BOTOX onabotulinumtoxinA See What's Possible.

Important Safety Information Including Boxed Warning| Full Product Information Including Boxed Warning| Medication Guide

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What Results Can I Expect With BOTOX®?

Proven to work when other OAB medications did not

In 2 clinical trials in patients with
MS or spinal cord injury, 6 weeks after
treatment, compared to placebo:

BOTOX® significantly
reduced leakage episodes

If you want leakage reduction, BOTOX® can help. Individual results may vary.

At week 6 in clinical trials:

BOTOX® reduced leakage episodes by half or more

The majority of patients receiving BOTOX® had at least 50% reduction of weekly leakage episodes.

Many of these patients reduced their leakage episodes by 75%.

Approximately 1 in 3 patients reported
no leakage episodes.

Reduction in urinary incontinence (UI) episodes in 2 clinical trials:

Study 1: BOTOX® 200 Units (n = 135); placebo (n = 149)

  • Patients with ≥ 50% reduction: BOTOX® 74.8%, placebo 38.3% (P < .001)
  • Patients with ≥ 75% reduction: BOTOX® 61.5%, placebo 25.5% (P < . 001)
  • Patients with 100% reduction: BOTOX® 36.3%, placebo 10.1% (P < .001)

Study 2: BOTOX® 200 Units (n = 92); placebo (n = 92)

  • Patients with ≥ 50% reduction: BOTOX® 77.2%, placebo 39.1% (P < .001)
  • Patients with ≥ 75% reduction: BOTOX® 64.1%, placebo 20.7% (P < .001)
  • Patients with 100% reduction: BOTOX® 38.0%, placebo 7.6% (P < .001)

BOTOX® may positively impact your daily life by significantly reducing leakage episodes

Patients in BOTOX® clinical trials reported improvement in their overall quality of life based on 3 categories*:

Avoidance and
limiting behavior

Such as overplanning
every detail of your
day in advance,
worrying about where
bathrooms are, and
limiting how much
fluid you drink.

Psychosocial impact
Such as being preoccupied or frustrated with how your condition impacts your everyday decisions, such as what you can wear, where you can go, and how you feel about your overall well-being.

Social embarrassment
Such as being
embarrassed or
worried that your
symptoms might be
noticed by others.

*These improvements were reported using the Incontinence Quality of Life questionnaire (iQOL). This is a validated questionnaire that is used to measure the impact of urinary incontinence on a patient’s quality of life.

IMPORTANT SAFETY INFORMATION

BOTOX® may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX®:

  • Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months
  • Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, 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

BOTOX® may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX®. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Do not receive BOTOX® if you: are allergic to any of the ingredients in BOTOX® (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.

Do not receive BOTOX® for the treatment of urinary incontinence if you: have a urinary tract infection (UTI) or cannot empty your bladder on your own (and are not routinely catheterizing). Due to the risk of urinary retention (difficulty fully emptying the bladder), only patients who are willing and able to initiate self-catheterization post-treatment, if required, should be considered for treatment. Patients with diabetes mellitus treated with BOTOX® were more likely to develop urinary retention than non-diabetics.

Patients treated for overactive bladder caused by 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 post-injection 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 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n = 7). Among patients not using CIC at baseline, those with MS were more likely to require CIC post-injection than those with SCI.

The dose of BOTOX® is not the same as, or comparable to, another botulinum toxin product.

Serious and/or immediate allergic reactions have been reported. They include itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you experience symptoms; further injection of BOTOX® should be discontinued.

Tell your doctor about all your muscle or nerve conditions such as ALS or Lou Gehrig's disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX®.

Tell your doctor if you have any breathing-related problems. Your doctor will want to monitor you for any breathing problems during your treatment with BOTOX® for detrusor overactivity associated with a neurologic condition. The risk of pulmonary effects in patients with compromised respiratory status is increased in patients receiving BOTOX®.

Autonomic dysreflexia. 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).

Tell your doctor about all your medical conditions, including if you: have or have had bleeding problems; have plans to have surgery; had surgery on your face; weakness of forehead muscles; trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; have symptoms of a urinary tract infection (UTI) and are being treated for urinary incontinence. Symptoms of a urinary tract infection may include pain or burning with urination, frequent urination, or fever; have problems emptying your bladder on your own and are being treated for urinary incontinence; are pregnant or plan to become pregnant (it is not known if BOTOX® can harm your unborn baby); are breastfeeding or plan to (it is not known if BOTOX® passes into breast milk).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX® with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® in the past.

Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.

Other side effects of BOTOX® include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes. In people being treated for urinary incontinence, other side effects include: urinary tract infection, painful urination, and/or inability to empty your bladder on your own. If you have difficulty fully emptying your bladder after receiving BOTOX®, you may need to use disposable self-catheters to empty your bladder up to a few times each day until your bladder is able to start emptying again.

For more information, refer to the Medication Guide or talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

Indications

BOTOX® is a prescription medicine that is injected into the bladder muscle and used:

  • To treat overactive bladder symptoms such as a strong need to urinate with leakage or wetting accidents, going too often, and the strong, sudden need to go in adults 18 years and older when another type of medication (anticholinergic) does not work well enough or cannot be taken
  • To treat leakage of urine (incontinence) in adults 18 years and older with overactive bladder caused by a neurologic disease who still have leakage or cannot tolerate the side effects after trying an anticholinergic medication

Please see BOTOX® full Product Information including Boxed Warning and Medication Guide.

Allergan Urology
Important Safety Information +