Usual Adult Dose for Blepharospasm

1.25 to 2.5 Units injected into the medial and lateral pretarsal orbicularis oculi of the upper lid and into the lateral pre-tarsal orbicularis oculi of the lower lid
Maximum dose: 5 Units/site (little benefit obtained from injecting more)
Maximum cumulative dose in a 30-day period: 200 Units

Repeat sessions: Dose may be increased up to 2-fold if response is considered insufficient (e.g., effect does not last longer than 2 months)

• Injections more frequently than every 3 months may result in some tolerance

Comments:

• Product labeling should be consulted for specific dilution, needle sizes and administration recommendations.
• Avoid injection near the levator palpebrae superioris to reduce the complication of ptosis.
• Avoid medial lower lid injections to reduce diffusion into the inferior oblique, and therefore reduce the complication of diplopia.
• Pressure should be applied at the injection site immediately after the injection to prevent ecchymosis
• The initial effect is usually seen within 3 days, peaks at 1 to 2 weeks, and lasts approximately 3 months, at which time the procedure may be repeated.

Use: Treatment of blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders.

Usual Adult Dose for Strabismus

Initial doses:

• Dose range covers small and large deviations; the lower dose should be used for the treatment of small deviations and the larger dose for larger deviations:
• For vertical muscles, and for horizontal strabismus of less than 20 prism diopters: 1.25 to 2.5 Units in any one muscle
• For horizontal strabismus of 20 to 50 prism diopters: 2.5 to 5 Units in any one muscle
• For persistent VI nerve palsy of 1 month or longer: 1.25 to 2.5 Units in the medial rectus muscle

Patients should be reexamined 7 to 14 days after each injection to assess effectiveness

• Subsequent injections should not be administered until the effects of the previous dose have dissipated

Subsequent Doses for Residual or Recurrent Strabismus:

• For patients who have experienced adequate paralysis of the target muscle: Subsequent injections should be comparable to the initial dose
• For patients who experienced incomplete paralysis of the target muscle: Dose may be increased up to 2-fold compared to previously administered dose

Maximum dose: 25 Units as a single injection in any one muscle

Comments:

• The volume of injection should be 0.05 and 0.15 mL per muscle; product labeling should be consulted for specific dilution and administration recommendations
• This drug is intended for injection into extraocular muscles utilizing the electrical activity recorded from the tip of the injection needle as a guide to placement within the target muscle; injection without surgical exposure or electromyographic guidance should not be attempted.
• To prepare the eye for injection, several drops of a local anesthetic and an ocular decongestant should be given several minutes prior to injection.
• Paralysis of injected muscles typically occurs 1 to 2 days after the initial injection, lasts 2 to 6 weeks, and resolves over a similar time-period; overcorrections lasting more than 6 months are rare.
• About 50% of patients will require subsequent doses because of inadequate paralytic response of the muscle or because of mechanical factors such as large deviations or restrictions, or because of the lack of binocular motor fusion to stabilize the alignment; subsequent injections should not be administered until the effects of the previous dose have dissipated as evidenced by substantial function in the injected and adjacent muscles.

Use: Treatment of strabismus

Usual Adult Dose for Upper Limb Spasticity

Dosing should be individualized based on size, number, and location of muscles involved; severity of spasticity; presence of local muscle weakness; and patient's response/experiences to previous treatments. The lowest recommended starting dose should be used and no more than 50 Units per site should generally be administered:

Clinical trial dose range: 75 to 400 Units divided among selected muscles per treatment session:

• Biceps Brachii: 60 to 200 Units divided in 2 to 4 sites
• Brachioradialis: 45 to 75 Units divided in 1 to 2 sites
• Brachialis: 30 to 50 Units divided in 1 to 2 sites
• Pronator Teres: 15 to 25 Units in 1 site
• Pronator Quadratus: 10 to 50 Units in 1 site
• 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
• Lumbricals/Interossei: 5 to 10 Units in 1 site
• Adductor Pollicis: 20 Units in 1 site
• Flexor Pollicis Longus: 20 Units in 1 site
• Flexor Pollicis Brevis/Opponens Pollicis: 5 to 25 Units in 1 site

Maximum Cumulative Total Dose (when treating for 1 or more indications): 400 Units in a 3 month period

Repeat treatments may be administered when the effect of a previous injection has diminished, but generally no sooner than 12 weeks. Dose alterations may be necessary at time of reinjection due to changes in degree and pattern of muscle spasticity.

