Version May 2024
Postmarketing reports indicate that the effects of all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life-threatening, and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses and in approved indications, cases of spread of effect have been reported at doses comparable with those used to treat cervical dystonia and spasticity and at lower doses.
Note: The lowest recommended dose should be used when initiating treatment (regardless of indication). In adults treated for 1 or more indications, the maximum cumulative dose should be ≤400 units per 3 months for Botox or Botox Cosmetic. Canadian labeling for Botox Cosmetic recommends a maximum cumulative dose of 6 units/kg (up to 360 units) over 3 months in adult patients receiving additional treatment for noncosmetic indications.
Achalasia (off-label use): Intrasphincteric during endoscopy: 20 to 25 units to each of the 4 quadrants in the lower esophageal sphincter. Note: Clinical response is short-acting and use does not provide complete relief of symptoms; retreatment may be required within 6 to 12 months (Ref).
Bladder dysfunction: Intradetrusor: Note: Prophylactic antimicrobial therapy (excluding aminoglycosides) should be administered 1 to 3 days prior to, on the day of, and for 1 to 3 days following onabotulinumtoxinA administration to decrease risk of urinary tract infection (UTI). Discontinue antiplatelet therapy at least 3 days prior to administration.
Detrusor overactivity associated with neurologic condition: 30 injections of 1 mL (recommended concentration: ~6.7 units/mL) for a total dose of 200 units/30 mL (maximum: 200 units); for the final injection, ~1 mL of sterile NS should be injected to ensure that the remaining medication in the needle is delivered to the bladder; may consider re-treatment with diminishing effect but no sooner than 12 weeks from previous administration (median time until second treatment in studies: 42 to 48 weeks).
Overactive bladder: 20 injections of 0.5 mL (recommended concentration: 10 units/mL) for a total dose of 100 units/10 mL (maximum: 100 units); for the final injection, ~1 mL of sterile NS should be injected to ensure that the remaining medication in the needle is delivered to the bladder; may consider re-treatment with diminishing effect but no sooner than 12 weeks from the previous administration (median time until second treatment in studies: ~24 weeks)
Blepharospasm: IM:
Botox: Initial dose: 1.25 to 2.5 units injected into the medial and lateral pretarsal orbicularis oculi of the upper lid and lateral pretarsal orbicularis oculi of lower lid
Dose may be increased up to twice the previous dose if the response from the initial dose lasted ≤2 months; maximum dose per site: 5 units. Tolerance may occur if treatments are given more often than every 3 months, but the effect is not usually permanent. Cumulative dose:
US labeling: ≤200 units in 30-day period
Canadian labeling (not in US labeling): Botox: ≤200 units in 2-month period
Cervical dystonia: IM: For dosing guidance, the mean dose is 236 units (25th to 75th percentile range 198 to 300 units) divided among the affected muscles in patients previously treated with botulinum toxin (maximum: ≤50 units/site). Initial dose in previously untreated patients should be lower. Sequential dosing should be based on the patient's head and neck position, localization of pain, muscle hypertrophy, patient response, and previous adverse reactions. The total dose injected into the sternocleidomastoid muscles should be ≤100 units to decrease the occurrence of dysphagia.
Canadian labeling (not in US labeling): IM: Botox: Effective range of 200 to 360 units has been used in clinical practice; administer no more frequently than every 2 months.
Migraine, chronic, prevention:
Note: Recommended for use in patients with ≥15 migraine days per month (Ref). An adequate trial for assessment of effect is considered to be 3 full treatment administrations separated by 12 weeks (Ref).
IM: Administer 5 units per 0.1 mL per site. Recommended total dose is 155 units once every 12 weeks. Each 155 unit dose should be equally divided and administered bilaterally into 31 total sites as described below (refer to prescribing information for specific diagrams of recommended injection sites):
Corrugator: 5 units to each side (2 sites).
Procerus: 5 units (1 site only).
Frontalis: 10 units to each side (divided into 2 sites/side).
Temporalis: 20 units to each side (divided into 4 sites/side).
Occipitalis: 15 units to each side (divided into 3 sites/side).
Cervical paraspinal: 10 units to each side (divided into 2 sites/side).
Trapezius: 15 units to each side (divided into 3 sites/side).
Some dosing strategies allow for up to 195 units divided into 39 total sites; refer to protocol description for further information (Ref).
Spasticity: IM: Individualize dose based on patient size, extent, and location of muscle involvement, degree of spasticity, local muscle weakness, and response to prior treatment. May repeat therapy at ≥3 months with appropriate dosage based upon the clinical condition of patient at time of re-treatment. Single session doses of ≤1,200 units (off-label dose) have been reported; however, safety and efficacy of routine use of doses >500 units has not been evaluated (Ref). Single site doses of ≤400 units (off-label dose) in a lower limb (off-label use) have been reported (Ref).
Lower limb spasticity: The lowest recommended starting dose should be used and ≤50 units/site should be administered. Note: Dose listed is total dose administered as divided separate intramuscular injection(s):
Flexor digitorum longus: 50 units (divided into 2 sites)
Flexor hallucis longus: 50 units (divided into 2 sites)
Gastrocnemius lateral head: 75 units (divided into 3 sites)
Gastrocnemius medial head: 75 units (divided into 3 sites)
Soleus: 75 units (divided into 3 sites)
Tibialis posterior: 75 units (divided into 3 sites)
Upper limb spasticity. The lowest recommended starting dose should be used and ≤50 units/site should be administered. Note: Dose listed is total dose administered as individual or separate intramuscular injection(s):
Adductor pollicis: 20 units (1 site).
Biceps brachii: 60 to 200 units (divided into 2 to 4 sites).
Brachialis: 30 to 50 units (divided into 1 to 2 sites).
Brachioradialis: 45 to 75 units (divided into 1 to 2 sites).
Flexor carpi radialis: 12.5 to 50 units (1 site).
Flexor carpi ulnaris: 12.5 to 50 units (1 site).
Flexor digitorum profundus: 30 to 50 units (1 site).
Flexor digitorum sublimes: 30 to 50 units (1 site).
Flexor pollicis brevis/opponens pollicis: 5 to 25 units (1 site).
Flexor pollicis longus: 20 units (1 site).
Lumbricals/interossei: 5 to 10 units (1 site).
Pronator teres: 15 to 25 units (1 site).
Pronator quadratus: 10 to 50 units (1 site).
Suggested guidelines for the treatment of stroke-related upper limb spasticity: Canadian labeling: Note: Dose listed is total dose administered as individual or separate intramuscular injection(s):
Adductor pollicis: 20 units (1 to 2 sites)
Biceps brachii: 100 to 200 units (up to 4 sites)
Flexor digitorum profundus: 15 to 50 units (1 to 2 sites)
Flexor digitorum sublimes: 15 to 50 units (1 to 2 sites)
Flexor carpi radialis: 15 to 60 units (1 to 2 sites)
Flexor carpi ulnaris: 10 to 50 units (1 to 2 sites)
Flexor pollicis longus: 20 units (1 to 2 sites)
Strabismus: IM: Note: Several minutes prior to injection, administration of local anesthetic and ocular decongestant drops are recommended.
Initial dose:
Vertical muscles and for horizontal strabismus <20 prism diopters: 1.25 to 2.5 units in any one muscle
Horizontal strabismus of 20 to 50 prism diopters: 2.5 to 5 units in any one muscle
Persistent VI nerve palsy ≥1 month: 1.25 to 2.5 units in the medial rectus muscle
Re-examine patients 7 to 14 days after each injection to assess the effect of that dose. Subsequent doses for patients experiencing incomplete paralysis of the target may be increased up to twice the previous administered dose. The maximum recommended dose as a single injection for any one muscle is 25 units. Do not administer subsequent injections until the effects of the previous dose are gone.
Primary axillary hyperhidrosis: Intradermal: 50 units/axilla. Injection area should be defined by standard staining techniques. Injections should be evenly distributed into multiple sites (10 to 15), administered in 0.1 to 0.2 mL aliquots, ~1 to 2 cm apart. May repeat when clinical effect diminishes.
Cosmetic uses:
Reduction of forehead lines
US labeling: IM: When identifying the location of the appropriate injection sites in the frontalis muscle, assess the overall relationship between the size of the subject's forehead and the distribution of frontalis muscle activity. The location, size, and use of the muscles vary markedly among individuals. Inject 0.1 mL (4 units) into 5 injection sites in the frontalis muscle for a total dose of 0.5 mL (20 units) administered no more frequently than every 3 months. Note: Treat forehead lines in conjunction with glabellar lines to reduce the risk of brow ptosis.
Canadian labeling: IM: Inject 2 to 6 units into each of four sites in the frontalis muscle every 1 to 2 cm along either side of forehead crease and 2 to 3 cm above eyebrows for total dose of 24 units.
Reduction of glabellar lines: IM: An effective dose is determined by gross observation of the patient's ability to activate the superficial muscles injected. The location, size, and use of muscles may vary markedly among individuals. Inject 0.1 mL (4 units) dose into each of five sites, two in each corrugator muscle and one in the procerus muscle for a total dose 0.5 mL (20 units) administered no more frequently than every 3 to 4 months. Note: Treatment of adults >65 years is approved in the Canadian labeling.
Reduction of lateral canthus lines:
US labeling: IM: Inject 0.1 mL (4 units) into 3 injection sites per side (6 total injection points) in the lateral orbicularis oculi muscle for a total dose of 0.6 mL (24 units) administered no more frequently than every 3 months.
Canadian labeling: IM: Inject 2 to 6 units into each of 1 to 3 injection sites, lateral to the lateral orbital rim.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Initiate therapy at lowest recommended dose. Refer to adult dosing.
(For additional information see "OnabotulinumtoxinA (Botox): Pediatric drug information")
Note: Potency units are specific to product and assay method utilized; do not interchange botulinum toxin products. Route of administration varies (IM, intradermal, intradetrusor, etc) based on indication; use precaution. The lowest recommended dose should be used when initiating treatment (regardless of indication). Unless otherwise noted in the indication-specific dosing, total maximum dose per 3 months are as follows: In pediatric patients <18 years, the maximum cumulative dose within a 3-month period is 10 units/kg or 340 units, whichever is less, for Botox; in adolescents ≥18 years treated for 1 or more indications, the maximum cumulative dose within a 3-month period should not exceed 400 units for Botox.
Bladder dysfunction:
Note: Prophylactic antimicrobial therapy should be administered 1 to 3 days prior to, on the day of, and for 1 to 3 days following onabotulinumtoxinA administration to decrease risk of urinary tract infection; IV antimicrobials (excluding aminoglycosides) may be used if onabotulinumtoxinA administered under general anesthesia or procedural sedation. Discontinue antiplatelet therapy at least 3 days prior to administration.
Children and Adolescents <18 years:
Neurogenic detrusor overactivity (NDO):
Children ≥5 years and Adolescents:
Patient weight <34 kg: Botox: Intradetrusor: 6 units/kg per treatment (total volume: 10 mL; final concentration variable) administered as 20 injections of 0.5 mL; for the final injection, ~1 mL of sterile NS should be injected to ensure that the remaining medication in the needle is delivered to the bladder; may consider re-treatment with diminishing effect but no sooner than 12 weeks from previous administration (median time until second treatment in studies was 30 weeks).
Patient weight ≥34 kg: Botox: Intradetrusor: 200 units per treatment (recommended as 20 units/mL; total volume: 10 mL) administered as 20 injections of 0.5 mL; for the final injection, ~1 mL of sterile NS should be injected to ensure that the remaining medication in the needle is delivered to the bladder; may consider re-treatment with diminishing effect but no sooner than 12 weeks from previous administration (median time until second treatment in studies was 30 weeks).
Iatrogenic overactive bladder, refractory: Limited data available (Ref); efficacy results variable (Ref):
Children ≥4 years and Adolescents <18 years: Intradetrusor: 100 units per treatment (recommended as 10 units/mL; total volume: 10 mL) administered as 10 to 20 injections of 0.5 to 1 mL; dosing based on a retrospective study evaluating 257 patients (median age at first treatment: 8 years [age range: 4 (n=1) to 18 years]) with iatrogenic treatment resistant overactive bladder; results showed the following complete response rates in patients with enuresis, daytime incontinence, or both: 50%, 45.7%, or 17%, respectively; reported mean estimated duration of effect was 12 months (Ref).
Adolescents ≥18 years:
Detrusor overactivity associated with neurologic condition: Botox: Intradetrusor: 30 injections of 1 mL (recommended concentration: ~6.7 units/mL) for a total dose of 200 units/30 mL (maximum total dose: 200 units); for the final injection, ~1 mL of sterile NS should be injected to ensure that the remaining medication in the needle is delivered to the bladder; may consider re-treatment with diminishing effect but no sooner than 12 weeks from previous administration (median time until second treatment in studies: 42 to 48 weeks).
Overactive bladder: Botox: Intradetrusor: 20 injections of 0.5 mL (recommended concentration: 10 units/mL) for a total dose of 100 units/10 mL (maximum total dose: 100 units); for the final injection, ~1 mL of sterile NS should be injected to ensure that the remaining medication in the needle is delivered to the bladder; may consider re-treatment with diminishing effect but no sooner than 12 weeks from the previous administration (median time until second treatment in studies: ~24 weeks).
