Patient Medication Information: uses, side effects, how to take - Xeomin
What is Xeomin used for?
Xeomin is used for the treatment of the following conditions in adults:
- eyelid spasm (blepharospasm) and spasm in one side of the face (hemifacial spasm)
- twisted neck (spasmodic torticollis)
- uncontrollable muscle stiffness and/ muscle tone in upper limbs (spasticity of the upper limb)
- to help treat stiffness in the lower limb involving the ankle and foot after a stroke in adults
- chronic drooling (sialorrhea) associated with neurologic disorders
Xeomin is also used for the treatment of the following conditions in children/adolescents:
- chronic drooling (sialorrhea) associated with neurological disorders in pediatric patients aged 2-17 years weighing 12 kg or more
How does Xeomin work?
Xeomin is a medicine that relaxes the muscles or decreases the flow of saliva at the administration site.
What are the ingredients in Xeomin?
Medicinal ingredients: incobotulinumtoxinA (purified BoNT/A, free from complexing proteins)
Non-medicinal ingredients: Human albumin, sucrose (sugar)
Serious Warnings and Precautions
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Xeomin comes in the following dosage forms:
incobotulinumtoxinA for injection, 50, 100, or 200 units per vial
Do not use Xeomin if:
- you are allergic (hypersensitive) to BoNT/A or any of the other ingredients of Xeomin
- you suffer from generalised disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome)
- an infection or inflammation is present at the injection site
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Xeomin. 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 or have had speech or breathing difficulties
- suffer or have suffered from seizures
- have had problems with injections of BoNT/A in the past
- are due to have surgery
- are receiving radiotherapy or if radiotherapy is planned
Other warnings you should know about:
In cases of repeated injections with Xeomin, the therapeutic effect of the product may vary. The possible reasons for an increase or decrease are:
- different techniques of preparation of the product by your healthcare professional
- different treatment intervals
- injections into another muscle
- marginally varying effectiveness of the active substance of Xeomin
- non-response/therapy failure during the course of treatment
Side effects may occur from misplaced injections of Xeomin temporarily paralysing 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.
Some medicines (e.g. clozapine, aripiprazole, pyridostigmine) may lead to excessive saliva production. Your healthcare professional may replace, reduce or stop your medication before using Xeomin as drooling treatment.
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 healthcare professional or pharmacist for advice before taking any medicine.
If you are pregnant or breast-feeding, Xeomin should not be used, unless you and your healthcare professional 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 problems occur. If in doubt ask your healthcare professional 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:
- 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 may be increased by these drugs.
- anticholinergics (e.g. atropine, glycopyrronium or scopolamine). When used for the treatment of chronic drooling, the effect of Xeomin may be increased by these drugs.
- therapeutic irradiation to the head and neck, including salivary glands.
How to take Xeomin:
Xeomin may only be used by health care professionals experienced in the application of Botulinum toxin.
Dissolved Xeomin is intended for injections into the muscle or into salivary glands.
Eyelid spasm (blepharospasm)
Please inform your healthcare professional prior to any treatment if you:
- have had an eye surgery. Your healthcare professional will then take additional precautions.
- are at risk of developing a disease called narrow angle glaucoma. This disease can cause the inner eye pressure to rise and may lead to a damaging of your optic nerve. Your healthcare professional will know if you are at risk.
Usually, the first onset of effect is observed within four days after injection. The effect of each treatment generally lasts for about 3-4 months; however, it may last significantly longer or shorter. The period between each treatment session is recommended to be at least 12 weeks. You should contact your healthcare professional for retreatment when you feel the treatment is wearing off as there can be flexibility in terms of re-treatment intervals. Your healthcare professional will determine if retreatment is necessary and may decide the intervals between treatments.
Twisted neck (spasmodic torticollis)
Usually, the first onset of effect is observed within seven days after injection. The effect of each treatment generally lasts for about 3-4 months; however, it may last significantly longer or shorter. The period between each treatment session is recommended to be at least 12 weeks. You should contact your healthcare professional for retreatment when you feel the treatment is wearing off as there can be flexibility in terms of re-treatment intervals. Your healthcare professional will determine if retreatment is necessary and may decide the intervals between the treatments.
Uncontrollable muscle stiffness and/or muscle tone in upper limbs (spasticity of the upper limb)
Usually, the first onset of effect is observed within four days after injection. The effect of each treatment generally lasts for about 3 months; however, it may last significantly longer or shorter. You should contact your healthcare professional for retreatment when you feel the treatment is wearing off. Your healthcare professional will determine if retreatment is necessary. Retreatment is possible but not more often than every 12 weeks.