Comments:

• Localization of the involved muscles with techniques such as needle electromyographic guidance or nerve stimulation is recommended.
• Product labeling should be consulted for specific dilution, needle sizes and administration recommendations.
• Safety and effectiveness have not been established for the treatment of other upper limb muscle groups; this drug has not been shown to improve upper extremity functional abilities or improve range of motion at a joint affected by a fixed contracture; drug therapy is not a substitute for standard of care rehabilitation regimens.

Use: For the treatment of upper limb spasticity in adult patients, to decrease the severity of increased muscle tone in elbow flexors (biceps), wrist flexors (flexor carpi radialis and flexor carpi ulnaris), finger flexors (flexor digitorum profundus and flexor digitorum sublimis), and thumb flexors (adductor pollicis and flexor pollicis longus).

Usual Adult Dose for Cervical Dystonia

Initial dose (onabotulinumtoxinA-naive): Start low and adjust based on individual response

• Study doses (onabotulinumtoxinA-experienced): Mean dose: 236 Units (25 th to 75 th percentile range 198 to 300 Units) divided among the affected muscle groups

Limiting total dose injected into the sternocleidomastoid muscle to 100 Units or less may decrease the occurrence of dysphagia

• Maximum Cumulative Total Dose (when treating for 1 or more indications): 400 Units in a 3 month period

Comments:

• Dosing should be individualized based on patient's head and neck position, localization of the pain, muscle hypertrophy, and patient's response/experiences to previous treatments.
• Localization of the involved muscles with electromyographic guidance may be useful.
• Product labeling should be consulted for specific dilution, needle sizes, and administration recommendations.
• Clinical improvement generally begins within the first 2 weeks with maximum benefit at approximately 6 weeks; the majority of patients return to pretreatment status by 3-months posttreatment.

Use: For the treatment of cervical dystonia; to reduce the severity of abnormal head position and neck pain associated with cervical dystonia

Usual Adult Dose for Hyperhidrosis

50 Units per axilla administered intradermally in 0.1 to 0.2 mL aliquots in 10 to 15 sites approximately 1 to 2 cm apart

• Repeat injections for hyperhidrosis should be administered when the clinical effect of a previous injection diminishes

Maximum Cumulative Total Dose (when treating for 1 or more indications): 400 Units in a 3 month period

Comments:

• Product labeling should be consulted for specific dilution, needle sizes and administration recommendations.
• Safety and effectiveness for hyperhidrosis in other body areas have not been established.
• Evaluate for potential causes of secondary hyperhidrosis (e.g., hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease.

Use: For the treatment of severe axillary hyperhidrosis that is inadequately managed with topical agents.

Usual Adult Dose for Glabellar Lines

OnabotulinumtoxinA (Botox Cosmetic):
Inject 4 Units (0.1 mL) IM into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 20 Units
Duration of effect: Approximately 3 to 4 months

• For simultaneous treatment with LATERAL CANTHAL LINES: Dose is 24 Units for lateral canthal lines and 20 Units for glabellar lines for a TOTAL DOSE of 44 Units
• For simultaneous treatment with LATERAL CANTHAL LINES and FOREHEAD LINES: Dose is 24 Units for lateral canthal lines and 20 Units for glabellar lines and 20 Units for forehead lines for a TOTAL DOSE of 64 Units

Comments:

• Refer to manufacturer information for dilution instructions and injection site diagrams.
• Typically, chemical denervation of the injected muscles occurs 1 to 2 days after injection and increases in intensity during the first week.
• To reduce the complication of ptosis the following steps should be taken:
• Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes.
• Lateral corrugator injections should be placed at least 1 cm above the bony supraorbital ridge.
• Ensure the injected volume/dose is accurate and where feasible kept to a minimum.
• Do not inject toxin closer than 1 cm above the central eyebrow.
• The safety and effectiveness of dosing more frequently than every 3 months have not been clinically evaluated.