Blepharospasm: Children ≥12 years and Adolescents: Botox: IM: Initial: 1.25 to 2.5 units injected into the medial and lateral pretarsal orbicularis oculi of the upper lid and into the lateral pretarsal orbicularis oculi of the lower lid. Dose may be increased up to twice the previous dose if the response from the initial dose is insufficient (ie, effect lasted ≤2 months); maximum dose per site: 5 units. Tolerance may occur if treatments are given more often than every 3 months, but the effect is not usually permanent. Maximum cumulative dose: 200 units in 30-day period.
Cervical dystonia: Adolescents ≥16 years: Botox: IM: For dosing guidance, the mean dose is 236 units (25th to 75th percentile range 198 to 300 units) divided among the affected muscles in patients previously treated with botulinum toxin (maximum: ≤50 units/site). Initial dose in previously untreated patients should be lower. Sequential dosing should be based on the patient's head and neck position, localization of pain, muscle hypertrophy, patient response, and previous adverse reactions. The total dose injected into sternocleidomastoid muscles should be ≤100 units to decrease the occurrence of dysphagia.
Spasticity: Note: Individualize dose based on patient size, extent, and location of muscle involvement, degree of spasticity, local muscle weakness, and response to prior treatment. When treating both upper and lower limb spasticity, the total dose should not exceed 10 units/kg or 340 units total in a 3-month period. May repeat therapy when the therapeutic effect of previous treatment has diminished; generally it should be no sooner than 12 weeks from previous injection.
Upper extremity:
Children ≥2 years and Adolescents ≤17 years: Botox: IM: Usual dose: 3 to 6 units/kg total per session divided up amongst affected muscles; maximum dose per site: 50 units/site; maximum total dose per treatment session in the upper limb: 6 units/kg or 200 units total, whichever is less. Refer to prescribing information for specific diagrams of recommended injection sites.
|
Muscle |
Total Dosage and Number of Sites |
|---|---|
|
Biceps brachii |
1.5 to 3 units/kg divided in 4 sites |
|
Brachialis |
1 to 2 units/kg divided in 2 sites |
|
Brachioradialis |
0.5 to 1 unit/kg divided in 2 sites |
|
Flexor carpi radialis |
1 to 2 units/kg divided in 2 sites |
|
Flexor carpi ulnaris |
1 to 2 units/kg divided in 2 sites |
|
Flexor digitorum profundus |
0.5 to 1 unit/kg divided in 2 sites |
|
Flexor digitorum sublimis |
0.5 to 1 unit/kg divided in 2 sites |
Adolescents ≥18 years: Botox: IM: 75 to 400 units per treatment session divided among selected muscle groups has been used in clinical trials. Note: The lowest recommended starting dose should be used not to exceed 50 units/site. Dose listed is total dose administered per muscle group and recommendations on dividing the total dose into individual IM injection(s) if applicable; refer to prescribing information for specific diagrams of recommended injection sites.
|
Muscle |
Total Dosage and Number of Sites |
|---|---|
|
Adductor pollicis |
20 units in 1 site |
|
Biceps brachii |
100 to 200 units divided in 4 sites |
|
Flexor carpi radialis |
12.5 to 50 units in 1 site |
|
Flexor carpi ulnaris |
12.5 to 50 units in 1 site |
|
Flexor digitorum profundus |
30 to 50 units in 1 site |
|
Flexor digitorum sublimis |
30 to 50 units in 1 site |
|
Flexor pollicis longus |
20 units in 1 site |
Lower extremity:
Children ≥2 years and Adolescents ≤17 years: Botox: IM: Usual dose: 4 to 8 units/kg total per session divided up amongst affected muscles; maximum dose per site: 50 units/site; maximum total dose per treatment session in the lower limb or visit: 8 units/kg or 300 units total, whichever is less. Refer to prescribing information for specific diagrams of recommended injection sites.
|
Muscle |
Total Dosage and Number of Sites |
|---|---|
|
Gastrocnemius lateral head |
1 to 2 units/kg divided in 2 sites |
|
Gastrocnemius medial head |
1 to 2 units/kg divided in 2 sites |
|
Soleus |
1 to 2 units/kg divided in 2 sites |
|
Tibialis posterior |
1 to 2 units/kg divided in 2 sites |
Equinus foot due to cerebral palsy: Canadian labeling: Children ≥2 years and Adolescents ≤17 years: Botox: IM: Initial: 4 units/kg total dose divided into 2 sites, the lateral and medial heads of the gastrocnemius muscle. For diplegia, the initial dose is 6 units/kg divided between the affected limbs. Repeat doses may be administered with diminishing effect but no sooner than 12 weeks from previous administration (Ref).
Multilevel approach (multiple muscles) in patients with cerebral palsy: Limited data available; variable dosing regimens reported; optimal dose not established; dosing based on trials and expert recommendations (Ref).
Children ≥18 months and Adolescents: Botox: IM: Total dose range: 10 to 30 units/kg divided into multiple muscle groups over multiple injection sites per muscle groups have been reported; maximum dose per site: 50 units/site; maximum total dose per treatment session: 400 units (Ref).
The following are reported total dose administered per muscle group to be divided into multiple injections spaced ≥4 to 5 cm (Ref).
|
Muscle |
Total Dosage (should be divided into multiple injections) |
|---|---|
|
Gastrocnemius |
3 to 6 units/kg |
|
Hip adductors |
1 to 3 units/kg |
|
Iliopsoas |
1 to 4 units/kg |
|
Lateral hamstrings |
1 to 2 units/kg |
|
Medial hamstrings (semitendinosus, semimebransosus, gracilis) |
3 to 5 units/kg |
|
Rectus femoris |
1 to 2 units/kg |
|
Soleus |
1 to 3 units/kg |
|
Tibialis posterior |
1 to 2 units/kg |
Adolescents ≥18 years: The lowest recommended starting dose should be used and ≤50 units/site should be administered; recommended total dose: 300 to 400 units divided across ankle and toe muscles. Note: Dose listed is total dose administered as divided separate IM injection(s); refer to prescribing information for specific diagrams of recommended injection sites.
|
Muscle |
Total Dosage and Number of Sites |
|---|---|
|
Flexor digitorum longus |
50 units divided in 2 sites |
|
Flexor hallucis longus |
50 units divided in 2 sites |
|
Gastrocnemius lateral head |
75 units divided in 3 sites |
|
Gastrocnemius medial head |
75 units divided in 3 sites |
|
Soleus |
75 units divided in 3 sites |
|
Tibialis Posterior |
75 units divided in 3 sites |
Strabismus: Limited data available in patients <12 years of age: Note: Several minutes prior to injection, administration of local anesthetic and ocular decongestant drops are recommended.
