Jeuveau

Last reviewed on RxList: 10/13/2020
Jeuveau Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Jeuveau?

Jeuveau (prabotulinumtoxinA-xvfs) is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical frown lines between the eyebrows, or "11's") associated with corrugator and/or procerus muscle activity in adult patients.

What Are Side Effects of Jeuveau?

Common side effects of Jeuveau include:

Dosage for Jeuveau?

The dose of Jeuveau for glabellar lines administration is 0.1 mL (4 units) by intramuscular injection into each of five sites, for a total dose of 20 units.

What Drugs, Substances, or Supplements Interact with Jeuveau?

Jeuveau may interact with aminoglycosides or other agents interfering with neuromuscular transmission (e.g. curare-like agents), muscle relaxants, anticholinergics, or botulinum neurotoxin products. Tell your doctor all medications and supplements you use.

Jeuveau During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Jeuveau; it is unknown how it would affect a fetus. It is unknown if Jeuveau passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Jeuveau (prabotulinumtoxinA-xvfs) for Injection, for Intramuscular Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Skin & Beauty: Anti-Aging Tips & Secrets to Look Younger See Slideshow
Jeuveau Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, itching; wheezing, difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

The botulinum toxin contained in Jeuveau can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulinum toxin injections, even for cosmetic purposes.

Call your doctor at once if you have any of these side effects (up to several hours or several weeks after an injection):

  • unusual or severe muscle weakness (especially in a body area that was not injected with the medication);
  • trouble breathing, talking, or swallowing;
  • loss of bladder control;
  • hoarse voice, drooping eyelids;
  • vision changes, eye pain, severely dry or irritated eyes (your eyes may also be more sensitive to light); or
  • chest pain or pressure, pain spreading to your jaw or shoulder, irregular heartbeats.

Common side effects may include:

  • headache;
  • drooping eyelids;
  • increased white blood cell counts; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Jeuveau (PrabotulinumtoxinA-xvfs)

Jeuveau Professional Information

SIDE EFFECTS

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

Clinical 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].

Glabellar Lines

The adverse reactions below reflect exposure to JEUVEAU in the treatment of glabellar lines in placebo-controlled trials [See Clinical Studies].

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.

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.

Read the entire FDA prescribing information for Jeuveau (PrabotulinumtoxinA-xvfs)

© Jeuveau Patient Information is supplied by Cerner Multum, Inc. and Jeuveau Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors