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Xeomin

Generic Name: IncobotulinumtoxinA
Class: Other Miscellaneous Therapeutic Agents
Chemical Name: Botulinum Toxin A
Molecular Formula: C2286H3500N578O666S9 (light chain) C4422H6863N1151O1329S23 (heavy chain).
CAS Number: 93384-43-1

Warning(s)

  • Distant Spread of Toxin Effects
  • Effects of any botulinum toxin may spread from local sites of injection, producing symptoms consistent with the mechanism of action of botulinum toxin.381 403 (See Distant Spread of Toxin Effects under Cautions.)

  • Symptoms reported hours to weeks following injection.381 403

  • Swallowing and/or breathing difficulties may be life-threatening.381 403

  • Risk is probably greatest in children with spasticity; however, such effects can occur in any individual receiving any botulinum toxin preparation.381 403

Introduction

Neurotoxin produced by Clostridium botulinum; disrupts neurotransmission by inhibiting release of acetylcholine from peripheral cholinergic and ganglionic autonomic nerve terminals.403 405 407 411

Uses for Xeomin

Currently, 3 botulinum toxin type A preparations (abobotulinumtoxinA [Dysport], incobotulinumtoxinA [Xeomin], and onabotulinumtoxinA [Botox, Botox Cosmetic]) and one botulinum toxin type B preparation (rimabotulinumtoxinB [Myobloc]) are commercially available in the US.1 2 5 384 403 411 414 These preparations are not interchangeable; assay methods used to determine potency of botulinum toxins are specific to each individual manufacturer and/or formulation.1 2 5 381 384 403 405 407 408 409 410 411 413 414 418 421

IncobotulinumtoxinA contains pure neurotoxin without any complexing proteins (hemagglutinins and nonhemaglutinins).405 407 408 411 414 Not established whether this formulation difference is associated with therapeutic benefit compared with other botulinum toxin preparations.408 409 411 413 414

Cervical Dystonia

Management of cervical dystonia (spasmodic torticollis) to decrease severity of abnormal head position and neck pain.387 391 403 405 406 408 411 Indicated for use in both previously treated and untreated (botulinum toxin-naive) adults.403 405 406 411

Appears to be as effective as onabotulinumtoxinA when given in comparable doses.405 408

Botulinum toxins are considered a treatment of choice for cervical dystonia.53 387 391 405 406 408 415

Blepharospasm

Management of blepharospasm in patients previously treated with onabotulinumtoxinA (Botox).387 391 403 408 409 413 414 416 Efficacy and safety of incobotulinumtoxinA in patients not previously treated with onabotulinumtoxinA not established.403

American Academy of Neurology (AAN) states that a botulinum toxin should be considered as a treatment option for patients with blepharospasm.415

Cosmesis of Glabellar Facial Lines

Temporary improvement in the appearance of moderate to severe glabellar facial (“frown”) lines associated with corrugator and/or procerus muscle activity in adults.396 403 417 418

Efficacy appears similar to onabotulinumtoxinA when given in equivalent doses.417

Xeomin Dosage and Administration

General

  • Individualize dosage according to patient response and condition being treated.403 Consider other factors such as severity of disease, number of muscles involved, muscle mass, and previous response to other botulinum toxin therapy.403

  • The effects of a single treatment usually last ≤3 months, but may be considerably longer or shorter depending on the individual.403 If repeat treatments required, manufacturer recommends ≥12 weeks between treatment sessions.403

Administration

IM Administration

Administer by IM injection into affected muscles.403

Clinicians who administer incobotulinumtoxinA should be familiar with the relevant neuromuscular and/or orbital anatomy of the therapeutic target area.403

Exercise caution when injecting into areas in close proximity to sensitive structures (e.g., carotid artery, lung apices, esophagus).403

When proposed injection sites are marked with ink, avoid direct injection into these areas to avoid permanent tattooing of the skin.403

Monitor for sudden swallowing or respiratory difficulties during or following administration.381 403 (See Distant Spread of Toxin Effects under Cautions.)

Reconstitution

Reconstitute lyophilized drug with preservative-free 0.9% sodium chloride injection prior to administration.403

Add appropriate amount of diluent to vial to provide desired dose (see Table 1).403 A vacuum should draw in the diluent; discard vial if vacuum is absent.403 Gently rotate until powder is completely dissolved.403

Preservative-free 0.9% sodium chloride injection.

Table 1. Diluent Volumes for Reconstitution of IncobotulinumtoxinA

Resulting Dose (units/0.1 mL)

Diluent Volume

50-Unit Vial

100-Unit Vial

0.25 mL

20 units

...