Use: For the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity.

Usual Adult Dose for Migraine Prophylaxis

155 Units IM divided in 31 sites across 7 specific head/neck muscle areas every 12 weeks:

• Frontalis (bilaterally): 20 Units divided in 4 sites
• Corrugator (bilaterally): 10 Units divided in 2 sites
• Procerus: 5 Units in 1 site
• Occipitalis (bilaterally): 30 Units divided in 6 sites
• Temporalis (bilaterally): 40 Units divided in 8 sites
• Trapezius (bilaterally): 30 Units divided in 6 sites
• Cervical Paraspinal Muscle Group (bilaterally): 20 Units divided in 4 sites

Maximum Cumulative Total Dose (when treating for 1 or more indications): 400 Units in a 3 month period

Comments:

• Product labeling should be consulted for dilution instructions, needle recommendations, and diagram of administration sites.
• Safety and effectiveness have not been established for the prophylaxis of episodic migraine (14 headache days or fewer per month).

Use: For the prophylaxis of headaches in adult patients with chronic migraine (15 days or more per month with headache lasting 4 hours a day or longer).

Usual Adult Dose for Urinary Incontinence

General Administration Instructions:

• An intravesical instillation of diluted local anesthetic with or without sedation or general anesthesia may be used prior to injection; if a local anesthetic instillation is performed, the bladder should be drained and irrigated with sterile saline before injection
• Ensure patients do not have an acute urinary tract infection (UTI) at time of treatment; to reduce likelihood of procedure-related UTI, administer prophylactic antibiotics (except aminoglycosides) 1 to 3 days prior to treatment, on treatment day, and for 1 to 3 days posttreatment.
• Antiplatelet therapy should be discontinued at least 3 days prior to the injection; patients on anticoagulant therapy should be managed appropriately to decrease the risk of bleeding.

OVERACTIVE BLADDER (OAB):
Treatment: 100 Units into detrusor muscle via a flexible or rigid cytoscope (avoid trigone); administer 20 injections of 0.5 mL (100 Units/10 mL) spaced about 1 cm apart
Maximum dose: 100 Units per treatment; median time until next treatment is about 24 weeks, but no sooner than 12 weeks

• Patient should demonstrate ability to void prior to leaving the clinic

DETRUSOR OVERACTIVITY ASSOCIATED WITH A NEUROLOGIC CONDITION:
Treatment: 200 units into detrusor muscle via a flexible or rigid cytoscope (avoid trigone); administer 30 injections of 1 mL (approximately 6.7 Units/injection) spaced about 1 cm apart
Maximum dose: 200 Units per treatment; median time until second treatment is about 42 to 48 weeks, but no sooner than 12 weeks

Maximum Cumulative Total Dose (when treating for 1 or more indications): 400 Units in a 3 month period

Comments:

• Appropriate caution should be exercised when performing a cystoscopy; observe patients closely for at least 30 minutes post-injection.
• Product labeling should be consulted for specific administration instructions.
• Retreatment should be considered when the clinical effect of the previous injection has diminished, but no sooner than 12 weeks from prior bladder injection.

Uses: For the treatment of bladder dysfunction in adults who have an inadequate response to or are intolerant of an anticholinergic medication:

• Treatment of OAB with symptoms of urge urinary incontinence, urgency, and frequency.
• Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g. SCI, MS).

Usual Adult Dose for Urinary Frequency

General Administration Instructions:

• An intravesical instillation of diluted local anesthetic with or without sedation or general anesthesia may be used prior to injection; if a local anesthetic instillation is performed, the bladder should be drained and irrigated with sterile saline before injection
• Ensure patients do not have an acute urinary tract infection (UTI) at time of treatment; to reduce likelihood of procedure-related UTI, administer prophylactic antibiotics (except aminoglycosides) 1 to 3 days prior to treatment, on treatment day, and for 1 to 3 days posttreatment.
• Antiplatelet therapy should be discontinued at least 3 days prior to the injection; patients on anticoagulant therapy should be managed appropriately to decrease the risk of bleeding.

