(IN koe BOT ue LYE num TOX in A) Brand: Xeomin
• The botulinum toxin contained in this medicine can spread to another body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulism toxin injections, even for cosmetic purposes.
• Call your doctor at once if you have a hoarse voice, drooping eyelids, vision problems, severe muscle weakness, loss of bladder control, or trouble breathing, talking, or swallowing. Some of these effects can occur up to different weeks after a botulinum toxin injection.
• Do not search botulinum toxin injections from more than one medical professional at a time. If you switch healthcare providers, be certain to speak your new provider how long it has been since your recent botulinum toxin injection.
• Using this medicine more often than predesigned will not create it more effective and may result in serious side effects.
• You must not receive this medicine if you are allergic to botulinum toxin, or if you have an infection, swelling, or muscle weakness in the area where the medication will be injected.
• Till receiving a botulinum toxin injection, speak your doctor if you have ALS (Lou Gehrig's disease), myasthenia gravis, Lambert-Eaton syndrome, a breathing mess, trouble swallowing, facial muscle weakness, a change in the appearance of your person, seizures, bleeding problems, heart malady, if you have had or will have surgery, or if you have ever received another botulinum toxin injections such as Botox, Dysport, or Myobloc.
• The effects of a botulinum toxin injection are temporary. Your symptoms may return completely within 3 months after an injection. After repeat injections, it may take smaller and smaller time till your symptoms return, especially if your body develops antibodies to the botulinum toxin.
• IncobotulinumtoxinA, also called botulinum toxin type A, is made from the bacteria that causes botulism. Botulinum toxin blocks nerve activity in the muscles, causing a temporary abbreviation in muscle activity.
• IncobotulinumtoxinA is used to treat cervical dystonia (severe spasms in the neck muscles).
• IncobotulinumtoxinA is also used to treat determined eye muscle conditions caused by nerve disorders. This includes uncontrolled blinking or spasm of the eyelids, and a condition in which the eyes do not point in the same direction.
• IncobotulinumtoxinA is also used to temporarily lessen the appearance of facial wrinkles (sometimes called "frown lines") between the eyebrows.
• IncobotulinumtoxinA may also be used for purposes not listed in this medicine guide.
• You must not receive this medicine if you are allergic to botulinum toxin, or if you have an infection, swelling, or muscle weakness in the area where the medication will be injected. Speak your doctor if you have ever had a side effect after receiving a botulinum toxin in the past.
• To create certain incobotulinumtoxinA is safety for you, speak your doctor if you have:
· amyotrophic lateral sclerosis (ALS, or "Lou Gehrig's disease");
· myasthenia gravis;
· Lambert-Eaton syndrome;
· a breathing mess such as asthma or emphysema;
· problems with swallowing;
· facial muscle weakness (droopy eyelids, weak forehead, trouble raising your eyebrows);
· a change in the usual appearance of your face;
· a seizure disorder;
· bleeding problems;
· if you have had or will have surgery (especially on your face); or
· if you have ever received another botulinum toxin injections such as Botox, Dysport, or Myobloc (especially in the recent 4 months).
• IncobotulinumtoxinA is made from human plasma (part of the blood) which may contain viruses and another infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a little possibility it could transmit malady. Conversation with your doctor about the risks and benefits of using this medication.
• FDA pregnancy category C. It is not known whether botulinum toxin will harm an unborn child. Speak your doctor if you are pregnant or plan to become pregnant while using this medication.
• It is not known whether incobotulinumtoxinA passes into breast milk or if it could harm a nursing child. Speak your doctor if you are breast-feeding a baby.
• This medicine is injected into a muscle. A doctor, nurse, or another healthcare provider will give you this injection. IncobotulinumtoxinA injections must be spaced at least 3 months apart.
• Botulinum toxin injections must be given only by a trained medical professional.
• Your injection may be given into more than one area at a time, depending on the condition being treated.
• While receiving botulinum toxin injections for an eye muscle conditions, you may need to use eye drops, ointment, a particular contact lens or another device to protect the surface of your eye. Follow your doctor's instructions.
• It may take up to 7 days after injection till neck muscle spasm symptoms begin to improve.
• The effects of a botulinum toxin injection are temporary. Your symptoms may return completely within 3 months after an injection. After repeat injections, it may take smaller and smaller time till your symptoms return, especially if your body develops antibodies to the botulinum toxin.
• Do not search botulinum toxin injections from more than one medical professional at a time. If you switch healthcare providers, be certain to speak your new provider how long it has been since your recent botulinum toxin injection.
• Using this medicine more often than predesigned will not create it more effective and may result in serious side effects.
• Since botulinum toxin has a temporary effect and is given at widely spaced intervals, missing a doze is not likely to be harmful.
• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.
• Overdose symptoms may not appear right away, but can include severe muscle weakness, trouble swallowing, weak or shallow breathing, or loss of movement in any part of your body.
• This medicine may impair your vision or depth perception. Be careful if you drive or do anything that requires you to be able to see clearly.
• Avoid going back to your usual physical activities too quickly after receiving an injection.
• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling like you might pass out; swelling of your person, lips, tongue, or throat.
• The botulinum toxin contained in this medicine can spread to another body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulism toxin injections, even for cosmetic purposes.
• Call your doctor at once if you have any of these side effects, some of which can occur up to different weeks after an injection:
· trouble breathing, talking, or swallowing;
· hoarse voice, drooping eyelids;
· blurred vision, double vision;
· unusual or severe muscle weakness (especially in a body area that was not injected with the medication);
· loss of power, loss of bladder control;
· wheezing, tightness in your chest;
· eye pain or irritation;
· severe skin rash or itching; or
· feeling like you might pass out.
• General side effects may include:
· neck pain;
· dry eyes;
· headache, weary feeling;
· diarrhea;
· eyelid swelling or bruising, blinking smaller than normal; or
· pain, redness, or swelling where the injection was given.
• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.
• Other medications such as cool or allergy medication, muscle relaxers, sleeping pills, bronchodilators, bladder or urinary medicines, and irritable bowel medicines can magnify some of the side effects of incobotulinumtoxinA. Speak your doctor if you regularly use any of these medications.
• Speak your doctor about all medicines you use, and those you start or stop using during your treatment with incobotulinumtoxinA, especially:
· a blood thinner such as warfarin, Coumadin; or
· an injected antibiotic--amikacin, gentamicin, kanamycin, neomycin, paromomycin, streptomycin, tobramycin.
• This list is not complete. Another drugs may interact with incobotulinumtoxinA, including prescription and over-the-counter medicines, vitamins, and herbal commodity. Not all possible interactions are listed in this medicine manual.
• Your doctor or pharmacist can provide more information about incobotulinumtoxinA.
Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.
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