Dose Units per 0.1 mL

2.5 mL

4 Units

Reconstituted JEUVEAU should be clear, colorless, and free of particulate matter otherwise it should not be injected. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

2.3 Administration

Glabellar facial lines arise from the activity of the corrugator and orbicularis oculi muscles. These muscles move the brow medially and the procerus and depressor supercilii pull the brow inferiorly. This creates a frown or “furrowed brow”. The location, size, and use of the muscles vary markedly among individuals. Lines induced by facial expression occur perpendicular to the direction of action of contracting facial muscles. An effective dose for facial lines is determined by gross observation of the patient’s ability to activate the superficial muscles injected.

In order to reduce the complication of eyelid ptosis the following steps should be taken:

Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes.
Lateral corrugator injections should be placed at least 1 cm above the bony supraorbital ridge.
Ensure the injected volume/dose is accurate and where feasible kept to a minimum.
Avoid injecting JEUVEAU closer than 1 centimeter above the central eyebrow.

Draw at least 0.5 mL of the properly reconstituted JEUVEAU into a sterile syringe and expel any air bubbles in the syringe barrel. Remove the needle used to reconstitute the product and attach a 30-33 gauge needle. Confirm the patency of the needle. Inject a dose of 0.1 mL (4 Units) intramuscularly into each of five sites: the inferomedial and superior middle of each corrugator, and one in the mid-line of the procerus muscle for a total dose of 20 Units (See Figure 1).

Figure 1-2
(click image for full-size original)

Figure 1

3 DOSAGE FORMS AND STRENGTHS

For injection: 100 Units, vacuum-dried powder in a single-dose vial for reconstitution with preservative-free 0.9% Sodium Chloride Injection, USP.

4 CONTRAINDICATIONS

4.1 Known 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) ].

4.2 Infection at the Injection Site(s)

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

5 WARNINGS AND PRECAUTIONS

5.1 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 [see Use in Specific Populations (8.4) ]. 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.

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