Uncontrollable muscle stiffness and/or muscle tone in lower limbs (spasticity of the lower limb)
You should contact your healthcare professional for retreatment when you feel the treatment is wearing off. Your healthcare professional will determine if retreatment is necessary. Retreatment is possible but not more often than every 12 weeks.
Chronic drooling (sialorrhea) (adults and children/adolescents)
The period between each treatment session is recommended to be at least 16 weeks. Your healthcare professional will determine if retreatment is necessary.
Your healthcare professional may consider reducing the dosage of Xeomin if you or your child experience dry mouth that is bothersome.
When saliva flow is reduced by Xeomin, oral health problems such as dental caries (tooth decay or cavities) may develop or existent problems may further progress. Contact a dentist when starting to use Xeomin for treatment of chronic drooling. Your dentist may decide to take measures for caries prevention, if needed.
Usual dose:
The optimum dosage, frequency and number of injection sites will be chosen by your healthcare professional individually for you or your child. The results of initial treatment with Xeomin should be evaluated and may lead to dose adjustment until the desired therapeutic effect is achieved.
If you have the impression that the effect of Xeomin is too strong or too weak, let your healthcare professional 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, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Symptoms of overdose 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 healthcare professional or pharmacist.
Missed Dose:
Not applicable.
What are possible side effects from using Xeomin?
These are not all the possible side effects you may have when taking Xeomin. If you experience any side effects not listed here, tell your healthcare professional.
General
Like all medicines, Xeomin can cause side effects, although not everybody gets 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 and may include localised muscle weakness, pain from the needle, local pain, inflammation, pins and needles, reduced sense of touch, tenderness, swelling, skin redness, itching, localised infection, bleeding and/or bruising, and flu-like symptoms. The insertion of the needle may cause pain. As with any injectable drug, this pain or the anxiety towards needles may lead to fainting, a low blood pressure, nausea or tinnitus.
Blepharospasm
Common side effects reported include: drooping eyelid, dry eye, dry mouth, blurred vision, injection site pain, bruising at the injection site, vision impairment, lip or speech problems, double vision, eye pain, tearing, difficulty swallowing, nausea, headache, and fatigue. Uncommon side effects include: paralysis of surrounding eye muscle and/or face muscles, itchy eye, muscle weakness, numbness or tingling feeling, bruising around the eye, rash, and skin lesions.
After you receive a Xeomin injection into your muscle around your eye, your blinking rate may be reduced. This can lead to a prolonged exposure of the transparent front part of the eye (cornea). This exposure may lead to a damaging of the surface and an inflammation (corneal ulceration). This can occur more often if you suffer from disorders of your facial nerves.
Twisted neck (spasmodic torticollis)
After the injection you may develop swelling, soreness or bruising where the injection was given.
Common side effects include swallowing difficulties, neck pain, muscle weakness, injection site pain, muscle and skeletal pain, muscle stiffness, muscle spasm, headache, nausea, dry mouth, weakness, increased sweating, dizziness, feeling faint, and upper respiratory infection. Uncommon side effects include: speech problems, difficulty breathing, involuntary head nodding, numbness or tingling feeling, pain, eye pain, inflammation of the colon, skin rash, skin redness, itching, flu syndrome, runny nose, and voice problems.
Uncontrollable muscle stiffness and/or muscle tone in upper limbs (spasticity of the upper limb)
Common side effects include: partial loss of sensation. Uncommon side effects include: headache, muscle pain or weakness, lack of energy, nausea, and pain in extremity.
Uncontrollable muscle stiffness and/or muscle tone in lower limbs (spasticity of the lower limb)
Common side effects include: Muscular weakness and Fall (especially the elderly)
Chronic drooling (sialorrhea)
For Adults: Common side effects include dry mouth, swallowing difficulties, thickened saliva, feeling of pins and needles, change in sense of taste, and speech problems.
For Pediatrics: Common side effects include bronchitis, headache, sore throat and vomiting.
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. |
Storage:
Xeomin, 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.
Keep out of reach and sight of children.
If you want more information about Xeomin:
- 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://health-products.canada.ca/dpd-bdpp/; the manufacturer’s website (https://www.merzcanada.com), or by calling 1-866-815-8715.