Class: Botulinum toxin
- Injection, lyophilized powder for solution 100 units
- Injection, lyophilized powder for solution 200 units
- Injection, lyophilized powder for solution 50 units
- Injection, lyophilized powder for solution 100 units
Blocks neuromuscular transmission by binding to acceptor sites on motor or sympathetic nerve terminals, entering the nerve terminals, and inhibiting the release of acetylcholine.
Produces partial chemical denervation of muscle and local reduction in muscle activity when injected IM. Produces temporary chemical denervation of sweat glands and local reduction in sweating when injected intradermally.
Not expected to be present in peripheral blood at measurable levels following IM or intradermal injection at recommended doses.
Indications and Usage
Treatment of cervical dystonia in adults to reduce severity of abnormal head position and neck pain associated with cervical dystonia ( Botox ); treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorder in patients 12 y and older ( Botox ); treatment of severe primary axillary hyperhidrosis inadequately managed with topical agents ( Botox ); temporary improvement in appearance of moderate to severe glabellar lines associated with corrugator or procerus muscle activity in patients 65 y or younger ( Botox Cosmetic ); treatment of upper limb spasticity in adults, to decrease the severity of increased muscle tone in elbow, wrist, and finger flexors ( Botox ); prophylaxis of headaches in adults with chronic migraine (at least 15 days per month with headache lasting 4 h per day or longer) ( Botox ); treatment of urinary incontinence in adults due to detrusor overactivity associated with a neurologic condition, such as spinal cord injury or multiple sclerosis ( Botox ).
Achalasia; facial lines and wrinkles; gustatory sweating; hand dystonia; headache (tension type); palmar hyperhidrosis; sialorrhea; Tourette syndrome.
Infection at the proposed injection site(s); hypersensitivity to any botulinum toxin preparation or ingredient in the formulations; patients with detrusor overactivity associated with a neurologic condition who have an acute UTI and in patients with acute urinary retention who are not routinely performing clean intermittent self-catheterization.
Dosage and AdministrationBotox
Axillary Hyperhidrosis Adults
Intradermal 50 units (2 mL) injected into defined hyperhidrotic area in 0.1 to 0.2 mL aliquots to each axilla, evenly distributed in multiple sites (10 to 15) approximately 1 to 2 cm apart. Administer repeat injections when clinical effect of previous injection diminishes.Blepharospasm Adults and Children 12 y and older
IM Initially, inject 1.25 to 2.5 units (0.05 to 0.1 mL at each site) into the medial and lateral pretarsal orbicularis oculi of the upper lid and into the lateral pretarsal orbicularis oculi of the lower lid. Cumulative dose in a 30-day period should not exceed 200 units. Each treatment lasts approximately 3 mo, following which the procedure may be repeated.Cervical Dystonia Adults and Children 16 y and older
IM In patients with known history of tolerance, the mean dose in a study was 236 units divided among the affected muscles. Tailor dosing in initial and sequential treatments to the individual patient based on patient's head and neck position, localization of pain, muscle hypertrophy, patient response, and adverse reaction history. In patients without prior use, use a lower dose than in patients with known history of tolerance, adjusting subsequent doses based on individual response. No more than 50 units per site should be administered. Max clinical benefit is seen at approximately 6 wk postinjection.Chronic migraine Adults
IM Total treatment dose is 155 units administered as 0.1 mL (5 units) injections per each site. Recommended dose range per muscle is as follows: 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 units divided in 8 sites; trapezius, 30 units divided in 6 sites; cervical paraspinal muscle group, 20 units divided in 4 sites. The recommended re-treatment schedule is every 12 wk.Strabismus Adults and Children 12 y and older
IM Use the lower doses for treatment of small deviations and larger doses for large deviations. Do not administer subsequent injections until the effects of the previous dose have dissipated. Maximum dose is 25 units as a single injection for any 1 muscle.Vertical muscles, and for horizontal strabismus of less than 20 prism diopters
1.25 to 2.5 units in any 1 muscle.Horizontal strabismus of 20 to 50 prism diopters
2.5 to 5 units in any 1 muscle.Persistent VI nerve palsy of 1 mo or longer duration
1.25 to 2.5 units in the medial rectus muscle.Upper Limb Spasticity Adults
IM The lowest recommended starting dose should be used. Tailor dosing based on size, number, and location of muscles involved; severity of spasticity; presence of local muscle weakness; and response to previous treatment or adverse reaction history. Recommended dose range per muscle is as follows: biceps brachii, 100 to 200 units divided in 4 sites; flexor carpi radialis or flexor carpi ulnaris, 12.5 to 50 units in 1 site; flexor digitorum profundus or flexor digitorum sublimis, 30 to 50 units in 1 site. No more than 50 units per site should be administered. Do not re-treat sooner than 12 wk after the previous injection.Urinary Incontinence Adults
IM 30 injections of 1 mL each (approximately 6.7 units) into the detrusor for a total dose of 200 units (30 mL). Max dose, 200 units per treatment. Re-treatment for diminished effectiveness may be considered no sooner than 12 wk from the previous bladder injection. Patients should not have an acute UTI prior to treatment. Prophylactic antibiotics (except aminoglycosides) should be administered 1 to 3 days pretreatment, on the day of treatment, and 1 to 3 days posttreatment.Botox Cosmetic
Glabellar Lines Adults 65 y or younger
IM Total treatment dose is 20 units in 0.5 mL (0.1 mL into each of 5 sites; 2 in each corrugator muscle and 1 in the procerus muscle) at intervals no more frequently than every 3 mo.
