incobotulinumtoxinA (Rx)

Brand and Other Names:Xeomin
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Dosing & Uses

AdultPediatric

Dosing Form & Strengths

injection, lyophilized powder for reconstitution

  • 50 units/single-dose vial
  • 100 units/single-dose vial
  • 200 units/single-dose vial

Chronic Sialorrhea

Indicated for chronic sialorrhea

Inject into the parotid and submandibular glands on both sides (ie, 4 injection sites per treatment session)

Recommended total dose is 100 units per treatment session; divide dose into a ratio of 3:2 between the parotid and submandibular gland; do not exceed cumulative dose of 400 units per treatment session

Dosing by glands

  • Parotid glands: 30 units/side; total dose is 60 units
  • Submandibular gland(s): 20 Units/side; total dose is 40 units
  • Both glands: 50 Units/side; total dose is 100 units

Repeat treatment based on the actual clinical need of the individual patient; frequency of treatments should be no sooner than every 16 weeks

Also see Administration

Upper Limb Spasticity

Indicated for the treatment of upper limb spasticity in adults

Adjust dosage, frequency, and number of injection sites 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

Frequency of treatments should be no sooner than every 12 weeks

If not 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 treatment session

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

Also see Administration

Cervical Dystonia

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

Consider past dose, response to treatment, duration of effect, and adverse event history when determining dose

Optimum dose and number of injection sites in treated muscle(s) individualized by MD for each patient based on number and location of muscle(s) to be treated, degree of spasticity/dystonia, muscle mass, body weight, and response to any previous botulinum toxin injections

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)

Frequency of repeat treatments should be determined by clinical response and generally be no more frequent than every 12 weeks Do not exceed cumulative dose of 400 units per treatment session

Also see Administration

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

Do not administer to patients who have not previously received onabotulinumtoxinA

Number and location of injection sites should be determined by MD based on severity of blepharospasm, and previous dose and response to onabotulinumtoxin A (Botox) injections; subsequent dosing should be tailored to individual patient, based on response, up to maximum dose of 35 units per eye

Frequency of repeat treatments should be determined by clinical response and generally be no more frequent than every 12 weeks

Not for administration to patients who have not previously received onabotulinumtoxin A; dosing not established in patients with blepharospasm not previously treated with onabotulinumtoxin A

In clinical trials, the mean number of injections per eye was 6, and the mean dose per eye was 33 units

Do not exceed cumulative dose of 400 units per treatment session

Also see Administration

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

Do not exceed cumulative dose of 400 units per treatment session

Also see Administration

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

and incobotulinumtoxinA

No Results

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Cervical dystonia

            • Musculoskeletal and connective tissue disorders (23-32%)
            • Dysphagia (13-18%)
            • Nervous system disorders (16-17%)
            • General disorders and administration site condition (11-16
            • Neck pain (7-15%)
            • Infections and infestations (13-14%)
            • Respiratory, thoracic, and mediastinal disorders (10-13%)
            • Muscular weakness (7-11%)

            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%

            Chronic sialorrhea

            • Tooth extraction (5%)
            • Dry mouth (4%)
            • Diarrhea (4%)
            • Hypertension (4%)
            • Fall (3%)
            • Bronchitis (3%)
            • Dysphonia (3%)
            • Back pain (3%)
            • Dry eye (3%)

            Upper limb spasticity

            • Seizure (3%)
            • Nasopharyngitis (2%)
            • Dry mouth (2%)
            • Upper respiratory tract infection (2%)

            Cervical dystonia

            • Injection site pain (9%)
            • Neck pain (7%)
            • Muscular weakness (7%)
            • Musculoskeletal pain (4-7%)

            Blepharospasm

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

            Glabellar lines

            • Headache (5.4%)

            <1%

            Glabellar lines

            • General disorders and administration site conditions
            • Injection site hematoma
            • Injection site pain
            • Facial pain
            • Injection site swelling
            • Sensation of pressure
            • Eye disorders
            • Eyelid edema
            • Blepharospasm
            • Eyelid ptosis

            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)

            This product contains albumin, a derivative of human blood; based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases; consider a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD)

            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
            • Ecchymosis easily occurs in the soft tissues of the eyelid
            • Immediate gentle pressure at the injection site can limit that risk

            Glabellar lines

            • Risk of ptosis
            • Do not exceed the recommended dosage and frequency of administration
            • To reduce the complication of ptosis, avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes, and place corrugator injections at least 1 cm above the bony supraorbital ridge

            Drug interaction overview

            • Coadministration with aminoglycosides or other agents interfering with neuromuscular transmission (eg, tubocurarine-type muscle relaxants) may potentiate the effect of the toxin; use with caution
            • Use of anticholinergic drugs after administration of incobotulinumtoxinA may potentiate systemic anticholinergic effects; effects of administering different botulinum toxin products at the same time or within several months of each other is unknown
            • Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin
            • Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of incobotulinumtoxinA
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            Pregnancy & Lactation

            Pregnancy

            There are no adequate data on the developmental risk associated with the use of incobotulinumtoxinA in pregnant women

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

            Animal data

            • IncobotulinumtoxinA was embryotoxic in rats and increased abortions in rabbits when given at doses higher than the maximum recommended human dose (MRHD) for cervical dystonia (120 units), on a body weight basis

            Lactation

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

            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

            The return of increased muscle tone following injection typically occurs within 3-4 months

            General characteristics of the active substance: It is not possible to detect incobotulinumtoxinA in the peripheral blood following IM or intraglandular injection at the recommended doses

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            Administration

            IM Preparation and Dilution

            Reconstitute each vial with sterile, preservative-free 0.9% NaCl

            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 discard vial (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 IM injection or intra-salivary gland injection only

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

            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)

            Chronic sialorrhea

            • Use a sterile needle (eg, 27-30 gauge [0.30-0.40 mm diameter], 12.5 mm length) for intra-salivary gland administration for the treatment of chronic sialorrhea; locate salivary glands using ultrasound imaging or surface anatomical landmarks

            Upper limb spasticity and cervical dystonia

            • Use a sterile needle (eg, 26-gauge [0.45 mm diameter], 37 mm length for superficial muscles; or 22-gauge [0.70 mm diameter], 75 mm length for injections into deeper muscles) in the IM administration in the treatment of upper limb spasticity and cervical dystonia
            • Localization of the involved muscles with electromyographic guidance or nerve stimulation techniques may be useful

            Blepharospasm

            • Use a suitable sterile needle (eg, 30-gauge [0.40 mm diameter], 12.5 mm length) in the intramuscular administration in the treatment of blepharospasm

            Glabellar lines

            • Use a sterile needle (eg, 30-33 gauge [0.3-0.2 mm diameter], 13 mm length) should be used in the IM administration in the treatment of glabellar lines

            Monitoring to assess effectiveness

            • Median first onset of incobotulinumtoxinA effect occurs within 7 days after injection
            • Typical duration of effect of each treatment is up to 3 months; however, the effect may last significantly longer, or shorter, in individual patients

            Storage

            Unopened vials

            • Unopened vials: Store at room temperature 20-25°C (68-77°F), in a refrigerator at 2-8°C (36-46°F), or a freezer at -20 to 10°C (-4 to 14°F); do not use after the expiration date on the vial

            Reconstituted vials

            • Refrigerate at 2-8°C (36-46°F) for up to 24 hr until time of use; discard any unused portion
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            Formulary

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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.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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