onabotulinum toxin A
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onabotulinum toxin A(bot-yoo-lye-num tox-in) ,
Botox Cosmetic(trade name)
Pregnancy Category: C
ClassificationTherapeutic: cosmetic agents
Botox Cosmetic: Temporary improvement in the appearance of moderate to severe glabellar lines (brow furrow) associated with corrugator and/or procerus muscle activity in adults.Botox Cosmetic: Temporary improvement in the appearance of moderate to severe lateral canthal lines (crow's feet) associated with orbicularis oculi activity in adults.Botox: Upper limb spasticity.Botox: Cervical dystonia.Botox: Severe axillary hyperhidrosis that is refractory to topical agents.Botox: Blepharospasm associated with dystonia.Botox: Strabismus.Botox: Prevention of migraines in patients with chronic migraines (≥15 headaches/mo with headache lasting ≥4 hr/day).Botox: Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition in adults who have an inadequate response to or are intolerant of an anticholinergic medication.Botox: Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
Produces partial chemical denervation by inhibiting the release of acetylcholine. Result is local decrease in muscle activity.
Decreased brow furrow and crow's feet with improved appearance.
Decreased muscle tone in upper limbs.
Decreased severity of abnormal head position and neck pain.
Decreased frequency and duration of headaches.
Absorption: Minimal systemic absorption; action is primarily local.
Metabolism and Excretion: Unknown.
Time/action profile (improvement)
|IM†||1–2 days||unknown||3–4 mo|
|IM‡||3–4 days||unknown||3–4 mo|
|IM*||2 wk||unknown||3–4 mo|
|IM††||<2 wk||unknown||3–4 mo|
|IM**||1–2 days||unknown||2–6 wk|
Contraindicated in: Hypersensitivity; Presence of infection at planned injection sites; Acute urinary tract infection and/or acute urinary retention (for urinary incontinence indication); Obstetric: Potential for spontaneous abortion or fetal deformity.
Use Cautiously in: Peripheral motor neuropathic diseases (e.g. amyotrophic lateral sclerosis, motor neuropathy) or neuromuscular junctional disorders (e.g. myasthenia gravis, Lambert—Eaton syndrome) (↑ risk of significant systemic effects such as dysphagia or respiratory compromise); Inflammation at planned injection site; Marked facial asymmetry, ptosis, excessive dermatochelasis, deep dermal scarring, thick sebaceous skin, inability to lessen glabellar lines by physical spreading; Excessive weakness or atrophy in target muscles; Swallowing or breathing problems (for treatment of cervical dystonia; ↑ risk of dysphagia); Respiratory problems (for treatment of spasticity; ↑ risk of pulmonary infection and worsening condition); Lactation: Lactation; Pediatric: Children <12 yr (safety not established); Geriatric: Use lowest effective dose.
Adverse Reactions/Side Effects
Central nervous system
Ear, Eye, Nose, Throat
- eye dryness
- temporary eyelid droop
- urinary retention
- urinary tract infection
- discomfort at injection sites
- distant spread of toxin effect
- local muscle weakness
- upper respiratory infection
- allergic reactions including anaphylaxis (rare) (life-threatening)
Drug-Drug interactionNeuromuscular effects may be potentiated by aminoglycosides, quindine and other drugs that alter neuromuscular transmission.Additive effects may occur with other forms of botulinum toxin.
Reduction of Glabellar Lines
Intramuscular (Adults) 0.1 mL (4 units) into each of five sites (two in each corrugator muscle and one in the procerus muscle; total dose of 20 units); not more frequently than every 3 mo.
Reduction of Lateral Canthal Lines
Intramuscular (Adults) 0.1 mL (4 units) into each of three sites per side in the lateral orbicularis oculi muscle (12 units per side; total dose of 20 units); not more frequently than every 3 mo.
Upper Limb Spasticity
Intramuscular (Adults) Biceps brachii-100–200 units divided in 4 sites; not more frequently than every 3 mo; Flexor carpi radialis or flexor carpi ulnaris-12.5–50 units in 1 site; not more frequently than every 3 mo; Flexor digitorum profundus or flexor digitorum sublimis-30–50 units in 1 site; not more frequently than every 3 mo.
