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
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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

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
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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, the dose should be distributed 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)
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Interactions

Interaction Checker

and abobotulinumtoxinA

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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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

            Asthma, neuromuscular disorder, facial abnormalities, ptosis

            Concomitant anticholinergic drugs, neuromuscular blockers or muscle relaxants

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

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            Pregnancy & Lactation

            Pregnancy: There are no adequate and well-controlled clinical studies in pregnant women; only use during pregnancy if potential benefit justifies potential risk to fetus

            Lactation: There are no data on the presence of drug in human or animal milk, the effects on the breastfed child, or effects on milk production; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from the drug 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

            IM Preparation

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

            Swirl gently to dissolve

            Parenteral drug products should be inspected visually 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

            Cervical dystonia

            • 500 units/vial: Reconstitute with 1 mL 0.9% NaCl (yields 50 units/0.1 mL)
            • 300 units/vial: Reconstitute with 0.6 mL 0.9% NaCl (yields 50 units/0.1 mL)

            Glabellar lines

            • 300 units/vial: Reconstitute with 2.5 mL 0.9% NaCl (yields 10 units/0.08 mL [12 units/0.1 mL]) OR,
            • Reconstitute 300 units/vial with 1.5 mL 0.0% NaCl (yields 10 units/0.05 mL [20 units/0.1 mL])

            Upper limb spasticity

            • Recommended concentration for ULS is 100-200 units/1 mL
            • For adult administration only
            • Steps for use of 5 mL of diluent for 500 unit vial
              • 1. 500 unit vial: Reconstitute with 2.5 mL 0.9% NaCl, gently mix and set the vial aside
              • 2. Withdraw 2.5 mL 0.9% NaCl into a 5 mL syringe
              • 3. Take the 5 mL syringe with the saline and draw up the reconstituted solution in the vial without inverting and gently mix the syringe (resulting concentration is 10 units/0.1 mL [100 units/1 mL])
              • 4. Use immediately after reconstitution in the syringe

            Lower limb spasticity (LLS)

            • For pediatric administration only
            • Recommended concentration for LLS is 100-200 units/1 mL
            • Vial reconstitution
              • 500-unit vial: Reconstitute with 2.5 mL 0.9% NaCl
              • 300-unit vial: Reconstitute with 1.5 mL 0.9% NaCl
              • Resulting concentrations are 20 units/0.1 mL; reconstituted solution should be clear, colorless, and without particulate matter
              • Further dilution with 0.9% NaCl may be required to achieve the final volume for injection

            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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            Images

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            Formulary

            FormularyPatient Discounts

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            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.
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