0.5 mL

10 units

20 units

1 mL

5 units

10 units

1.25 mL

4 units

8 units

2 mL

2.5 units

5 units

2.5 mL

2 units

4 units

4 mL

1.25 units

2.5 units

5 mL

1 unit

2 units

8 mL

...

1.25 units

Use reconstituted solutions immediately or store at 2–8°C for ≤24 hours.403

Use reconstituted solution for a single treatment session and for only one patient.403 Carefully discard any unused portions as medical waste.403

Injection Techniques/Precautions (Cervical Dystonia)

Administer total dose as several injections divided among affected muscles.403 Usual injection sites include sternocleidomastoid, levator scapulae, splenius capitis, scalenus, and/or trapezius muscles, although treatment may be required in any muscle involved in the control of head position.403

Use a suitable sterile needle (e.g., 26-gauge, 37-mm length needle for superficial muscles or 22-gauge, 75-mm length needle for deeper muscles) for injections.403

Electromyogram (EMG) guidance or nerve stimulation techniques may be helpful in locating target injection sites.403

Injection Techniques/Precautions (Blepharospasm)

Use a suitable sterile needle (e.g., 26-gauge, 37-mm length needle for superficial muscles or 22-gauge, 75-mm length needle for deeper muscles) for injections.403

Reduce or prevent ecchymosis by applying gentle pressure to the injection site immediately postinjection.403

Do not inject into medial lower eyelid area to prevent ectropion.403 (See Ocular Effects in Patients with Blepharospasm under Cautions.)

Injection Techniques/Precautions (Glabellar Facial Lines)

Divide total dose at each treatment session into 5 equal injections; administer 2 injections in each corrugator muscle and 1 in the procerus muscle.403

Use a suitable sterile 30- to 33-gauge, 13-mm length needle for injections.403

To minimize risk of ptosis, avoid injections near the levator palpebrae superioris, especially in individuals with larger brow-depressor complexes.403 Injections into the medial corrugator muscle should be ≥1 cm above the bony supraorbital ridge.403 (See Risk of Ptosis under Cautions.)

Dosage

Potency of incobotulinumtoxinA expressed in units of biologic activity; each unit is equivalent to the median intraperitoneal lethal dose (LD50) in mice.403 407

Units of biologic activity of incobotulinumtoxinA cannot be compared with or converted to units of other botulinum toxin preparations; assay methods used to determine potency of various botulinum toxin preparations are specific to each individual preparation.403

Adults

Cervical Dystonia
IM

Previously treated and botulinum-toxin naive patients: Initially, 120 units as a divided dose among affected muscles.403

Whenever possible, use minimum effective dosage to reduce risk of adverse effects and maintain responsiveness to drug.403 Limit total dose injected into sternocleidomastoid muscle to decrease risk of dysphagia.403

In clinical studies, median doses of 25, 48, 25, 25, and 20 units were administered to the sternocleidomastoid, splenius capitis/semispinalis capitis, trapezium, levator scapulae, and scalenus (medius and anterior) muscles, respectively.403 411

May repeat treatments at intervals of ≥12 weeks; determine frequency of repeat treatments by clinical response.403

Blepharospasm
IM

Previously treated patients: Initial dose should be the same as the patient's previous dose of onabotulinumtoxinA (Botox); dosing requirements may vary depending on individual response.403

If previous dose of onabotulinumtoxinA not known, give initial doses of 1.25–2.5 units at each site.403

Individualize subsequent dose based on patient response.403 Total dose administered during the initial or any subsequent treatment session should be ≤70 units (or 35 units per eye).403

In clinical trials, mean dose was 33.5 units per eye (range 10–50 units); mean number of injections was 6 per eye (average dose of 5.6 units in each site).403

May repeat treatments at intervals of ≥12 weeks; determine frequency of repeat treatments by clinical response.403

Dosing not established in patients not previously treated with onabotulinumtoxinA.403

Glabellar Facial Lines
IM

Total dose of 20 units per treatment session, divided into 5 equal injections of 4 units each (2 into each corrugator muscle and one in the procerus muscle).403

May repeat treatments at intervals of ≥3 months.403

Do not exceed recommended dose and frequency to minimize risk of ptosis.403

Prescribing Limits

Adults

Cervical Dystonia
IM

Initial doses >120 units not shown to provide additional efficacy and may be associated with increased incidence of adverse effects.403

Blepharospasm
IM

Total dose of 70 units (or 35 units per eye).403

Glabellar Facial Lines
IM

Do not repeat treatments more frequently than once every 3 months.403

Cautions for Xeomin

Contraindications

  • Known hypersensitivity to any botulinum toxin preparation or ingredient (e.g., albumin) in their formulations.403

  • Infection at injection site.403

Warnings/Precautions

Warnings

Distant Spread of Toxin Effects

Potential for distant spread of toxin effects beyond local sites of injection.381 403 (See Boxed Warning.)

