Botulinum toxin type a 300 unit and 500 unit injection
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Powder for solution for injection containing Clostridium botulinum type A toxin-haemagglutinin complex.
Drugs List
Therapeutic Indications
Uses
Arm symptoms associated with focal spasticity
Blepharospasm and hemifacial spasm
Dynamic equinus foot deformity in cerebral palsy paed. patients 2yrs & over
Focal spasticity affecting the lower limb & ankle joint due to stroke/TBI
Focal spasticity of upper limbs in paediatric cerebral palsy patients
Severe hyperhidrosis of the axillae unresponsive to topical treatment
Treatment of cervical dystonia (torticollis)
Dosage
Patients may present with excessive muscle weakness. The risk may be reduced by using the lowest effective dose and not exceeding the recommended dose.
Adults
Spasmodic torticollis
Initial dose of 500 units given as a divided dose, administered to the two or three most active neck muscles. A reduced dose may be appropriate if the patient is markedly underweight or in the elderly, where reduced muscle mass may exist.
For rotational torticollis distribute the 500 units by administering 350 units into the splenius capitis muscle, ipsilateral to the direction of the chin/head rotation and 150 units into the sternomastoid muscle, contralateral to the rotation.
For laterocollis, distribute the 500 units by administering 350 units into the ipsilateral splenius capitis muscle and 150 units into the ipsilateral sternomastoid muscle. In cases associated with shoulder elevation the ipsilateral trapezoid or levator scapulae muscles may also require treatment, according to visible hypertrophy of the muscle or electromyographic (EMG) findings. Where injections of three muscles are required, distribute the 500 units as follows, 300 units splenius capitis, 100 units sternomastoid and 100 units to the third muscle.
For retrocollis distribute the 500 units by administering 250 units into each of the splenius capitis muscles. Bilateral splenii injections may increase the risk of neck muscle weakness.
All other forms of torticollis are highly dependent on specialist knowledge and EMG to identify and treat the most active muscles. EMG should be used diagnostically for all complex forms of torticollis, for reassessment after unsuccessful injections in non complex cases, and for guiding injections into deep muscles or in overweight patients with poorly palpable neck muscles.
Improvement may be expected within one week. Injections may be repeated approximately every 16 weeks or as required but no sooner than every 12 weeks.
Subsequent doses may be adjusted according to the clinical response and side effects observed. Doses within the range of 250 to 1000 units are recommended, although the higher doses may be accompanied by an increase in side-effects, particularly dysphagia. Maximum dose 1000 units.
Blepharospasm and hemifacial spasm
For this indication, the product should be reconstituted to yield a solution containing 200 units per ml of botulinum toxin type A.
In trials, a dose of 40 units per eye has been significantly effective. Doses of 80 units and 120 units resulted in a longer duration of effect, but the incidence of adverse effects appears to be dose related.
For both blepharospasm and hemifacial spasm the maximum dose must not exceed 120 units per eye.
The manufacturer recommends the following procedure: Injection of 10 units medially and 10 units laterally should be made into the junction between the preseptal and orbital parts of both the upper and lower orbicularis oculi muscles of each eye. In order to reduce to risk of ptosis, avoid injections near the levator palpebrae superioris. For injections into the upper lid the needle should be directed away from its centre to avoid the levator muscle. The relief of symptoms may be expected to begin within 2 to 4 days with maximal effect within 2 weeks.
Injections may be repeated every 12 weeks.
On subsequent administrations the dose may need to be increased to:
60 units: Administered as 10 units medially and 20 units laterally or
80 units: Administered as 20 units medially and 20 units laterally or
120 units: Administered as 20 units medially and 40 units laterally
Additional sites in frontalis muscle above brow may also be injected if spasms here interfere with vision.
In cases of unilateral blepharospasm the injections should be confined to the affected eye. Patients with hemifacial spasm should be treated as for unilateral blepharospasm.
Focal spasticity (upper and lower limbs)
For this indication, the product should be reconstituted to yield a solution containing either 100 units per ml, 200 units per ml or 500 units per ml of botulinum toxin type A, dependent on the dose to be administered.