Infants and Children 2 months to 11 years (Ref): Botox: IM:
Horizontal or vertical deviations <20 prism diopters: Patients weight ≥6 kg: 1.25 units into any one muscle.
Horizontal or vertical deviations 20 to 50 prism diopters:
Patient weight <6 kg: 1 unit into any one muscle.
Patient weight 6 to 9 kg: 1.25 units into any one muscle.
Patient weight 10 to 12.5 kg: 1.25 to 1.75 units into any one muscle.
Patient weight >12.5 kg: 1.25 to 2.5 units into any one muscle.
Persistent VI nerve palsy of ≥1 month duration:
Patient weight <6 kg: 1 unit into the medial rectus muscle.
Patient weight ≥ 6 kg: 1.25 units into the medial rectus muscle.
Children ≥12 years and Adolescents: Botox: IM:
Initial dose:
Vertical muscles and for horizontal strabismus <20 prism diopters: 1.25 to 2.5 units into any one muscle.
Horizontal strabismus 20 to 50 prism diopters: 2.5 to 5 units into any one muscle.
Persistent VI nerve palsy of ≥1 month duration: 1.25 to 2.5 units into the medial rectus muscle.
Maintenance dose: Re-examine patient 7 to 14 days after each injection to assess the effect of that dose. Subsequent doses for patients experiencing incomplete paralysis of the target may be increased up to twice the previous administered dose; maximum recommended dose as a single injection for any one muscle is 25 units. Do not administer subsequent injections until the effects of the previous dose are gone.
Hyperhidrosis, primary axillary: Adolescents ≥18 years: Botox: Intradermal: 50 units/axilla. Injection area should be defined by standard staining techniques. Injections should be evenly distributed into multiple sites (10 to 15), administered in 0.1 to 0.2 mL aliquots, ~1 to 2 cm apart. May repeat when clinical effect diminishes.
Migraine, chronic: Adolescents ≥18 years: Botox: IM: Administer 5 units/0.1 mL per site; recommended total dose: 155 units once every 12 weeks. Each 155 unit dose should be equally divided and administered bilaterally, into 31 total sites as described below (refer to prescribing information for specific diagrams of recommended injection sites):
Corrugator: 5 units to each side (1 site per side).
Procerus: 5 units (1 site only).
Frontalis: 10 units to each side (divided into 2 sites per side).
Temporalis: 20 units to each side (divided into 4 sites per side).
Occipitalis: 15 units to each side (divided into 3 sites per side).
Cervical paraspinal: 10 units to each side (divided into 2 sites per side).
Trapezius: 15 units to each side (divided into 3 sites per side).
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. As reported with adult patients, unless otherwise noted. Adverse effects usually occur in 1 week and may last up to several months.
>10%:
Bladder dysfunction: Genitourinary: Bacteriuria (4% to 18%), increased post-void residual urine volume (not requiring catheterization: 3% to 17%), urinary retention (6% to 17%), urinary tract infection (18% to 49%)
Cervical dystonia:
Gastrointestinal: Dysphagia (19%)
Nervous system: Headache (11%)
Neuromuscular & skeletal: Neck pain (11%)
Respiratory: Upper respiratory tract infection (12%)
Upper limb spasticity:
Respiratory: Upper respiratory tract infection (children and adolescents: 10% to 17%)
Other indications (blepharospasm, forehead lines, glabellar lines, lateral canthal lines, primary axillary hyperhidrosis, strabismus):
Nervous system: Vertical strabismus (17%)
Ophthalmic: Blepharoptosis (strabismus: 1% to 38%; blepharospasm: 21%; forehead lines, glabellar lines: 2% to 3%)
1% to 10%:
Bladder dysfunction:
Gastrointestinal: Constipation (4%)
Genitourinary: Dysuria (4% to 9%), hematuria (4% to 5%)
Immunologic: Antibody development (neutralizing: 1%)
Nervous system: Abnormal gait (3%), falling (3%), myasthenia (4%)
Neuromuscular & skeletal: Muscle spasm (2%)
Cervical dystonia:
Gastrointestinal: Nausea (2% to 10%), xerostomia (2% to 10%)
Immunologic: Antibody development (1%)
Local: Local soreness/soreness at injection site (2% to 10%)
Nervous system: Dizziness (2% to 10%), drowsiness (2% to 10%), hypertonia (2% to 10%), numbness (2% to 10%), speech disturbance (2% to 10%)
Neuromuscular & skeletal: Asthenia (2% to 10%), back pain (2% to 10%), stiffness (2% to 10%)
Ophthalmic: Blepharoptosis (2% to 10%), diplopia (2% to 10%)
Respiratory: Cough (2% to 10%), dyspnea (2% to 10%), flu-like symptoms (2% to 10%), rhinitis (2% to 10%)
Miscellaneous: Fever (2% to 10%)
Chronic migraines:
Cardiovascular: Hypertension (2%)
Local: Pain at injection site (3%)
Nervous system: Exacerbation of migraine headache (4%), facial paresis (2%), headache (5%), myasthenia (4%)
Neuromuscular & skeletal: Muscle spasm (2%), musculoskeletal pain (3%), myalgia (3%), neck pain (9%), stiffness (4%)
Ophthalmic: Blepharoptosis (4%)
Respiratory: Bronchitis (3%)
Lower limb spasticity:
Dermatologic: Excoriation of skin (children and adolescents: 2%)
Gastrointestinal: Decreased appetite (children and adolescents: 2%)
Local: Erythema at injection site (children and adolescents: 2%), pain at injection site (children, adolescents, and adults: 2%)
Neuromuscular & skeletal: Arthralgia (3%), back pain (3%), myalgia (2%), sprain (1% to 2%)
Respiratory: Oropharyngeal pain (children and adolescents: 2%), upper respiratory tract infection (2%)
Upper limb spasticity:
Gastrointestinal: Constipation (children and adolescents: 3%), nausea (2% to 4%)
Local: Pain at injection site (children and adolescents: 3% to 4%)
Nervous system: Fatigue (2% to 3%), myasthenia (2% to 4%), seizure (children and adolescents: 1% to 5%)
Neuromuscular & skeletal: Limb pain (5% to 9%)
Respiratory: Bronchitis (2% to 3%), nasal congestion (children and adolescents: 3%), rhinorrhea (children and adolescents: 4%)
Other indications (blepharospasm, forehead lines, glabellar lines, lateral canthal lines, primary axillary hyperhidrosis, reduction of glabellar lines, strabismus):
Dermatologic: Diaphoresis (3% to 10%; nonaxillary), pruritus (3% to 10%), skin tightness (2%)
Immunologic: Antibody development (2%)
Infection: Infection (3% to 10%)
Local: Bleeding at injection site (3% to 10%), pain at injection site (3% to 10%)
Nervous system: Anxiety (3% to 10%), facial pain (1%), facial paresis (1%), headache (9%), myasthenia (1%)
Neuromuscular & skeletal: Back pain (3% to 10%), neck pain (3% to 10%)
Ophthalmic: Dry eye syndrome (6%), eyelid edema (1%), superficial punctate keratitis (6%)
Respiratory: Flu-like symptoms (3% to 10%), pharyngitis (3% to 10%)
Miscellaneous: Fever (3% to 10%)
