50 units, 100 units, 200 units powder for injection, solution
Clostridium Botulinum‑neurotoxin type A (150 kD), free from complexing proteins
What Xeomin is and what it is used for
Xeomin is a medicine that contains the active substance botulinum neurotoxin type A, which has a relaxing effect on the injected muscles or reduces the flow of saliva at the respective injection site.
Xeomin is used to treat the following conditions in adults
- spasm in the eyelids ( blepharospasm ) and spasms in one half of the face (hemifacial spasm )
- twisted neck (spastic torticollis )
- increased muscle tension/uncontrolled muscle stiffness in the shoulders, arms, and/or hands (spasticity in the upper extremities )
- chronic drooling (hypersalivation) due to neurological diseases.
Xeomin is used in children and adolescents aged 2 to 17 years who weigh 12 kg or more for the treatment of
- chronic drooling (hypersalivation) due to neurological/developmental neurological diseases.
The Clostridium botulinum neurotoxin type A contained in Xeomin may also be approved to treat other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Xeomin
Do not use Xeomin
- if you are allergic to botulinum neurotoxin type A or any of the other ingredients of this medicine (listed in section 6).
- if you suffer from a disease affecting the muscles (eg myasthenia gravis or Eaton-Lambert syndrome).
- if you have an infection or inflammation at the intended injection site.
Warnings and precautions
Side effects can occur from misplaced injections of botulinum neurotoxin type A that temporarily paralyze nearby muscle groups. There have been very rare reports of side effects that may be related to the spread of toxin far from the injection site and may produce symptoms consistent with effects from botulinum toxin type A (eg, marked muscle weakness, difficulty swallowing, or getting food or liquid into the airways). . Patients receiving the recommended doses may experience increased muscle weakness.
If the dose is too high or if botulinum toxin is injected too often, the risk of antibody formation may increase. Antibody formation can lead to botulinum toxin type A treatment failure regardless of the reason for treatment.
Talk to your doctor or pharmacist before using Xeomin:
- if you have any kind of bleeding disorder
- if you receive medicines that prevent the blood from clotting (e.g. coumarin, heparin, aspirin, clopidogrel)
- if you suffer from pronounced weakness or reduced muscle volume in the muscles where the injection is to be given
- if you suffer from amyotrophic lateral sclerosis ( ALS ), which can lead to generalized muscle wasting.
- if you suffer from any disease that disrupts the interaction between nerves and skeletal muscles (peripheral neuromuscular disorders)
- if you have or have had to swallow difficulties you suffer or have suffered from convulsions
- if you have had problems injecting yourself with botulinum toxin type A before
- if you are going to have surgery.
Contact your doctor and seek hospital care immediately if you experience any of the following:
- difficulty breathing, swallowing, or speaking
- hives, swelling including swelling of the face or throat, wheezing, feeling faint and difficulty breathing (may be symptoms of a serious allergic reaction ).
Repeated injection with Xeomin
If you receive repeated injections of Xeomin, the effect may increase or decrease. Possible reasons for this are:
- your doctor may apply different preparation methods when preparing the solution for injection
- different injection intervals
- the injection is given in another muscle
- marginally varying effect of the active substance in Xeomin
- absence of effect/treatment failure during treatment
Eyelid spasm ( blepharospasm ) and spasms in one half of the face (hemifacial spasm )
Talk to your doctor before starting treatment with Xeomin if you:
- previously operated on the eyes. The doctor will take the necessary safety measures.
- are at risk of developing a disease called narrow-angle glaucoma ( glaucoma ). This disease can cause increased pressure in the eye which can lead to damage to the optic nerve. Your doctor can determine if you are at any risk for this.
During the treatment, small hemorrhages may appear in the soft tissue of the eyelid. Your doctor can limit this by applying light pressure to the injection site immediately after the injection.
After a Xeomin injection into the eye muscles, you may have reduced blinking. This can lead to prolonged exposure to the cornea. This exposure can lead to permanent damage to the surface layer and inflammation (ulceration of the cornea).
Twisted neck (Spastic torticollis )
After the injection of Xeomin t, there is a risk of mild to severe swallowing difficulties. This can lead to breathing problems and you may be at a higher risk of inhaling foreign substances or liquids. Foreign substances in your lungs can lead to inflammation or infection ( pneumonia ). Your doctor will give you medical treatment if necessary (eg in the form of tube feeding).
Difficulty swallowing may persist for up to two to three weeks after injection, t has been reported in one patient to persist for up to five months.
If you have had a physically inactive lifestyle for a long period, the start of all physical activity should be done gradually after injection with Xeomin.
