Generic Name: incobotulinumtoxina (IN-koe-BOT-ue-LYE-num-TOX-in-AY)
Brand Name: Xeomin
Incobotulinumtoxina may spread from the injection site to other areas of the body, causing symptoms of a serious condition called botulism. These symptoms may occur hours to weeks after you receive incobotulinumtoxina. Symptoms may include loss of strength; muscle weakness; double or blurred vision; drooping eyelids; hoarseness; change or loss of voice; loss of bladder control; or trouble speaking, breathing, or swallowing. The risk may be greater in children being treated for spasticity (muscle spasms), but these symptoms may also occur in adults. Contact your doctor immediately if these symptoms occur.
Severe and sometimes fatal breathing or swallowing problems have been reported. The risk may be greater in patients who already have breathing or swallowing problems. Tell your doctor if you have or are at risk of developing breathing or swallowing problems.
Incobotulinumtoxina is used for:
Reducing the severity of abnormal head position and neck pain associated with neck problems. It may be used to treat certain types of eyelid muscle spasms after you have been treated with another medicine (onabotulinumtoxinA). It may be used to temporarily improve the appearance of moderate to severe lines between the eyebrows in certain patients. It may also be used for other conditions as determined by your doctor.
Incobotulinumtoxina is a neurotoxin. It works by blocking nerve impulses to the muscles, temporarily paralyzing the muscle.
Do NOT use incobotulinumtoxina if:
- you are allergic to any ingredient in incobotulinumtoxina, including botulinum neurotoxin type A, human albumin, sucrose, or to another botulinum toxin product
- you have an infection at the injection site
Contact your doctor or health care provider right away if any of these apply to you.
Before using incobotulinumtoxina:
Some medical conditions may interact with incobotulinumtoxina. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have nerve problems or disease (eg, amyotrophic lateral sclerosis, motor neuropathy), muscle problems or disease (eg, myasthenia gravis, Lambert-Eaton syndrome), bleeding problems, or severe weakness or wasting of the muscles at the injection site
- if you have a history of swallowing problems or aspiration (inhaling food or fluids into your lungs), breathing problems (eg, asthma, emphysema), eye problems (eg, glaucoma, drooping eyelid), or eye surgery
- if you have a skin infection, or inflammation, scarring, or other skin disorders at the injection site
- if you plan to have surgery or if you have received incobotulinumtoxina or any other botulinum toxin in the past, especially within the last 4 months
- if you have weakness in your forehead muscles, any change in the way your face normally looks, you plan to have surgery, or you have had surgery on your face
- if you are taking an allergy or cold medicine
Some MEDICINES MAY INTERACT with incobotulinumtoxina. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Aminoglycoside antibiotics (eg, gentamicin), muscle relaxants (eg, cyclobenzaprine), or sleep medicines (eg, zolpidem) because they may increase the risk of incobotulinumtoxina's side effects
- Anticoagulants (eg, warfarin) because the risk of bleeding at the injection site may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if incobotulinumtoxina may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use incobotulinumtoxina:
Use incobotulinumtoxina as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Incobotulinumtoxina comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get incobotulinumtoxina refilled.
- Incobotulinumtoxina is usually given as an injection at your doctor's office, hospital, or clinic.
- If you miss a dose of incobotulinumtoxina, contact your doctor right away.
Ask your health care provider any questions you may have about how to use incobotulinumtoxina.
Important safety information:
- Incobotulinumtoxina may cause dizziness, loss of strength, weakness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use incobotulinumtoxina with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Tell your doctor or dentist that you take incobotulinumtoxina before you receive any medical or dental care, emergency care, or surgery.
- Do not switch brands of incobotulinumtoxina or switch it with other botulinum toxin products. Contact your doctor if you have any questions.
- Incobotulinumtoxina contains albumin, which comes from human blood. There is a very rare risk of getting a viral disease or a central nervous system disease called Creutzfeldt-Jakob disease from products with albumin. No cases of these problems have been found in patients who have used incobotulinumtoxina.
- To prevent injury, resume normal activities gradually after using incobotulinumtoxina.
- Incobotulinumtoxina should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using incobotulinumtoxina while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use incobotulinumtoxina, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of incobotulinumtoxina:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Decreased blinking; diarrhea; dry mouth; dry or irritated eyes; headache; increased cough; muscle or bone pain; muscle weakness or spasms; nausea; neck pain; pain, redness, swelling, or tenderness at the injection site; runny nose; tiredness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bleeding at the injection site; difficulty swallowing or breathing; dizziness; double or blurred vision or other vision changes; drooping of the upper eyelid; eye or eyelid swelling; eye pain or irritation; fainting; fever, chills, or persistent sore throat; loss of bladder control; loss of strength; severe or persistent muscle weakness or spasms; shortness of breath; speech changes or problems; wheezing.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include body weakness; difficulty breathing; paralysis. Incobotulinumtoxina may be harmful if swallowed.Proper storage of incobotulinumtoxina:
Incobotulinumtoxina is usually handled and stored by a health care provider. If you are using incobotulinumtoxina at home, store incobotulinumtoxina as directed by your pharmacist or health care provider. Keep incobotulinumtoxina out of the reach of children and away from pets.
- If you have any questions about incobotulinumtoxina, please talk with your doctor, pharmacist, or other health care provider.
- Incobotulinumtoxina is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take incobotulinumtoxina or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about incobotulinumtoxina. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to incobotulinumtoxina. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using incobotulinumtoxina.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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Other brands: Xeomin