Dose should be individualised dependent on the size, location and number of muscles involved, severity of spasticity, presence of local muscle weakness and previous response. Specific recommendations are provided in the product literature.
For upper limb spasticity, the total maximum dose is 1000 units.
For lower limb spasticity, the total maximum dose is 1500 units.
For simultaneous treatment of upper and lower limb spasticity, the total maximum dose is 1500 units.
To be administered as an intramuscular injection into the affected muscle(s). Maximum volume of 1ml per injection site. Injection site location can be determined by palpation however the use of injection site guiding techniques is recommended.
Improvement may be expected after 1 week and may last up to 20 weeks. Injections may be repeated every 12 to 16 weeks as required. Subsequent doses and/or administration sites may need to be adjusted dependent on the degree and pattern of muscle spasticity.
Axillary hyperhidrosis
For this indication, the product should be reconstituted to yield a solution containing 200 units per ml of botulinum toxin type A.
The recommended initial dosage is 100 units per axilla by intradermal injection. If the desired effect is not attained, up to 200 units per axilla can be administered for subsequent injections. The maximum dose administered should not exceed 200 units per axilla.
The area to be injected should be determined using the iodine-starch test. Both axillae should be cleaned and disinfected before administration.
Administration should be split as intradermal injections at ten sites with each site receiving 10 units, i.e., to deliver a total of 100 units per axilla.
The maximum effect should be seen within two weeks and the recommended dose should provide adequate suppression of sweat secretion for approximately 48 weeks. Further administrations should be determined on an individual basis according to clinical need taking into account previous administrations and potential for a cumulative effect. Injections should not be repeated more frequently than every 12 weeks.
Children
Dynamic equinus foot deformity due to focal spasticity in ambulant patients with cerebral palsy.
Children aged 2 to 18 years
Dose should be individualised dependent on the size, location and number of muscles involved, severity of spasticity, presence of local muscle weakness, previous response and/or history of adverse events with botulinum toxins. Specific recommendations are provided in the product literature.
Where possible, administer the doses as multiple injections across the target muscle (see product literature).
For unilateral lower limb injections, the total maximum dose is 15 units/kg.
For bilateral injections, the total maximum dose is 30 units/kg.
In addition, the total dose must not exceed 1000 units or 30 units/kg, whichever is lower.
To be administered as an intramuscular injection into the affected muscle(s). Maximum volume of 0.5ml per injection site. Injection site location can be determined by palpation, however the use of injection guiding techniques is also recommended.
Improvement may be expected within 2 weeks. Repeat injections can be given when the effects of previous doses has diminished but must be more than 12 weeks apart. Subsequent doses and/or administration sites may need to be adjusted dependent on the degree and pattern of muscle spasticity.
Focal spasticity of upper limbs in paediatric cerebral palsy patients.
Children aged 2 to 18 years
Dose should be individualised dependent on the size, location and number of muscles involved, severity of spasticity, presence of local muscle weakness, previous response and/or history of adverse events with botulinum toxins. Specific recommendations are provided in the product literature.
Where possible, administer the doses as multiple injections across the target muscle (see product literature).
For unilateral upper limb injections, the total maximum dose is 640 units or 16 units/kg.
For bilateral injections, the total maximum dose is 840 units 21 units/kg.
In addition, the total dose must not exceed 1000 units or 30 units/kg, whichever is lower.
To be administered as an intramuscular injection into the affected muscle(s). Maximum volume of 0.5ml per injection site. Injection site location can be determined by palpation, however the use of injection guiding techniques is also recommended.
Treatment should be repeated when the effect of previous injection has diminished, but no sooner than 16 weeks after previous injection.
Administration
Focal spasticity, dynamic equinus foot deformity in cerebral palsy and spasmodic torticollis: By intramuscular injection.
Blepharospasm and hemifacial spasm: By subcutaneous injection.
Axillary hyperhidrosis: By intradermal injection.
