Expert Dosing With Real Patients
Botulinum toxin products' units are not interchangeable. Units of Dysport cannot be compared to or converted into units of other botulinum toxin products.
Case Study 1: Gary
Gary: 52 years old
HISTORY
- Torticollis
- Diagnosed 6 years ago
- Treated previously with Botox® (onabotulinumtoxinA) for 3 years
- Previous Botox dosage: 500 Units
Botulinum toxin products' units are not interchangeable. Units of Dysport cannot be compared to or converted into units of other botulinum toxin products.
PRESENTATION
- Head rotation to the left with right tilt
- Deep muscle involvement
- Overactivity of left inferior capitis oblique, splenius capitis, semispinalis capitis, levator scapulae, trapezius, and right sternocleidomastoid, trapezius, scalene, levator scapulae
- Injection aided by EMG
CURRENT TREATMENT WITH DYSPORT
1000 Units total, divided among:
- Inferior capitis oblique* 125 Units (L)
- Splenius capitis 125 Units (L - 2 sites; upper and lower)
- Semispinalis capitis 125 Units (L - 4 sites)
- Levator scapulae 100 Units (L - 2 sites and R - 1 site)
- Trapezius 250 Units (L and R - 2 sites)
- Sternocleidomastoid 125 Units (R)
- Scalene 150 Units (R - 3 sites)
Recommended dose and frequency of administration should not be exceeded.
NEXT SCHEDULED TREATMENT: 12 WEEKS
Treatment should be individualized for each patient.
Case Study 2: Dolores
Dolores: 62 years old
HISTORY
- Torticollis
- Diagnosed 15 years ago
- Intermittently treated with Botox over past 10 years
- Previous Botox dosage: 300 Units
Botulinum toxin products' units are not interchangeable. Units of Dysport cannot be compared to or converted into units of other botulinum toxin products.
PRESENTATION
- Head rotation to the left
- Overactivity of left splenius capitis, semispinalis capitis, levator scapulae, trapezius, scalene, and right sternocleidomastoid
CURRENT TREATMENT WITH DYSPORT
762.5 Units total, divided among:
- Splenius capitis 200 Units (L - 4 sites)
- Semispinalis capitis 125 Units (L - 2 sites)
- Levator scapulae 125 Units (L - 3 sites)
- Trapezius 62.5 Units (R - anterior head)
- Scalene 125 Units (L - 3 sites)
- Sternocleidomastoid 125 Units (R - 3 sites)
Recommended dose and frequency of administration should not be exceeded.
NEXT SCHEDULED TREATMENT: 18 WEEKS
Treatment should be individualized for each patient.
Case Study 3: Ana
Ana: 54 years old
HISTORY
- Torticollis
- Diagnosed 4 years ago
- Treated previously with botulinum toxin
- Previous botulinum toxin dosage: 225 Units
Botulinum toxin products' units are not interchangeable. Units of Dysport cannot be compared to or converted into units of other botulinum toxin products.
PRESENTATION
- Head rotation to the right
- Deep muscle involvement
- Overactivity of right inferior capitis oblique, splenius capitis, semispinalis capitis, scalene, and left sternocleidomastoid
- Injection aided by EMG
CURRENT TREATMENT WITH DYSPORT
500 Units total, divided among:
- Inferior capitis oblique* 125 Units (R)
- Semispinalis capitis 60 Units (R - 2 sites)
- Splenius capitis 60 Units (R - 2 sites)
- Levator scapulae 125 Units (R - 2 sites)
- Scalene 50 Units (R)
- Sternocleidomastoid 80 Units (L - 2 sites)
Recommended dose and frequency of administration should not be exceeded.
NEXT SCHEDULED TREATMENT: 14 WEEKS
Treatment should be individualized for each patient.
Case Study 4: Bernice
Bernice: 75 years old
HISTORY
- Torticollis
- Diagnosed 14 years ago
- Treated previously with Botox for 10 years
- Previous Botox dosage: 350 Units
Botulinum toxin products' units are not interchangeable. Units of Dysport cannot be compared to or converted into units of other botulinum toxin products.
PRESENTATION
- Head rotation to the left
- Overactivity of left splenius capitis, semispinalis capitis, levator scapulae, trapezius, and right sternocleidomastoid
CURRENT TREATMENT WITH DYSPORT
1000 Units total, divided among:
- Splenius capitis 250 Units (L - 2 sites)
- Semispinalis capitis 250 Units (L - 2 sites)
- Levator scapulae 125 Units (L - 2 sites)
- Trapezius 125 Units (L anterior - 3 sites)
- Sternocleidomastoid 250 Units (R - 4 sites)
Recommended dose and frequency of administration should not be exceeded.
NEXT SCHEDULED TREATMENT: 14 WEEKS
Treatment should be individualized for each patient.
Case Study 5: Louise
Louise: 67 years old
HISTORY
- Torticollis
- Newly diagnosed
- Patient is toxin-naïve
Botulinum toxin products’ units are not interchangeable. Units of Dysport cannot be compared to or converted into units of other botulinum toxin products.
