DAXXIFY- botulinum toxin type a injection, powder, lyophilized, for solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Revance Therapeutics, Inc.

प्रशासन का मार्ग:

INTRAMUSCULAR

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

DAXXIFY 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. DAXXIFY is indicated for the treatment of cervical dystonia in adult patients. DAXXIFY is contraindicated in: - patients with known hypersensitivity to any botulinum toxin preparation, DAXXIFY, or any of the components in the DAXXIFY formulation [see Warnings and Precautions (5.4)]. - the presence of infection at the proposed injection sites. Risk Summary There are no available data on DAXXIFY use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, intramuscular administration of DAXXIFY during pregnancy resulted in adverse effects on fetal growth (decreased fetal body weight and skeletal ossification) at maternally toxic doses approximately equivalent to 40 times the maximum recommended human dose (MRHD) (see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Embryofetal development studies were conducted in rats and rabbits with DAXXIFY. For comparison of animal to human doses based on a body weight comparison, the MRHD is set at 40 Units/subject (0.67 Units/kg for an average 60 kg subject). Intramuscular administration of DAXXIFY (3, 10, or 30 Units/kg) to pregnant rats four times during the period of organogenesis (on gestation days 7, 10, 13, and 16) caused decreased fetal body weight and decreased fetal skeletal ossification at the highest dose, which was associated with maternal toxicity. No embryofetal developmental toxicity was noted at doses up to 10 Units/kg, which is 15 times the MRHD. Intramuscular administration of DAXXIFY (0.02, 0.1, 0.48, or 2.4 Units/kg/day) to pregnant rabbits during the period of organogenesis (total of 13 doses) resulted in maternal lethality at 2.4 Units/kg/day and significant decreased maternal body weight at 0.48 Units/kg/day. No embryofetal developmental toxicity was noted at doses up to 0.48 Units/kg/day, which is approximately equivalent to the MRHD. Risk Summary There are no data on the presence of DAXXIFY in human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for DAXXIFY and any potential adverse effects on the breastfed infant from DAXXIFY or from the underlying maternal condition. Safety and effectiveness of DAXXIFY in patients less than 18 years of age have not been established. Glabellar Lines Among the 406 subjects treated with DAXXIFY in the placebo-controlled clinical trials, 36 subjects were 65 years or older. There was no increase in the incidence of treatment-related adverse events in patients over 65 years treated with DAXXIFY. Clinical studies of DAXXIFY did not include sufficient numbers of subjects aged 65 and older to determine whether they responded differently from younger subjects [see Clinical Studies (14)]. Cervical Dystonia Among the 255 patients treated with DAXXIFY in the placebo-controlled clinical trial, 83 patients were 65 years or older. There was no increase in the incidence of treatment-related adverse events in patients over 65 years treated with DAXXIFY. Clinical studies of DAXXIFY did not include sufficient numbers of patients aged 65 and older to determine whether they responded differently from younger patients [see Clinical Studies (14)].

उत्पाद समीक्षा:

How Supplied DAXXIFY (daxibotulinumtoxinA-lanm) for injection is a sterile lyophilized powder supplied in a single-dose vial in the following sizes: Carton containing one 50 Units/Vial NDC 72960-111-01 Carton containing one 100 Units/Vial NDC 72960-112-01 Storage and Handling Unopened DAXXIFY vials should be stored at room temperature 20°C to 25°C (68°F to 77°F) or refrigerated at 2°C to 8° C (36°F to 46°F) in the original carton to protect from light.

प्राधिकरण का दर्जा:

Biologic Licensing Application

सूचना पत्रक

Revance Therapeutics, Inc.
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MEDICATION GUIDE
DAXXIFY® (DAX'-I-FYE)
DAXIBOTULINUMTOXINA-LANM
FOR INJECTION, FOR INTRAMUSCULAR USE
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: 11/2023
What is the most important information I should know about DAXXIFY?
DAXXIFY 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 DAXXIFY:
•
Problems swallowing, speaking, or breathing. These problems can happen
hours, days, or weeks
after an injection of DAXXIFY 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 DAXXIFY.
•
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
DAXXIFY.
•
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 DAXXIFY 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:
•
loss of strength and
muscle weakness all over
the body
•
blurred vision and
drooping eyelids
•
trouble saying words
clearly
•
trouble breathing
•
double vision
•
hoarseness or change or loss of voice
•
loss of bladder control
•
trouble swallowing
These symptoms can happen hours, days, or weeks after you receive an
injection of DAXXIFY.
These problems could make it unsafe for you to drive a car or do other
dangerous activities. See "What
shoul

उत्पाद विशेषताएं

DAXXIFY- BOTULINUM TOXIN TYPE A INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
REVANCE THERAPEUTICS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DAXXIFY SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DAXXIFY.
DAXXIFY (DAXIBOTULINUMTOXINA-LANM) FOR INJECTION, FOR INTRAMUSCULAR
USE
INITIAL U.S. APPROVAL: 2022
WARNING: DISTANT SPREAD OF TOXIN EFFECT
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
THE EFFECTS OF DAXXIFY AND ALL BOTULINUM TOXIN PRODUCTS 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.
THE RISK OF SYMPTOMS IS PROBABLY GREATEST IN CHILDREN TREATED FOR
SPASTICITY, AN
UNAPPROVED USE FOR DAXXIFY, BUT SYMPTOMS CAN ALSO OCCUR IN ADULTS,
PARTICULARLY IN
THOSE PATIENTS WHO HAVE AN UNDERLYING CONDITION THAT WOULD PREDISPOSE
THEM TO THESE
SYMPTOMS. (5.1)
RECENT MAJOR CHANGES
Boxed Warning
8/2023
Indications and Usage (1)
8/2023
Dosage and Administration (2.1, 2.3, 2.4)
8/2023
Warnings and Precautions (5.1)
8/2023
INDICATIONS AND USAGE
DAXXIFY is an acetylcholine release inhibitor and
neuromuscular-blocking agent indicated for:
Temporary improvement in the appearance of moderate to severe
glabellar lines associated with
corrugator and/ or procerus muscle activity in adult patients. (1.1)
The treatment of cervical dystonia in adult patients. (1.2)
DOSAGE AND ADMINISTRATION
Glabellar Lines: the recommended dose is 0.1 mL (8 Units) by
intramuscular injection into each of five
sites, for a total dose of 40 Units. (2.2)
Cervical Dystonia: the recommended dose is 125 Units to 250 Units
given intramuscularly as a divided
dose among affected muscles. (2.3)
DOSAGE FORMS AND STRENGTHS
For injection: 50 Units or 100 Units sterile lyophilized powder in a
single-dose vial. (3)
CONTRAINDICATIONS
Known hypersensit