<1% (any indication):
Hematologic & oncologic: Retrobulbar hemorrhage
Immunologic: Antibody development (neutralizing)
Nervous system: Vertigo
Neuromuscular & skeletal: Jaw pain
Ophthalmic: Eye infection
Frequency not defined (any indication):
Dermatologic: Skin rash
Hematologic & oncologic: Leukocyturia
Ophthalmic: Corneal perforation, corneal ulcer, ectropion, eye irritation, eyelid entropion, keratitis, lacrimation, lagophthalmos, photophobia, reduced blinking
Postmarketing (any indication):
Cardiovascular: Acute myocardial infarction, cardiac arrhythmia, syncope
Dermatologic: Alopecia, erythema multiforme, hyperhidrosis, madarosis of the eyebrow, psoriasiform eruption, urticaria
Gastrointestinal: Abdominal pain, anorexia, diarrhea, vomiting
Genitourinary: Urinary incontinence
Hypersensitivity: Anaphylaxis, hypersensitivity reaction, serum sickness
Nervous system: Brachial plexopathy, denervation, dysarthria, exacerbation of myasthenia gravis, focal facial paralysis, hypoesthesia, malaise, nerve root disorder, paresthesia, peripheral neuropathy, voice disorder
Neuromuscular & skeletal: Amyotrophy, muscle twitching (localized)
Ophthalmic: Blurred vision, retinal vein occlusion, visual disturbance
Otic: Hypoacusis, tinnitus
Respiratory: Aspiration pneumonia, respiratory depression, respiratory failure
Miscellaneous: Drug toxicity (botulinum toxin effects)
Hypersensitivity to any botulinum toxin preparation or any component of the formulation; infection at the proposed injection site(s).
Botox (only): Intradetrusor injection in patients with a UTI; intradetrusor injection in patients with urinary retention and in patients with postvoid residual urine volume >200 mL who are not routinely performing clean intermittent self-catheterization
Canadian labeling: Additional contraindications (not in US labeling): Intradetrusor injection in patients who are not willing and able to have clean intermittent catheterization (CIC) initiated; intradetrusor injection in patients with a recent history of frequent urinary tract infections.
Concerns related to adverse effects:
• Anaphylaxis/hypersensitivity reactions: Serious and/or immediate hypersensitivity reactions (eg, anaphylaxis, serum sickness, urticaria, soft tissue edema, dyspnea) have occurred. If a reaction occurs, discontinue and institute immediate treatment.
• Antibody formation: Higher doses or more frequent administration may result in neutralizing antibody formation and loss of efficacy.
• Autonomic dysreflexia: Autonomic dysreflexia has been observed with use and may occur in patients receiving intradetrusor injections for detrusor overactivity associated with a neurologic condition. Clinical presentation often includes headache, a marked increase in blood pressure, and diaphoresis; prompt treatment may be required in patients presenting with severe symptoms (eg, hypertensive crisis) (Furlan 2013).
• Cardiovascular events: Arrhythmia and myocardial infarction (some fatal) have been reported following administration. Some of these patients had risk factors including preexisting cardiovascular disease. The exact relationship to onabotulinumtoxinA has not been established.
• Dysphagia: Common when used for cervical dystonia and may persist for several months after administration. In severe cases (some fatal), patients may require alternative feeding methods (eg, feeding tube). Risk factors include smaller neck muscle mass, bilateral injections into the sternocleidomastoid muscle, or injections into the levator scapulae. Risk of aspiration resulting from severe dysphagia is increased in patients when swallowing is already compromised. Limiting the dose injected into the sternocleidomastoid muscle may reduce the occurrence of dysphagia.
• Hematologic: Use with caution in patients with bleeding disorders and/or receiving anticoagulation therapy.
• Ophthalmic effects: Dry eye, irritation, ocular pain, photophobia, and visual changes have been reported with injection in or near the orbicularis oculi muscle; if symptoms persist, consider ophthalmologic referral.
• Respiratory effects: Bronchitis and upper respiratory infection have been reported more frequently in adults treated for upper or lower limb spasticity.
• Systemic toxicity: Distant spread of botulinum toxin beyond the site of injection has been reported. Immediate medical attention required if respiratory disorders, speech, or swallowing difficulties appear.
• Urinary retention: An increased incidence of urinary retention and need for catheterization has been observed in patients receiving therapy for bladder dysfunction (overactive bladder or detrusor overactivity associated with a neurologic condition); due to the risk of urinary retention, treatment should only be used in patients able and willing to initiate post-treatment catheterization, if required. Patients with diabetes had an increased incidence of urinary retention. Patients experiencing difficulty in voiding should be instructed to consult their health care provider.
• Urinary tract infection: Therapy in patients with overactive bladder increases the incidence of urinary tract infections (UTIs); clinical trials for overactive bladder excluded patients with >2 UTIs in the previous 6 months and those taking chronic antibiotics for prophylaxis of recurrent UTIs. Consider risks versus benefits when contemplating use in these patients or patients experiencing recurrent UTIs during treatment. Patients with diabetes had an increased incidence of UTI.
Disease-related concerns:
• Neuromuscular disease: Avoid use in myasthenia gravis (AAN [Narayanaswami 2021]). Use with caution in patients with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (eg, Lambert-Eaton syndrome). Risk of adverse events including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise may be increased.
• Ocular diseases: Reduced blinking from injection in or near the orbicularis oculi muscle can lead to corneal exposure, persistent corneal epithelial defect, and ulceration when treating blepharospasm. Retrobulbar hemorrhages may occur from needle penetration into orbit when treating strabismus; spatial disorientation, double vision, or past-pointing may occur if one or more extraocular muscles are paralyzed. Covering the affected eye may help. Careful testing of corneal sensation, avoidance of lower lid injections, and treatment of corneal epithelial defects are necessary. Use caution in patients with angle closure glaucoma.
