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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.
Chronic Migraine
BOTOX® (onabotulinumtoxinA) for injection 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.
Spasticity
BOTOX is indicated for the treatment of spasticity in patients 2 years of age and older.
Limitations of Use
BOTOX has not been shown to improve upper extremity functional abilities or range of motion at a joint affected by a fixed contracture.
Cervical Dystonia
BOTOX is indicated for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.
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.
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.
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 preexisting 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 Preexisting 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 preexisting 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).
Pulmonary Effects of BOTOX in Patients With Compromised Respiratory Status Treated for Spasticity
Patients with compromised respiratory status treated with BOTOX for spasticity should be monitored closely.
Bronchitis and Upper Respiratory Tract Infections in Patients Treated for Spasticity
Bronchitis was reported more frequently as an adverse reaction in adult patients treated for upper limb spasticity with BOTOX (3% at 251 Units to 360 Units total dose) compared to placebo (1%). In adult patients with reduced lung function treated for upper limb spasticity, upper respiratory tract infections were also reported more frequently as adverse reactions in patients treated with BOTOX (11% at 360 Units total dose; 8% at 240 Units total dose) compared to placebo (6%). In adult patients treated for lower limb spasticity, upper respiratory tract infections were reported more frequently as an adverse reaction in patients treated with BOTOX (2% at 300 Units to 400 Units total dose) compared to placebo (1%).
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 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 vs placebo include, respectively, neck pain (9% vs 3%); headache (5% vs 3%); eyelid ptosis (4% vs <1%); migraine (4% vs 3%); muscular weakness (4% vs <1%); musculoskeletal stiffness (4% vs 1%); bronchitis (3% vs 2%); injection-site pain (3% vs 2%); musculoskeletal pain (3% vs 1%); myalgia (3% vs 1%); facial paresis (2% vs 0%); hypertension (2% vs 1%); and muscle spasms (2% vs 1%).
Adult Upper Limb Spasticity
The most frequently reported adverse reactions following injection of BOTOX for upper limb spasticity include pain in extremity, muscular weakness, fatigue, nausea, and bronchitis.
Adult Lower Limb Spasticity
The most frequently reported adverse reactions following injection of BOTOX for lower limb spasticity include arthralgia, back pain, myalgia, upper respiratory tract infection, and injection-site pain.
Cervical Dystonia
The most frequently reported adverse reactions following injection of BOTOX for cervical dystonia include dysphagia (19%), upper respiratory infection (12%), neck pain (11%), and headache (11%).
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.
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 BOTOX® full Prescribing Information, including Boxed Warning and Medication Guide, or visit https://www.rxabbvie.com/pdf/botox_pi.pdf.