What is BOTOX®: BOTOX® is a treated toxin produced by the bacterium Clostridium botulinum called botulinum toxin. It is used medically to treat certain muscular conditions and cosmetically remove wrinkles.
How can BOTOX® help me: while you may have earned every one of your worry lines, you don’t have to show them if you don’t want to! If dynamic wrinkles are starting to make you look older or more negative, BOTOX® can help restore the rested, confident appearance you desire. BOTOX® is a remarkably safe and effective treatment which can help you control your facial expressions so that you don’t look angry or worried when you aren’t. BOTOX® treatments can help prevent the unintended display of negative feelings, and as such help some people express themselves more accurately. Injected around the skin wrinkles, BOTOX® makes the underlying muscles relax and stop pulling the skin.
Is it safe: side effects caused by injections of BOTOX® are not severe nor long lasting and are easily improved.
Is it painful: pain during injection of BOTOX® is minimal. Numbing creams may be used to alleviate discomfort. No pain is expected after the procedure.
How long does the effect last: effect usually lasts anywhere from 3—6 months.
SAVE YOUR RECEIPTS!
All BOTOX® cosmetic treatment expenses that are not covered by a drug plan or health spending account are a tax-deductible medical expense.
IMPORTANT SAFETY INFORMATION
- 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.
- BOTOX® is contraindicated for intradetrusor injection in patients with a urinary tract infection; or in patients with urinary retention or post-void residual (PVR) urine volume > 200 mL who are not routinely performing clean intermittent self-catheterization (CIC).
WARNINGS AND PRECAUTIONS
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.
No definitive serious adverse event reports of distant spread of toxin effect associated with BOTOX®for Blepharospasm at the recommended dose (30 Units and below), severe primary axillary hyperhidrosis at the recommended dose (100 Units), Strabismus, or for Chronic Migraine at the labeled doses have been reported.
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).
- Pulmonary Effects of BOTOX®in Patients With Compromised Respiratory Status Treated for Spasticity or for Detrusor Overactivity Associated With a Neurologic Condition
- Patients with compromised respiratory status treated with BOTOX®for adult spasticity detrusor overactivity associated with a neurologic condition should be monitored closely.
- Corneal Exposure and Ulceration in Patients Treated With BOTOX®for Blepharospasm
- Reduced blinking from BOTOX®injection of the orbicularis muscle can lead to corneal exposure, persistent epithelial defect, and corneal ulceration, especially in patients with VII nerve disorders.
- Retrobulbar Hemorrhages in Patients Treated With BOTOX®for Strabismus
- During the administration of BOTOX®for the treatment of Strabismus, retrobulbar hemorrhages sufficient to compromise retinal circulation have occurred. It is recommended that appropriate instruments to decompress the orbit be accessible.
- 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%). In pediatric patients treated for upper limb spasticity, upper respiratory tract infections were reported more frequently as an adverse reaction in patients treated with BOTOX® (17% at 6 Units/kg and 10% at 3 Units/kg) compared to placebo (9%).
- Autonomic Dysreflexia in Patients Treated for Detrusor Overactivity Associated With a Neurologic Condition
- Autonomic dysreflexia associated with intradetrusor injections of BOTOX®could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in patients treated with BOTOX® 200 Units compared with placebo (1.5% versus 0.4%, respectively).
- Urinary Tract Infections in Patients With Overactive Bladder
- BOTOX®increases the incidence of urinary tract infection. Clinical trials for overactive bladder excluded patients with more than 2 UTIs in the past 6 months and those taking antibiotics chronically due to recurrent UTIs. Use of BOTOX® for the treatment of overactive bladder in such patients and in patients with multiple recurrent UTIs during treatment should only be considered when the benefit is likely to outweigh the potential risk.
- Urinary Retention in Patients Treated for Bladder Dysfunction
- Due to the risk of urinary retention, treat only patients who are willing and able to initiate catheterization post treatment, if required, for urinary retention.
- In patients who are not catheterizing, post-void residual (PVR) urine volume should be assessed within 2 weeks post treatment and periodically as medically appropriate up to 12 weeks, particularly in patients with multiple sclerosis or diabetes mellitus. Depending on patient symptoms, institute catheterization if PVR urine volume exceeds 200 mL and continue until PVR falls below 200 mL. Instruct patients to contact their physician if they experience difficulty in voiding as catheterization may be required.