• Respiratory disease: Use extreme caution in patients with preexisting respiratory disease; treatment with botulinum toxin may weaken accessory muscles that are necessary for these patients to maintain adequate ventilation. Serious breathing difficulties, including respiratory failure, have been reported. Risk of aspiration resulting from severe dysphagia is increased in patients with decreased respiratory function.
Concurrent drug therapy issues:
• Neuromuscular transmission: Use with extreme caution in patients receiving other agents that may interfere with neuromuscular transmission (eg, aminoglycosides, neuromuscular-blocking agents)
Dosage form specific issues:
• Albumin: Product may contain albumin; albumin carries an extremely remote risk for transmission of viral diseases, Creutzfeldt-Jakob disease (CJD) and variant CJD (vCJD). No cases of transmission of viral diseases, CJD, or vCJD have been identified for licensed albumin or albumin contained in other licensed products.
• Product interchangeability: Botulinum products (abobotulinumtoxinA, daxibotulinumtoxinA, incobotulinumtoxinA, onabotulinumtoxinA, prabotulinumtoxinA, rimabotulinumtoxinB) are not interchangeable; potency units are specific to each preparation and cannot be compared or converted to any other botulinum product.
Other warnings/precautions:
• Bladder dysfunction: Appropriate use: Rule out acute UTI prior to treatment; appropriate prophylactic antimicrobial therapy is required prior to, during, and following treatment. Discontinue antiplatelet therapy at least 3 days prior to administration.
• Hazardous tasks: May impair ability to drive and/or operate machinery due to the intended effects of treatment; if loss of strength, muscle weakness, or impaired vision occurs, patients should avoid driving or engaging in other hazardous activities.
• Injection site: Use with caution if there is inflammation or excessive weakness or atrophy at the proposed injection site(s); use is contraindicated if infection is present. Serious events (including fatalities) have been observed with direct injection into the esophagus, stomach, salivary glands, and oro-lingual-pharyngeal region. Use caution when administering in close proximity to the lungs (especially the apices); pneumothorax has been reported following administration near the thorax.
• Primary axillary hyperhidrosis: Appropriate use: Evaluate for secondary causes prior to treatment (eg, hyperthyroidism). Safety and efficacy for treatment of hyperhidrosis in other areas of the body have not been established.
• Temporary reduction in glabellar lines: Appropriate use: Do not use more frequently than every 3 months (Canadian labeling states not to use more frequently than every 2 months). Patients with marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or the inability to substantially lessen glabellar lines by physically spreading them apart were excluded from clinical trials. Use with caution in patients with surgical alterations to the facial anatomy. Reduced blinking from injection of the orbicularis muscle can lead to corneal exposure and ulceration. Spatial disorientation, double vision, or past pointing may occur if one or more extraocular muscles are paralyzed.
• Unapproved use: Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, including fatalities, have been reported in patients who have received injections for unapproved uses. In these cases, the reactions were not necessarily related to distant spread of toxin but may have resulted from administration to the site of injection and/or adjacent structures; several patients had preexisting dysphagia or other significant disabilities.
• Upper or lower limb spasticity: Appropriate use: Safety and effectiveness of other upper or lower limb muscle groups have not been established in adults. Treatment has not been shown to improve upper extremity functional abilities or range of motion at a joint affected by a fixed contracture in adults.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Injection [preservative free]:
Botox: 100 units (1 ea); 200 units (1 ea) [contains albumin human]
Solution Reconstituted, Intramuscular:
Botox Cosmetic: 100 units (1 ea) [contains albumin human]
Solution Reconstituted, Intramuscular [preservative free]:
Botox Cosmetic: 50 units (1 ea) [contains albumin human]
No
Solution (reconstituted) (Botox Cosmetic Intramuscular)
50 unit (per each): $420.00
100 unit (per each): $760.80
Solution (reconstituted) (Botox Injection)
100 unit (per each): $760.80
200 unit (per each): $1,521.60
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Injection:
Botox: 50 units (1 ea) [contains albumin human]
Botox: 100 units (1 ea)
Botox: 200 units (1 ea) [contains albumin human]
Solution Reconstituted, Intramuscular:
Botox Cosmetic: 100 units (1 ea) [contains albumin human]
Bladder dysfunction (including overactive bladder and detrusor overactivity associated with neurologic condition): Intradetrusor: Prophylactic antimicrobial therapy (excluding aminoglycosides) should be administered 1 to 3 days prior to, on the day of, and for 1 to 3 days following onabotulinumtoxinA administration. Discontinue antiplatelet therapy at least 3 days prior to administration. If a local anesthetic is instilled into the bladder prior to treatment, drain bladder and irrigate with normal saline prior to injection. Instill saline into bladder to optimize visualization but avoid overdistention. The injection needle should be primed with ~1 mL of reconstituted onabotulinumtoxinA prior to injection to remove any air. Administer onabotulinumtoxinA via flexible or rigid cystoscope by inserting needle with the recommended volume ~2 mm into the detrusor (avoid the trigone). Injections should be spaced ~1 cm apart. After completion of injections, drain saline from bladder and monitor patient for ≥30 minutes. In overactive bladder patients, a spontaneous void should also occur prior to patient leaving the clinic.
Blepharospasm: Use a 27- or 30-gauge needle without electromyography guidance. Avoid injecting near the levator palpebrae superioris (may decrease ptosis); avoid medial lower lid injections (may decrease diplopia). Apply pressure at the injection site to prevent ecchymosis in the soft eyelid tissues.
Cervical dystonia: Use 25-, 27-, or 30-gauge needle for superficial muscles and a longer 22-gauge needle for deeper musculature; electromyography may help localize the involved muscles.
Detrusor overactivity associated with neurologic condition: Prophylactic antimicrobial therapy (excluding aminoglycosides) should be administered 1 to 3 days prior to, on the day of, and for 1 to 3 days following onabotulinumtoxinA administration. If a local anesthetic is instilled into the bladder prior to treatment, drain bladder and irrigate with normal saline prior to injection. Instill saline into bladder to optimize visualization but avoid overdistention. Administer onabotulinumtoxinA via flexible or rigid cystoscope by inserting needle ~2 mm into the detrusor. A total of 30 injections (1 mL per injection) should be administered ~1 cm apart. After completion of injections, drain saline from bladder and monitor patient for ≥30 minutes.
Migraine, chronic, prevention: Use a 0.5 inch, 30 gauge needle to administer 5 units per 0.1 mL to each injection site.
Spasticity (upper or lower limb): Use a 25-, 27-, or 30-gauge needle for superficial muscles and a longer 22-gauge needle for deeper musculature; electromyography or nerve stimulation may help localize the involved muscles.
