XEOMIN- incobotulinumtoxina 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:

Merz Pharmaceuticals, LLC

INN (International Name):

Botulinum Toxin Type A

Composition:

Botulinum Toxin Type A 50 [USP'U]

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

XEOMIN is indicated for the treatment of chronic sialorrhea in patients 2 years of age and older. Upper Limb Spasticity in Adult Patients XEOMIN is indicated for the treatment of upper limb spasticity in adult patients. Upper Limb Spasticity in Pediatric Patients, Excluding Spasticity Caused by Cerebral Palsy XEOMIN is indicated for the treatment of upper limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy. XEOMIN is indicated for the treatment of cervical dystonia in adult patients. XEOMIN is indicated for the treatment of blepharospasm in adult patients. XEOMIN 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. XEOMIN is contraindicated in patients with: - Known hypersensitivity to any botulinum toxin product or to any of the components in the formulation [see Warnings and Precautions (5.3) and Description (11)] . - Infection at t

Product summary:

XEOMIN for injection is a sterile white to off-white lyophilized powder supplied in Type 1 borosilicate glass single-dose vials with tamper-proof aluminum seals and bromobutyl rubber closures that are not made with natural rubber latex in the following pack sizes: Upper Limb Spasticity and Cervical Dystonia Chronic Sialorrhea and Blepharospasm Glabellar Lines Unopened vials of XEOMIN should be stored at or below 25°C (77°F). Refrigeration of unopened vials is not required. Do not use after the expiration date on the vial. Reconstituted XEOMIN may be stored in a refrigerator at 2°C to 8°C (36°F to 46°F) for up to 24 hours until time of use [see Dosage and Administration (2.7)].

Authorization status:

Biologic Licensing Application

Patient Information leaflet

Merz Pharmaceuticals, LLC
----------
This Medication Guide has been approved by the U. S. Food
and Drug Administration.
Revised: 9/2023
MEDICATION GUIDE
XEOMIN® (Zeo-min)
(incobotulinumtoxinA)
for injection, for intramuscular or intraglandular use
What is the most important information I should know about XEOMIN?
XEOMIN may cause serious side effects that can be life-threatening.
Call your doctor or get medical
help right away if you have any of these problems after treatment with
XEOMIN:
•
Problems with swallowing, speaking, or breathing. These problems can
happen hours to weeks
after an injection of XEOMIN 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 XEOMIN.
•
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
XEOMIN.
•
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 XEOMIN 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
•
trouble saying words clearly
•
loss of bladder control
•
trouble breathing
•
trouble swallowing
These symptoms can happen hours to weeks after you receive an
injection of XEOMIN..
These problems could make it unsafe for you to drive a car or do other
dangerous activities. See "What
should I avoid while rec

Summary of Product characteristics

XEOMIN- INCOBOTULINUMTOXINA INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
MERZ PHARMACEUTICALS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
XEOMIN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR XEOMIN.
XEOMIN (INCOBOTULINUMTOXINA) FOR INJECTION, FOR INTRAMUSCULAR OR
INTRAGLANDULAR USE
INITIAL U.S. APPROVAL: 2010
WARNING: DISTANT SPREAD OF TOXIN EFFECT
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
THE EFFECTS OF XEOMIN 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 UNDERLYING
CONDITIONS THAT WOULD PREDISPOSE THEM TO THESE SYMPTOMS. (5.1)
RECENT MAJOR CHANGES
Dosage and Administration (2.8)
9/2023
Warnings and Precautions (5.8)
9/2023
INDICATIONS AND USAGE
XEOMIN is an acetylcholine release inhibitor and neuromuscular
blocking agent indicated for the treatment
or improvement of:
Chronic sialorrhea in patients 2 years of age and older (1.1)
Upper limb spasticity in adults (1.2)
Upper limb spasticity in pediatric patients 2 to 17 years of age,
excluding spasticity caused by cerebral
palsy (1.2)
Cervical dystonia in adults (1.3)
Blepharospasm in adults (1.4)
Temporary improvement in the appearance of moderate to severe
glabellar lines with corrugator and/or
procerus muscle activity in adults (1.5)
DOSAGE AND ADMINISTRATION
Chronic Sialorrhea:
Chronic Sialorrhea in Adults: the recommended total dose is 100 Units
per treatment session
consisting of 30 Units per parotid gland and 20 Units per
submandibular gland, no sooner than every 16
weeks (2.2)
Chronic Sialorrhea in Pediatric Patients: the recommended dose is
based