Drug Detail:Abobotulinumtoxina (Abobotulinumtoxina (dysport) [ a-boe-bot-ue-lye-num-tox-in-a ])
Drug Class: Skeletal muscle relaxants
Usual Adult Dose for Cervical Dystonia
Initial dose: 500 Units IM divided among affected muscles
- Adjustments may be made in accordance with response; adjustments are generally made in steps of 250 Units
Maximum Dose: 1000 Units per treatment
Comments:
- The initial dose is the same for patients with or without a history of prior treatment with botulinum toxin.
- Simultaneous EMG-guided application may be helpful in locating active muscles.
- Limiting the dose injected into the sternocleidomastoid muscle may reduce the occurrence of dysphagia.
CLINICAL TRIAL DOSING: MUSCLE: MEDIAN DOSE (MINIMUM & MAXIMUM DOSE):
- Sternocleidomastoid: 125 Units (50, 350)
- Splenius capitis: 200 Units (75, 450)
- Trapezius: 102.6 Units (50, 300)
- Levator scapulae: 105.3 Units (50, 200)
- Scalenus (medius and anterior): 115.5 Units (50, 300)
- Semispinalis capitis: 131.6 Units (50, 250)
- Longissimus: 150 Units (100, 200)
Use: For the treatment of adults with cervical dystonia
Usual Adult Dose for Glabellar Lines
Initial dose: 50 Units IM divided into 5 equal aliquots (10 Units each)
Re-treatment: No sooner than 3 months
Comments:
- The clinical effect of this drug may last up to 4 months.
- Repeat dose studies have demonstrated continued efficacy with up to 4 repeated administrations.
- To reduce the complication of ptosis: avoid injection near the levator palpebrae superioris, especially in patients with larger brow depressor complexes; place medial corrugator injections at least 1 centimeter above the bony supraorbital ridge; ensure injected volume is accurate and as minimal as possible; and do not inject toxin closer than 1 centimeter above central eyebrow.
Use: For the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adult patients less than 65 years of age
Usual Adult Dose for Upper Limb Spasticity
Individualize dose based on the size, number and location of muscles involved; severity of spasticity; presence of local muscle weakness; and previous response to treatment and/or adverse event history with botulinum toxins
Clinical Trial Doses:
- Upper Limb Spasticity: 500 and 1000 Units IM in divided doses at a given treatment session
- Lower Limb Spasticity: 1000 and 1500 Units IM in divided doses at a given treatment session
Maximum total dose (upper and lower limbs combined): 1500 Units per treatment
Comments:
- Administer no more than 1 mL IM at any single injection site.
- The use of injection guiding technique e.g. electromyography, electric stimulation is recommended to target the injection sites.
- Treatment may be repeated when the effect of previous injections has diminished, but no sooner than 12 weeks; the majority of patients in clinical trials were retreated between 12 and 16 weeks, although some patients experienced a longer duration of response (e.g., 20 weeks).
- Improvement may be expected 1 week after administration.
CLINICAL TRIAL DOSING: MUSCLE INJECTED/DOSE/NUMBER OF INJECTIONS PER MUSCLE:
UPPER LIMB SPASTICITY:
- Flexor carpi radialis (FCR)/ 100 to 200 Units/1 to 2 injections
- Flexor carpi ulnaris (FCU)/ 100 to 200 Units/1 to 2 injections
- Flexor digitorum profundus (FDP)/100 to 200 Units/1 to 2 injections
- Flexor digitorum superficialis (FDS)/100 to 200 Units/1 to 2 injections
- Brachialis/200 to 400 Units/1 to 2 injections
- Brachioradialis/100 to 200 Units/1 to 2 injections
- Biceps Brachii (BB)/200 to 400 Units/1 to 2 injections
- Pronator Teres/100 to 200 Units/1 injection
LOWER LIMB SPASTICITY:
Gastrocnemius, Medial head/100 to 150 Units/1 injection
Gastrocnemius, Lateral head/100 to 150 Units/1 injection
Soleus/330 to 500 Units/3 injections
Tibialis posterior/200 to 300 Units/2 injections
Flexor digitorum longus/130 to 200 Units/1 to 2 injections
Flexor hallucis longus/70 to 200 Units/1 injection
Use: For the treatment of spasticity in adult patients.
Usual Adult Dose for Spasticity
Individualize dose based on the size, number and location of muscles involved; severity of spasticity; presence of local muscle weakness; and previous response to treatment and/or adverse event history with botulinum toxins
Clinical Trial Doses:
- Upper Limb Spasticity: 500 and 1000 Units IM in divided doses at a given treatment session
- Lower Limb Spasticity: 1000 and 1500 Units IM in divided doses at a given treatment session
Maximum total dose (upper and lower limbs combined): 1500 Units per treatment
Comments:
- Administer no more than 1 mL IM at any single injection site.
