JEUVEAU- prabotulinum toxin type a powder

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

BOTULINUM TOXIN TYPE A (UNII: E211KPY694) (BOTULINUM TOXIN TYPE A - UNII:E211KPY694)

Beszerezhető a:

Evolus, Inc.

Az alkalmazás módja:

INTRAMUSCULAR

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 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) ]. JEUVEAU is contraindicated in the presence of infection at the proposed injection site(s). The limited available data on JEUVEAU use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. An embryofetal developmental study conducted with JEUVEAU in pregnant rats revealed no treatment-related effects to the developing fetus when JEUVEAU was administered intramuscularly during organogenesis at doses up to 12 times the maximum recommended human dose (MRHD) (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Animal Data In an embryofetal developmental study, intramuscular doses up to 4 Unit/kg JEUVEAU were administered to pregnant rats once daily during organogenesis (gestation days 6 to 16). No maternal or embryofetal toxicities were observed at doses up to 4 Unit/kg (12 times the MRHD of 20 Units, based on Unit/kg comparison). There is no information regarding the presence of prabotulinumtoxinA-xvfs in human or animal milk, its effects on the breastfed infant, or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for JEUVEAU and any potential adverse effects on the breastfed infant from JEUVEAU or from the underlying maternal condition Safety and effectiveness in pediatric patients have not been established. The two clinical trials of JEUVEAU included 68 subjects age 65 and greater. Although no differences in safety or efficacy were observed between older and younger subjects, clinical studies of JEUVEAU did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Termék összefoglaló:

JEUVEAU (prabotulinumtoxinA-xvfs) for injection is a vacuum-dried powder supplied in a single-dose vial in the following size: 100 Units (NDC 72301-595-10) Storage Unopened vials of JEUVEAU should be stored in a refrigerator between 2° to 8°C (36° to 46° F) in the original carton to protect from light.

Engedélyezési státusz:

Biologic Licensing Application

Betegtájékoztató

Evolus, Inc.
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MEDICATION GUIDE
JEUVEAU (pronounced Jū vō)
(prabotulinumtoxinA-xvfs)
for Injection
What is the most important information I should know about JEUVEAU?
JEUVEAU may cause serious side effects that can be life threatening.
Call your healthcare provider or
get medical help right away if you have any of these problems after
treatment with JEUVEAU:
•
Problems swallowing, speaking, or breathing. These problems can happen
hours, days, or weeks
after an injection of JEUVEAU if the muscles that you use to breathe
and swallow become weak
after the injection. Death can happen as a complication if you have
severe problems with
swallowing or breathing after treatment with JEUVEAU.
o
People with certain breathing problems may need to use muscles in
their neck to help them
breathe. These people may be at greater risk for serious breathing
problems with
JEUVEAU.
o
Swallowing problems may last for several months. People who cannot
swallow well may
need a feeding tube to receive food and water. If swallowing problems
are severe, food or
liquids may go into your lungs. People who already have swallowing or
breathing problems
before receiving JEUVEAU have the highest risk of getting these
problems.
•
Spread of toxin effects. In some cases, the effect of botulinum toxin
may affect areas of the body
away from the injection site and cause symptoms of a serious condition
called botulism. The
symptoms of botulism include:
o
loss of strength and muscle weakness all
over the body
o
blurred vision and drooping eyelids
o
trouble saying words clearly
o
trouble breathing
o
double vision
o
hoarseness or change or loss of voice
o
loss of bladder control
o
trouble swallowing
These symptoms can happen hours, days, or weeks after you receive an
injection of JEUVEAU.
These problems could make it unsafe for you to drive a car or do other
dangerous activities. See “What
should I avoid while receiving JEUVEAU?”
What is JEUVEAU?
JEUVEAU is a prescription medicine that is injected into muscles and
used in adults for a sh

Termékjellemzők

JEUVEAU- PRABOTULINUM TOXIN TYPE A POWDER
EVOLUS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
JEUVEAU SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR JEUVEAU.
JEUVEAU (PRABOTULINUMTOXINA-XVFS) FOR INJECTION, FOR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 2019
WARNING: DISTANT SPREAD OF TOXIN EFFECT
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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. (5.1)
INDICATIONS AND USAGE
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)
DOSAGE AND ADMINISTRATION
Glabellar Lines Administration: 0.1 mL (4 Units) by intramuscular
injection into each of five sites, for a total
dose of 20 Units (2.2, 2.3)
DOSAGE FORMS AND STRENGTHS
For Injection: 100 Units vacuum-dried powder in a single-dose vial (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
ADVERSE REACTIONS
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.
DRUG INTERACTIONS
Closely observe patients receiving concomitant treatment of JEUVEAU
and aminoglycosides or other
agents interfering with neuromuscular transmission (e.g., curare-like
agents), or muscle relaxants because
JEUVEAU’s ef