Patient Medication Information: uses, side effects, how to take - Dysport Aesthetic
What is Dysport Aesthetic used for?
- Dysport Aesthetic is used for the temporary improvement in the appearance of moderate to severe frown lines (glabellar lines) and crow’s feet lines (lateral canthal lines) in adult patients < 65 years of age.
How does Dysport Aesthetic work?
Dysport Aesthetic is a drug that temporarily reduces movement of certain upper facial muscles that cause wrinkles. Some patients see results as soon as 24 hours with a median time to onset of three days.
What are the ingredients in Dysport Aesthetic?
Medicinal ingredients: abobotulinumtoxinA
Non-medicinal ingredients: Human serum albumin and lactose monohydrate
Dysport Aesthetic comes in the following dosage forms:
Dysport Aesthetic is supplied in a single-use, sterile 300 Unit vial.
Do not use Dysport Aesthetic if:
Serious Warnings and Precautions
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- 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 Aesthetic. Talk about any health conditions or problems you may have, including if you:
- You have myasthenia gravis or Lambert Eaton Syndrome, amyotrophic lateral sclerosis or any other muscle disorders
- You have received any other botulinum toxin product in the last four months
- You have any eye disorders including drooping eyes, dry eyes
- You have bleeding problems
- You are allergic or sensitive to any botulinum toxin product
- You have an infection at the proposed injection site
- You are scheduled to have surgery using a general anesthetic
- You are taking or are likely to take antibiotics, especially aminoglycoside antibiotics
You are pregnant or become pregnant while taking this drug.
- You are nursing. It is not known whether this drug is excreted in human milk.
- You have pre-existing swallowing or breathing difficulties.
Other warnings you should know about:
Dysport Aesthetic is for intramuscular use only.
Dysport Aesthetic should only be given by a physician with the appropriate qualifications and experience in the treatment and use of Dysport Aesthetic.
Side effects may occur from misplaced injections of Dysport Aesthetic 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.
Dysport Aesthetic may cause loss of strength or general muscle weakness, blurred vision, or drooping eyelids within hours to weeks after injection. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
Seek immediate medical attention if swallowing, speech or respiratory problems arise.
Tell your doctor if you experience any difficulties in swallowing food while on Dysport Aesthetic, 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 Aesthetic:
The effect of Dysport Aesthetic may be increased by aminoglycoside antibiotics (e.g.,
- kanamycin, amikacin), spectinomycin, polymyxins, tetracyclines, lincomycin, muscle relaxant, or any other drugs that interfere with neuromuscular transmission.
How to take Dysport Aesthetic:
Usual dose:
Dysport Aesthetic can only be used by healthcare professionals experienced in the application of Botulinum toxin.
The optimum dosage and number of injection sites in the treated muscle will be chosen by your doctor.
Overdose:
Overdose with Dysport Aesthetic is a relative term that can reflect undesired aesthetic effect. 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 Aesthetic, 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 Aesthetic?
These are not all the possible side effects you may have when taking Dysport Aesthetic. If you experience any side effects not listed here, tell your healthcare professional.
The most commonly reported side effects (≥ 3%) were:
- Headache
- Injection site pain
- Upper respiratory infection, or sinus infection
The following additional side effects have been reported with Dysport Aesthetic:
- Drooping Eyelid (ptosis)
- Eyelid edema
- Injection site reactions (e.g. bruising, itchy skin, swelling)
- Temporary facial paralysis close to injection site
- Blurred or double vision
- Dry eyes
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell 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 Aesthetic must be stored under refrigeration at 2–8°C. Protect from light. Once reconstituted, it can be stored under refrigeration at 2–8°C 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 Aesthetic:
- 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 http://www.DysportCanada.ca, or by calling 1-800-467-2081.
DYSPORT AESTHETIC is a trademark of IPSEN BIOPHARM LTD.