OVERACTIVE BLADDER (OAB):
Treatment: 100 Units into detrusor muscle via a flexible or rigid cytoscope (avoid trigone); administer 20 injections of 0.5 mL (100 Units/10 mL) spaced about 1 cm apart
Maximum dose: 100 Units per treatment; median time until next treatment is about 24 weeks, but no sooner than 12 weeks

• Patient should demonstrate ability to void prior to leaving the clinic

DETRUSOR OVERACTIVITY ASSOCIATED WITH A NEUROLOGIC CONDITION:
Treatment: 200 units into detrusor muscle via a flexible or rigid cytoscope (avoid trigone); administer 30 injections of 1 mL (approximately 6.7 Units/injection) spaced about 1 cm apart
Maximum dose: 200 Units per treatment; median time until second treatment is about 42 to 48 weeks, but no sooner than 12 weeks

Maximum Cumulative Total Dose (when treating for 1 or more indications): 400 Units in a 3 month period

Comments:

• Appropriate caution should be exercised when performing a cystoscopy; observe patients closely for at least 30 minutes post-injection.
• Product labeling should be consulted for specific administration instructions.
• Retreatment should be considered when the clinical effect of the previous injection has diminished, but no sooner than 12 weeks from prior bladder injection.

Uses: For the treatment of bladder dysfunction in adults who have an inadequate response to or are intolerant of an anticholinergic medication:

• Treatment of OAB with symptoms of urge urinary incontinence, urgency, and frequency.
• Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g. SCI, MS).

Usual Adult Dose for Bladder Muscle Dysfunction - Overactive

General Administration Instructions:

• An intravesical instillation of diluted local anesthetic with or without sedation or general anesthesia may be used prior to injection; if a local anesthetic instillation is performed, the bladder should be drained and irrigated with sterile saline before injection
• Ensure patients do not have an acute urinary tract infection (UTI) at time of treatment; to reduce likelihood of procedure-related UTI, administer prophylactic antibiotics (except aminoglycosides) 1 to 3 days prior to treatment, on treatment day, and for 1 to 3 days posttreatment.
• Antiplatelet therapy should be discontinued at least 3 days prior to the injection; patients on anticoagulant therapy should be managed appropriately to decrease the risk of bleeding.

OVERACTIVE BLADDER (OAB):
Treatment: 100 Units into detrusor muscle via a flexible or rigid cytoscope (avoid trigone); administer 20 injections of 0.5 mL (100 Units/10 mL) spaced about 1 cm apart
Maximum dose: 100 Units per treatment; median time until next treatment is about 24 weeks, but no sooner than 12 weeks

• Patient should demonstrate ability to void prior to leaving the clinic

DETRUSOR OVERACTIVITY ASSOCIATED WITH A NEUROLOGIC CONDITION:
Treatment: 200 units into detrusor muscle via a flexible or rigid cytoscope (avoid trigone); administer 30 injections of 1 mL (approximately 6.7 Units/injection) spaced about 1 cm apart
Maximum dose: 200 Units per treatment; median time until second treatment is about 42 to 48 weeks, but no sooner than 12 weeks

Maximum Cumulative Total Dose (when treating for 1 or more indications): 400 Units in a 3 month period

Comments:

• Appropriate caution should be exercised when performing a cystoscopy; observe patients closely for at least 30 minutes post-injection.
• Product labeling should be consulted for specific administration instructions.
• Retreatment should be considered when the clinical effect of the previous injection has diminished, but no sooner than 12 weeks from prior bladder injection.

Uses: For the treatment of bladder dysfunction in adults who have an inadequate response to or are intolerant of an anticholinergic medication:

• Treatment of OAB with symptoms of urge urinary incontinence, urgency, and frequency.
• Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g. SCI, MS).