- The potency units of onabotulinumtoxinA are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of onabotulinumtoxinA cannot be compared with or converted into units of any other botulinum toxin products assessed with any other specific assay method.
- Use caution when treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).
- Reconstitute powder for injection following manufacturer's guidelines for dilution using sterile, preservative-free sodium chloride 0.9% injection.
- Discard vial if vacuum does not pull diluent into vial.
- Use a new sterile needle and syringe to enter vial on each occasion for removal of medication.
- Ensure that epinephrine or another precautionary method is available should an anaphylactic reaction occur.
- Do not exceed recommended dosages or frequencies of administration.
- When using Botox for 1 or more indications, the max cumulative dose should not exceed 360 units in a 3-mo interval.
- Antiplatelet medications should be discontinued at least 3 days prior to injection in any patient receiving treatment for bladder detrusor overactivity. Manage patients on anticoagulant therapy appropriately to decrease the risk of bleeding.
Store unopened vials in refrigerator (36° to 46°F) for up to 24 mo ( Botox 200 unit vial, Botox Cosmetic 50 unit vial) or 36 mo ( Botox and Botox Cosmetic 100 unit vial). Reconstituted solution may be stored for up to 24 h if refrigerated. Do not freeze reconstituted solution. Discard any remaining solution.
Drug InteractionsAminoglycosides (eg, gentamicin), drugs interfering with neuromuscular transmission (eg, lincomycin, quinidine, succinylcholine)
The effects of onabotulinumtoxinA may be potentiated. Use with caution. Closely monitor the patient.Anticholinergic agents (eg, atropine)
Use of anticholinergic agents after onabotulinumtoxinA administration may potentiate systemic anticholinergic effects (eg, blurred vision). Use with caution.Botulinum neurotoxin (eg, botulinum toxin type B)
Administration of a different botulinum neurotoxin at the same time or within several months of each other may exacerbate excessive neuromuscular weakness. Use with caution. Closely monitor the patient.Muscle relaxants (eg, metaxalone)
Excessive weakness may be exaggerated. Use with caution. Closely monitor the patient.Nondepolarizing muscle relaxants (eg, tubocurarine)
Neuromuscular action may be enhanced, resulting in protracted respiratory depression. Use with caution. Closely monitor the patient.
Hypertension (2%); arrhythmia, MI, syncope (postmarketing).
Headache (11%); anxiety (3% to 10%); asthenia, dizziness, drowsiness, hypertonia, speech disorder (2% to 10%); fatigue (6%); migraine (4%); fall, gait disturbance, insomnia (3%); hypoesthesia, malaise, new-onset or recurrent seizures, paresthesia, vertigo with nystagmus (postmarketing).
Nonaxillary sweating, pruritus (3% to 10%); skin tightness (1%); erythema multiforme, hyperhidrosis, psoriasiform eruption, skin rash (postmarketing).
Ptosis (21%); pharyngitis (3% to 10%); rhinitis (2% to 10%); eye dryness, superficial punctate keratitis (6%); eyelid ptosis (4%); blepharoptosis (3%); blurred vision, decreased hearing, ear noise, glaucoma, hypoacusis, retinal vein occlusion, tinnitus, visual disturbances (postmarketing).
Dysphagia (19%); nausea, oral dryness (2% to 10%); constipation (4%); dyspepsia, tooth disorder (1%); abdominal pain, anorexia, diarrhea, loss of appetite, vomiting (postmarketing).
