BOTOX® is the first medicine in its class approved by the FDA to treat Pediatric Upper Limb Spasticity in children 2 to 17 years of age.

BOTOX® is a prescription medicine that is injected into muscles to treat increased muscle stiffness in people 2 years of age and older with spasticity.

BOTOX® has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles.

experience

Doctors have been using BOTOX® since 1989 to treat people 12 years and older for certain types of eye muscle problems (Strabismus) or abnormal spasm of the eyelids (Blepharospasm).

How Does BOTOX® Work?

BOTOX® works by temporarily blocking nerve signals that cause muscle stiffness.

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THIS HELPS REDUCE SPASTICITY IN YOUR CHILD’S ARM.
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How Is BOTOX® Given?

BOTOX® is injected by a doctor directly into muscles of the arm that are affected by spasticity.

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THIS IS DIFFERENT FROM ORAL MEDICATIONS YOUR CHILD MAY TAKE.
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What Are the Possible Side Effects of BOTOX®?

The most common side effects seen in clinical study for pediatric upper limb spasticity were:

  • Upper respiratory tract infection*
  • Stuffy and runny nose
  • Injection-site pain
  • Constipation
  • Nausea
  • Seizure

*Includes viral upper respiratory tract infection.
Includes partial seizure.

These side effects occurred in ≥ 2% of patients who received 6 Units/kg of BOTOX® in the clinical studies.

These do not cover all the possible serious side effects of BOTOX®. Please see the Medication Guide, the Important Safety Information, and talk to your child’s doctor.

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Ask your child’s doctor if BOTOX® is right for them
IMPORTANT SAFETY INFORMATION AND APPROVED USES

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 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, and trouble swallowing
IMPORTANT SAFETY INFORMATION AND APPROVED USES

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 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, and trouble swallowing

There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX® has been used at the recommended dose to treat Blepharospasm or Strabismus.

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.

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 breathing problems during your treatment with BOTOX® for spasticity. The risk of developing lung disease in patients with reduced lung function is increased in patients receiving BOTOX®.

Upper respiratory tract infections (common colds) have been reported. In pediatric patients treated with BOTOX® for upper limb spasticity, upper respiratory tract infections were reported more frequently. In pediatric patients treated with BOTOX® for lower limb spasticity, upper respiratory tract infections were not reported more frequently than placebo.

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; 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 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: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, dry eyes; drooping eyebrows; and upper respiratory tract infection.

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 muscles and used:

  • To treat increased muscle stiffness in people 2 years of age and older with spasticity
  • To treat certain types of eye muscle problems (Strabismus) or abnormal spasm of the eyelids (Blepharospasm) in people 12 years and older

BOTOX® has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles.

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