Usual Adult Dose for Crow's Feet

OnabotulinumtoxinA (Botox Cosmetic):
Inject 4 units (0.1 mL) IM into 3 sites per side (6 total injection points) in the lateral orbicularis oculi muscle for a total of 24 Units (12 units per side)

• For simultaneous treatment with GLABELLAR LINES: Dose is 24 Units for lateral canthal lines and 20 Units for glabellar lines for a TOTAL DOSE of 44 Units
• For simultaneous treatment with GLABELLAR LINES and FOREHEAD LINES: Dose is 24 Units for lateral canthal lines and 20 Units for glabellar lines and 20 Units for forehead lines for a TOTAL DOSE of 64 Units

Comments:

• Refer to manufacturer information for specific administration instructions including dilution, needle orientation, and injection site diagrams.
• The safety and effectiveness of dosing more frequently than every 3 months have not been clinically evaluated.

Use: For the temporary improvement in the appearance of moderate to severe lateral canthal lines associated with orbicularis oculi activity.

Usual Adult Dose for Lower Limb Spasticity

Dosing should be individualized based on size, number, and location of muscles involved; severity of spasticity; presence of local muscle weakness; and patient's response/experiences to previous treatments. The lowest recommended starting dose should be used.

Dose range: 300 to 400 Units divided among 5 muscles per treatment session (gastrocnemius, soleus, tibialis posterior, flexor hallucis longus, and flexor digitorum longus):

• Gastrocnemius medial head: 75 Units divided in 3 sites
• Gastrocnemius lateral head: 75 Units divided in 3 sites
• Soleus: 75 Units divided in 3 sites
• Tibialis Posterior: 75 Units divided in 3 sites
• Flexor hallucis longus: 50 Units divided in 2 sites
• Flexor digitorum longus: 50 Units divided in 2 sites

Maximum Cumulative Total Dose (when treating for 1 or more indications): 400 Units in a 3 month period

Repeat treatment may be administered when the effect of a previous injection has diminished, but generally no sooner than 12 weeks after the previous injection; dose alterations may be necessary at time of reinjection due to changes in degree and pattern of muscle spasticity

Comments:

• Product labeling should be consulted for specific dilution, needle sizes and administration recommendations.
• Safety and effectiveness have not been established for the treatment of other lower limb muscle groups; this drug has not been shown to improve range of motion at a joint affected by a fixed contracture or as a substitute for standard of care rehabilitation regimens.

Use: For the treatment of lower limb spasticity; to decrease the severity of increased muscle tone in ankle and toe flexors (gastrocnemius, soleus, tibialis posterior, flexor hallucis longus, and flexor digitorum longus).

Usual Adult Dose for Forehead Lines

OnabotulinumtoxinA (Botox Cosmetic):

• Forehead line should be treated in conjunction with GLABELLAR LINES to minimize the potential for brow ptosis:

Forehead lines: 20 Units as 4 Units into 5 sites in the frontalis muscle
Glabellar lines: 20 Units as 4 Units into 5 sites (see Adult Dose for Glabellar lines)
Total Dose: 40 Units

For Simultaneous Treatment of GLABELLAR LINES and LATERAL CANTHAL LINES:

• Administer 20 Units for forehead lines, 20 Units for glabellar lines, and 24 Units for lateral canthal lines for a TOTAL DOSE of 64 Units

Comments:

• When identifying the location of the appropriate injection sites in the frontalis muscle, assess the overall relationship between the size of the forehead, and the distribution of frontalis muscle activity; location, size, and use of this muscle varies markedly among individuals.
• Refer to manufacturer information for specific administration instructions including dilution, needle orientation, and injection site diagrams.
• The safety and effectiveness of dosing more frequently than every 3 months have not been clinically evaluated.

Use: For the temporary improvement in the appearance of moderate to severe forehead line associated with frontalis muscle activity.

