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Text Content

Full Prescribing Information, including Boxed Warning Medication Guide

Program ID: MF164014

EVENT DETAILS

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TOPIC

 * Masterclass-On-Demand Series


PROGRAM COORDINATOR

Catie Suliga
(732) 889-2600


CSULIGA@MEDFORCE.NET

Please be advised that we will use your personally identifiable information to
contact you about your participation at this program. This information will be
shared only with AbbVie and Medforce in support of this program. If you are not
an HCP, click here to register.

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SamoaArizonaArkansasCaliforniaColoradoConnecticutDelawareDistrict of
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DakotaTennesseeTexasU.S. Armed Forces of AmericasU.S. Armed Forces of EuropeU.S.
Armed Forces of PacificU.S. Virgin IslandsUtahVermontVirginiaWashingtonWest
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Topic

 * Masterclass-On-Demand Series


PROGRAM COORDINATOR

Catie Suliga

(732) 889-2600

csuliga@medforce.net

INDICATION AND IMPORTANT SAFETY INFORMATION

Expand

CHRONIC MIGRAINE

BOTOX® is indicated for the prophylaxis of headaches in adult patients with
Chronic Migraine (≥ 15 days per month with headache lasting 4 hours a day or
longer).

LIMITATIONS OF USE

Safety and effectiveness have not been established for the prophylaxis of
episodic migraine (14 headache days or fewer per month) in 7 placebo-controlled
studies.

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

WARNING: DISTANT SPREAD OF TOXIN EFFECT

Postmarketing reports indicate that the effects of BOTOX® and all botulinum
toxin products may spread from the area of injection to produce symptoms
consistent with botulinum toxin effects. These may include asthenia, generalized
muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary
incontinence, and breathing difficulties. 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 treated for spasticity and other conditions, particularly in
those patients who have an underlying condition that would predispose them to
these symptoms. In unapproved uses and approved indications, cases of spread of
effect have been reported at doses comparable to those used to treat Cervical
Dystonia and spasticity and at lower doses.

CONTRAINDICATIONS

BOTOX® is contraindicated in the presence of infection at the proposed injection
site(s) and in patients who are hypersensitive to any botulinum toxin product or
to any of the components in the formulation.


WARNINGS AND PRECAUTIONS

SPREAD OF TOXIN EFFECT

See Boxed Warning.
No definitive serious adverse event reports of distant spread of toxin effect
associated with BOTOX® for Chronic Migraine at the labeled doses have been
reported.

Lack of Interchangeability Between Botulinum Toxin Products
The potency Units of BOTOX® are specific to the preparation and assay method
utilized. They are not interchangeable with other preparations of botulinum
toxin products and, therefore, Units of biological activity of BOTOX® cannot be
compared to nor converted into Units of any other botulinum toxin products
assessed with any other specific assay method.

SERIOUS ADVERSE REACTIONS WITH UNAPPROVED USE

Serious adverse reactions, including excessive weakness, dysphagia, and
aspiration pneumonia, with some adverse reactions associated with fatal
outcomes, have been reported in patients who received BOTOX® injections for
unapproved uses. In these cases, the adverse reactions were not necessarily
related to distant spread of toxin, but may have resulted from the
administration of BOTOX® to the site of injection and/or adjacent structures. In
several of the cases, patients had pre-existing dysphagia or other significant
disabilities. There is insufficient information to identify factors associated
with an increased risk for adverse reactions associated with the unapproved uses
of BOTOX®. The safety and effectiveness of BOTOX® for unapproved uses have not
been established.

HYPERSENSITIVITY REACTIONS

Serious and/or immediate hypersensitivity reactions have been reported. These
reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and
dyspnea. If such a reaction occurs, further injection of BOTOX® should be
discontinued and appropriate medical therapy immediately instituted. One fatal
case of anaphylaxis has been reported in which lidocaine was used as the
diluent, and consequently the causal agent cannot be reliably determined.

