Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Botulinum toxin A

Generic name
Botulinum toxin A
Brand name
ATC Code
M03AX01

Pharmacokinetics in children

No information about the pharmacokinetic parameters in children

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

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Dosages

Focal spasticity of the upper limbs
  • Intramuscular
    • 2 years up to 18 years

      • Dysport®:  

        Muscle Dosis IE/kg Number of injections sites
        Brachialis 3-6 1-2
        Brachioradialis 1,5-3 1
        Biceps brachii 3-6 1-2
        Pronator teres 1-2 1
        Pronator quadratus 0,5-1 1
        Flexor carpi radialis 2-4 1-2
        Flexor carpi ulnaris 1,5-3 1
        Flexor digitorum profundus 1-2 1
        Flexor digitorum superficialis 1,5-3 1-4
        Flexor pollicis brevis / opponens pollicis 0,5-1 1
        Adductor pollicis 0,5-1 1

        In unilaterale treatment: max 16 E/kg  not exceeding 640 E
        In bilaterale treatment: max 21 E/kg not exceeding 840 E 

    • 2 years up to 18 years
      [3]

      • Dysport®:  

        Muscle Dosis IE/kg Number of injections sites
        Brachialis 3-6 1-2
        Brachioradialis 1,5-3 1
        Biceps brachii 3-6 1-2
        Pronator teres 1-2 1
        Pronator quadratus 0,5-1 1
        Flexor carpi radialis 2-4 1-2
        Flexor carpi ulnaris 1,5-3 1
        Flexor digitorum profundus 1-2 1
        Flexor digitorum superficialis 1,5-3 1-4
        Flexor pollicis brevis / opponens pollicis 0,5-1 1
        Adductor pollicis 0,5-1 1

        In unilaterale treatment: max 16 E/kg  not exceeding 640 E
        In bilaterale treatment: max 21 E/kg not exceeding 840 E 
CAUTION:
  • Route of administration not applicable
    • 0 years up to 18 years

      • Before using botulinum toxin A, check the prescribed amounts of units. The unit designation (E) is specific to each product. Interchange can have serious consequences. 
Hemifacial spasms
  • Subcutaneous
    • 12 years up to 18 years

      • Dysport®: initial dose 40 E per affected eye, divided equally into 4 injection sites, medial and lateral at the level of the junction between the preseptal and orbital portions of both the upper and lower m. orbicularis oculi; repeat if necessary after at least 12 weeks, if necessary the dose can be increased to 60-120 E per eye, if necessary also 2 injections into the frontalis muscle above the brow.

    • 12 years up to 18 years

      • Dysport®: initial dose 40 E per affected eye, divided equally into 4 injection sites, medial and lateral at the level of the junction between the preseptal and orbital portions of both the upper and lower m. orbicularis oculi; repeat if necessary after at least 12 weeks, if necessary the dose can be increased to 60-120 E per eye, if necessary also 2 injections into the frontalis muscle above the brow.

  • Intramuscular
    • 12 years up to 18 years

      • Botox ® : initial dose of 1.25-2.5 U per injection site, repeat after 12 weeks. If there is insufficient effect, double the initial dose to a maximum of 5 U per injection site. Cumulative dose in 3 months max. 100 U.
Blepharospasms
  • Intramuscular
    • 12 years up to 18 years

      • Botox ®: initial dose of 1.25-2.5 U per injection site, medial and lateral in the upper eyelid and lateral in the lower eyelid; repeat after 3 months. If there is insufficient effect, double the initial dose to a maximum of 5 U per injection site. Max 25 U per eye; cumulative dose in 3 months: 100 U.
Cervical dystonia (spasmodic torticollis)
  • Intramuscular
    • 12 years up to 18 years

      • Botox®: First treatment session: up to 200 E. Maximum of 50 E per injection site
        Repeat and adjust the dose depending on effect to a maximum of 300 E per session.
        Repeating within 10 weeks is not recommended; the sternocleidomastoid muscle must not be injected bilaterally in order to minimize dysphagia; Maximum dose in the sternocleidomastoid muscle 100 E. 

        Dysport®: initial dose 500 E, distributed in the 2 or 3 most active neck muscles;

        • for rotational torticollis 350 E in the splenius capitis muscle ipsilateral to the direction of chin/head rotation and 150 E in the sternocleidomastoid muscle contralateral to the direction of rotation;
        • in laterocollis 350 E in the ipsilateral m. splenius capitis and 150 E in the contralateral m. sternocleidomastoideus; if there is a shoulder elevation, treatment of the ipsilateral trapezius or levator scapula muscles may also be necessary; if in laterocollis in 3 muscles must be injected 300 E in the m. splenius capitis, 100 E in the m. sternocleidomastoideus and 100 E in the third muscle;
        • for retrocollis, 250 E in each m. splenius capitis;

        Repeat injections every 12-16 weeks; adjust dose if necessary to 250-1000 E, according to effect.

         
Hyperhidrosis of the armpits
  • Intracutaneous
    • 12 years up to 18 years

      • Botox®: 50 units per axilla; distributed over multiple sites 1-2 cm apart in the hyperhidrosis zone.

        Dysport®: initial dose 100 E per axilla, divided evenly into 10 injection sites, repeat if necessary after at least 12 weeks (usually 48 weeks); if necessary, increase dose to max 200 E per axilla next time.

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Myalgia, muscle weakness, pain in extremity, urinary incontinence, flu-like symptoms, reaction at injection site (pain, erythema, bruising), gait disturbance, fatigue, asthenia, falls. (SmPC Dysport)

 

 

 

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Do not use in children aged < 12 years, except for use in spastic paralysis in children.

There have been rare, spontaneous reports of death, sometimes associated with aspiration pneumonia in children with severe cerebral palsy after treatment with botulinum toxin, including after off-label use (e.g., in the neck). Extreme caution should be exercised when treating pediatric patients with significant neurologic weakness, dysphagia, or a recent history of aspiration pneumonia or pulmonary disease. (SmPC Botox)

There have been very rare reports of toxin dissemination to other sites in the body, in pediatric patients with comorbidities, especially cerebral palsy. Generally, the dose used in these cases was higher than the recommended dose (SmPC Botox).

 

 

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Choline derivatives
M03AB01
Other quaternary ammonium compounds
M03AC04
M03AC11
M03AC10
M03AC01
M03AC09
M03AC03

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References

  1. Allergan Pharmaceuticals Ireland, SPC Botox (RVG 117147) 15-05-2020, www.cbg-meb.nl
  2. Ipsen Farmaceutica BV, SmPC Dysport (RVG 110868) 08-01-2019, www. geneesmiddeleninformatiebank.nl
  3. Ipsen Pharma GmbH, SmPC Dysport (2-00212) , 07-2022
  4. Ipsen Pharma GmbH, SmPC Dysport (2-00212), 07-2022

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Changes

Changes