abobotulinumtoxinA (Rx)

Brand and Other Names:Dysport
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, powder for reconstitution

  • 300 units/vial
  • 500 units/vial

Cervical Dystonia

Indicated for cervical dystonia

Initial: 500 unit IM divided among affected muscles

Retreat every 12-16 weeks or longer: 250-1000 unit IM

Titrate in 250-unit steps

Spasticity

Indicated for treatment of spasticity in adults

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

Do not inject >1 mL at any single injection site; the maximum total dose (upper and lower limb combined) is 1500 units

Repeat treatment when the effect of a previous injection has diminished, but no sooner than 12 weeks after the previous injection

A majority of patients are retreated between 12-16 weeks, although some may have a longer response (eg, 20 wk)

Upper limb spasticity

  • Dose per muscle
    • In the clinical trial, doses of 500-1000 units were divided among selected upper limb muscles at a given treatment session
    • Flexor carpi radialis: 100-200 units in 1-2 sites
    • Flexor carpi ulnaris: 100-200 units in 1-2 sites
    • Flexor digitorum profundus: 100-200 units in 1-2 sites
    • Flexor digitorum sublimis: 100-200 units in 1-2 sites
    • Brachialis: 200-400 units in 1-2 sites
    • Brachioradialis: 100-200 units in 1-2 sites
    • Biceps brachii: 200-400 units divided in 1-2 sites
    • Pronator Teres: 100-200 units in 1 site

Lower limb spasticity

  • Dose per muscle
    • In the clinical trial, doses of 1000-1500 units were divided among selected lower limb muscles at a given treatment session
    • Gastrocnemius medial head: 100-150 units in 1 site
    • Gastrocnemius lateral head: 100-150 units in 1 site
    • Soleus: 330-500 units in 3 sites
    • Tibialis posterior: 200-300 units in 2 sites
    • Flexor digitorum longus: 130-200 units in 1-2 sites
    • Flexor hallucis longus: 70-200 units in 1 site

Glabellar Lines

Indicated for temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults aged <65 years

50 units total divided in 5 equal doses IM to affected muscles

Retreat no sooner than 3 months

Dosage Modifications

Renal or hepatic impairment: No dose adjustment necessary

Essential Blepharospasm (Orphan)

Orphan indication sponsor

  • Porton International, Inc; 1155 15th Street, N.W., #315; Washington, DC 20005

Spasmodic Torticollis (Orphan)

Treatment of spasmodic torticollis (cervical dystonia)

Orphan indication sponsor

  • Ipsen Biopharm Limited; 1 Bath Road Maidenhead, Berkshire, SL6 4UH; UK

Dosage Forms & Strengths

injection, powder for reconstitution

  • 300 units/vial
  • 500 units/vial

Lower Limb Spasticity

Indicated for lower limb spasticity in children aged ≥2 yr

<2 years: Safety and efficacy not established

≥2 years

  • Select dose based on affected muscle, spasticity severity, and treatment history with botulinum toxins
  • Total dose per treatment session: Not to exceed 10-15 units/kg for unilateral lower limb injections or 20-30 units/kg for bilateral lower limb injections or 1000 units, whichever is less
  • Divide the total dose between the affected spastic muscles of the lower limb(s)
  • When possible, distribute dose across more than 1 injection site in any single muscle
  • Not to exceed 0.5 mL in any single injection site
  • Gastrocnemius (unilateral injection)
    • 6-9 units/kg per muscle per leg
    • Up to 4 injections per muscle
  • Soleus (unilateral injection)
    • 4-6 units/kg per muscle per leg
    • Up to 2 injections per muscle
  • Total dose
    • 10-15 units/kg divided across both muscles (unilateral), OR
    • 30 units/kg for bilateral injection, OR
    • 100 units, whichever is lower
    • Up to 6 injections per muscle (unilateral)