PRESENTATION
- Mild head rotation to right with chin deviation to left
- Injection aided by EMG
CURRENT TREATMENT WITH DYSPORT
300 Units total, divided among:
- Right sternocleidomastoid 100 Units, 2 injection sites
- Right scalene 100 Units, 2 injection sites
- Left splenius capitis 100 Units, 2 injection sites
Recommended dose and frequency of administration should not be exceeded.
Treatment should be individualized for each patient.
Case Study 6: Ronald
Ronald: 52 years old
HISTORY
- Spasmodic torticollis
- Diagnosed 3 years ago
- Previous treatment includes:
- Epidural steroidal injections - cervical spine
- Vicodin
- 500 Units of Dysport 3 months ago
Botulinum toxin products’ units are not interchangeable. Units of Dysport cannot be compared to or converted into units of other botulinum toxin products.
PRESENTATION
- Head tilt to left with chin deviation to left
- Mild left shoulder elevation
- Injection aided by EMG
CURRENT TREATMENT WITH DYSPORT
500 Units total, divided among:
- Right sternocleidomastoid 150 Units, 4 injection sites
- Left levator scapulae 100 Units, 2 injection sites
- Left splenius capitis 250 Units, 3 injection sites
Recommended dose and frequency of administration should not be exceeded.
Treatment should be individualized for each patient.
Case Study 7: Sue
Sue: 62 years old
HISTORY
- Torticollis
- Diagnosed 7 years ago
- Previous treatment includes:
- 250 Units of Botox
- 200 Units of Xeomin
Botulinum toxin products’ units are not interchangeable. Units of Dysport cannot be compared to or converted into units of other botulinum toxin products.
PRESENTATION
- Head tilt to right with head bobble
- Clonic muscle contractions
CURRENT TREATMENT WITH DYSPORT
500 Units total, divided among:
- Left sternocleidomastoid 50 Units, 1 injection site
- Left levator scapulae 200 Units, 2 injection sites
- Left scalene 50 Units, 1 injection site
- Right splenius capitis 200 Units, 2 injection sites
Recommended dose and frequency of administration should not be exceeded.
Treatment should be individualized for each patient.
Case Study 8: Chris
Chris: 52 years old
HISTORY
- Spasmodic torticollis
- Diagnosed 18 years ago
- Previous treatment includes:
- 25,000 Units of Myobloc
- 400 Units of Botox
- 1000 Units of Dysport
Botulinum toxin products’ units are not interchangeable. Units of Dysport cannot be compared to or converted into units of other botulinum toxin products.
PRESENTATION
- Head rotation to right, with right tilt
- Significant muscle tightness makes turning head to left difficult
CURRENT TREATMENT WITH DYSPORT
1000 Units total, divided among:
- Right splenius capitis 250 Units, 2 injection sites
- Left sternocleidomastoid 200 Units, 2 injection sites
- Right levator scapulae 200 Units, 2 injection sites
- Left scalene 50 Units, 1 injection site
- Right trapezius 300 Units, 6 injection sites
Recommended dose and frequency of administration should not be exceeded.
Treatment should be individualized for each patient.
Indication
Dysport is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain in both toxin-naïve and previously treated patients.
Important Safety Information
Distant Spread of Toxin Effect: Postmarketing reports indicate that the effects of Dysport 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. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.
Dysport is contraindicated in patients with hypersensitivity to any botulinum toxin product or its excipients, including human albumin, lactose, and cow's milk protein, or who have an infection at the proposed injection site.
The potency Units of Dysport are not interchangeable with other preparations of botulinum toxin products and, therefore, Units of biological activity of Dysport cannot be compared to or converted into Units of any other botulinum toxin products. Recommended dose and frequency of administration should not be exceeded.
Immediate medical attention may be required in cases of respiratory, speech, or swallowing difficulties. Dysphagia may persist for several weeks, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised. Concomitant neuromuscular disorder may exacerbate clinical effects of treatment.
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects, including severe dysphagia and respiratory compromise from typical doses of Dysport.
Dysport contains human albumin. Based on effective donor screening and product manufacturing processes, Dysport carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.
The possibility of an immune reaction when injected intradermally is unknown. The safety of Dysport for the treatment of hyperhidrosis has not been established.
Patients receiving concomitant treatment of Dysport and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents), or muscle relaxants, should be observed closely because the effect of botulinum toxin may be potentiated. Use of anticholinergic drugs may potentiate systemic anticholinergic effects. The effect of administering different botulinum neurotoxins during the course of treatment with Dysport is unknown.
There are no adequate and well-controlled studies in pregnant women. Dysport should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
The most commonly observed adverse reactions (>5% of patients) with Dysport for the treatment of cervical dystonia are muscular weakness, dysphagia, dry mouth, injection site discomfort, fatigue, headache, neck pain, musculoskeletal pain, dysphonia, injection site pain, and eye disorders.
To report SUSPECTED ADVERSE REACTIONS or product complaints, contact Ipsen at 1-877-397-7671 (877- DYSPOR1). You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information, including Boxed Warning, and Medication Guide.
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