Nabota

Blepharospasm associated w/ dystonia including benign essential blepharospasm, hemifacial spasm or VII^th nerve disorders in patients ≥12 yr; spasmodic torticollis (cervical dystonia) in adults; dynamic equinus foot deformity due to spasticity in ped cerebral palsy patients ≥2 yr; focal hyperhidrosis of axilla; urinary incontinence due to neurogenic detrusor overactivity eg, spinal cord injury or multiple sclerosis in adults. Correction of strabismus in patients ≥12 yr. Adult: Temporary treatment of glabellar lines associated w/ corrugator &/or procerus muscle activity in patients <65 yr. Management of focal spasticity including spasticity associated w/ stroke. Temporary improvement in appearance of upper facial rhytides (glabellar lines, crow's feet & forehead lines). Prophylaxis of headaches in chronic migraine.

Blepharospasm Initially 1.25-2.5 u (0.05-0.1 mL at each site) inj into the medial & lateral orbicularis oculi of the upper lid & into the lateral orbicularis oculi of the lower lid. Dose may be increased up to 2-fold at repeat-treatment sessions. Max: Not to exceed initial dose of 25 u/eye & total dosing of 100 u every 12 wk. Hemifacial spasm Treat as for unilateral blepharospasm w/ other affected facial muscles each being injected as needed. Cumulative dose in a 2-mth period should not exceed 200 u. Strabismus 0.05-0.15 mL/muscle, vertical muscles & horizontal strabismus of <20 prism diopters 1.25-2.5 u in any 1 muscle, horizontal strabismus of 20-50 prism diopters 2.5-5 u in any 1 muscle, persistent VII^th nerve palsy of ≥1 mth duration 1.25-2.5 u in medial rectus muscle. Residual or recurrent strabismus Subsequent dose: Re-examine patient 7-14 days after each inj. Patients experiencing adequate paralysis that require subsequent inj should receive a dose comparable to initial dose. May increase up to 2-fold compared to previous dose for patients w/ incomplete paralysis of the target muscle. Max: 25 u as single inj for any 1 muscle. Spasmodic torticollis (cervical dystonia) Individualized dosage. Max total dose: 6 u/kg every 2 mth. Ped cerebral palsy 4 u/kg, up to max of 200 u at any single treatment session. May repeat dose but not more frequently than every 3 mth. Upper facial lines Individualized dosage. Usually 0.1 mL/inj site. Glabellar lines 4 u/0.1 mL in each 5 sites, 2 in each corrugator muscle & 1 in procerus muscle for a total dose of 20 u. Inj intervals should be no more frequent than every 3 mth. Crow's feet 2-6 u/inj site at 2-3 mm depth injected bilaterally at 3 sites in the lateral aspect of orbicularis oculi, for a total dose of 6-18 u/side. Forehead lines 2-6 u/inj site IM every 1-2 cm along either side of a deep forehead crease (4 inj sites), for a total dose of 8-24 u. Focal spasticity Adult Individualized dosage. Recommended dose up to 360 u, divided among selected muscles. Hyperhidrosis of the axilla 50 u to each axilla intradermally, evenly distributed in multiple sites approx 1-2 cm apart. Repeat inj when effects from previous inj subside but not more frequently than every 2 mth. Chronic migraine 155-195 u IM divided across 7 specific head/neck muscle areas [0.1 mL (5 u)/inj site]. Schedule re-treatment every 12 wk. Neurogenic detrusor overactivity 200 u. Administer prophylactic antibiotics 1-3 days pre-treatment, on treatment day & 1-3 days post-treatment.

Hypersensitivity. Myasthenia gravis or Eaton-Lambert syndrome, presence of infection at the proposed inj site. Treatment of urinary incontinence due to neurogenic detrusor overactivity in patients w/ acute UTI & patients w/ acute urinary retention who are not routinely performing clean intermittent self-catheterization.

Toxin effect may be observed beyond local inj site. Relevant anatomy & any alterations due to prior surgical procedures must be understood prior to administration. Avoid inj into vulnerable anatomic structures. Caution when injecting in proximity to the lung, particularly apices; in the presence of inflammation at the inj site or when weakness or atrophy is present; in patients w/ amyotrophic lateral sclerosis or disorders that produce peripheral neuromuscular dysfunction. Extremely remote risk of viral diseases transmission due to albumin content. Sedentary patients should resume activity gradually. Risk of malaise lasting up to 6 wk after inj. Consider effects on neuromuscular junction w/ consequent effects on muscle activity when advising patients on their suitability to drive or operate machinery. Not recommended during pregnancy & lactation. Safety & effectiveness in childn & adolescents <20 yr were not investigated for improvement of glabellar lines. Safety & efficacy have not been established in childn & adolescents <18 yr for upper limb spasticity; in childn <12 yr for blepharospasm, hemifacial spasm & associated focal dystonias, spasmodic torticollis or upper facial lines. Blepharospasm/chronic migraine: Reduced blinking following inj can lead to corneal exposure, persistent epithelial defects & corneal ulceration especially in patients w/ VII^th nerve disorders. Avoid inj into the lower lid to prevent ectropion & promptly treat any epithelial defects. Caution in patients at risk for angle-closure glaucoma including patients w/ anatomically narrow angles. Strabismus/chronic migraine: Risk of retrobulbar hemorrhages sufficient to compromise retinal circulation; ocular (globe) penetrations by needles. Cervical dystonia/chronic migraine: Reports of dysphagia, w/ dyspnea reported on occasion. Cerebral palsy & focal spasticity in adults: Not likely to be effective in improving range of motion at a joint affected by a fixed contracture. Hyperhidrosis: Evaluate for potential causes of secondary hyperhidrosis (eg, hyperthyroidism, pheochromocytoma) to avoid symptomatic treatment w/o diagnosis &/or treatment of the underlying disease. Neurogenic detrusor overactivity: Autonomic dysreflexia associated w/ cystoscopy may occur. Risk of urinary retention; consider catheterization.

Denervation/muscle atrophy, resp depression &/or resp failure (noncosmetic indications), dyspnea, aspiration pneumonia (noncosmetic indications), dysarthria, dry mouth, strabismus, peripheral neuropathy, abdominal pain, diarrhea, nausea, vomiting, pyrexia, anorexia, blurred vision, visual disturbance, hypoacusis, tinnitus, vertigo, facial palsy, facial paresis, brachial plexopathy, radiculopathy, syncope, hypoesthesia, malaise, myalgia, myasthenia gravis, paresthesia, rash, erythema multiforme, pruritus, dermatitis psoriasiform, hyperhidrosis, alopecia including madarosis. IM inj: Localized pain, tenderness &/or bruising.

Potentiated effect w/ aminoglycosides or other drugs that interfere w/ neuromuscular transmission eg, tubocurarine-type muscle relaxants or curare-like non-depolarising blockers. Contraindicated w/ aminoglycosides or spectinomycin. Caution in concomitant use w/ polymyxin, tetracycline & lincomycin. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin product before the effects of previously administered botulinum toxin disappear.

Muscle Relaxants

M03AX01 - botulinum toxin ; Belongs to the class of other agents used as peripherally-acting muscle relaxants.

Rx