Upper Limb Spasticity

<2 years: Safety and efficacy not established

≥2 years

  • Indicated for upper limb spasticity in children aged ≥2 year, excluding spasticity caused by cerebral palsy
  • Select dose based on affected muscle, spasticity severity, and treatment history with botulinum toxins
  • Total dose per treatment session: Not to exceed 16 Units/kg or 640 Units, whichever is lower
  • May administer repeat treatment when effect of a previous injection has diminished but no sooner than 16 weeks after the previous injection; majority of patients in the clinical study were retreated between 16-28 weeks
  • Degree and pattern of muscle spasticity at time of reinjection may necessitate alterations in dose and muscles to be injected
  • Brachialis
    • 3-6 units/kg per muscle per upper limb
    • Up to 2 injection sites per muscle
  • Brachioradialis
    • 1.5-3 units/kg per muscle per upper limb
    • 1 injection site per muscle
  • Biceps brachii
    • 3-6 units/kg per muscle per upper limb
    • Up to 2 injection sites per muscle
  • Pronator teres
    • 1-2 units/kg per muscle per upper limb
    • 1 injection site per muscle
  • Pronator quadratus
    • 0.5-1 units/kg per muscle per upper limb
    • 1 injection site per muscle
  • Flexor carpi radialis (FCR)
    • 2-4 units/kg per muscle per upper limb
    • Up to 2 injection sites per muscle
  • Flexor carpi ulnaris (FCU)
    • 1.5-3 units/kg per muscle per upper limb
    • 1 injection site per muscle
  • Flexor digitorum profundus (FDP)
    • 1-2 units/kg per muscle per upper limb
    • 1 injection site per muscle
  • Flexor digitorum superficialis (FDS)
    • 1.5-3 units/kg per muscle per upper limb
    • Up to 4 injection sites per muscle
  • Total dose
    • 8-16 units/kg in upper limbs (and not exceeding 640 units)
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Interactions

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse Effects

            >10%

            Dysphagia (15%)

            Dry mouth (13%)

            Headache (11%)

            Inj site discomfort (13%)

            Muscle weakness (16%)

            Fatigue (12%)

            1-10%

            Dyspnea (3%)

            Facial paresis (5%)

            Dysphonia (6%)

            Injection site pain (5%)

            Musculoskeletal pain (7%)

            Eye disorders (7%)

            Postmarketing Reports

            Hypoesthesia

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            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

            Allergy to cow milk protein

            Injection site infection

            Cautions

            Exercise caution when administering to patients with surgical alterations to facial anatomy, excessive weakness or atrophy in the target muscle(s), marked facial asymmetry, inflammation at the injection site(s), ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin or the inability to substantially lessen glabellar lines by physically spreading them apart

            Not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of abobotulinumtoxin cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method

            Toxin may spread - watch for dyspnea, dysphagia or speech impairment

            Product contains albumin, a derivative of human blood; based on effective donor screening and product manufacturing processes; carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD); there is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote; no cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products

            Neutralizing antibody formation and loss of efficacy associated with higher doses or more frequent administration of the drug

            Arrhythmia and myocardial infarction reported with use

            Dysphagia reported with use for cervical dystonia; may persist for several weeks following administration and could cause the patient to require alternative feeding methods, including a feeding tube; smaller neck muscle mass, injections into the elevator scapulae or injections into the sternocleidomastoid muscle may increase risk of dysphagia; risk of aspiration may result from severe dysphagia when swallowing is already compromised; occurrence may be reduced by limiting the dose injected into sternocleidomastoid muscle

            Use caution in patients with neuromuscular disease, including myasthenia gravis and Eaton-Lambert syndrome, and neuropathic disorders, such as, amyotrophic lateral sclerosis

            Injection of the orbicularis muscle may reduce blinking and lead to corneal exposure and ulceration, when treating blepharospasm

            Use caution when treating patients with preexisting respiratory disease; treatment of cervical dystonia, may weaken accessory muscles necessary to patients to maintain adequate ventilation; serious breathing difficulties, including respiratory failure reported

            Dry eye has been reported in the treatment of glabellar lines; reduce tear production, reduced blinking, and corneal disorders, may occur with use of botulinum toxins; if symptoms of dry eye (eg, eye irritation, photophobia, visual changes) persist, consider referring patient to an ophthalmologist

            Possibility of an immune reaction when injected intradermally is unknown; safety for the treatment of hyperhidrosis has not been established; approved only for IM injection

