Patient Medication Information: uses, side effects, how to take - Xeomin Cosmetic
Serious Warnings and Precautions
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What is Xeomin Cosmetic® used for?
Xeomin Cosmetic® is used in adults for the temporary improvement in the appearance of upper facial lines including forehead, crow’s feet and frown lines.
How does Xeomin Cosmetic®work?Xeomin Cosmetic® is a medicine that relaxes the muscles.
Do not use Xeomin Cosmetic®if: you are allergic (hypersensitive) to Botulinum neurotoxin type A or any of the other ingredients of Xeomin Cosmetic®
an infection or inflammation is present at the proposed injection site
you suffer from generalized disorders of muscle activity (e.g., myasthenia gravis, Lambert- Eaton Syndrome).
What are the ingredients in Xeomin Cosmetic®?Medicinal ingredients: incobotulinumtoxinA (purified BoNT/A, free from complexing proteins)
Nonmedicinal ingredients: Albumin (human) and sucrose (sugar)
Xeomin Cosmetic® comes in the following dosage forms:
incobotulinumtoxinA solution for injection, 100 units per vial
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Xeomin Cosmetic®. Talk about any health conditions or problems you may have, including if you:
- suffer from any type of bleeding disorder
- receive substances that prevent the blood from clotting (e.g. coumarin, heparin, acetylsalicylic acid, clopidogrel)
- suffer from pronounced weakness or decreased muscle volume in the muscle where you will receive the injection
- suffer from a disease called amyotrophic lateral sclerosis (ALS) which can lead to generalized muscle decrease
- suffer from any disease that disturbs the interaction between nerves and skeletal muscles (peripheral neuromuscular dysfunction)
- have or have had swallowing difficulties
- have had problems with injections of BoNT/A in the past
- are due to have surgery
Other warnings you should know about:
Side effects may occur after injections of Xeomin Cosmetic® temporarily paralysing affected 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 rarely experience excessive muscle weakness.
Xeomin should only be given by physicians with the appropriate qualifications and experience in the treatment and use of the required equipment.
The risks for development of neutralizing antibodies to Botulinum toxins have been reported to be related to high dosage and too frequent injections. Antibodies may reduce the therapeutic effectiveness of the product.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant or breast-feeding, Xeomin Cosmetic® should not be used, unless you and your doctor together discuss your particular situation and agree that there is a clear necessity, and the potential benefit justifies the risk.
Driving and using machines
You should not drive or engage in other potentially hazardous activities if drooping eyelids, weakness (asthenia), muscle weakness, dizziness, or vision disorder occur. If in doubt ask your doctor for advice.
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 Xeomin Cosmetic®:
- aminoglycoside antibiotics (e.g. streptomycin, tobramycin, neomycin, gentamicin, netilmicin, kanamycin, amikacin), spectinomycin, polymyxins, tetracyclines, lincomycin or any other drugs that interfere with neuromuscular transmission. The effect of Xeomin Cosmetic® may be increased by these drugs.
How to take Xeomin Cosmetic®:
Xeomin Cosmetic® may only be used by health care professionals experienced in the application of Botulinum toxin.
Dissolved Xeomin Cosmetic® is intended for injections into the muscle. Usual dose:
The optimum dosage, frequency and number of injection sites in the treated muscle will be chosen by your doctor individually for you. The results of initial treatment with Xeomin Cosmetic® should be evaluated and may lead to dose adjustment until the desired therapeutic effect is achieved. Treatments should generally be more than 3 months apart.
If you have the impression that the effect of Xeomin Cosmetic® is too strong or too weak, let your doctor know. In cases where no therapeutic effect is apparent, alternative therapies should be taken into consideration.
Overdose:
| If you think you, or a person you are caring for, have taken too much Xeomin Cosmetic, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Overdose with Xeomin Cosmetic® is a relative term that can reflect undesired esthetic 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, breathing and speech difficulties, and paralysis of the respiratory muscles or swallowing difficulties which may result in 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.
Missed Dose:
Not applicable.
What are possible side effects from using Xeomin Cosmetic®?
These are not all the possible side effects you may have when taking Xeomin Cosmetic®. If you experience any side effects not listed here, tell your healthcare professional.
General
Like all medicines, Xeomin Cosmetic® can cause side effects, although few people get them. Usually, side effects are observed within the first week after treatment and are temporary in nature.
Side effects may be restricted to the area around the injection site (e.g. localised muscle weakness, local pain, inflammation, pins and needles, reduced sense of touch, tenderness, swelling (general), swelling of the soft tissue, skin redness, itching, localised infection, bleeding and/or bruising). Flu-like symptoms have been reported.
The most commonly reported side effects include headache, swelling around the eye/eyelid, changes in the shape of the eyebrow, including raised eyebrow, drooping of the eyelid, pain, bleeding and/or bruising, and redness near the injection site, dry eye, heavy feeling of frontal area, reduced sense of touch, facial asymmetry, and nausea. Uncommon side effects include heavy feeling of the eyelid/eyebrow, fatigue, muscle twitching, blurred vision, and inflammation of the nose and throat (nasopharyngitis).
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| RARE | |||
Anaphylaxis (allergic reaction): Hives, swelling including swelling of the face, lips, mouth or throat, swelling of the hands, feet or ankles, wheezing, feeling faint or shortness of breath | √ | ||
| Excessive muscle weakness including swallowing, speech and/or breathing difficulties | √ | ||
| Inflammation of lungs or infection (pneumonia) as a result of inhalation of foreign substances or fluids | √ | ||
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. |
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Storage:
Keep out of reach and sight of children.
Xeomin Cosmetic®, unreconstituted, is stored at room temperature (up to 25°C). Once reconstituted with physiological saline, it may be stored for up to 24 hours at 2 to 8°C.
If you want more information about Xeomin Cosmetic®:
- 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 (https://www.merzcanada.com), or by calling 1-866-815-8715.
Date of Revision: October 3, 2023