incobotulinumtoxinA (Rx)

Brand and Other Names:Xeomin
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Dosing & Uses

AdultPediatric

Dosing Form & Strengths

lyophilized powder for reconstitution

  • 50 units/vial
  • 100 units/vial
  • 200 units/vial

Upper Limb Spasticity

Indicated for the treatment of upper limb spasticity in adults

Dosage, frequency, and number of injection sites should be tailored to the individual patient based on the size, number, and location of muscles to be treated, severity of spasticity, presence of local muscle weakness, patient’s response to previous treatment, and adverse event history with incobotulinumtoxinA

The frequency of treatments should be no sooner than every 12 weeks

If previously treated with botulinum toxins, initial dosing should begin at the low end of the recommended dosing range and titrated as clinically necessary

Do not exceed cumulative dose of 400 units per 12-wk interval

Recommended dose per muscle

  • Clenched fist
    • Flexor digitorum superficialis: 25-100 units divided in 2 sites
    • Flexor digitorum profundus: 25-100 units divided in 2 sites
  • Flexed wrist
    • Flexor carpi radialis: 25-100 units divided in 1-2 sites
    • Flexor carpi ulnaris: 20-100 units divided in 1-2 sites
  • Flexed elbow
    • Brachioradialis: 25-100 units divided in 1-3 sites
    • Biceps: 50-200 units divided in 1-4 sites
    • Brachialis: 25-100 units divided in 1-2 sites
  • Pronated forearm
    • Pronator quadratus: 10-50 units in 1 site
    • Pronator teres: 25-75 units divided in 1-2 sites
  • Thumb-in-palm
    • Flexor pollicis longus: 10-50 units in 1 site
    • Adductor pollicis: 5-30 units in 1 site
    • Flexor pollicis brevis/Opponens pollicis: 5-30 units in 1 site

Cervical Dystonia

Indicated to decrease the severity of abnormal head position and neck pain in both botulinum toxin-naive and previously treated patients

Optimum dose and number of injection sites in treated muscle(s) individualized for each patient as determined by MD

Total dose is 120 units IM per treatment session; higher doses not shown to provide additional efficacy and were associated with increased adverse effects

Usually injected into sternocleidomastoid, splenius capitis, levator scapulae, scalenus, and/or trapezius muscles(s)

Blepharospasm

Indicated for blepharospasm in patients who were previously treated with onabotulinumtoxinA (Botox)

Optimum dose and number of injection sites in treated muscle(s) individualized for each patient as determined by MD

Dose, number, and location of injections should be based on the previous dosing of onabotulinumtoxinA (Botox)

Do not administer to patients who have not previously received onabotulinumtoxinA

If previous dose of onabotulinumtoxinA unknown, the recommended starting dose is 1.25-2.5 units IM per injection site

In clinical trials, the mean dose per injection site was 5.6 units, the mean number of injections per eye was 6, and the mean dose per eye was 33.5 units

Glabellar Lines

Indicated for temporary improvement of moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity

Total dose is 20 units per treatment session divided into 5 equal IM injections of 4 units each (2 injections in each corrugator muscle and 1 injection in procerus muscle)

Retreat no more frequently than q3months

Safety and efficacy not established

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Interactions

Interaction Checker

and incobotulinumtoxinA

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Cervical dystonia

            • Nervous system disorders (16%)
            • Dysphagia (13%)
            • Respiratory, thoracic, and mediastinal disorders (13%)

            Blepharospasm

            • Eyelid ptosis (19%)
            • Dry eye (16%)
            • Xerostomia (16%)
            • Nervous system disorders (14%)
            • Visual impairment, including blurred vision (12%)
            • Respiratory, thoracic, and mediastinal disorders (11%)

            1-10%

            Cervical dystonia

            • Injection site pain (9%)
            • Neck pain (7%)
            • Muscular weakness (7%)
            • Musculoskeletal pain (7%)

            Blepharospasm

            • Diarrhea (8%)
            • Headache (7%)
            • Dyspnea (5%)
            • Nasopharyngitis (5%)
            • Respiratory tract infection (5%)

            Glabellar lines

            • Headache (5.4%)

