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Onabotulinumtoxina Dosage

Medically reviewed on July 9, 2018.

Applies to the following strengths: 100 units; 50 units; 200 units

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 (as little benefit obtained from injecting more than 5 Units per site)
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

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 prism diopters 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

Subsequent doses for residual or recurrent strabismus:
-Reexamination should occur 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
-For patients experiencing adequate paralysis of the target muscle: Subsequent injections should be comparable to the initial dose
-For patients experiencing 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 for any one muscle

Comments:
-The volume of injection should be between 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, it is recommended that several drops of a local anesthetic and an ocular decongestant 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 one-half 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.

Use: Treatment of strabismus

Usual Adult Dose for Upper Limb Spasticity

Treatment should be individualized: Generally no more than 50 Units/site should be administered

-Clinical trial dose range: 75 to 400 Units divided among selected muscles per treatment session:
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
Adductor Pollicis: 20 Units in 1 site
Flexor Pollicis Longus: 20 Units in 1 site

Repeat treatment may be administered when the effect of a previous injection has diminished, but generally no sooner than 12 weeks

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 upper limb muscle groups; this drug has not been shown to improve upper extremity functional abilities or improve range of motion in 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

Treatment should be individualized: Generally, no more than 50 Units/site should be administered

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

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

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.
-Product labeling should be consulted for specific dilution, needle sizes, and administration recommendations.
-Improvement generally begins within the first 2 weeks with maximum benefit at approximately 6 weeks. Most subjects will return to pretreatment status by 3-months posttreatment.

Use: For the treatment patients with 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
-Repeat injections for hyperhidrosis should be administered when the clinical effect of a previous injection diminishes

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.

Use: Treatment of severe axillary hyperhidrosis that is inadequately managed by topical agents.

Usual Adult Dose for Glabellar Lines

OnabotulinumtoxinA (Botox (R) Cosmetic):
4 Units 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.
-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 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

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/day or longer).

Usual Adult Dose for Urinary Incontinence

OVERACTIVE BLADDER (OAB): 100 Units per treatment
-Median time until second treatment is about 24 weeks, but no sooner than 12 weeks

DETRUSOR OVERACTIVITY ASSOCIATED WITH A NEUROLOGIC CONDITION: 200 Units per treatment
-Median time until second treatment is about 42 to 48 weeks, but no sooner than 12 weeks

Administration is by injection into the detrusor muscle via a flexible or rigid cystoscope; appropriate caution should be exercised when performing a cystoscopy

Comments:
-Patients should not have an acute urinary tract infection at time of treatment.
-Prophylactic antibiotics (except aminoglycosides) should be administered 1 to 3 days pretreatment, on treatment day, and for 1 to 3 days posttreatment to reduce the likelihood of procedure-related UTI.
-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.
-An intravesical instillation of diluted local anesthetic with or without sedation 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.
-Product labeling should be consulted for specific administration recommendations.
-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 including OAB and DETRUSOR OVER ACTIVITY ASSOCIATED WITH A NEUROLOGIC CONDITION in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

Usual Adult Dose for Urinary Frequency

OVERACTIVE BLADDER (OAB): 100 Units per treatment
-Median time until second treatment is about 24 weeks, but no sooner than 12 weeks

DETRUSOR OVERACTIVITY ASSOCIATED WITH A NEUROLOGIC CONDITION: 200 Units per treatment
-Median time until second treatment is about 42 to 48 weeks, but no sooner than 12 weeks

Administration is by injection into the detrusor muscle via a flexible or rigid cystoscope; appropriate caution should be exercised when performing a cystoscopy

Comments:
-Patients should not have an acute urinary tract infection at time of treatment.
-Prophylactic antibiotics (except aminoglycosides) should be administered 1 to 3 days pretreatment, on treatment day, and for 1 to 3 days posttreatment to reduce the likelihood of procedure-related UTI.
-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.
-An intravesical instillation of diluted local anesthetic with or without sedation 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.
-Product labeling should be consulted for specific administration recommendations.
-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 including OAB and DETRUSOR OVER ACTIVITY ASSOCIATED WITH A NEUROLOGIC CONDITION in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

Usual Adult Dose for Crow's Feet

OnabotulinumtoxinA (Botox (R) Cosmetic):
4 units IM into 3 sites per side (6 total injection points) into 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

Treatment should be individualized: Generally no more than 50 Units/site should be administered

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

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.

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; this drug has not been shown to improve range of motion of a joint affected by a fixed contracture or 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 (R) 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:

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 (as little benefit obtained from injecting more than 5 Units per site)
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

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 prism diopters 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

Subsequent doses for residual or recurrent strabismus:
-Reexamination should occur 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
-For patients experiencing adequate paralysis of the target muscle: Subsequent injections should be comparable to the initial dose
-For patients experiencing 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 for any one muscle

Comments:
-The volume of injection should be between 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, it is recommended that several drops of a local anesthetic and an ocular decongestant 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 one-half 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.

Use: Treatment of strabismus

Usual Pediatric Dose for Cervical Dystonia

16 years or older:

Treatment should be individualized: Generally, no more than 50 Units/site should be administered

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

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

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.
-Product labeling should be consulted for specific dilution, needle sizes, and administration recommendations.
-Improvement generally begins within the first 2 weeks with maximum benefit at approximately 6 weeks. Most subjects will return to pretreatment status by 3-months posttreatment.

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

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Precautions

US BOXED WARNINGS: Distant Spread of Toxin Effect:
-Postmarketing reports indicated 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 with an underlying condition that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in unapproved 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 of the components in the formulation
-Infection at the proposed injection site
Intradetrusor Injections:
-Overactive bladder or detrusor overactivity associated with a neurological condition who have a UTI
-Urinary retention in patients with post-void residual urine volume greater than 200 mL, who are not routinely performing clean intermittent self-catheterization

-Safety and efficacy of onabotulinumtoxinA Cosmetic have not been established in patients under 18 years old.
-Safety and efficacy of onabotulinumtoxinA have not been established in patients under 18 years for bladder dysfunction, prophylaxis of headaches in chronic migraine, spasticity, or axillary hyperhidrosis; under 16 years for cervical dystonia; or under 12 years for blepharospasm or strabismus.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Safe and effective use depends upon selection of the correct dose, dilution, and proper administration techniques; see product labeling for indication specific administration recommendations.
-OnabotulinumtoxinA (Botox[R]Cosmetic) is for the treatment of glabellar, lateral canthal, and forehead lines; OnabotulinumtoxinA (Botox[R]) should be used for all other indications.

-Patients receiving therapy for 1 or more indications: Maximum cumulative dose should not exceed 400 Units in a 3-month interval

Storage requirements:
-Unopened vials: Store in refrigerator (2C to 8C [36F to 46F])
-Reconstituted vials: Store in refrigerator 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 product labeling for indication specific reconstitution and injection techniques; product labeling provides dilution charts and detailed diagrams of injection sites

General:
-Potency Units of onabotulinumtoxinA are specific to preparation and assay method utilized; botulinum toxins are not interchangeable
-When initiating treatment, the lowest recommended dose should be used.
-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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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