Increased muscle tension/uncontrolled muscle stiffness
Xeomin can be used to treat increased muscle tension/uncontrolled muscle stiffness in parts of your upper extremities,e.g. your arm or hand. Xeomin is effective in combination with the usual standard treatment methods. Xeomin should be used in conjunction with these methods.
It is unlikely that this medicine will improve joint mobility if surrounding musculature has lost its ability to move
If you have had a physically inactive lifestyle for a long period, the start of all physical activity should be done gradually after injection with Xeomin.
Chronic drooling (hypersalivation)
Certain drugs (eg clozapine, aripiprazole, pyridostigmine) can lead to excessive salivation. First of all, the possibility of changing, reducing o,r even discontinuing the drug that causes drooling should be considered before Xeomin is used as an anti-drooling treatment. The use of Xeomin to reduce drug-induced drooling has not been studied.
If cases of “dry mouth” develop in connection with the administration of Xeomin, the doctor will consider reducing the dose.
If your saliva flow is reduced with Xeomin, oral health problems such as caries in the teeth, develop or existing problems may worsen. Consult a dentist when you start using Xeomin for the treatment of chronic drooling. The dentist can decide which measures should be taken to prevent caries, if necessary.
Children and young people
Do not give this medicine to children under 2 years of age, to children weighing less than 12 kg, or to children and adolescents for treatments other than chronic drooling because the use of Xeomin has not been established in these groups and therefore cannot be recommended.
Other medicines and Xeomin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of Xeomin may increase:
- of medicines used to treat certain infectious diseases (spectinomycin or aminoglycoside antibiotics [eg neomycin, kanamycin, tobramycin])
- of other medicines that relax muscles (eg tubocurarine-type muscle relaxants). Such drugs are used e.g. in case of general anesthesia (sedation/anesthesia). If you are going to have surgery, tell your anesthetist if you have received Xeomin.
- when used to treat chronic drooling: by other medicines that also reduce saliva flow (eg anticholinergics such as atropine, glycopyrronium, or scopolamine) or by radiation therapy to the head and neck, including the salivary glands. Tell your doctor if you are receiving radiation therapy or if radiation therapy is planned for you.
In these cases, Xeomin must be used with caution.
The effect of Xeomin can be reduced by certain medicines against malaria and rheumatism (called aminoquinolines).
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before administering this medicine.
Xeomin should not be used during pregnancy unless the doctor judges that the need and possible benefit of the treatment outweigh the possible risk to the fetus.
Xeomin is not recommended if you are breastfeeding.
Driving ability and use of machinery
You should not drive or participate in other potentially dangerous activities if droopy eyelids, weakness ( asthenia ), muscle weakness, dizziness or vision problems occur.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
How to use Xeomin
Xeomin may only be administered by doctors with appropriate specialist skills for treatment with botulinum neurotoxin type A.
Your doctor adjusts the optimal dose, treatment interval, and the number of injection sites individually for you. The result of the first injection of Xeomin is evaluated and may lead to an adjustment of the dose until the desired effect is achieved. Your doctor will determine the length of time intervals between treatments based on your actual need.
Tell your doctor if you feel that the effect of Xeomin is too strong or too weak. If no effect is achieved, other treatment options should be considered.
Eyelid spasm ( blepharospasm ) and spasms in one half of the face (hemifacial spasm )
The recommended initial dose is up to 25 units per eye and the total recommended dose for follow-up treatment is up to 50 units per eye. Usually, the first effect can be observed within four days after injection one. The effect of each treatment generally lasts about 3-5 months, but it can be significantly longer or shorter. Treatment intervals of less than 12 weeks are not recommended.
Normally, no further improvement is obtained if the treatment is done more often than every three months.
If you have spasms in one half of the face (hemifacial spasm ), your doctor will follow the treatment recommendations for eyelid spasms ( blepharospasm ) limited to one half of the face. The spasm affecting one half of the face (hemifacial spasm ) is treated only in the upper part of the face because Xeomin injections in the lower part of the face can lead to an increased risk of side effects such as a pronounced risk of local weakness.
Twisted neck (spastic torticollis )
The recommended dose of one per individual injection site is up to 50 units and the total dose of one at the first treatment is 200 units. A dose er up to 300 units can be administered by your doctor in subsequent treatments depending on treatment response. Usually, the first effect can be observed within seven days after injection one. The effect of each treatment lasts about 3-4 months, but it can be significantly shorter or longer. Treatment intervals shorter than 10 weeks are not recommended.