Contraindications
Administration site infection
Children under 2 years
Breastfeeding
Myasthenia gravis
Precautions and Warnings
Children aged 2 to 18 years
Inflammation of injection site
Predisposition to aspiration or regurgitation
Predisposition to narrow angle glaucoma
Prolonged bleeding times
Chronic respiratory impairment
Dysphagia
Neurological disorder
Neuromuscular disorder
Pregnancy
Advise ability to drive/operate machinery may be affected by side effects
Contains human albumin
Derived from human proteins - transmission of infective agents possible
Discard any unused portion
For single patient use only
Residual drug, spillage, etc - neutralise with dilute hypochlorite solution
Treatment to be administered by or under supervision of specialist
Advise pt to seek medical attention if diff. swallowing or breathing occurs
Neutralising antibodies may develop that decrease clinical efficacy
'Unit' of potency is brand specific. Refer to brand data sheet for dose
Do not exceed recommended dosages and frequency of administration
Not licensed for all indications in all age groups
Side effects related to spread of toxin distant from the site of administration have been reported, which in some cases was associated with dysphagia, pneumonia and/or significant debility resulting in death very rarely. This risk may be increased in patients with defective neuromuscular transmission or difficulty swallowing or breathing. Extreme caution should be exercised when treating paediatric patients who have significant neurological debility, dysphagia, or have a recent history of aspiration pneumonia or lung disease. Only use in patients with poor underlying health status where the benefit outweighs any individual risks.
Caution should be exercised when treating adult patients especially the elderly, with focal spasticity affecting the lower limbs, who may be at increased risk of fall.
This product is not indicated in patients with spasticity who have developed a fixed contracture.
Blepharospasm or hemifacial spasm:
Caution if risk of angle-closure glaucoma; reduced blinking can lead to corneal exposure, persistent epithelial defect and corneal ulceration (especially in those with VIIth nerve disorders). Careful testing of corneal sensation in previously operated eyes, avoidance of injection in lower lid area to avoid ectropion, and vigorous treatment of epithelial defect needed.
Pregnancy and Lactation
Pregnancy
Use Botulinum toxin type A with caution during pregnancy.
There is limited data regarding the use of Botulinum toxin type A during pregnancy. Animal studies have shown reproductive toxicity at high doses causing maternal toxicity.
The manufacturer recommends only using Botulinum toxin type A if the benefit justifies any potential risk to the foetus.
Lactation
Botulinum toxin type A is contraindicated in breastfeeding.
It is not known whether botulinum toxin type A is excreted in human milk and has not been studied in animals.
Side Effects
Antibody formation
Aspiration pneumonia
Asthenia
Blepharitis
Blurred vision
Bruising at injection site
Diplopia
Dizziness
Dry eyes
Dry mouth
Dysaesthesia
Dysphagia
Dysphonia
Dyspnoea
Entropion
Erythema at injection site
Eyelid oedema
Facial nerve paresis
Falls
Fatigue
Gait abnormality
Gastric aspiration
Headache
Hypersensitivity reactions
Influenza-like syndrome
Itching (injection site)
Lacrimation
Local pain (injection site)
Local reaction at injection site
Muscle weakness
Muscular atrophy
Musculoskeletal pain
Myalgia
Nausea
Neck pain
Neuralgic amyotrophy
Oedema (injection site)
Ophthalmoplegia
Painful extremities
Paralysis in muscles distant to the injection site
Perceived increase in non axillary sweating
Photosensitivity
Pruritus
Ptosis
Rash
Rash at injection site
Reduced visual acuity
Respiratory disorders
Stiffness
Urinary incontinence
Visual disturbances
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last full review date: January 2019
Reference Sources
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Summary of Product Characteristics: Dysport 300 units. Ipsen Ltd. Revised January 2020.
Summary of Product Characteristics: Dysport 500 units. Ipsen Ltd. Revised January 2020.
NICE Evidence Services Available at: www.nice.org.uk
Last accessed: 24 February 2020
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.