- Overactive Bladder
- In clinical trials, 6.5% of patients (36/552) initiated clean intermittent catheterization for urinary retention following treatment with BOTOX®100 Units as compared to 0.4% of patients (2/542) treated with placebo. The median duration of catheterization for patients treated with BOTOX® 100 Units was 63 days (minimum 1 day to maximum 214 days) as compared to a median duration 11 days (minimum 3 days to maximum 18 days) for patients receiving placebo.
- Patients with diabetes mellitus treated with BOTOX®were more likely to develop urinary retention than nondiabetics. In clinical trials, 12.3% of patients (10/81) with diabetes developed urinary retention following treatment with BOTOX® 100 Units vs 0% of patients (0/69) treated with placebo. In patients without diabetes, 6.3% of patients (33/526) developed urinary retention following treatment with BOTOX® 100 Units vs 0.6% of patients (3/516) treated with placebo.
- Detrusor Overactivity Associated With a Neurologic Condition
- In clinical trials, 30.6% of patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection, required catheterization for urinary retention following treatment with BOTOX® 200 Units as compared to 6.7% of patients (7/104) treated with placebo. The median duration of postinjection catheterization for these patients treated with BOTOX® 200 Units (n = 33) was 289 days (minimum 1 day to maximum 530 days) as compared to a median duration of 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n = 7).
- Among patients not using CIC at baseline, those with multiple sclerosis (MS) were more likely to require CIC post injection than those with spinal cord injury (SCI).
- 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.
- Hypersensitivity Reactions
- The most frequently reported adverse reactions for overactive bladder occurring within 12 weeks of injection include urinary tract infection (BOTOX®18%, placebo 6%), dysuria (BOTOX® 9%, placebo 7%), urinary retention (BOTOX® 6%, placebo 0%), bacteriuria (BOTOX® 4%, placebo 2%), and residual urine volume (BOTOX® 3%, placebo 0%).
- A higher incidence of urinary tract infection was observed in patients with diabetes mellitus treated with BOTOX® 100 Units and placebo than nondiabetics.
- The incidence of UTI increased in patients who experienced a maximum post-void residual (PVR) urine volume ≥ 200 mL following BOTOX®injection compared to those with a maximum PVR < 200 mL following BOTOX® injection, 44% vs 23%, respectively.
- The most frequently reported adverse reactions within 12 weeks of BOTOX® injection for detrusor overactivity associated with a neurologic condition include urinary tract infection (BOTOX® 24%, placebo 17%), urinary retention (BOTOX® 17%, placebo 3%), and hematuria (BOTOX® 4%, placebo 3%).
- The following adverse event rates were reported at any time following initial injection and prior to reinjection or study exit (median duration of 44 weeks of exposure): urinary tract infections (49%), urinary retention (17%), constipation (4%), muscular weakness (4%), dysuria (4%), fall (3%), gait disturbance (3%), and muscle spasm (2%).
- 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%).
- 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 with 0.3% of placebo-treated patients.
- The most frequently reported adverse reactions following injection of BOTOX®for upper limb spasticity include pain in extremity, muscle weakness, fatigue, nausea, and bronchitis.
- 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.
- The most frequently reported adverse reactions following injection of BOTOX®in pediatric patients 2 to 17 years of age with upper limb spasticity include upper respiratory tract infection (includes upper respiratory tract infection and viral upper respiratory tract infection), injection-site pain, nausea, constipation, rhinorrhea, nasal congestion, and seizure (includes seizure and partial seizure).
- 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%).
- The most frequently reported adverse reactions following injection of BOTOX®for Blepharospasm include ptosis (21%), superficial punctate keratitis (6%), and eye dryness (6%).
- The most frequently reported adverse events following injection of BOTOX®for Strabismus include ptosis (15.7%) and vertical deviation (16.9%).
- The most frequently reported adverse events (3%-10% of adult patients) following injection of BOTOX®for severe primary axillary hyperhidrosis include in double-blind studies injection-site pain and hemorrhage, nonaxillary sweating, infection, pharyngitis, flu syndrome, headache, fever, neck or back pain, pruritus, and anxiety.
- 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.