Increased muscle tension/uncontrolled muscle stiffness in the shoulders, arms, or hands (spasticity in the upper extremities )
The recommended dose is up to 500 units per treatment and a maximum of 250 units should be given to the shoulder muscles. Patients reported that the effect started 4 days after treatment. An improvement in muscle tone was noticed within 4 weeks. The effect lasted 12 weeks, but it can be significantly longer or shorter. The period between each treatment session should be at least 12 weeks.
Chronic drooling (hypersalivation, adults)
The recommended dose is 100 units per treatment session. This maximum dose must not be exceeded. The period between each treatment session should be at least 16 weeks.
Chronic drooling (hypersalivation, children/adolescents)
The recommended dose of one per treatment session depends on body weight. This maximum dose should not exceed 75 units. The period between each treatment session should be at least 16 weeks.
Mode of administration
Ready-made Xeomin is intended for injection into the muscles ( intramuscular use) and the salivary glands (intraglandular use) (see information for healthcare professionals at the end of the leaflet). When it comes to locating the salivary glands in adults, the doctor can use both anatomical landmarks and ultrasound guidance, but the ultrasound method is preferred for efficiency reasons. For children and adolescents, ultrasound guidance should be used.
Before injection, children and young people may be given a local anesthetic (e.g. local anesthetic cream), sedative, or an anesthetic combined with a sedative.
If you are given too much Xeomin
If you have received too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
Symptoms of overdose
Symptoms of overdose do not come immediately after injection one. They may consist of general weakness, drooping eyelids, double vision, difficulty breathing, difficulty speaking, and paralysis of respiratory muscles or difficulty swallowing which may lead to pneumonia.
Measures in case of overdose
If you notice symptoms of overdose, you should immediately seek hospital care or ask your loved ones for help in seeking hospital care. Medical monitoring for several days and artificial respiration may be required.
Ask your doctor, pharmacist, or nurse if you have any further questions about this medicine.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are usually observed within the first week after treatment and are transient. Side effects can be related to the drug, the injection technique, or both. Adverse effects may be limited to the area around the injection site (e.g. local muscle weakness, local pain, inflammation, tingling ( paresthesia ), reduced sense of touch ( hypoesthesia ), tenderness, swelling (general), swelling of soft tissues ( edema ), skin redness ( erythema ), itching, local infection, hemorrhage, bleeding and/or bruising).
The needle injection may cause pain. This pain or the fear of needles can lead to fainting, nausea, tinnitus (ringing in the ears), or a drop in blood pressure.
Side effects such as significant muscle weakness or difficulty swallowing can be caused by muscle relaxation far from the site where Xeomin was injected. Difficulty swallowing can lead to inhalation of foreign bodies leading to pneumonia and sometimes death.
An allergic reaction may occur during treatment with Xeomin. Serious and/or immediate allergic reactions ( anaphylaxis ) or allergic reactions to the serum et in the product (serum sickness) which for example lead to difficulty breathing ( dyspnoea ), hives ( urticaria ), or swelling of the soft parts ( edema ) have been reported in rare cases. Some of these reactions have been observed following the use of a common botulinum toxin type A complex. They occurred when toxin it was given alone or in combination with other drugs known to cause similar reactions. An allergic reaction may cause any of the following symptoms:
- difficulty breathing, swallowing, or speaking due to swelling of the face, lips, mouth, or throat.
- swelling of the hands, feet, or ankles
Immediately inform your doctor or ask your relatives to contact you if you notice any of these side effects and visit the emergency department of the nearest hospital.
The following side effects have been observed during treatment with Xeomin:
Eyelid spasm ( blepharospasm )
Very common (may affect more than 1 in 10 users):
Droopy eyelids ( ptosis )
Common (may affect up to 1 in 10 users):
Dry eyes, blurred vision, visual impairment, dry mouth, pain at the injection site
Uncommon (may affect up to 1 in 100 users):
Headache, facial muscle weakness (facial paralysis), double vision ( diplopia ), increased lacrimation, difficulty swallowing ( dysphagia ), fatigue, muscle weakness, rash
Cramps in one half of the face (hemifacial spasm )
Similar side effects as for eyelid spasms can be expected when treating spasms in one half of the face.
