IncobotulinumtoxinA

IncobotulinumtoxinA is a prescription medication indicated for the treatment or improvement of:

• Chronic sialorrhea in patients 2 years of age and older 
• Upper limb spasticity in adults  
• Upper limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy 
• Cervical dystonia in adults 
• Blepharospasm in adults 
• Appearance of upper facial lines (glabellar lines [GL], horizontal forehead lines [HFL], and lateral canthal lines [LCL]) in adults

IncobotulinumtoxinA is available under the following different brand names: Xeomin.

Dosages of IncobotulinumtoxinA:

Dosing Form and Strengths

Injection, Lyophilized Powder for Reconstitution

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

Dosage Considerations – Should be Given as Follows: Chronic Sialorrhea

• Indicated for chronic sialorrhea
• Inject into the parotid and submandibular glands on both sides (i.e., 4 injection sites per treatment session)
• The recommended total dose is 100 units per treatment session; divide the dose into a ratio of 3:2 between the parotid and submandibular gland; do not exceed the 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

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
• The 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 titrate as clinically necessary
• Do not exceed the cumulative dose of 400 units per treatment session

The recommended dose per muscle

• Clenched fist
  • Flexor digitorum superficialis: 25-100 units divided into 2 sites
  • Flexor digitorum profundus: 25-100 units divided in 2 sites

• Flexed wrist
  • Flexor carpi radialis: 25-100 units divided into 1-2 sites
  • Flexor carpi ulnaris: 20-100 units divided in 1-2 sites

• Flexed elbow
  • Brachioradialis: 25-100 units divided into 1-3 sites
  • Biceps: 50-200 units divided into 1-4 sites
  • Brachialis: 25-100 units divided into 1-2 sites

• Pronated forearm
  • Pronator quadratus: 10-50 units in 1 site
  • Pronator teres: 25-75 units divided into 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
• Consider past dose, response to treatment, duration of effect, and adverse event history when determining the dose
• Optimum dose and number of injection sites in treated muscle(s) individualized by a doctor 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
• The total dose is 120 units intramuscularly (IM) per treatment session; higher doses were 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 muscle(s)
• The frequency of repeat treatments should be determined by clinical response and generally be no more frequent than every 12 weeks Do not exceed the cumulative dose of 400 units per treatment session

Blepharospasm

• Indicated for the treatment of blepharospasm
• Optimum dose and number of injection sites in treated muscle(s) individualized for each patient as determined by the doctor
• Treatment-naïve, initial dose: 25 units per eye
• Previously treated: In patients previously treated with a botulinum toxin A, their past dose, response to treatment, duration of effect, and adverse event history should be taken into consideration when determining the dose
• Not to exceed 100 units per treatment session (i.e., 50 units per eye)
• The frequency of repeat treatments should be determined by clinical response and generally be no more frequent than every 12 weeks

Glabellar Lines

• Indicated for temporary improvement of moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity
• The 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 every 3 months
• Do not exceed the cumulative dose of 400 units per treatment session

Children under 18 years: Safety and efficacy not established

Common side effects of incobotulinumtoxinA include:

Cervical dystonia

• Musculoskeletal and connective tissue disorders
• Problems swallowing
• Nervous system disorders
• General disorders and administration site condition
• Neck pain
• Infections and infestations
• Respiratory, thoracic, and mediastinal disorders
• Muscular weakness
• Injection site pain
• Neck pain
• Musculoskeletal pain

Blepharospasm

• Drooping eyelids
• Dry eye
• Dry mouth
• Nervous system disorders
• Visual impairment, including blurred vision
• Respiratory, thoracic, and mediastinal disorders
• Diarrhea
• Headache
• Shortness of breath
• Runny or stuffy nose
• Respiratory tract infection

Chronic sialorrhea

• Tooth extraction
• Dry mouth
• Diarrhea
• High blood pressure (hypertension)
• Fall
• Bronchitis
• Hoarseness
• Back pain
• Dry eye

Upper limb spasticity

• Seizure
• Runny or stuffy nose
• Dry mouth
• Upper respiratory tract infection

Glabellar lines

• Headache
• General disorders and administration site conditions
• Injection site hematoma
• Injection site pain
• Facial pain
• Injection site swelling
• Sensation of pressure
• Eye disorders
• Eyelid swelling
• Eyelid twitching
• Eyelid drooping

Postmarketing side effects of incobotulinumtoxinA reported include:

• 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 (e.g., swelling, edema, redness, itching, rash)
• Infection: Herpes zoster
• Musculoskeletal: Muscular weakness, muscle spasm, muscle pain
• Neurologic: Speech disorder, problems swallowing

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• IncobotulinumtoxinA has no listed severe interactions with other drugs.
• Serious interactions of incobotulinumtoxinA include:
  • abobotulinumtoxinA
  • amikacin
  • amphotericin B deoxycholate
  • gentamicin
  • glycopyrronium tosylate topical
  • neomycin oral
  • onabotulinumtoxinA
  • polymyxin B
  • prabotulinumtoxinA
  • pramlintide
  • streptomycin
  • tobramycin
• IncobotulinumtoxinA has moderate interactions with at least 41 different drugs.
• Mild interactions of incobotulinumtoxinA include:
  • acetazolamide
  • amlodipine
  • nifedipine
  • nisoldipine
  • primidone
  • rufinamide
  • sevoflurane
  • tiagabine
  • topiramate

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains incobotulinumtoxinA. Do not take Xeomin if you are allergic to incobotulinumtoxinA or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Black Box Warnings

Distant spread of toxin effect

• Botulinum toxin products may spread from injected area to produce symptoms consistent with botulinum toxin effects (e.g., asthenia, generalized muscle weakness, double vision, blurred vision, drooping eyelids, difficulty swallowing, hoarseness, speech problems, 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
• The 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 (e.g., peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders [myasthenia gravis, Lambert-Eaton syndrome])

Contraindications

• Hypersensitivity
• Infection at the proposed injection site(s)

Effects of Drug Abuse

• No information is available

Short-Term Effects

• See "What Are Side Effects Associated with Using IncobotulinumtoxinA?”

Long-Term Effects

• See "What Are Side Effects Associated with Using IncobotulinumtoxinA?”

Cautions

• Doses NOT interchangeable with other botulinum toxin products
• Can cause swallowing and breathing difficulties, caution with compromised respiratory function or difficulty swallowing
• Concomitant neuromuscular disorders may exacerbate adverse effects
• Serious hypersensitivity reactions reported with botulinum toxin products, including anaphylaxis, serum sickness, hives, soft-tissue edema, and shortness of breath; if serious and/or immediate hypersensitivity reactions occur, discontinue further injections and institute appropriate medical therapy immediately
• Discontinue and immediately initiate medical therapy if a hypersensitivity reaction occurs (e.g., anaphylaxis, serum sickness, hives, edema, shortness of breath)
• 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 difficulty swallowing
• Limit dose injected into the sternocleidomastoid muscle may decrease the occurrence of difficulty swallowing

Blepharospasm

• 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 double vision occurred with previous botulinum toxin injections
• Bruising easily occurs in the soft tissues of the eyelid
• Immediate gentle pressure at the injection site can limit that risk

Glabellar lines

• Risk of eyelid drooping
• 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 (e.g., 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 before 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

Pregnancy and Lactation

• There are no adequate data on the developmental risk associated with the use of incobotulinumtoxinA in pregnant women. Use incobotulinumtoxinA during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• There are no data on the presence of incobotulinumtoxinA in human milk, the effects on the breastfed infant, or the effects on milk production. Consult your doctor before breastfeeding.