IMPORTANT SAFETY INFORMATION & APPROVED USE

BOTOX® (onabotulinumtoxinA)
Important Information

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; urgency and frequency in adults when another type of medication (anticholinergic) does not work well enough or cannot be taken
  • To treat leakage of urine (incontinence) in adults, with overactive bladder due to neurologic condition, 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 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.

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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 take 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 an infection at the planned injection site.

Do not take 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 post-treatment, if required, should be considered for treatment.

Patients treated for overactive bladder due to 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®.

For patients treated for overactive bladder due to a neurologic condition:

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 overactive bladder 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; 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 nonprescription medicines, vitamins, and herbal products. 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: 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. Other side effects 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

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.

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

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; urgency and frequency in adults when another type of medication (anticholinergic) does not work well enough or cannot be taken
  • To treat leakage of urine (incontinence) in adults, with overactive bladder due to neurologic condition, who still have leakage or cannot tolerate the side effects after trying an anticholinergic medication

Reference:

BOTOX (onabotulinumtoxinA) Prescribing Information, April 2017.

Program Terms, Conditions, and Eligibility Criteria:

  1. This offer is good for use only with a valid prescription for BOTOX® (onabotulinumtoxinA).
  2. Based on insurance coverage, the offer is valid for up to $500 off per treatment for up to 4 treatments received in 2018, for people with Overactive Bladder or Overactive Bladder due to a neurologic disease. All treatments must be received during 2018. Maximum savings limit of $2000 per year for people with Overactive Bladder or Overactive Bladder due to a neurologic disease applies; patient out-of-pocket expense may vary.
  3. This offer is not valid for use by patients enrolled in Medicare, Medicaid, or other federal or state programs (including any state pharmaceutical assistance programs), or private indemnity or HMO insurance plans that reimburse you for the entire cost of your prescription drugs. Patients may not use this offer if they are Medicare-eligible and enrolled in an employer-sponsored health plan or prescription drug benefit program for retirees. This offer is not valid for cash-paying patients.
  4. This offer is valid for up to 4 treatments per year. Offer applies only to treatment received before the program expires on 12/31/18.
  5. Offer is valid only for BOTOX® and BOTOX® treatment-related costs not covered by insurance.
  6. A BOTOX® Savings Program check will be provided upon approval of a claim. The claim must be submitted with treatment details from an Explanation of Benefits (EOB) or a Specialty Pharmacy Provider (SPP) receipt. (If the BOTOX® prescription was filled by a Specialty Pharmacy Provider, both an EOB and SPP details must be provided.) All claims must be submitted within 90 days of the date of EOB receipt. You may be required to provide a copy of your EOB or SPP receipt for your claim to be approved.
  7. Allergan reserves the right to rescind, revoke, or amend this offer without notice.
  8. Offer good only in the USA, including Puerto Rico, at participating retail locations.
  9. Void where prohibited by law, taxed, or restricted.
  10. This offer is not health insurance.
  11. By redeeming the BOTOX® Savings Program check, you acknowledge that you are an eligible patient and that you understand and agree to comply with the terms and conditions of this offer.

For questions about this program, please call 1-800-44-BOTOX.