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OnabotulinumtoxinA Solution for injection

This medicine is used to treat crossed eyes, eyelid spasms, severe neck muscle spasms, and elbow, wr... more

Generic Name: botulinum toxin type A  |  Brand Name: Botox

Brand Names: Botox, Botox Cosmetic

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[UPDATED 08/03/2009] FDA notified healthcare professionals of changes to the established drug names for botulinum toxin Type A (Botox/Botox Cosmetic, Dysport) and botulinum toxin Type B (Myobloc) to reinforce individual potencies and prevent medication errors, and provided recommendations for healthcare professionals to consider, plus information for patients, family members, and caregivers. For more information visit the FDA website at: [Web] and [Web].

Summary of FDA-Approved Botulinum Toxin Products
Trade Name NEW Drug Name OLD Drug Name Indication
Botox OnabotulinumtoxinA Botulinum toxin type A Cervical dystonia, Severe primary axillary hyperhidrosis, Strabismus, Blepharospasm
Botox Cosmetic OnabotulinumtoxinA Botulinum toxin type A Temporary improvement in the appearance of moderate to severe glabellar lines
Dysport AbobotulinumtoxinA Botulinum toxin type A Cervical dystonia, temporary improvement in the appearance to moderate to severe glabellar lines
Myobloc RimabotulinumtoxinB Botulinum toxin type B Cervical dystonia
The marketed trade names and the product formulations have not changed.

[Posted 04/30/2009] FDA notified healthcare professionals that after an ongoing safety review initiated in February 2008, the manufacturers of licensed botulinum toxin products [botulinum toxin Type A (Botox and Botox Cosmetic) and botulinum toxin Type B (Myobloc)] will be required by FDA to strengthen warnings in product labeling and add a boxed warning regarding the risk of adverse events when the effects of the toxin spread beyond the site where it was injected.

FDA will also require that manufacturers develop and implement a Risk Evaluation and Mitigation Strategy [REMS], including a communication plan to provide more information regarding the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that botulinum toxin products cannot be interchanged. The REMS would also include a Medication Guide that explains the risks to patients, their families, and caregivers. FDA is requiring the manufacturers to submit safety data after multiple administrations of the product in a specified number of children and adults with spasticity to assess the signal of serious risk regarding distant spread of toxin effects.

FDA’s evaluation of the data continues to support the recommendations made in the 2008 Early Communication. For more information visit the FDA website at: [Web], and [Web].

REMS:

FDA approved a REMS for onabotulinumtoxina (formerly botulinum toxin a) to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of onabotulinumtoxina (formerly botulinum toxin a) and consists of the following: medication guide and communication plan. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

What is this medicine?

ONABOTULINUMTOXINA is a neuro-muscular blocker. This medicine is used to treat crossed eyes, eyelid spasms, severe neck muscle spasms, and elbow, wrist, and finger muscle spasms. It is also used to treat excessive underarm sweating, to prevent chronic migraine headaches, and to treat loss of bladder control due to neurologic conditions such as multiple sclerosis or spinal cord injury.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • breathing problems
  • cerebral palsy spasms
  • difficulty urinating
  • heart problems
  • history of surgery where this medicine is going to be used
  • infection at the site where this medicine is going to be used
  • myasthenia gravis or other neurologic disease
  • nerve or muscle disease
  • surgery plans
  • take medicines that treat or prevent blood clots
  • thyroid problems
  • an unusual or allergic reaction to botulinum toxin, albumin, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

This medicine is for injection into a muscle. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 years old for selected conditions, precautions do apply.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

  • aminoglycoside antibiotics like gentamicin, neomycin, tobramycin
  • muscle relaxants
  • other botulinum toxin injections

What should I watch for while using this medicine?

Visit your doctor for regular check ups.

This medicine will cause weakness in the muscle where it is injected. Tell your doctor if you feel unusually weak in other muscles. Get medical help right away if you have problems with breathing, swallowing, or talking.

This medicine might make your eyelids droop or make you see blurry or double. If you have weak muscles or trouble seeing do not drive a car, use machinery, or do other dangerous activities.

This medicine contains albumin from human blood. It may be possible to pass an infection in this medicine, but no cases have been reported. Talk to your doctor about the risks and benefits of this medicine.

If your activities have been limited by your condition, go back to your regular routine slowly after treatment with this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • breathing problems
  • changes in vision
  • chest pain or tightness
  • eye irritation, pain
  • fast, irregular heartbeat
  • infection
  • numbness
  • speech problems
  • swallowing problems
  • unusual weakness

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • bruising or pain at site where injected
  • drooping eyelid
  • dry eyes or mouth
  • headache
  • muscles aches, pains
  • sensitivity to light
  • tearing

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.


Last Updated: October 25, 2011
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