Serious adverse effects consistent with mechanism of botulinum toxin action (e.g., dysphagia, dysarthria, generalized muscle weakness, ptosis, blurred vision, diplopia, respiratory compromise, speech difficulties, urinary incontinence) reported.381 403

In some cases, severe swallowing or breathing difficulties required hospitalization, ventilatory support, or gastric feeding tube and/or resulted in death.381 403 (See Dysphagia/Breathing Difficulties under Cautions.)

Risk of toxin spread probably highest in children treated for spasticity (currently not an FDA-labeled use for incobotulinumtoxinA).381 383 384 403 410

Sensitivity Reactions

Hypersensitivity Reactions

Potential risk of hypersensitivity.403 (See Contraindications under Cautions.)

If a serious and/or immediate hypersensitivity reaction occurs, discontinue further injection and initiate appropriate medical therapy.403

Other Warnings/Precautions

Lack of Interchangeability Among Botulinum Toxin Preparations

The method used to determine potency (“units”) of incobotulinumtoxinA is specific to the Xeomin preparation; therefore, units of biologic activity for incobotulinumtoxinA cannot be compared with or converted to units of any other botulinum toxin preparation.403

Dysphagia/Breathing Difficulties

Risk of dysphagia in patients receiving a botulinum toxin for cervical dystonia.381 383 403 405 411 412 Usually a consequence of cervical muscle weakening from local areas of injection, but also may be related to distant spread of toxin effects.381 403 (See Distant Spread of Toxin Effects under Cautions.)

Botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation, resulting in critical loss of breathing capacity in patients with respiratory disorders.403 Aspiration and death reported as a complication of severe dysphagia.381 383 403

Patients with smaller neck muscle mass or who require bilateral injections into the sternocleidomastoid muscles appear to be at greater risk.403 (See Dosage under Dosage and Administration.)

Use with caution in patients with dysphagia.403 Risk of aspiration is increased in patients with compromised swallowing function.403

Immediate medical attention may be required if sudden speech or swallowing difficulties develop during or following treatment; such effects may occur hours to weeks after injection.403 Gastric feeding tube may be required to support adequate nutrition and hydration.403

Preexisting Neuromuscular Disorders

Risk of adverse effects (e.g., severe dysphagia and/or respiratory compromise) may be increased in patients with neuromuscular disorders (e.g., peripheral motor neuropathic diseases [e.g., amyotrophic lateral sclerosis, motor neuropathy] or neuromuscular junction disorders [e.g., myasthenia gravis, Lambert-Eaton syndrome]); closely monitor such patients.403

Ocular Effects in Patients with Blepharospasm

Risk of corneal exposure, corneal ulceration, and ectropion following injections of botulinum toxins into the orbicularis muscle, particularly in patients with seventh cranial nerve disorders.403

Carefully evaluate for corneal sensation in those with prior eye surgery.403 To decrease risk of ectropion, avoid injection of lower lid area.403 414 Aggressively treat any epithelial defect with protective drops, ointments, therapeutic soft contact lenses, or closure of the eye by patching or other means.403

Use with caution in patients at risk of developing angle-closure glaucoma.403

Limit risk of ecchymosis by immediately applying gentle pressure at the injection site.403

Do not repeat injections into lower lid if diplopia has occurred with previous botulinum toxin therapy.403

Risk of Ptosis

To minimize risk of ptosis, avoid injections near the levator palpebrae superioris, especially in individuals with larger brow-depressor complexes.403 Injections into the corrugator muscle should be placed ≥1 cm above the bony superior orbital margin.403

Do not exceed recommended dose and frequency in patients receiving the drug for glabellar lines.403

Risk of Viral Transmission

Preparation contains albumin derived from human blood.403 Remote risk of transmission of Creutzfeldt-Jakob disease (CJD) and other viral diseases via albumin component; however, no cases identified to date.403

Immunogenicity

Potential immunogenicity.403 412 Neutralizing antibodies reported in approximately 1% of patients receiving incobotulinumtoxinA in clinical studies;412 however, long-term immunogenicity remains to be established.405 414

Preclinical studies demonstrated reduced antigenicity with incobotulinumtoxinA versus onabotulinumtoxinA; however, further study needed to confirm this finding.407 408 411 414

Reporting Adverse Effects or Overdosage

If the patient receives an overdose of incobotulinumtoxinA or the drug is injected into the wrong muscle (i.e., misinjection), contact the local or state health department to process a request for botulism antitoxin through the CDC Drug Service.403 If a response is not received within 30 minutes, contact the CDC Emergency Operations Center directly at 770-488-7100.403 Information about the antitoxin is available at .