- The use of injection guiding technique e.g. electromyography, electric stimulation is recommended to target the injection sites.
- Treatment may be repeated when the effect of previous injections has diminished, but no sooner than 12 weeks; the majority of patients in clinical trials were retreated between 12 and 16 weeks, although some patients experienced a longer duration of response (e.g., 20 weeks).
- Improvement may be expected 1 week after administration.
CLINICAL TRIAL DOSING: MUSCLE INJECTED/DOSE/NUMBER OF INJECTIONS PER MUSCLE:
UPPER LIMB SPASTICITY:
- Flexor carpi radialis (FCR)/ 100 to 200 Units/1 to 2 injections
- Flexor carpi ulnaris (FCU)/ 100 to 200 Units/1 to 2 injections
- Flexor digitorum profundus (FDP)/100 to 200 Units/1 to 2 injections
- Flexor digitorum superficialis (FDS)/100 to 200 Units/1 to 2 injections
- Brachialis/200 to 400 Units/1 to 2 injections
- Brachioradialis/100 to 200 Units/1 to 2 injections
- Biceps Brachii (BB)/200 to 400 Units/1 to 2 injections
- Pronator Teres/100 to 200 Units/1 injection
LOWER LIMB SPASTICITY:
Gastrocnemius, Medial head/100 to 150 Units/1 injection
Gastrocnemius, Lateral head/100 to 150 Units/1 injection
Soleus/330 to 500 Units/3 injections
Tibialis posterior/200 to 300 Units/2 injections
Flexor digitorum longus/130 to 200 Units/1 to 2 injections
Flexor hallucis longus/70 to 200 Units/1 injection
Use: For the treatment of spasticity in adult patients.
Usual Adult Dose for Lower Limb Spasticity
Individualize dose based on the size, number and location of muscles involved; severity of spasticity; presence of local muscle weakness; and previous response to treatment and/or adverse event history with botulinum toxins
Clinical Trial Doses:
- Upper Limb Spasticity: 500 and 1000 Units IM in divided doses at a given treatment session
- Lower Limb Spasticity: 1000 and 1500 Units IM in divided doses at a given treatment session
Maximum total dose (upper and lower limbs combined): 1500 Units per treatment
Comments:
- Administer no more than 1 mL IM at any single injection site.
- The use of injection guiding technique e.g. electromyography, electric stimulation is recommended to target the injection sites.
- Treatment may be repeated when the effect of previous injections has diminished, but no sooner than 12 weeks; the majority of patients in clinical trials were retreated between 12 and 16 weeks, although some patients experienced a longer duration of response (e.g., 20 weeks).
- Improvement may be expected 1 week after administration.
CLINICAL TRIAL DOSING: MUSCLE INJECTED/DOSE/NUMBER OF INJECTIONS PER MUSCLE:
UPPER LIMB SPASTICITY:
- Flexor carpi radialis (FCR)/ 100 to 200 Units/1 to 2 injections
- Flexor carpi ulnaris (FCU)/ 100 to 200 Units/1 to 2 injections
- Flexor digitorum profundus (FDP)/100 to 200 Units/1 to 2 injections
- Flexor digitorum superficialis (FDS)/100 to 200 Units/1 to 2 injections
- Brachialis/200 to 400 Units/1 to 2 injections
- Brachioradialis/100 to 200 Units/1 to 2 injections
- Biceps Brachii (BB)/200 to 400 Units/1 to 2 injections
- Pronator Teres/100 to 200 Units/1 injection
LOWER LIMB SPASTICITY:
Gastrocnemius, Medial head/100 to 150 Units/1 injection
Gastrocnemius, Lateral head/100 to 150 Units/1 injection
Soleus/330 to 500 Units/3 injections
Tibialis posterior/200 to 300 Units/2 injections
Flexor digitorum longus/130 to 200 Units/1 to 2 injections
Flexor hallucis longus/70 to 200 Units/1 injection
Use: For the treatment of spasticity in adult patients.
Usual Pediatric Dose for Lower Limb Spasticity
Age: 2 years or older:
Individualize dose based on the size, number and location of muscles involved; severity of spasticity; presence of local muscle weakness; and previous response to treatment and/or adverse event history with botulinum toxins
Gastrocnemius-Soleus Complex:
- Gastrocnemius Muscle: 6 to 9 Units/kg IM divided in up to 4 injections
- Soleus: 4 to 6 Units/kg IM divided in up to 2 injections
Unilateral Lower Limb injections: 10 to 15 Units/kg IM in divided doses into affected spastic muscles
Bilateral Lower Limb injections: 20 to 30 Units/kg IM in divided doses into affected spastic muscles
Maximum Dose: 1000 Units OR 15 Units/kg (unilateral) or 30 Units/kg (bilateral) whichever is less, per treatment session
Comments:
- Administer no more than 0.5 mL IM at any single injection site; whenever possible the dose should be distributed across more than 1 injection site in any single muscle.
