(in'' koh bot'' ue lye' num tox'' in ay'')
IncobotulinumtoxinA injection may spread from the area of injection and cause symptoms of botulism, including severe or life threatening difficulty breathing or swallowing. People who develop difficulty swallowing during their treatment with this medication may continue to have this difficulty for several months. They may need to be fed through a feeding tube to avoid getting food or drink into their lungs. Symptoms can occur within hours of an injection with incobotulinumtoxinA or as late as several weeks after treatment. Symptoms may occur in people of any age being treated for any condition. The risk is probably highest in children being treated for spasticity (muscle stiffness and tightness). Tell your doctor if you have or have ever had any swallowing problems or breathing problems, such as asthma or emphysema, or any condition that affects your muscles or nerves such as amyotrophic lateral sclerosis (ALS, Lou Gehrig's disease; condition in which the nerves that control muscle movement slowly die, causing the muscles to shrink and weaken), motor neuropathy (condition in which the muscles weaken over time), myasthenia gravis (condition that causes certain muscles to weaken, especially after activity), or Lambert-Eaton syndrome (condition that causes muscle weakness that may improve with activity). If you experience any of the following symptoms, call your doctor immediately: loss of strength or muscle weakness all over the body; double or blurred vision; drooping eyelids; difficulty swallowing, breathing, or speaking; or inability to control urination.
Your doctor will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with incobotulinumtoxinA injection and each time you receive treatment. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
WHY is this medicine prescribed?
IncobotulinumtoxinA injection is used to treat a number of conditions.
IncobotulinumtoxinA injection is used to:
IncobotulinumtoxinA injection is in a class of medications called neurotoxins. When incobotulinumtoxinA injection is injected into saliva glands, it blocks the nerve signals that causes excessive saliva production. When incobotulinumtoxinA injection is injected into a muscle, it blocks the nerve signals that cause uncontrollable tightening and movements of the muscle.
HOW should this medicine be used?
IncobotulinumtoxinA injection comes as a powder to be mixed with a liquid and injected into the saliva glands or a muscle by a doctor. Your doctor will choose the best place to inject the medication in order to treat your condition. You may receive additional injections every 3–4 months, depending on your condition and on how long the effects of the treatment last.
Your doctor will probably start you on a low dose of incobotulinumtoxinA injection and gradually change your dose according to your response to the medication.
One brand or type of botulinum toxin cannot be substituted for another.
IncobotulinumtoxinA injection may help to control your condition, but will not cure it. It may take a few days or up to several weeks before you feel the full benefit of incobotulinumtoxinA injection.
Are there OTHER USES for this medicine?
Botulinum toxin products similar to incobotulinumtoxinA injection have been used to treat other conditions in which abnormal muscle tightening causes pain, abnormal or restricted movements, or other symptoms. These products are also sometimes used to treat excessive sweating, many other types of facial wrinkles, anal fissures, and to prevent headaches in patients with chronic migraine or other types of headache.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before receiving incobotulinumtoxinA injection,
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What SIDE EFFECTS can this medicine cause?
IncobotulinumtoxinA injection may cause side effects. Ask your doctor which side effects you are most likely to experience since some side effects may be related to (or occur more often in) the part of the body where you received the injection. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:
IncobotulinumtoxinA injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( http://www.fda.gov/Safety/MedWatch ) or by phone (1-800-332-1088).
What should I do in case of OVERDOSE?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online athttps://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose usually do not appear right after receiving the injection. If you received too much incobotulinumtoxinA or if you swallowed the medication, tell your doctor right away and also tell your doctor if you experience any of the following symptoms during the next several weeks:
What OTHER INFORMATION should I know?
Keep all appointments with your doctor.
Ask your pharmacist any questions you have about incobotulinumtoxinA injection.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: July 15, 2019.
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