            Postmarketing Reports

            Allergic disorders: Hypersensitivity, eye swelling/edema, allergic dermatitis

            Gastroenterology: Nausea

            Body as a whole: Flu-like symptoms

            Local reactions: Injection site pain, injection site reaction, localized allergic reactions (eg, swelling, edema, erythema, pruritus, rash)

            Infection: Herpes zoster

            Musculoskeletal: Muscular weakness, muscle spasm, myalgia

            Neurologic: Dysarthria, dysphagia

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            Warnings

            Black Box Warnings

            Distant spread of toxin effect

            • Botulinum toxin products may spread from injected area to produce symptoms consistent with botulinum toxin effects (eg, asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, respiratory distress)
            • 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
            • Greatest risk in children treated for spasticity
            • Can also occur in adults, particularly in those with underlying conditions that would predispose them to these symptoms (eg, peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders [myasthenia gravis, Lambert-Eaton syndrome])

            Contraindications

            Hypersensitivity

            Infection at proposed injection site(s)

            Cautions

            Dose NOT interchangeable with other botulinum toxin products

            Can cause swallowing and breathing difficulties, caution with compromised respiratory function or dysphagia

            Concomitant neuromuscular disorders may exacerbate adverse effects

            Discontinue and immediately initiate medical therapy if hypersensitivity reaction occurs (eg, anaphylaxis, serum sickness, urticaria, edema, dyspnea)

            Cervical dystonia

            • Patients with smaller neck muscle mass and patients who require bilateral injections into the sternocleidomastoid muscles are at greater risk of dysphagia
            • Limit dose injected into the sternocleidomastoid muscle may decrease the occurrence of dysphagia

            Blepharospasm

            • Do not administer to patients who have not previously received onabotulinumtoxinA (Botox)
            • Injection into orbicularis oculi muscle may lead to reduced blinking and corneal exposure with possible ulceration or perforation
            • Lower lid injections should not be repeated if diplopia occurred with previous botulinum toxin injections

            Glabellar lines

            • Risk of ptosis
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            Pregnancy & Lactation

            Pregnancy Category: C; based on animal data, may cause fetal harm

            Lactation: Unknown whether distributed in breast milk, do not nurse

            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

            Blocks cholinergic transmission at the neuromuscular junction by inhibiting acetylcholine release from the peripheral cholinergic nerve endings

            Pharmacokinetics

            Onset of action: 4-7 days

            Duration: 3-4 months

            Absorption: Absence from peripheral blood at recimmended IM injections

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            Administration

            IM Preparation & Dilution

            Prior to injection, reconstitute each vial with sterile, preservative-free 0.9% NaCl Injection USP

            Draw up an appropriate amount of 0.9% NaCl to result in desired units/0.1 mL (per Manufacturer’s instructions)

            Clean the exposed portion of the vial’s rubber stopper with 70% alcohol prior to needle insertion

            Gently inject the 0.9% NaCl into the vial

            If the vacuum does not pull the solvent into the vial, then vial must be discarded (vacuum seal compromised)

            Gently mix with the saline by rotating the vial (do not shake to prevent flocculation)

            Reconstituted solution should be clear, colorless, and free of particulate matter

            Do not use if reconstituted solution is cloudy or contains floccular or particulate matter

            IM Administration

            For intramuscular (IM) injection only

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

            Select suitable sterile needle for administration (eg, 26-gauge, 37 mm length for superficial muscles; or 22-gauge, 75 mm length for injections into deeper muscles)

            Localization of the involved muscles with electromyographic guidance or nerve stimulation techniques may be useful

            If proposed injection sites are marked with a pen, the product must not be injected through the pen marks; otherwise a permanent tattooing effect may occur

            Number of injection sites is dependent upon the size of the muscle to be treated and the volume of reconstituted incobotulinumtoxinA injected

            Inject carefully when administration sites are close to sensitive structures (eg, carotid artery, lung apices, esophagus)

            Physician should be familiar with the patient’s anatomy and any anatomic alterations due to prior surgical procedures.

            Storage

            May store unopened vials at room temperature, refrigerated, or frozen for up to 36 months (not to exceed expiration date)

            Reconstituted vials should be refrigerated and administered within 24 hr

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            Formulary

            FormularyPatient Discounts

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            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.
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            Code Definition
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