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.
OnabotulinumtoxinA (BOTOX®) FDA APPROVED FOR MIGRAINE PREVENTION CLICK HERE TO EXPAND
Brands:
- BOTOX® (OnabotulinumtoxinA) For Complete Prescribing Information Click Here for the Package Insert
- 200 unit vial
- 155 units injected intramuscularly in 31 pre-specified sites in the head & neck
- 155 units injected intramuscularly in 31 sites in the head & neck every 12 weeks over 31 sites
- No titration necessary
- A fixed dosage is administered every three months
- 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)
- 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.
- Chronic migraine is defined as those with:
- Consider its use in:
- Chronic migraine
- with or without medication overuse
- In those that have medication intolerances
- has no side effects of memory loss or weight gain
- Chronic migraine
- 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
- 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
- Infection at the proposed injection site
- Neuromuscular disorders, such as myasthenia gravis
- Click BOTOX® and navigate to #8 Use in Specific Populations (8.1 & 8.2)
- 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
- 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.