Close
New

Medscape is available in 5 Language Editions – Choose your Edition here.

 

onabotulinumtoxinA (Rx)Brand and Other Names:Botox, Botox Cosmetic, more...botulinum toxin

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable, powder for reconstitution

  • 50 units/vial
  • 100 units/vial
  • 200 units/vial
more...

Blepharospasm

1.25-2.5 units injected into medial and lateral pretarsal orbicularis oculi of upper lid and lateral pretarsal orbicularis oculi of lower lid; not to exceed 200 units in 30 days

May increase dose 2-fold if response to initial treatment dose does not last longer than 2 months

Little benefit obtained from injecting >5 units per site

Tolerance may develop if treatment given more than every 3 months; effect not usually permanent

Strabismus

1.25-5 units IM; <25 units per injection

Vertical muscles, and horizontal strabismus of <20 prism diopters: 1.25-2.5 units in any one muscle

Persistent VI nerve palsy of >1 month of duration: 1.25-2.5 units in the medial rectus muscle

Horizontal strabismus of 20-50 prism diopters: 2.5-5 units in any one muscle

Incomplete paralysis of target muscle: May increase dose 2-fold if patient experience incomplete paralysis of the target

Primary Axillary Hyperhidrosis

50 units injected intradermally to each axilla evenly distributed in multiple sites approximately 1-2 cm apart

Upper and Lower Limb Spasticity

Indicated for the treatment of upper and lower limb spasticity in adults to decrease the severity of increased muscle stiffness

Select dose based on muscles affected, severity of muscle activity, prior response to treatment, and adverse event history (EMG guidance recommended)

Do not exceed a cumulative dose of 400 units in 3-month interval when treating adults for 1 or more indications

Upper limb spasticity

  • Selected muscles: 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)
  • In clinical trials, doses ranging from 75 units to 400 units were divided among selected muscles to treat upper limb spasticity at a given treatment session
  • Recommended dose per muscle for upper limb spasticity
    • Biceps brachii: 100-200 units divided in 4 sites
    • Flexor carpi radialis: 12.5-50 units in 1 site
    • Flexor carpi ulnaris: 12.5-50 units in 1 site
    • Flexor digitorum profundus: 30-50 units in 1 site
    • Flexor digitorum sublimis: 30-50 units in 1 site
    • Adductor pollicis: 20 units in 1 site
    • Flexor pollicis longus: 20 units in 1 site

Lower limb spasticity

  • Selected muscles: Gastrocnemius, soleus, tibialis posterior, flexor hallucis longus, and flexor digitorum longus
  • Recommended dose for treating lower limb spasticity is 300 units to 400 units divided among 5 muscles
  • Recommended dose per muscle for lower limb spasticity
    • 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

Chronic Migraine

Indicated for prophylactic treatment of headaches in adults with chronic migraine, a distinct and severe neurological disorder characterized by patients with migraine history who suffer from headaches on 15 or more days/month. Headaches typically last 4 h/day or longer

Recommended total dose 155 units, as 0.1 mL (5 units) IM injections per each site divided across 7 head/neck muscles q12wk

Recommended dose per muscle site (totaling 155 units)

  • Frontalis: 20 units divided in 4 sites
  • Corrugator: 10 units divided in 2 sites
  • Procerus: 5 units in 1 site
  • Occipitalis: 30 units divided in 6 sites
  • Temporalis: 40 untied divided in 8 sites
  • Trapezius: 30 units divided in 6 sites
  • Cervical paraspinal muscle group: 20 units divided in 4 sites

Detrusor Overactivity

Indicated for urinary incontinence caused by detrusor overactivity in patients with neurologic conditions (eg, spinal cord injury, multiple sclerosis) in adults who have an inadequate response to or are intolerant to anticholinergic medication

200 units (divided into 30 intradetrusor injections) administered using cystoscopy

Duration of effect may last up to 10 months; may repeat procedure when effect of previous injection diminishes, but no sooner than 12 weeks from the prior bladder injection

Overactive Bladder

Indicated for adults with overactive bladder symptoms (urge incontinence, urgency, frequency) who cannot use or do not adequately respond to anticholinergic medication

100 units (divided into 20 intradetrusor injections of 5 units each) administered using cystoscopy

Requirements for repeating procedure

  • 12 weeks have elapsed since prior treatment
  • Post-void residual urine volume >200 mL
  • At least 2 reported urinary incontinence episodes over 3 days