- The use of injection guiding technique e.g. electromyography, electric stimulation is recommended to target the injection sites.
- Treatment may be repeated when the effect of previous injections has diminished, but no sooner than 12 weeks; the majority of patients in clinical trials were retreated between 16 and 22 weeks.
- Improvement may be expected 1 week after administration.
- The safety and efficacy of injection into the proximal muscles of the lower limb has not been established.
Use: For the treatment of lower limb spasticity in pediatric patients 2 years of age and older.
Usual Pediatric Dose for Upper Limb Spasticity
Age: 2 years and older with a weight of at least 10 kg
Individualize dose based on the size, number and localization of muscles involved, severity of spasticity, and presence of local muscle weakness.
- Recommended total dose: 8 Units/kg to 16 Units/kg divided among affected muscles per treatment session.
- Maximum recommended total dose: 16 Units/kg or 640 Units (whichever is lower)
Suggested Dosing Ranges by Muscle:
- Brachialis: 3 to 6 Units/kg (Up to 2 injection sites per muscle)
- Brachioradialis: 1.5 to 3 Units/kg (1 injection site per muscle)
- Biceps brachii: 3 to 6 Units/kg (Up to 2 injection sites per muscle)
- Pronator teres: 1 to 2 Units/kg (1 injection site per muscle)
- Pronator quadratus: 0.5 to 1 Units/kg (1 injection site per muscle)
- Flexor carpi radialis: 2 to 4 Units/kg (Up to 2 injection sites per muscle)
- Flexor carpi ulnaris: 1.5 to 3 Units/kg (1 injection site per muscle)
- Flexor digitorum profundus: 1 to 2 Units/kg (1 injection site per muscle)
- Flexor digitorum superficialis: 1.5 to 3 Units/kg (Up to 4 injection sites per muscle)
Comments:
- Administer no more than 0.5 mL IM at any injection site.
- Localization of the involved muscles with techniques such as electromyographic guidance, nerve stimulation, or ultrasound is recommended.
- Frequency of repeat treatments should be determined by clinical response, but generally no more frequent than every 12 weeks.
Use: For the treatment of upper limb spasticity, excluding spasticity caused by cerebral palsy.
Renal Dose Adjustments
No adjustment recommended
Liver Dose Adjustments
No adjustment recommended
Dose Adjustments
Elderly: Use with caution due to the greater frequency of concomitant disease and other drug therapies
- The safety and effectiveness of use in patients 65 years or older for the temporary improvement of glabellar lines has not been established
Precautions
US BOXED WARNING: DISTANT SPREAD OF TOXIN EFFECT
- Postmarketing reports indicate that the effects of this drug and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. 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 risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms.
CONTRAINDICATIONS:
- Hypersensitivity to any of the ingredients
- Allergy to cow's milk protein
- Infection at the proposed injection sites
- In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to or lower than the maximum recommended total dose.
Safety and effectiveness have not been established for the treatment of cervical dystonia, glabellar lines, or proximal muscles of the lower limbs in patients less than 18 years of age. Safety and effectiveness have not been established in pediatric patients younger than 2 years for any indication.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- For IM administration only
- Once reconstituted, vial should be used in only 1 injection session and for only 1 patient
- Manufacturer product labeling should be consulted for injection techniques and additional guidance on administration
Storage requirements:
- Once vial is reconstituted, protect from light, store refrigerated (36F to 46F [2C to 8C]) in the original container for up to 24 hours; discard after 24 hours; do not freeze reconstituted vial
Reconstitution/preparation techniques:
- Available in vials of 300 Units and 500 Units
- Reconstitution instructions are specific for each vial strength and Preparation Instructions are specific for each indication, see Manufacturer Product Labeling for complete instructions
General:
- Potency Units are not interchangeable with other preparations of botulinum toxin products and can therefore not be compared to, or converted into units of any other botulinum toxin product.
- During treatment of cervical dystonia, simultaneous EMG-guided application may be helpful in locating active muscles.
- For treatment of spasticity; the actual location of the injection site can be palpated, however, the use of injection guiding technique e.g. EMG, electrical stimulation is recommended to target the injection sites.
- Recommended dose and frequency should not be exceeded.
Monitoring:
- Monitor for distant spread of toxin effect
Patient advice:
- Patients should be instructed to seek immediate medical attention if swallowing, speech or respiratory difficulties occur.
- Patients should understand that toxin effects may spread within hours, days, or weeks after an injection; patients should contact their healthcare professional with new or worsening symptoms.
- Patients should understand that loss of muscle strength, muscle weakness, blurred vision, or drooping eyelids may occur; patients should avoid driving a car or engaging in other potentially hazardous activities if these events develop.
Frequently asked questions
- What is botulinum toxin used to treat?