            Drug interaction overview

            • Aminoglycosides and other agents interfering with neuromuscular transmission
              • Coadministration with aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like agents) should only be used with caution because the effect of the botulinum toxin may be potentiated
              • If coadministered, closely monitor patients
            • Anticholinergic drugs
              • Use of anticholinergic drugs after administration may potentiate systemic anticholinergic effects such as blurred vision
            • Other botulinum neurotoxin products
              • Effect of administering botulinum neurotoxin products, at the same time or within several months of each other is unknown
              • Excessive weakness may be exacerbated by another administration of botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin
            • Muscle relaxants
              • Excessive weakness may be exaggerated by administration of a muscle relaxant before or after botulinum toxin administration
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            Pregnancy & Lactation

            Pregnancy

            There are no adequate and well-controlled clinical studies in pregnant women

            Use only during pregnancy if the potential benefit justifies the potential risk to the fetus

            In rats, abobotulinumtoxinA produced adverse effects on mating behavior and fertility

            Animal data

            • AbobotulinumtoxinA produced embryofetal toxicity in relation to maternal toxicity when given to pregnant rats and rabbits at doses lower than or similar to the maximum recommended human dose (MRHD) of 1000 units on a body weight (units/kg) basis

            Lactation

            There are no data on the presence in human or animal milk, the effects on the breastfed infant, or the effects on milk production

            Consider developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed infant or from the underlying maternal condition

            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.

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            Pharmacology

            Mechanism of Action

            Neurotoxin from Clostridium botulinum; prevents ACh release from presynaptic membrane

            Pharmacokinetics

            Onset of action: Cervical Dystonia: 2-4 weeks

            Duration cervical dystonia: Up to 4 months

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            Administration

            Instructions for safe use

            Potency units of abobotulinumtoxinA are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of abobotulinumtoxinA cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method

            IM Preparation

            Only use sterile preservative-free 0.9% NaCl injection for reconstituting vials

            Swirl gently to dissolve

            Visually inspect for particulate matter and discoloration prior to administration

            Reconstituted solution should be a clear, colorless, and free of particulate matter, otherwise it should not be injected

            Dilution

            • Dilute with preservative-free 0.9% NaCl
            • 500 units/vial
              • Reconstitute with 1 mL 0.9% NaCl (yields 50 units/0.1 mL)
              • Reconstitute with 2 mL 0.9% NaCl (yields 25 units/0.1 mL)
              • Reconstitute with 2.5 mL 0.9% NaCl (yields 20 units/0.1 mL)
              • Reconstitute with 5 mL 0.9% NaCl (yields 10 units/0.1 mL)
            • 300 units/vial
              • Reconstitute with 0.6 mL 0.9% NaCl (yields 50 units/0.1 mL)
              • Reconstitute with 1.5 mL 0.9% NaCl (yields 20 units/0.1 mL)
              • Reconstitute with 2.5 mL 0.9% NaCl (yields 12 units/0.1 mL)
              • Reconstitute with 3 mL 0.9% NaCl (yields 10 units/0.1 mL)

            Recommended concentration for adults

            • Cervical dystonia: 50 units/0.1 mL or 25 units/0.1 mL
            • Glabellar lines: 12 units/0.1 mL or 20 units/0.1 mL
            • Spasticity: 10 units/0.1 mL or 20 units/0.1 mL

            Recommended concentration for children and adolescents

            • Spasticity: 20 units/0.1 mL or 50 units/0.1 mL

            IM Administration

            IM administration only

            Reconstituted solution should be a clear, colorless solution, free of particulate matter, otherwise it should not be injected

            Expel any air bubbles in the syringe barrel

            After reconstitution, use for only 1 injection session and for only 1 patient

            Storage

            Store unreconstituted vials in refrigerator at 2-8°C (36-46°F)

            Use each vial for only 1 injection session and for only 1 patient

            Once reconstituted, store in the original container, refrigerated at 2-8°C (36-46°F) for up to 24 hr (must discard if not used within 24 hr)

            Protected from light

            Do not freeze reconstituted solution

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            Formulary

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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