Patient Medication Information: uses, side effects, how to take - Dysport Therapeutic
What is Dysport Therapeutic used for?
- to reduce the symptoms of cervical dystonia in adults
- to temporarily relieve muscle stiffness in patients 2 year of age and older with spasticity
How does Dysport Therapeutic work?
Dysport Therapeutic is a drug that relaxes the muscles.
What are the ingredients in Dysport Therapeutic?
Medicinal ingredients: abobotulinumtoxinA
Non-medicinal ingredients: human serum albumin, lactose monohydrate and water for injection
Dysport Therapeutic comes in the following dosage forms:
Single-use, sterile 300 and 500 Unit vial
Serious Warnings and Precautions
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Do not use Dysport Therapeutic if:
- you are allergic or sensitive to any of the ingredients
- you have an infection in the muscles where it would normally be injected
- you are allergic to cow’s milk protein
- you have any muscle disorders in other parts of your body, including myasthenia gravis, Lambert-Eaton Syndrome or amyotrophic lateral sclerosis
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Dysport Therapeutic. Talk about any health conditions or problems you may have, including if you:
- have myasthenia gravis or Lambert-Eaton Syndrome, amyotrophic lateral sclerosis or another muscle disorder
- are allergic or sensitive to any botulinum toxin product
- have an infection at the proposed injection site
- are scheduled to have surgery using a general anesthetic
- are taking or are likely to take antibiotics, especially aminoglycoside antibiotics
are pregnant or become pregnant while taking this drug.
- are nursing. It is not known whether this drug is excreted in human milk.
- have pre-existing swallowing or breathing difficulties.
- suffer or have suffered from seizures
Other warnings you should know about:
Side effects may occur from misplaced injections of Dysport Therapeutic temporarily paralyzing nearby muscle groups. There have been very rare reports of side effects that may be related to the spread of botulinum neurotoxin distant from the injection site. These may include excessive muscle weakness, swallowing and breathing difficulties or accidental swallowing of food or drink into the airways, which can be life threatening or fatal. These symptoms have been reported hours to weeks after injection. Patients who receive the recommended doses may very rarely experience excessive muscle weakness.
Tell your doctor if you experience any difficulties in swallowing food while on Dysport Therapeutic, as it could be related to the dosage. Difficulty in swallowing food, ranging from very mild to severe, can persist for 2–3 weeks after injection, or longer.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Dysport Therapeutic:
- Aminoglycoside antibiotics (e.g., streptomycin, tobramycin, neomycin, gentamicin, kanamycin, amikacin)
- Spectinomycin
- Polymyxins
- Tetracyclines
- Lincomycin
- Any other drugs that interfere with neuromuscular transmission
How to take Dysport Therapeutic:
Dysport Therapeutic is for intramuscular use only.
Dysport Therapeutic should only be given by a physician with the appropriate qualifications and experience in the treatment and use of Dysport Therapeutic.
Usual dose:
The optimum dosage and number of injection sites in the treated muscle will be chosen by your doctor.
There should be at least a 12 week treatment interval in adult patients and pediatric patients with lower limb spasticity; and a 16 week treatment interval in pediatric patients with upper limb spasticity between two treatment sessions. When combining indications, the injection intervals should be no more frequent than every 12 weeks in adult patients and 16 weeks in pediatric patients.
Overdose:
Symptoms of overdose for this product, as for all botulinum toxins, are related to the dose, the condition being treated and susceptibility of the patient. Symptoms are not apparent immediately after the injection and may include general weakness, drooping eyelid, double vision, swallowing and speech difficulties, and pneumonia.
In case you feel symptoms of overdose please seek medical emergency services immediately or ask your relatives to do so, and have yourself admitted to hospital. Medical supervision for up to several days and assisted ventilation may be necessary.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
| If you think you, or a person you are caring for, have taken too much Dysport Therapeutic, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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What are possible side effects from using Dysport Therapeutic?
These are not all the possible side effects you may have when taking Dysport Therapeutic. If you experience any side effects not listed here, tell your healthcare professional.
Cervical Dystonia
The most commonly reported side effects (≥ 5%) were muscular weakness, dysphagia, dry mouth, injection site discomfort, fatigue, headache, neck pain, musculoskeletal pain, difficulty in swallowing, injection site pain, and eye disorders (consisting of blurred vision, reduced visual acuity and accommodation), and difficulty in speaking.
Adult Upper Limb Spasticity
The most commonly reported side effects (≥ 4%) were muscular weakness and nasopharyngitis.
Adult Lower Limb Spasticity
The most commonly reported side effects (≥ 4%) were fall, pain in the extremities and muscular weakness.
Pediatric Upper Limb Spasticity
The most commonly reported side effects (≥ 5%) were upper respiratory tract infections, muscular weakness, headache, fever and rhinorrhea.
Pediatric Lower Limb Spasticity
The most commonly observed adverse reactions (≥5% of patients) were influenza-like illness, myalgia and muscular weakness.
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Dysport Therapeutic must be stored under refrigeration at 2-8ºC. Protect from light. Once reconstituted, it can be stored under refrigeration at 2-8ºC for up to 24 hours. Do not freeze after reconstitution.
Keep out of reach and sight of children.
If you want more information about Dysport Therapeutic:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.ipsen.ca, or by calling 1-855-215-2288.