UTI (49%); urinary retention (17%); dysuria, hematuria (4%).
Hemorrhage, pain (3% to 10%); soreness (2% to 10%); erythema, facial pain (less than 3%).
Neck pain (11%); back pain (2% to 10%); pain in extremity (9%); muscle weakness, musculoskeletal stiffness (4%); musculoskeletal pain, myalgia (3%); muscle spasm (2%); muscle atrophy (1%); myalgia, myasthenia gravis (postmarketing).
Upper respiratory tract infection (12%); cough (2% to 10%); bronchitis (3%); dyspnea (postmarketing).
Infection (3% to 10%); fever, flu syndrome (2% to 10%); facial paresis (2%); brachial plexopathy, facial palsy, localized numbness, radiculopathy (postmarketing).
WarningsSpread of toxin effect
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, blurred vision, breathing difficulties, diplopia, dysarthria, dysphagia, dysphonia, generalized muscle weakness, ptosis, and urinary incontinence. 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 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 occurred at doses comparable with those used to treat cervical dystonia and at lower doses.
Closely monitor patients with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis (ALS), or neuromuscular junction disorders when administering botulinum toxin. Closely monitor patients with compromised respiratory status treated with onabotulinumtoxinA for upper limb spasticity.
Category C .
Botox Cosmetic is not recommended for use in children.Axillary hyperhidrosis, chronic migraine, upper limb spasticity, and urinary incontinence due to detrusor overactivity
Safety and efficacy of Botox in children younger than 18 y not established.Blepharospasm and strabismus
Safety and efficacy of Botox in children younger than 12 y not established.Cervical dystonia
Safety and efficacy of Botox in children younger than 16 y not established.
Use with caution; therapy should reflect higher frequency of decreased hepatic, renal, or cardiac function, and comorbidity in this population.
Serious and/or immediate hypersensitivity reactions have occurred.
Because this product contains albumin, a derivative of human blood, it carries a remote risk of viral disease transmission.
Autonomic dysreflexia and urinary retention
May occur in patients treated for detrusor overactivity associated with a neurologic condition.
Rare reports of CV adverse reactions, including arrhythmia and MI, some with fatal outcomes, have occurred.
Use Botox Cosmetic with caution in patients who have an inflammatory skin problem at the injection site or in those with excessive weakness or atrophy in the target muscle(s), marked facial asymmetry, ptosis, dermatochalasis, deep dermal scarring, or thick sebaceous skin; or the inability to substantially lessen glabellar lines by physically spreading them apart.
Dysphagia and breathing difficulties
May occur within hours to weeks after injection and dysphagia may persist for several weeks to months. Death as a complication of severe dysphagia has been reported. Risk may be increased in patients with smaller neck muscle mass and patients requiring bilateral injections into sternocleidomastoid muscle.
Treatment with onabotulinumtoxinA may cause formation of neutralizing antibodies that may reduce the efficacy of subsequent treatments.
Use with caution in patients with peripheral motor neuropathic diseases, ALS, or neuromuscular junctional disorders (eg, myasthenia gravis) because of increased risk of systemic effects, including dysphagia and respiratory compromise.
Retrobulbar hemorrhage sufficient to compromise retinal circulation has occurred. Reduced blinking from injection of the orbicularis muscle can lead to corneal exposure, persistent epithelial defect, and corneal ulceration, especially in patients with VII nerve disorders.
Bronchitis and upper respiratory tract infections have been reported in patients treated for upper limb spasticity. Decreases in forced vital capacity were greater in onabotulinumtoxinA-treated patients.
Needle-related pain and/or anxiety may result in vasovagal responses (eg, syncope, hypotension) that may require appropriate medical therapy.
Muscle paralysis, muscle weakness.
- Advise patient or caregiver that medication will be prepared and administered by a health care provider in a health care setting.
- Advise patient or caregiver to immediately seek medical assistance if swallowing, speech, or breathing problems develop.
- Advise patient to report intolerable injection-site reactions or unusual symptoms to health care provider.
- Counsel patients to avoid driving or engaging in other potentially hazardous activities if loss of strength, muscle weakness, blurred vision, or drooping eyelids occur.
- Advise patients that injections may cause reduced blinking or effectiveness of blinking and that they should seek immediate medical attention if eye pain or irritation occurs following treatment.
- Instruct patients to contact their health care provider if they experience difficulties in voiding after bladder injection for urinary incontinence.
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