Botox Cosmetic

Glabellar lines: Inject 4 units (0.1 mL) into each of 5 sites, 2 in each corrugator muscle and 1 in procerus muscle for a total dose of 20 units

Canthal lines: Inject 4 units (0.1 mL) into 3 sites per side (6 total injection points) in the lateral orbicularis oculi muscle for a total of 24 units/0.6 mL (12 units per side)

Duration of activity is approximately 3-4 months

More frequent dosing not recommended

Indications (Botox Cosmetic)

  • Indicated for temporary improvement in the appearance of moderate-to-severe:
  • -glabellar lines (ie, frown lines) associated with corrugators and/or procerus muscle activity
  • -lateral canthal lines (ie, crow’s feet) associated with orbicularis oculi activity

Dosing considerations (Botox Cosmetic)

  • Treatment for both glabellar and lateral canthal lines can be given at the same time
  • Do not exceed a cumulative dose of 360 units per 3 months when treating patients for 1 or more indication

Dosing Considerations

Lower initial dose if no prior botulinum toxin treatment

Adjust dose based on response

When treating adult patients for 1 or more indications, the maximum cumulative dose should generally not exceed 360 Units in a 3 month interval

Bladder dysfunction indications: Administer prophylactic antibiotics (except aminoglycosides) beginning 1-3 days pretreatment and continue 1-3 days post treatment to reduce risk for procedure-releated UTI

Administration

Blepharospasm: Use sterile, 27- or 30-gauge needle without EMG guidance to inject into the medial & lateral pretarsal orbicularis oculi of upper lid and into the lateral pretarsal orbicularis oculi of lower lid

Axillary Hyperhidrosis: Standard staining techniques (eg, Minor's iodine starch test) are used to identify the hyperhidrotic area to be injected; patients should shave their underarms and refrain from using over the counter deodorants/antiperspirants for 24 hours prior to such staining tests

Strabismus: Inject into extraocular muscles

Dosage Forms & Strengths

injectable solution

  • 100 units
more...

<12 Years

Safety and efficacy not established

≥12 Years

Blepharospasm

  • 1.25-2.5 units IM; < 200 units in 30 days
  • May increase dose 2-fold if response to initial treatment dose does not last longer than 2 months
  • Little benefit obtained from injecting >5 units per site

Strabismus

  • 1.25-5 units IM; <25 units per injection
  • Vertical muscles, and horizontal strabismus of <20 prism diopters: 1.25-2.5 units in any one muscle
  • Persistent VI nerve palsy of >1 month of duration: 1.25-2.5 units in the medial rectus muscle
  • Horizontal strabismus of 20-50 prism diopters: 2.5-5 units in any one muscle
  • Incomplete paralysis of target muscle: May increase dose 2-fold if response to initial treatment dose

Primary axillary hyperhidrosis

  • Safety and efficacy not established

Chronic migraine

  • <18: Safety and efficacy not established

Muscle Contractures (Orphan)

Treatment of dynamic muscle contractures in pediatric cerebral palsy patients

Orphan indication sponsor

  • Allergan, Inc; 2525 Dupont Drive, P.O. Box 19534; Irvine, CA 92713
Next

Interactions

Interaction Checker

onabotulinumtoxinA and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            Sort by :  
             activity indicator 
            Previous
            Next

            Adverse Effects

            >10%

            Dysphagia (19-74% )

            Ptosis of eyelid (1-20.8% )

            Dry eyes (6.3-19% )

            Urinary retention with intradetrusor injections (17%)

            Influenza-like symptoms (2-16% )

            Upper respiratory infection (12% )

            Headache (3-11% )

            Neck pain (3-11% )

            1-10%

            Injection site pain (3% to 10% ),

            Sweating symptom, non-axillary (3% to 10% )

            Backache (2-10% )

            Fever (2-10% )

            Chronic migraine

            • Migraine (4%)
            • Musculoskeletal stiffness (4%)
            • Muscular weakness (4%)
            • Myalgia (3%)
            • Musculoskeletal pain (3%)
            • Facial paresis (2%)
            • Muscle spasms (2%)
            • Hypertension (2%)