Botulism antitoxin will not reverse any botulinum toxin-induced muscle weakness evident at the time of antitoxin administration but may stabilize the deficits.403

Specific Populations

Pregnancy

Category C.403

Lactation

Not known whether distributed into milk.403 Caution advised.403

Pediatric Use

Manufacturer states that safety and efficacy not established in patients <18 years of age.403

Geriatric Use

Among geriatric patients >65 years of age included in clinical studies of incobotulinumtoxinA for cervical dystonia or blepharospasm, approximately 53–76% experienced an adverse event.403

A limited number of individuals ≥65 years of age were included in clinical studies of incobotulinumtoxinA for treatment of glabellar lines; efficacy was demonstrated in 20% of these individuals and no increase in adverse effects observed.403

Common Adverse Effects

Cervical dystonia: Dysphagia, neck pain, muscle weakness, injection site pain, musculoskeletal pain.403 405 407 408 411

Blepharospasm: Eyelid ptosis, dry eye, dry mouth, diarrhea, headache, visual impairment, dyspnea, nasopharyngitis, respiratory tract infection.403 407 414

Glabellar facial lines: Headache, facial paresis, injection site hematoma, eyelid edema.403

Interactions for Xeomin

No formal drug interaction studies performed to date.403

Specific Drugs

Drug

Interaction

Comments

Anticholinergic agents

Potential for additive anticholinergic effects403

Anti-infective agents interfering with neuromuscular transmission (e.g., aminoglycosides)

Potential for additive botulinum toxin effects403

Closely monitor for adverse effects403

Botulinum toxin treatment, concurrent or sequential

Possible excessive neuromuscular paralysis with concurrent or sequential use of incobotulinumtoxinA403

Data on concurrent or sequential use of botulinum toxins lacking403

Neuromuscular blocking agents (e.g., tubocurarine-type muscle relaxants)

Potential for prolonged paralytic effect of toxin403

Use concomitantly with caution403

Xeomin Pharmacokinetics

Absorption

Bioavailability

Not detectable in peripheral circulation following IM administration.403

Duration

Usual duration of effect ≤3 months.403

Stability

Storage

Parenteral

Powder for Injection

Store unopened vials at room temperature (20–25°C), refrigerator (2–8°C), or freezer (-20 to -10°C).403

Following reconstitution, store at 2–8°C and use within 24 hours.403

Actions

  • Purified neurotoxin type A complex produced by fermentation of Clostridium botulinum (Hall strain).403 405 407 411 Differs from other currently available botulinum toxin type A preparations in that it contains active neurotoxin without complexing accessory proteins (hemagglutinins and nonhemaglutinins).403 407 408 411

  • Disrupts neurotransmission by inhibiting release of acetylcholine at peripheral cholinergic nerve terminals, inducing a chemical denervation and muscle paralysis.403 408

  • Neurotoxic effects occur in 3 phases: binding, internalization, and inhibition of acetylcholine from nerve terminals resulting in neuromuscular blockade.403

  • Causes temporary weakening or paralysis of muscles in local injection sites; however, adjacent or distant muscles also may be affected if spread of toxin effects occurs.381 403 408

  • Recovery of neuromuscular activity occurs through regeneration and recovery of nerve endings, usually within 3–4 months following an injection.403

Advice to Patients

  • Importance of providing a copy of the FDA-approved medication guide and reviewing its contents with every patient.403 404 Instruct patients to read medication guide prior to initiation of therapy and each time prescription is refilled.403 404

  • Advise patients to seek immediate medical attention if any swallowing, speech, or respiratory difficulties arise.403 404

  • Advise immobile or sedentary patients to gradually resume activities following treatment with incobotulinumtoxinA for cervical dystonia or blepharospasm.403 404

  • Inform patients that incobotulinumtoxinA may cause dyspnea or dysphagia with associated risk of aspiration.403 404

  • Advise patients that incobotulinumtoxinA can cause loss of strength, muscle weakness, blurred vision, or drooping eyelids, and that they should not drive a car, operate machinery, or engage in any other potentially hazardous activities during treatment.403 404

  • Advise patients that incobotulinumtoxinA may cause reduced blinking or effectiveness of blinking and that they should seek immediate medical attention if eye pain or irritation occurs following treatment.403 404

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.403 404

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.403 404

  • Importance of informing patients of other important precautionary information.403 404 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

IncobotulinumtoxinA

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For injection

50 units

Xeomin

Merz

100 units

Xeomin

Merz

AHFS DI Essentials. © Copyright, 2016, American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814. Review Date: September 06, 2016.

References

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