Usual Pediatric Dose for Blepharospasm

12 years or older:

• Inject 1.25 to 2.5 Units into the medial and lateral pretarsal orbicularis oculi of the upper lid and into the lateral pre-tarsal orbicularis oculi of the lower lid

Maximum dose: 5 Units/site (little benefit obtained from injecting more)
Maximum cumulative dose in a 30 day period: 200 Units

Repeat sessions: Dose may be increased up to 2-fold if response is considered insufficient (effect does not last longer than 2 months)

• Injections more frequently than every 3 months may result in some tolerance

Comments:

• Product labeling should be consulted for specific dilution, needle sizes and administration recommendations.
• Avoid injection near the levator palpebrae superioris to reduce the complication of ptosis.
• Avoid medial lower lid injections to reduce diffusion into the inferior oblique, and therefore reduce the complication of diplopia.
• Pressure should be applied at the injection site immediately after the injection to prevent ecchymosis
• The initial effect is usually seen within 3 days, peaks at 1 to 2 weeks, and lasts approximately 3 months, at which time the procedure may be repeated.

Use: Treatment of blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in pediatric patients 12 years or older.

Usual Pediatric Dose for Strabismus

12 years or older:
Initial doses: Dose range covers small and large deviations; the lower dose should be used for the treatment of small deviations and the larger dose for larger deviations:

• For vertical muscles, and for horizontal strabismus of less than 20 prism diopters: 1.25 to 2.5 Units in any one muscle
• For horizontal strabismus of 20 to 50 prism diopters: 2.5 to 5 Units in any one muscle
• For persistent VI nerve palsy of 1 month or longer: 1.25 to 2.5 Units in the medial rectus muscle

Patients should be reexamined 7 to 14 days after each injection to assess effectiveness

• Subsequent injections should not be administered until the effects of the previous dose have dissipated

Subsequent Doses for Residual or Recurrent Strabismus:

• For patients who have experienced adequate paralysis of the target muscle: Subsequent injections should be comparable to the initial dose
• For patients who experienced incomplete paralysis of the target muscle: Dose may be increased up to 2-fold compared to previously administered dose

Maximum dose: 25 Units as a single injection in any one muscle

Comments:

• The volume of injection should be 0.05 and 0.15 mL per muscle; product labeling should be consulted for specific dilution and administration recommendations
• This drug is intended for injection into extraocular muscles utilizing the electrical activity recorded from the tip of the injection needle as a guide to placement within the target muscle; injection without surgical exposure or electromyographic guidance should not be attempted.
• To prepare the eye for injection, several drops of a local anesthetic and an ocular decongestant should be given several minutes prior to injection.
• Paralysis of injected muscles typically occurs 1 to 2 days after the initial injection, lasts 2 to 6 weeks, and resolves over a similar time-period; overcorrections lasting more than 6 months are rare.
• About 50% of patients will require subsequent doses because of inadequate paralytic response of the muscle or because of mechanical factors such as large deviations or restrictions, or because of the lack of binocular motor fusion to stabilize the alignment; subsequent injections should not be administered until the effects of the previous dose have dissipated as evidenced by substantial function in the injected and adjacent muscles.

Use: Treatment of strabismus in pediatric patients 12 years or older.

Usual Pediatric Dose for Cervical Dystonia

16 years or older:

• Initial dose (onabotulinumtoxinA-naive): Start low and adjust based on individual response
• Study doses (onabotulinumtoxinA-experienced): Mean dose: 236 Units (25 th to 75 th percentile range 198 to 300 Units) divided among the affected muscle groups

Limiting total dose injected into the sternocleidomastoid muscle to 100 Units or less may decrease the occurrence of dysphagia
Maximum Cumulative Total Dose (when treating for 1 or more indications): 400 Units in a 3 month period

Comments:

• Dosing should be individualized based on patient's head and neck position, localization of the pain, muscle hypertrophy, and patient's response/experiences to previous treatments.
• Localization of the involved muscles with electromyographic guidance may be useful.
• Product labeling should be consulted for specific dilution, needle sizes, and administration recommendations.
• Clinical improvement generally begins within the first 2 weeks with maximum benefit at approximately 6 weeks; the majority of patients return to pretreatment status by 3-months posttreatment.