Twisted neck (spasmodic torticollis )
Very common (may affect more than 1 in 10 users):
Difficulty swallowing ( dysphagia )
Common (may affect up to 1 in 10 users):
Neck pain, muscle weakness, musculoskeletal pain ( myalgia ), musculoskeletal stiffness, muscle spasm, headache, dizziness, injection site pain, weakness ( asthenia ), dry mouth, nausea, increased sweating ( hyperhidrosis ), upper respiratory tract infection, feeling faint (presyncope)
Uncommon (may affect up to 1 in 100 users):
Difficulty speaking ( dysphonia ), shortness of breath ( dyspnea ), rash
The treatment of a twisted neck can cause difficulty in swallowing of varying degrees of severity, which may entail a risk of inhaling foreign objects and thus may require medical attention. Difficulty swallowing may persist for two to three weeks after injection, but in one case has been reported to last up to five months. Difficulty swallowing appears to be dose-dependent.
Increased muscle tension/uncontrolled muscle stiffness in the shoulders, arms, or hands (spasticity in the upper extremities )
Common (may affect up to 1 in 10 users):
Dry mouth
Uncommon (may affect up to 1 in 100 users)
Headache, decreased sense of touch ( hypoaesthesia ), muscle weakness, pain in arm or leg, weakness ( asthenia ), muscle pain ( myalgia ), difficulty swallowing ( dysphagia ), nausea
Has been reported (occurring in an unknown number of users):
Pain at the injection site
Chronic drooling (hypersalivation) in adults
Common (may affect up to 1 in 10 users):
Dry mouth, difficulty swallowing ( dysphagia ), tingling ( paraesthesia )
Uncommon (may affect up to 1 in 100 users):
Thicker saliva, speech difficulties, taste disturbance ( dysgeusia )
Cases of persistent dry mouth (more than 110 days) of severe intensity have been reported, which can lead to further complications such as gingivitis ( gingivitis ), difficulty swallowing, and caries .
Chronic drooling (hypersalivation) in children/adolescents
Uncommon (may affect up to 1 in 100 people):
Difficulty swallowing ( dysphagia )
Has been reported (occurring in an unknown number of users):
Dry mouth, thicker saliva, pain in the mouth, dental caries
Post-marketing experience
The following side effects have been reported as “no frequency known” when using Xeomin after launch and regardless of indication:
Flu-like symptoms, wasting of injected muscle, and hypersensitivity reactions, such as swelling, soft tissue swelling ( edema, even far from the injection site), redness, itching, skin rash (local and generalized), and shortness of breath.
How to store Xeomin
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and vial after “EXP”. The expiration date is the last day of the specified month.
Unopened vial: Store at a maximum of 25 °C.
Reconstituted solution for injection: Chemical and physical stability of the reconstituted preparation has been demonstrated for 24 hours at 2°C to 8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions before use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution has taken place under controlled and validated aseptic conditions.
Your doctor should not use Xeomin if the solution looks cloudy or contains visible particles.
For disposal instructions, please see the information for healthcare professionals at the end of this leaflet.
Contents of the packaging and other information
Contents declaration
- The active substance is Clostridium Botulinum‑neurotoxin type A (150 kD), free of complex proteins. Xeomin 50 units powder for solution for injection One vial contains 50 units of Clostridium Botulinum‑neurotoxin type A (150 kD), free from complexing proteins*.Xeomin 100 units powder for solution for injection vial contains 100 units of Clostridium Botulinum‑neurotoxin type A (150 kD), free from complexing proteins*. Xeomin 200 units powder for solution for injection vial contains 200 units of Clostridium Botulinum‑neurotoxin type A (150 kD), free from complexing proteins*.* Botulinum‑neurotoxin type A, purified from cultures of Clostridium Botulinum (Hall strain)
- Other ingredients are human albumin, and sucrose.
Appearance and package sizes of the medicine
Xeomin is a powder solution for injection. The powder is white.
After preparation, the powder becomes a clear, colorless solution.
Xeomin 50 units powder for solution for injection: Pack sizes of 1, 2, 3, or 6 bottles.
Xeomin 100 units powder for solution for injection: Pack sizes of 1, 2, 3, 4, or 6 bottles.
Xeomin 200 units powder for solution for injection: Pack sizes of 1, 2, 3, 4, or 6 bottles.
Not all pack sizes may be marketed.
Merz Pharmaceuticals GmbH
Eckenheimer Landstrasse 100
60318 Frankfurt/Main
Germany
Box 11 13 53
60048 Frankfurt/Main
Germany
Phone: +49-69/1503-1
Fax: +49-69/1503-200
This medicine is approved in the European Economic Area and the United Kingdom (Northern Ireland) under the names:
| Xeomin: | Austria, Bulgaria, Cyprus, Croatia, Czech Republic, Denmark, Estonia, Germany, Greece, Finland, France, Hungary, Ireland, Iceland, Italy, Latvia, Lichtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland) |
| XEOMIN: | Belgium |