Strabismus injections: Must use surgical exposure or electromyographic guidance; use the electrical activity recorded from the tip of the injections needle as a guide to placement within the target muscle. Local anesthetic and ocular decongestant should be given before injection. The volume of injection should be 0.05 to 0.15 mL per muscle. Many patients will require additional doses because of inadequate response to initial dose.
Primary axillary hyperhidrosis: Inject each dose intradermally to a depth of ~2 mm and at a 45° angle. Do not inject directly into areas marked in ink (to avoid permanent tattoo effect). Prior to administration, injection area should be defined by standard staining techniques such as Minor's Iodine-Starch Test.
Instructions for Minor's Iodine-Starch Test: Patient should shave underarms and refrain from using deodorants or antiperspirants for 24 hours prior to test. At 30 minutes prior to test, patient should be at rest, no exercise, and not consume hot beverages. Underarm area should be dried and immediately painted with iodine solution. After area dries, lightly sprinkle with starch powder. Gently blow off excess powder. A deep blue-black color will develop over the hyperhidrotic area in ~10 minutes.
Reduction of forehead lines (Botox Cosmetic): For intramuscular use only. Use as 30- to 33-gauge needle. Inject into 5 injection sites in the frontalis muscle. Refer to indication-specific administration information in manufacturer's location for details on locating injection sites.
Reduction of glabellar lines (Botox Cosmetic): For intramuscular use only. Use a 30- to 33-gauge needle. Inject into each of 5 sites (2 injections in each corrugator muscle and 1 injection in the procerus muscle). Ensure injected volume/dose is accurate and where feasible keep to a minimum. Avoid injection near the levator palpebrae superioris. Refer to indication-specific administration information in manufacturer's location for details on locating injection sites.
Reduction of lateral canthal lines (Botox Cosmetic): For intramuscular use only. Use a 30- to 33-gauge needle and give injections with the needle bevel tip up and oriented away from the eye. Inject into 3 sites per side (6 total injection points) in the lateral orbicularis oculi muscle. Refer to indication-specific administration information in manufacturer's location for details on locating injection sites.
Parenteral: Note: Should only be administered by individuals understanding the relevant neuromuscular and orbital anatomy and any alterations to the anatomy due to prior surgical procedures and standard electromyographic techniques. Local site reactions may be minimized by careful injection into the target muscle, using a minimal volume, and slowing the rate of injection. Route of administration varies based on indication; use extra precaution.
Note : Dilution concentration is dependent on indication; see product labeling for details.
IM:
Blepharospasm: Administer IM using a 27- or 30-gauge needle without electromyography guidance. Avoid injecting near the levator palpebrae superioris (may decrease ptosis); avoid medial lower lid injections (may decrease diplopia). Apply pressure at the injection site to prevent ecchymosis in the soft eyelid tissues.
Cervical dystonia: Administer IM using 25-, 27-, or 30-gauge needle for superficial muscles and a longer 22-gauge needle for deeper musculature; electromyography may help localize the involved muscles.
Spasticity: Administer IM using a 25-, 27-, or 30-gauge needle for superficial muscles and a longer 22-gauge needle for deeper musculature; electromyography or nerve stimulation may help localize the involved muscles.
Strabismus: Administer IM into extraocular muscles utilizing the electrical activity recorded from the tip of the injections needle as a guide to placement within the target muscle. Injection without surgical exposure or EMG guidance should not be attempted. Health care providers should be familiar with EMG technique. To prepare the eye for injection, it is recommended that several drops of a local anesthetic and an ocular decongestant be given several minutes prior to injection. The volume of injection should be 0.05 to 0.15 mL per muscle. Many patients will require additional doses because of inadequate response to initial dose.
Intradermal: Primary axillary hyperhidrosis: Adolescents ≥18 years: Inject each dose intradermally to a depth of ~2 mm and at a 45° angle. Do not inject directly into areas marked in ink (to avoid permanent tattoo effect). Prior to administration, injection area should be defined by standard staining techniques such as Minor's Iodine-Starch Test.
Instructions for Minor's Iodine-Starch Test: Patient should shave underarms and refrain from using deodorants or antiperspirants for 24 hours prior to test. At 30 minutes prior to test, patient should be at rest, no exercise, and not consume hot beverages. Underarm area should be dried and immediately painted with iodine solution. After area dries, lightly sprinkle with starch powder. Gently blow off excess powder. A deep blue-black color will develop over the hyperhidrotic area in ~10 minutes.
Intradetrusor: Bladder dysfunction (including overactive bladder and detrusor overactivity associated with neurologic condition):
Age <18 years:
Neurogenic detrusor overactivity: Children ≥5 years and <18 years: All patients should receive a diluted instillation of local anesthetic. For patients 5 to <12 years, consider administration under general or procedural sedation; consult local protocols. Instill sterile saline into bladder to optimize visualization but avoid overdistention. The injection needle should be primed with ~1 mL of reconstituted onabotulinumtoxinA solution prior to injection to remove any air. Administer onabotulinumtoxinA via flexible or rigid cystoscope by inserting needle with the recommended volume ~2 mm into the detrusor (per the manufacturer, avoid the trigone; although in some pediatric trials, the trigone was not spared (Ref)). Injections should be spaced ~1 cm apart. After completion of injections, drain saline from bladder and monitor patient for ≥30 minutes.
Iatrogenic overactive detrusor: Children ≥4 years and Adolescents: In trials, patients received urinary tract infection antimicrobial prophylaxis, and injections were administered under general anesthesia; refer to institutional procedures.
Adolescents ≥18 years: Bladder dysfunction (including overactive bladder and detrusor overactivity associated with neurologic condition): If a local anesthetic is instilled into the bladder prior to treatment, drain bladder and irrigate with NS prior to injection. Instill saline into bladder to optimize visualization but avoid overdistention. The injection needle should be primed with ~1 mL of reconstituted onabotulinumtoxinA prior to injection to remove any air. Administer onabotulinumtoxinA via flexible or rigid cystoscope by inserting needle with the recommended volume ~2 mm into the detrusor (avoid the trigone). Injections should be spaced ~1 cm apart. After completion of injections, drain saline from bladder and monitor patient for ≥30 minutes. In overactive bladder patients, a spontaneous void should also occur prior to patient leaving the clinic.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Botox, Botox Cosmetic: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103000s5327lbl.pdf#page=49
Axillary hyperhidrosis (Botox):
Treatment of severe primary axillary hyperhidrosis in adults not adequately managed with topical agents.
