BOTOX for OAB
OnabotulinumtoxinA
Allergan Injection
Prescription Only Medication BOTOX® is a prescription medicine that is injected into the bladder muscle to treat overactive bladder symptoms.

What is OAB?

Overactive Bladder (OAB) is a condition where the bladder contracts uncontrollably, creating leakage, the strong sudden need to "go right away", and going too often.

So what exactly is going on?

First, it's important to realize that OAB is not a “weak” bladder. In fact, OAB occurs when nerves are affected. These nerves send signals to your bladder at the wrong time, causing the muscle to squeeze without warning. This process causes your bladder to spasm uncontrollably, creating leakage, the strong sudden need to “go,” and going too often.

Does this sound like you?

You may still be experiencing leakage despite taking OAB medication and coping by:

  • Using multiple leakage pads per day
  • Planning all your travel around bathrooms
  • Not doing things you like because of the fear of leakage
  • Worrying about the problem every day

Are OAB symptoms impacting your quality of life?

LEARN MORE ABOUT BOTOX® TREATMENT

How long are you willing to suffer in silence?

OAB is actually a chronic condition that can be treated

  • Many people think that symptoms of OAB are just part of getting older.
  • They will often cope with OAB for years before being offered something other than a pill.

Make your voice heard and
tell your doctor how OAB affects you.

You may have already tried OAB medications

Did you discover that your OAB medications:

  1. Didn't work well enough? OR
  2. Had side effects you couldn't handle?

If this sounds familiar, you are not alone.

In 1 study of about 100,000 patients:
71%
reported that they stopped taking their OAB medication at some point within 6 months.

Speak up and tell your doctor if your OAB medication isn’t working the way you want. There are other options to try.

BOTOX® is different from other treatments

BOTOX® is different from other treatments

BOTOX® is placed in the bladder muscle about every 6 months to target the source of your OAB

  • In your body, certain chemicals travel from nerve cells to muscle cells to make your bladder contract so that you can urinate
  • For people who have OAB, these muscles contract uncontrollably, creating leakage, the strong sudden need to go, and going too often
  • BOTOX® is placed directly in the bladder muscle, where it helps block the nerve signals that trigger OAB

BOTOX® 101

Have questions about BOTOX® for Overactive Bladder? We have answers.

Watch the video  

Proven to work when other OAB medications did not

BOTOX® significantly reduced daily leakage episodes

Average decrease in leakage episodes in 3 clinical trials 3 months after treatment, compared to placebo.

BOTOX® reduced daily leakage episodes by half or more

At week 12 in clinical trials:

  • The majority of patients receiving BOTOX® had at least a 50% reduction of daily leakage episodes.
  • Many of these patients reduced their leakage episodes by 75%.
  • Approximately 1 in 4 of these patients reported leakage episodes stopped completely.

Reduction of urinary incontinence episodes in
3 clinical trials:

Study 1

  • Patients with ≥ 50% reduction: BOTOX® 57.5%, placebo 28.9% (P < .001)
  • Patients with ≥ 75% reduction: BOTOX® 44.6%, placebo 15.2% (P < .001)
  • Patients with 100% reduction: BOTOX® 22.9%, placebo 6.5% (P < .001)
BOTOX® n = 280;
placebo n = 277

Study 2

  • Patients with ≥ 50% reduction: BOTOX® 63.5%, placebo 33.2% (P < .001)
  • Patients with ≥ 75% reduction: BOTOX® 47.3%, placebo 20.3% (P < .001)
  • Patients with 100% reduction: BOTOX® 31.4%, placebo 10.3% (P < .001)
BOTOX® n = 277;
placebo n = 271

Study 3

  • Patients with ≥ 50% reduction: BOTOX® 77.2%, placebo 33.3% (P < .001)
  • Patients with ≥ 75% reduction: BOTOX® 55.2%, placebo 21.7% (P < .001)
  • Patients with 100% reduction: BOTOX® 33.8%, placebo 11.7% (P < .001)
BOTOX® n = 145;
placebo n = 60

Is BOTOX® covered by my insurance?

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

Results of a questionnaire

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 & APPROVED USE

BOTOX® (onabotulinumtoxinA)
Important Information


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 leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults 18 years and older when another type of medicine (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

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 preexisting 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; drooping eyelids; hoarseness or change or loss of voice; trouble saying words clearly; loss of bladder control; trouble breathing; and trouble swallowing

Scroll for Important Safety Information.

BOTOX® may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of receiving 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 catheterization posttreatment, if required, should be considered for treatment.

Patients treated for overactive bladder: In clinical trials, 36 of the 552 patients had to self-catheterize for urinary retention following treatment with BOTOX® compared to 2 of the 542 treated with placebo. The median duration of postinjection catheterization for these patients treated with BOTOX® 100 Units (n = 36) was 63 days (minimum 1 day to maximum 214 days), as compared to a median duration of 11 days (minimum 3 days to maximum 18 days) for patients receiving placebo (n = 2). Patients with diabetes mellitus treated with BOTOX® were more likely to develop urinary retention than nondiabetics.

Adult patients treated for overactive bladder caused by a neurologic disease: 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 adult patients not using CIC at baseline, those with MS were more likely to require CIC postinjection 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, including itching, rash, red itchy welts, wheezing, asthma symptoms, 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 may monitor you for any breathing problems during treatment with BOTOX® for detrusor overactivity associated with a neurologic condition. The risk of developing lung disease in patients with reduced lung function is increased in patients receiving BOTOX®.

Autonomic dysreflexia in patients treated for overactive bladder due to a neurologic disease. 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 adult 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; have weakness of forehead muscles, trouble raising your eyebrows, drooping eyelids, and 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 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; eye problems such as double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, dry eyes; drooping eyebrows; and upper respiratory tract infection. In adults being treated for urinary incontinence, other side effects include urinary tract infection and painful urination. If you have difficulty fully emptying your bladder on your own 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. Visitwww.fda.gov/medwatch or call
1-800-FDA-1088.

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