Use in Adults
OnabotulinumtoxinA

THIS GUIDE PROVIDES A PARTIAL LISTING OF PRESCRIBING INFORMATION FOR THIS MEDICATION. FOR A FULL LISTING OF PRESCRIBING INFORMATION PLEASE REFER TO THE PACKAGE INSERT. CLICK ON THE BRAND NAME® TO VIEW THE LINK TO THE PACKAGE INSERT.

Brands:

• BOTOX® (OnabotulinumtoxinA) For Complete Prescribing Information Click Here for the Package Insert​

Available Dosages:

• 200 unit vial

Initial Dose:

• 155 units injected intramuscularly in 31 pre-specified sites in the head & neck

​Maintenance Dose: 

• 155 units injected intramuscularly in 31 sites in the head & neck every 12 weeks over 31 sites

Suggested Titration Schedule:

• No titration necessary
• A fixed dosage is administered every three months​

Common and Rarer Side Effects:

• Ptosis in 3-4%
• Neck pain/weakness, injection site pain
• Migraines may flare for 2-5 days after injection  
• Rare systemic spread of toxin (dysphagia, diplopia, vocal cord paralysis, respiratory depression)

Headache Specialist Suggestions:
OnabotulinumtoxinA is used for the prevention of chronic migraine.  

• Chronic migraine is defined as those with:
  •  Diagnosis of migraine
  • 15 or more headache days per month (includes migraine + non migraine headaches)
  • 8 or more days per month that meet migraine criteria

It is NOT indicated for the prevention of episodic migraine.
Consider its use in: Chronic migraine

• has no side effects of memory loss or weight gain
• In those that have medication intolerances
• with or without medication overuse
• Avoid its use in:
  • Those with cellulitis overlying the injection sites
  • Neuromuscular disorders such as myasthenia gravis
• Advantages are:
  • Good efficacy, long track record and moderate side effect profile, when administered by an experienced, well-trained injector
  • Few drug interactions
• Disadvantages are:
  • Ptosis in 3-4%
  • Patients often lose facial expression, as forehead muscles are paralyzed
  • Cost and need for a prior authorization
  • Need for 31 injections to administer each course of botox

Precautions and Risk:

• Spread of toxin effects; swallowing and breathing difficulties have rarely led to death 
• Immediate medical attention may be required in cases of respiratory, speech or swallowing difficulties
• Use with caution in patients with compromised respiratory function
• Corneal exposure and ulceration
• Retrobulbar hemorrhages and compromised retinal circulation
• Bronchitis and upper respiratory tract infections in patients treated for upper limb spasticity
• Pregnancy & lactation: lack of definitive safety data; avoid unless benefit clearly outweighs risk
• Avoid in patients with known generalized neuromuscular disease

Contraindications:

• Infection at the proposed injection site
• Neuromuscular disorders, such as myasthenia gravis

Pregnancy & Breast Feeding:

• Click BOTOX® and navigate to #8 Use in Specific Populations (8.1 & 8.2)

Drug Interactions:

• Concomitant treatment of BOTOX and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare -like agents), or muscle relaxants, should be observed closely because the effect of BOTOX may be potentiated

Counseling Tips: 

• Please see package insert for recommendations for storage and preparation of drug.
• OnabotulinumtoxinA injections should be administered in- office by a trained injector.
• A 29-30 gauge needle and 1 cc syringe should be used
• Mix 200 units of botox in 4 ccs of 0.9% saline; do not shake, merely roll the vial in one’s hands, until mixed.
• Inject 0.1 ccs (5 units) into each of the prespecified 31 sites of the head & neck. 
• The total dosage is 155 units of onabotulinumtoxinA.
• Benefit should be assessed after two or three treatments (6 – 9 months). Response is generally observed at 3-6 weeks.   Many patients respond to a first treatment, but guidelines suggest that patient should have two cycles of treatment before deciding on response and continuation of drug.
• OnabotulinumtoxinA paralyzes any muscle in which it is injected.