Use: For the treatment of cervical dystonia in patients 16 years or older; to reduce the severity of abnormal head position and neck pain associated with cervical dystonia

Usual Pediatric Dose for Upper Limb Spasticity

2 years or older:
Localization of the involved muscles with techniques such as needle electromyographic guidance, nerve stimulation, or ultrasound is recommended:

Dose: 3 to 6 Units/kg divided among affected muscles; total dose per treatment session should not exceed 6 Units/kg or 200 Units, whichever is lower

• Maximum: If treating both lower limbs, or upper and lower limbs in combination, the total dose should not exceed 10 Units/kg or 340 Units, which ever is lower, in a 3-month interval

Dosing by Muscle

• 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 Units/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 Units/kg divided in 2 sites
• Flexor Digitorum Sublimis: 0.5 to 1 Units/kg divided in 2 sites

Repeat treatment may be administered when the effect of a previous injection has diminished, but generally no sooner than 12 weeks. Dose alterations may be necessary at time of reinjection due to changes in degree and pattern of muscle spasticity

Comments:

• Drug therapy is not intended to substitute for usual standard of care rehabilitation regimens.
• Dosing should be individualized based on size, number, and location of muscles involved; severity of spasticity; presence of local muscle weakness; and patient's response/experiences to previous treatments. The lowest recommended starting dose should be used.
• This drug has not been shown to improve upper extremity functional abilities or range of motion at a joint affected by a fixed contracture.
• Product labeling should be consulted for specific dilution, needle sizes and administration recommendations.

Use: For the treatment of upper limb spasticity in pediatric patients 2 year or older.

Usual Pediatric Dose for Lower Limb Spasticity

2 years or older:
Localization of the involved muscles with techniques such as needle electromyographic guidance, nerve stimulation, or ultrasound is recommended

Dose: 4 to 8 Units/kg divided among affected muscles; total dose per treatment session should not exceed 8 Units/kg or 300 Units, whichever is lower
Maximum doses: If treating both lower limbs, or upper and lower limbs in combination, the total dose should not exceed the 10 Units/kg or 340 Units, which ever is lower, in a 3-month interval

Dosing by Muscle:

• Gastrocnemius medial head: 1 to 2 Units/kg divided in 2 sites
• Gastrocnemius lateral 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

Repeat treatment may be administered when the effect of a previous injection has diminished, but generally no sooner than 12 weeks after the previous injection. Dose alterations may be necessary at time of reinjection due to changes in degree and pattern of muscle spasticity.

Comments:

• Dosing should be individualized based on size, number, and location of muscles involved; severity of spasticity; presence of local muscle weakness; and patient's response/experiences to previous treatments. The lowest recommended starting dose should be used.
• Product labeling should be consulted for specific dilution, needle sizes and administration recommendations.
• Safety and effectiveness have not been established for the treatment of other lower limb muscle groups.

Use: For the treatment of lower limb spasticity in pediatric patients 2 years or older, excluding spasticity caused by cerebral palsy.

Usual Pediatric Dose for Bladder Muscle Dysfunction - Overactive

5 years or older:

• Weight 34 kg or greater: 200 units/treatment administered as an intradetrusor injection
• Weight less than 34 kg: 6 Units/kg/treatment administered as a bladder injection
• Retreatment should be considered when the clinical effect of the previous injection diminishes (median time in clinical trials 30 weeks) but no sooner than 12 weeks
• Maximum Cumulative Total Dose (when treating for 1 or more indications): The lower of 10 Units/kg or 340 Units in a 3-month interval should not be exceeded

General Administration Instructions:

• This drug should be diluted prior to administration; see manufacturer product labeling for dilution instructions, dosing table for patients with weight less than 34 kg, and more detailed administration instructions.
• Appropriate caution should be exercised when performing a cystoscopy. For patients 5 to less than 12 years, consider general anesthesia; for patients 12 years of older, consider intravesical instillation of diluted local anesthetic with or without sedation or general anesthesia
• When a local anesthetic instillation is performed, the bladder should be drained and irrigated with sterile saline before injection.
• Ensure patients do not have an acute urinary tract infection (UTI) at time of treatment. To reduce likelihood of procedure-related UTI, administer prophylactic antibiotics (except aminoglycosides) orally 1 to 3 days prior, on, and for 1 to 3 days after treatment OR a administer a single IV dose on treatment day.
• Antiplatelet therapy should be discontinued at least 3 days prior to the injection; patients on anticoagulant therapy should be managed appropriately to decrease the risk of bleeding.