            Frequency Not Defined

            Cardiac dysrhythmia

            Myocardial infarction

            Seizure

            Dry mouth

            Dyspepsia

            Anaphylaxis

            Respiratory depression

            Lagophthalmus

            Treatment of upper limb spasticity

            • Fatigue
            • Nausea
            • Muscle weakness
            • Pain in the arms
            • Bronchitis
            Previous
            Next

            Warnings

            Black Box Warnings

            Effects of all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects

            These symptoms may include asthenia, generalized muscle weakness, diplopia, blurred vision, 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 death have been reported

            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 underlying conditions that would predispose them to these symptoms

            In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses

            Contraindications

            Hypersensitivity

            Neuromuscular disease

            Infection at the proposed injection site

            Intradetrusor injection: Urinary tract infection or urinary retention (post-void residual >200 mL)

            Cautions

            Avoid injections near the levator palpebrae superioris minimize the risk of ptosis, especially in individuals with larger brow-depressor complexes

            Risk of respiratory compromise & death esp in children treated for cerebral palsy-associated spasticity

            Effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism - watch for dyspnea, dysphagia or speech impairment

            The different botulinum toxin products are not interchangeable

            Pre-existing neuromuscular disorders

            Only consider for treatment of urinary incontinence for patients willing and able to initiate catheterization post-treatment, if required (due to risk of urinary retention); patients with diabetes mellitus more likely to develop urinary retention than non-diabetics

            Increased risk for UTI; do not use for treatment of urinary incontinence with present UTI, routine catheterization, or if patient is unable to empty bladder without assistance

            Use with caution in patients with compromised respiratory function

            Corneal exposure and ulceration due to reduced blinking may occur when treating blepharospasm

            Retrobulbar hemorrhages and compromised retinal circulation may occur when treating strabismus

            Bronchitis and upper respiratory tract infections in patients treated for upper limb spasticity reported

            Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, reported in patients who received injections for unapproved uses

            Tailor dosing in initial and sequential treatment sessions to the individual based on the size, number and location of muscles involved, severity of spasticity, presence of local muscle weakness, patient’s response to previous treatment, or adverse event history with this therapy

            Previous
            Next

            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Not known if excreted in breast milk; effect on nursing infant not known

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
            Previous
            Next

            Pharmacology

            Mechanism of Action

            Neurotoxin from Clostridium botulinum; prevents ACh release from presynaptic membrane, causing temporary calming of muscle contractions by blocking the transmission of nerve impulses

            Pharmacokinetics

            Metabolism: unknown

            Excretion: unknown

            Minimal levels in circulation after IM injection

            Onset of action

            • Blepharospasm: 3-4 days
            • Strabismus: 1-2 days
            • Cervical Dystonia: 2 weeks
            • Detrusor overactivity: 2 weeks

            Duration

            • Blepharospasm: 3-4 months
            • Strabismus: 1-2 days
            • Cervical Dystonia: 3-4 months
            • Detrusor overactivity: 42-48 weeks
            Previous
            Next

            Administration

            IM Administration

            Blepharospasm: use sterile, 27- or 30-gauge needle without EMG guidance to inject into the medial & lateral pretarsal orbicularis oculi of upper lid and into the lateral pretarsal orbicularis oculi of lower lid

            Axillary Hyperhidrosis: standard staining techniques (eg, Minor's iodine starch test) are used to identify the hyperhidrotic area to be injected; pts should shave their underarms & refrain from using OTC deodorants/antiperspirants for 24 hr prior to such staining tests

            Strabismus: Inject into extraocular muscles

            IM Preparation

            Vacuum dried powder for reconstitution only with sterile, non-preserved 0.9% Sodium Chloride Injection USP prior to injection

            Chronic migraine: The recommended dilution is 200 Units/4 mL or 100 Units/2 mL, with a final concentration of 5 Units per 0.1 mL

            Storage

            Administer within 24 hours following reconstitution

            Store reconstituted solution in refrigerator (2-8°C)

            Store unreconstituted powder in refrigerator (2-8°C)

            Previous
            Next

            Images

            Previous
            Next

            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Add or Remove Plans
            Plans for
            Select State:
            Non-Medicare PlansMedicare Plans

            Select a box to add or remove a plan.

            Select a class to view formulary status for similar drugs

            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous
             
             
             
            All material on this website is protected by copyright, Copyright © 1994-2016 by WebMD LLC. This website also contains material copyrighted by 3rd parties.