INCREASED RISK OF CLINICALLY SIGNIFICANT EFFECTS WITH PRE-EXISTING NEUROMUSCULAR
DISORDERS

Individuals with peripheral motor neuropathic diseases, amyotrophic lateral
sclerosis (ALS), or neuromuscular junction disorders (eg, myasthenia gravis or
Lambert-Eaton syndrome) should be monitored when given botulinum toxin. Patients
with known or unrecognized neuromuscular disorders or neuromuscular junction
disorders may be at increased risk of clinically significant effects, including
generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe
dysphagia, and respiratory compromise from therapeutic doses of BOTOX® (see
Warnings and Precautions).

DYSPHAGIA AND BREATHING DIFFICULTIES

Treatment with BOTOX® and other botulinum toxin products can result in
swallowing or breathing difficulties. Patients with pre-existing swallowing or
breathing difficulties may be more susceptible to these complications. In most
cases, this is a consequence of weakening of muscles in the area of injection
that are involved in breathing or oropharyngeal muscles that control swallowing
or breathing (see Boxed Warning).

HUMAN ALBUMIN AND TRANSMISSION OF VIRAL DISEASES

This product contains albumin, a derivative of human blood. Based on effective
donor screening and product manufacturing processes, it carries an extremely
remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob
disease (vCJD). There is a theoretical risk for transmission of
Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of
transmission would also be considered extremely remote. No cases of transmission
of viral diseases, CJD, or vCJD have ever been identified for licensed albumin
or albumin contained in other licensed products.

ADVERSE REACTIONS

Adverse reactions to BOTOX® for injection are discussed in greater detail in the
following sections: Boxed Warning, Contraindications, and Warnings and
Precautions.

CHRONIC MIGRAINE

The most frequently reported adverse reactions following injection of BOTOX® for
Chronic Migraine include neck pain (9%), headache (5%), eyelid ptosis (4%),
migraine (4%), muscular weakness (4%), musculoskeletal stiffness (4%),
bronchitis (3%), injection-site pain (3%), musculoskeletal pain (3%), myalgia
(3%), facial paresis (2%), hypertension (2%), and muscle spasms (2%).

Severe worsening of migraine requiring hospitalization occurred in approximately
1 of BOTOX treated patients in study 1 and study 2, usually within the first
week after treatment, compared to 0.3% of placebo-treated patients.

POSTMARKETING EXPERIENCE

Adverse reactions that have been identified during postapproval use of BOTOX®
are discussed in greater detail in Postmarketing Experience (Section 6.3 of the
Prescribing Information).

There have been spontaneous reports of death, sometimes associated with
dysphagia, pneumonia, and/or other significant debility or anaphylaxis, after
treatment with botulinum toxin. There have also been reports of adverse events
involving the cardiovascular system, including arrhythmia and myocardial
infarction, some with fatal outcomes. Some of these patients had risk factors
including cardiovascular disease. The exact relationship of these events to the
botulinum toxin injection has not been established.

DRUG INTERACTIONS

Co-administration of BOTOX® and other agents interfering with neuromuscular
transmission (eg, aminoglycosides, curare-like compounds) should only be
performed with caution as the effect of the toxin may be potentiated. Use of
anticholinergic drugs after administration of BOTOX® may potentiate systemic
anticholinergic effects. The effect of administering different botulinum
neurotoxin products at the same time or within several months of each other is
unknown. Excessive neuromuscular weakness may be exacerbated by administration
of another botulinum toxin prior to the resolution of the effects of a
previously administered botulinum toxin. Excessive weakness may also be
exaggerated by administration of a muscle relaxant before or after
administration of BOTOX®.

Please see full Prescribing Information, including Boxed Warning and Medication
Guide .

Allergan adheres to all applicable federal and state laws and regulations,
including disclosure requirements. Attendance at speaker programs is limited to
active healthcare professionals. Accordingly, we appreciate your support in not
bringing a spouse and/or guest to this promotional program. Additional
attendance restrictions may apply based on specific state or federal
requirements and where otherwise prohibited by law. It is Abbvie policy to only
include healthcare professionals who are involved in patient care consistent
with our product indication(s).

For any technical difficulties contact: Medforce at (888) 358-5572 or
support@allerganspeakerprograms.com

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© 2023 AbbVie. All rights reserved. BOTOX® and its design are registered
trademarks of Allergan, Inc., an AbbVie company. All trademarks are the property
of their respective owners.
US-BCM-220071 04/22

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