Intramuscular (Adults) Mean dose is 236 units divided among the affected muscles in patients previously treated with botulinum toxin; initial dose should be lower in previously untreated patients; subsequent dosing should be based on patient's head and neck position, localization of pain, muscle hypertrophy, patient response and previous tolerability; total dose injected into sternocleidomastoid muscles should be ≤100 units (to ↓ incidence of dysphagia); not more frequently than every 3 mo.
Intramuscular (Adults) 50 units per axilla; may repeat when clinical effect diminishes.
Intramuscular (Adults and Children) 1.25-2.5 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; not more frequently than every 3 mo.
Intramuscular (Adults and Children ≥12 yr) Vertical muscles and for horizontal strabismus <20 prism diopters-1.25–2.5 units in any one muscle; Horizontal strabismus of 20–50 prism diopters-2.5–5 units in any one muscle; Persistent VI nerve palsy of ≥1 mo-1.25–2.5 units in the medial rectus muscle.
Intramuscular (Adults) 155 units divided among 7 specific head/neck muscle areas (see prescribing information for dose to be injected into each area) every 12 wk.
Intramuscular (Adults) 200 units injected into the detrusor muscle every 12 wk.
Intramuscular (Adults) 100 units injected into the detrusor muscle every 12 wk.
Powder for reconstitution (Botox Cosmetic): 50 units/vial, 100 units/vial
Powder for reconstitution (Botox): 50 units/vial, 100 units/vial, 200 units/vial
- Assess for signs of anaphylactic reaction (dyspnea, rash, pruritus, laryngeal edema, wheezing) following administration. Keep epinephrine, an antihistamine, and resuscitation equipment close by in the event of an anaphylactic reaction.
- Monitor for asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. Medication may spread from the injection site to distant parts of the body.
- Physicians administering botulinum toxin should understand neuromuscular anatomy of the area involved and potential alterations.
- Botulinum toxin products are not interchangeable. Determine appropriate product prior to administration.
- Injections should be made no more frequently than every 3 mo and using the lowest effective dose.
- Botox Cosmetic: Reconstitute vial with 2.5 mL of 0.9% NaCl without preservatives for a concentration of 4.0 units/0.1 mL and a total treatment dose of 20 units in 0.5 mL. Inject diluent slowly into vial at a 45° angle. Discard vial if vacuum does not pull diluent into vial. Rotate vial gently and record date and time of reconstitution on label. Solution should be clear, colorless, and free of particulate matter. Refrigerate solution and use within 4 hr of reconstitution; do not freeze. Discard unused solution. Unopened vials should be stored in refrigerator.
- Intramuscular: Draw at least 0.5 mL of reconstituted solution into tuberculin syringe and expel any air bubbles from syringe barrel. Remove needle used for reconstitution and replace with a 30–gauge needle; ensure patency of needle. Inject each dose of 0.1 mL.
- Botox: Reconstitute vial with 2.5 mL of 0.9% NaCl without preservatives. Draw up amount of diluent in appropriate size syringe (see Package insert). Discard vial if vacuum does not pull diluent into vial. Rotate vial gently and record date and time of reconstitution on label. Solution should be clear, colorless, and free of particulate matter. Refrigerate solution and use within 24 hr of reconstitution; do not freeze. Discard unused solution. Unopened vials should be stored in refrigerator.
- Intramuscular: Follow specific dose and administration recommendations for each indication.
- Review Medication Guide with patient prior to each administration.
- Inform patient that the material has the potential to spread from the injection site to distant parts of the body. May occur within hrs or several wks after injection. Advise patient to notify health care professional immediately if swallowing, speech, or respiratory disorders arise.
- Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
- Decreased brow furrow and lateral canthal lines beginning 1–2 days after injection and increasing in intensity during the first week.
- Decreased muscle tone in upper limbs.
- Decreased severity of abnormal head position and neck pain.
- Decreased sweating.
- Decreased blepharospasm.
- Decreased strabismus.
- Decreased frequency and duration of headaches.
- Decreased urinary incontinence.
Drug Guide, © 2015 Farlex and Partners