Use: For the treatment of neurogenic detrusor overactivity in pediatric patients 5 years or older who have an inadequate response to or are intolerant of an anticholinergic medication.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

Potency Units of onabotulinumtoxinA are specific to the preparation and assay method utilized; they are not interchangeable with other botulinum toxin preparations

Precautions

US BOXED WARNING: Distant Spread of Toxin Effect:

• 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, such as asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties.
• Symptoms have been reported hours to weeks after injection; swallowing and breathing difficulties can be life-threatening and there have been reports of death.
• 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 patients with underlying conditions that may predispose them to these symptoms.
• In unapproved uses and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses.

CONTRAINDICATIONS:

• Hypersensitivity to any botulinum toxin preparation or to any product ingredients
• Infection at the proposed injection site(s)
• Intradetrusor injection in patients with a urinary tract infection, or in patients with urinary retention or post-void residual urine volume greater than 200 mL who are not routinely performing clean intermittent self-catheterization

Safety and efficacy onabotulinumtoxinA (Botox) have not been established in patients younger than 18 years for overactive bladder, migraine prophylaxis or axillary hyperhidrosis; for patients younger than 16 years for cervical dystonia; for patients younger than 12 years for blepharospasm and strabismus; for patients less than 5 years for detrusor overactivity associated with a neurologic condition; and for patients less than 2 years for spasticity.

Safety and efficacy of onabotulinumtoxinA (Botox Cosmetic) have not been established in patients under 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Indication specific dosage and administration recommendations should be followed
• The safe and effective use depends upon proper storage, selection of the correct dose, and proper reconstitution and administration techniques; see manufacturer product labeling for indication specific administration recommendations including preparation and dilution instructions.
• Maximum Cumulative Adult Dose: 400 Units in a 3 month period
• Maximum Total Pediatric Dose: 10 Units/kg or 340 Units (whichever is lower) in a 3 month period

BotoxCosmetic (onabotulinumtoxinA) is for the treatment of glabellar, lateral canthal, and forehead lines; Botox (onabotulinumtoxinA) should be used for all other indications

Storage requirements:

• Unopened vials: Store in refrigerator (2C to 8C [36F to 46F])
• Reconstituted vials: Store refrigerated for up to 24 hours

Do not use product if:

• Carton labeling does not contain an intact seal with a translucent silver Allergan logo (on both ends of the carton) or the seal has a black circle with a diagonal line through it
• Vial label does not contain a holographic film containing the name Allergan within rainbow colored horizontal lines
• U.S. License number 1145 is not present on the vial label and carton labeling

Reconstitution/preparation techniques:

• Single-use vials
• See manufacturer product labeling for indication specific reconstitution and injection techniques; additionally, dilution charts and detailed diagrams of injection sites is included in the manufacturer product labeling.

General:

• Potency Units of onabotulinumtoxinA are specific to preparation and assay method utilized; botulinum toxins are not interchangeable.
• The lowest recommended dose should be used when initiating treatment.
• Standard electromyographic techniques are required for treatment of strabismus, upper or lower limb spasticity, and may be useful for the treatment of cervical dystonia.

Monitoring:

• Monitor for distant spread of toxin

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• Patients and caregivers should be instructed to inform their healthcare provider if they develop any unusual symptoms or if any existing symptoms worsen; they should be instructed to seek immediate medical attention if they have trouble swallowing, speaking, or breathing.
• Patients experiencing loss of strength, muscle weakness, blurred vision, dizziness, or drooping eyelids should avoid engaging in potentially hazardous activities including driving.
• Patients undergoing bladder injections should contact their physician if they experience difficulty voiding or have a burning sensation upon voiding.

Frequently asked questions

• What is botulinum toxin used to treat?