BOTOX COSMETIC- onabotulinumtoxina injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Allergan, Inc.

INN (International Name):

botulinum toxin type A

Composition:

botulinum toxin type A 50 [USP'U]

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

BOTOX Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of: - moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity - moderate to severe lateral canthal lines  associated with orbicularis oculi activity - moderate to severe forehead lines associated with frontalis muscle activity BOTOX Cosmetic 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 )] . BOTOX Cosmetic is contraindicated in the presence of infection at the proposed injection site(s). Risk Summary There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX Cosmetic in pregnant women.   In animal studies, administrations of BOTOX Cosmetic during pregnancy resulted in adverse effects on fetal growth (decreased fetal body weight and skeletal ossification) at clinically relevant doses, which were associated with maternal toxicity [see Data]. 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. The background risk of major birth defects and miscarriage for the indicated populations is unknown. Data Animal Data When BOTOX Cosmetic (4, 8, or 16 Units/kg) was administered intramuscularly to pregnant mice or rats two times during the period of organogenesis (on gestation days 5 and 13), reductions in fetal body weight and decreased fetal skeletal ossification were observed at the two highest doses. The no-effect dose for developmental toxicity in these studies (4 Units/kg) is approximately 4 times the average high human dose for glabellar lines, lateral canthal lines, and forehead lines of 64 Units on a body weight basis (Units/kg). When BOTOX Cosmetic was administered intramuscularly to pregnant rats (0.125, 0.25, 0.5, 1, 4, or 8 Units/kg) or rabbits (0.063, 0.125, 0.25, or 0.5 Units/kg) daily during the period of organogenesis (total of 12 doses in rats, 13 doses in rabbits), reduced fetal body weights and decreased fetal skeletal ossification were observed at the two highest doses in rats and at the highest dose in rabbits. These doses were also associated with significant maternal toxicity, including abortions, early deliveries, and maternal death. The developmental no-effect doses in these studies of 1 Unit/kg in rats is approximately equal the average high human dose of 64 Units based on Units/kg, and the developmental no-effect dose of 0.25 Units/kg in rabbits is less than the average high human dose based on Units/kg. When pregnant rats received single intramuscular injections (1, 4, or 16 Units/kg) at three different periods of development (prior to implantation, implantation, or organogenesis), no adverse effects on fetal development were observed. The developmental no-effect level for a single maternal dose in rats (16 Units/kg) is approximately 16 times the average high human dose of 64 Units based on Units/kg. Risk Summary There are no data on the presence of BOTOX Cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production.   The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for BOTOX Cosmetic and any potential adverse effects on the breastfed infant from BOTOX Cosmetic or from the underlying maternal conditions. Safety and effectiveness in patients below the age of 18 years have not been established. Glabellar Lines In the two initial glabellar lines clinical studies of BOTOX Cosmetic, the responder rates appeared to be higher for subjects younger than age 65 than for subjects 65 years or older [see Clinical Studies ( 14 )] . Lateral Canthal Lines In the two lateral canthal lines clinical studies of BOTOX Cosmetic, the responder rates appeared to be higher for subjects younger than age 65 than for subjects 65 years or older. Forehead Lines In the two forehead lines clinical studies of BOTOX Cosmetic, the responder rates appeared to be higher for subjects younger than age 65 than for subjects 65 years or older.

Product summary:

BOTOX Cosmetic (onabotulinumtoxinA)  for injection is a vacuum-dried powder supplied in a single-dose vial in the following sizes: 50 Units: NDC 0023-3919-50 100 Units: NDC 0023-9232-01 BOTOX Cosmetic cartons have features to alert users if contents may have been compromised. Each BOTOX Cosmetic vial label and carton labeling also contain the U.S. License number 1889 [see Dosage and Administration ( 2.1 )] . Do not use the product and contact AbbVie for additional information at 1-800-678-1605 if the labeling is not as described above. Storage Unopened vials of BOTOX Cosmetic should be stored in a refrigerator 2° to 8°C (36º to 46ºF). Do not use after the expiration date on the vial. Reconstituted BOTOX Cosmetic should be stored in a refrigerator 2° to 8°C (36º to 46ºF) and administered within 24 hours. 

Authorization status:

Biologic Licensing Application

Patient Information leaflet

Allergan, Inc.
----------
MEDICATION GUIDE
BOTOX®
BOTOX® Cosmetic
(Boe-tox)
(onabotulinumtoxinA)
for injection, for intramuscular, intradetrusor,
or intradermal use
What is the most important information I should know about BOTOX and
BOTOX Cosmetic?
BOTOX and BOTOX Cosmetic may cause serious side effects that can be
life threatening, including:
•
Problems breathing or swallowing
•
Spread of toxin effects
These problems can happen hours, days, to weeks after an injection of
BOTOX or BOTOX Cosmetic.
Call your doctor or get medical help right away if you have any of
these problems after treatment with
BOTOX or BOTOX Cosmetic:
•
Problems swallowing, speaking, or breathing. These problems can happen
hours, days, to weeks
after an injection of BOTOX or BOTOX Cosmetic usually because the
muscles that you use to
breathe and swallow can become weak after the injection. Death can
happen as a complication if
you have severe problems with swallowing or breathing after treatment
with BOTOX or
BOTOX Cosmetic.
•
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 BOTOX or BOTOX Cosmetic.
•
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 BOTOX or BOTOX Cosmetic 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
•
double vision, blurred vision and drooping eyelids
•
hoarseness or change or loss of voice (dysphonia)
•
trouble saying words clearly (dysarthria)
•
loss of bladder control
•
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Summary of Product characteristics

BOTOX COSMETIC- ONABOTULINUMTOXINA INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
ALLERGAN, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BOTOX COSMETIC SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BOTOX COSMETIC.
BOTOX COSMETIC (ONABOTULINUMTOXINA) FOR INJECTION,
FOR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1989
WARNING: DISTANT SPREAD OF TOXIN EFFECT
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
THE EFFECTS OF BOTOX COSMETIC 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 BUT
SYMPTOMS CAN ALSO OCCUR IN ADULTS, PARTICULARLY IN THOSE PATIENTS WHO
HAVE AN
UNDERLYING CONDITION THAT WOULD PREDISPOSE THEM TO THESE SYMPTOMS.
(5.2)
INDICATIONS AND USAGE
BOTOX Cosmetic is an acetylcholine release inhibitor and a
neuromuscular blocking agent indicated in
adult patients for the temporary improvement in the appearance of (1):
Moderate to severe glabellar lines associated with corrugator and/or
procerus muscle activity
Moderate to severe lateral canthal lines associated with orbicularis
oculi activity
Moderate to severe forehead lines associated with frontalis muscle
activity
DOSAGE AND ADMINISTRATION
Botox Cosmetic is administered by intramuscular injection
Glabellar Lines Administration: 0.1 mL (4 Units) into each of 5 sites,
for a total dose of 20 Units (2.3)
Lateral Canthal Lines Administration: 0.1 mL (4 Units) into each of 3
sites per side (6 total injection
points), for a total of 24 Units (2.3)
Forehead Lines Administration: 0.1 mL (4 Units) into each of 5
forehead line sites (20 Units) with 0.1 mL
(4 Units) into each of 5 glabellar line sites (20 Units), for a
recommended total of 40 Units (