Limitations of use: The safety and effectiveness for hyperhidrosis in other body areas have not been established. Weakness of hand muscles and blepharoptosis may occur in patients who receive onabotulinumtoxinA for palmar hyperhidrosis and facial hyperhidrosis, respectively. Patients should be evaluated for potential causes of secondary hyperhidrosis (eg, hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease.
Cervical dystonia (Botox): Treatment of cervical dystonia in patients ≥16 years of age to reduce the severity of abnormal head position and neck pain.
Glabellar lines (Botox Cosmetic): Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults.
Forehead lines (Botox Cosmetic): Temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adults.
Lateral canthal lines (Botox Cosmetic): Temporary improvement in the appearance of moderate to severe lateral canthal lines associated with orbicularis oculi activity in adults.
Migraine, chronic, prevention (Botox): Prophylaxis of chronic migraine headaches (≥15 days/month with headache lasting ≥4 hours/day) in adults.
Limitations of use: Safety and efficacy have not been established in patients with ≤14 headaches per month.
Neurogenic detrusor overactivity (Botox): Treatment of neurogenic detrusor overactivity in pediatric patients ≥5 years of age who have an inadequate response to or who are intolerant to an anticholinergic medication.
Overactive bladder (Botox): Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency in adults who have an inadequate response to or who are intolerant to an anticholinergic medication.
Spasticity (Botox): Treatment of spasticity in patients ≥2 years of age.
Limitations of use: Improvement in upper extremity functional abilities or range of motion at a joint affected by a fixed contracture has not been shown.
Strabismus and blepharospasm associated with dystonia (Botox): Treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders, in patients ≥12 years of age.
Urinary incontinence due to detrusor overactivity (Botox): Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (eg, spinal cord injury, multiple sclerosis) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
Achalasia; Anal fissures; Raynaud phenomenon, severe, refractory to initial conventional therapy; Sialorrhea (drooling); Tardive dyskinesia
Botulinum products are not interchangeable; potency differences may exist between the products.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Aminoglycosides: May enhance the neuromuscular-blocking effect of Botulinum Toxin-Containing Products. Risk C: Monitor therapy
Anticholinergic Agents: Botulinum Toxin-Containing Products may enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy
Botulinum Toxin-Containing Products: May enhance the neuromuscular-blocking effect of other Botulinum Toxin-Containing Products. Risk C: Monitor therapy
Muscle Relaxants (Centrally Acting): May enhance the adverse/toxic effect of Botulinum Toxin-Containing Products. Specifically, the risk for increased muscle weakness may be enhanced. Risk C: Monitor therapy
Neuromuscular-Blocking Agents: Botulinum Toxin-Containing Products may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Risk C: Monitor therapy
OnabotulinumtoxinA has not been detected systemically in peripheral blood at recommended doses following intramuscular injection.
Data related to the use of onabotulinumtoxinA in pregnancy are limited to case reports for the treatment of cervical dystonia (Aranda 2012; Bodkin 2005; Krug 2015; Newman 2004), achalasia (Holliday 2016; Hooft 2015; Neubert 2019; Wataganara 2009), and migraine (Robinson 2014; Wong 2020). In addition, case reports collected by the manufacturer include pregnancy outcome data following use for cosmetic procedures, movement disorders, pain disorders, and hyperhidrosis (Brin 2016, Brin 2023).
Because data related to the use of onabotulinumtoxinA in pregnancy are limited, use for indications, such as cervical dystonia and cosmetic procedures, is generally avoided (Contarino 2017; Garg 2022; Morgan 2006; Trivedi 2017). In general, preventive treatment for migraine should be avoided during pregnancy. Options for pregnant patients should be considered as part of a shared decision-making process. Nonpharmacologic interventions should be considered initially. When needed, preventive treatment should be individualized considering the available safety data, the potential for adverse maternal and fetal events, and needs of the patient (ACOG 2022; AHS [Ailani 2021]). If preventive therapy for migraine headache is needed, agents other than onabotulinumtoxinA are preferred in pregnant patients (ACOG 2022; CHS [Pringsheim 2012]). OnabotulinumtoxinA is not recommended to treat episodic or tension type headaches during pregnancy (ACOG 2022). OnabotulinumtoxinA may be considered to temporarily improve symptoms of achalasia in pregnant patients when preferred therapies are not effective but treatment is needed before delivery (Vosko 2021).
It is not known if onabotulinumtoxinA is present in breast milk.
OnabotulinumtoxinA has not been detected systemically in peripheral blood at recommended doses following intramuscular injection. Outcome data following use in breastfeeding patients are limited (Cupitt 2018). According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
In general, preventive treatment for migraine in lactating patients should be avoided. When needed, therapy should be individualized considering the available safety data and needs of the patient (AHS [Ailani 2021]).
Detrusor overactivity associated with neurologic condition: Evaluate postvoid residual (PVR) urine volume within 2 weeks post-treatment and periodically thereafter up to 12 weeks in patients not catheterizing. Initiate catheterization with PVR urine volume >200 mL and continue until PVR <200 mL.
OnabotulinumtoxinA (previously known as botulinum toxin type A) is a neurotoxin produced by Clostridium botulinum, spore-forming anaerobic bacillus, which appears to affect only the presynaptic membrane of the neuromuscular junction in humans, where it prevents calcium-dependent release of acetylcholine and produces a state of denervation. Muscle inactivation persists until new fibrils grow from the nerve and form junction plates on new areas of the muscle-cell walls. Intradetrusor injection affects efferent pathways of detrusor activity by inhibiting release of acetylcholine. Intradermal injection results in temporary sweat gland denervation, reducing local sweating.
Onset of action (improvement):
Blepharospasm: ~3 to 4 days
Cervical dystonia: ~2 weeks
Detrusor overactivity associated with neurologic condition: ~2 weeks
Reduction of glabellar lines (Botox Cosmetic): 1 to 2 days, increasing in intensity during first week
Spasticity: Focal and cerebral palsy related: <2 weeks
Strabismus: ~1 to 2 days
Duration:
Blepharospasm: ~3 to 4 months
Cervical dystonia: ≤3 to 4 months
Detrusor overactivity associated with neurologic condition: ~42 to 48 weeks
Primary axillary hyperhidrosis: 201 days (mean)
Reduction of glabellar lines (Botox Cosmetic): ~3 to 4 months
Spasticity: ~3 to 3.5 months
Strabismus: ~2 to 6 weeks
Absorption: Not expected to be present in peripheral blood at recommended doses following intramuscular (IM) injection
Time to peak:
Blepharospasm: 1 to 2 weeks
Cervical dystonia: ~6 weeks
Spasticity (focal): 4 to 6 weeks
Strabismus: Within first week
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