WARNING

An injection of incobotulinumtoxinA may spread beyond the injection site and result in severe or fatal botulism symptoms, such as difficulty swallowing or breathing. When using this drug, people who experience trouble swallowing may not be able to do so for several months. To prevent food or liquids from entering their lungs, they might need to be fed via a feeding tube. After receiving an injection of incobotulinumtoxinA, symptoms may appear hours later or even weeks later. People receiving treatment for any ailment, regardless of age, may have symptoms. Children receiving treatment for spasticity, a condition characterized by tight and rigid muscles are most likely at risk. Inform your physician if you suffer from any respiratory or swallowing issues, such as asthma or emphysema, or if you have ever had any neurological or muscular conditions, such as amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig’s disease; a disorder in which the nerves controlling muscle movement gradually die, causing the muscles to weaken and shrink), Lambert-Eaton syndrome, myasthenia gravis, and motor neuropathy are three conditions that can cause muscle weakness that may improve with activity. Motor neuropathy is characterized by progressive weakness of the muscles. Give your doctor a call right away if you encounter any of the following symptoms: drooping eyelids; double or blurred vision; difficulty breathing, speaking, or swallowing; loss of strength or weakness in all bodily muscles; or inability to control urination.

The patient information sheet (Medication Guide) from the manufacturer will be given to you by your doctor at the start of your incobotulinumtoxinA injectable treatment and at subsequent treatments. If you have any questions, make sure to approach your pharmacist or doctor after thoroughly reading the material.

Why is this medication prescribed?

IncobotulinumtoxinA injection is used to treat chronic sialorrhea (ongoing drooling or excessive salivation) in adults and children 2 years of age and older. It is also used to treat children 2 years of age and older who do not have cerebral palsy (a condition that causes difficulty with movement and balance) for spasticity, or muscle stiffness and tightness, of the arm muscles. Injections of incobotulinumtoxinA are also used to treat blepharospasm, which is an uncontrollably tightening of the muscles that close the eyes, which can cause abnormal movements of the eyes, as well as spasticity, or stiffness, of the muscles in the arms. Additionally, it relieves the symptoms of cervical dystonia (spasmodic torticollis, an uncontrollably tightening of the neck muscles that can result in neck pain and aberrant head positions), and it is used to temporarily smooth the lines between adults’ eyebrows, or frown lines. A class of drugs known as neurotoxins includes incobotulinumtoxinA injection. The nerve signals responsible for excessive salivation are blocked when incobotulinumtoxinA injection is administered into the saliva glands. The nerve signals that cause an uncontrollably tightened muscle and its movements are blocked when incobotulinumtoxinA injection is administered into a 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. To treat your disease, your doctor will determine where to inject the drug. You may receive more injections every 3–4 months, depending on your condition and on how long the effects of the medication continue.

Depending on how you respond to the drug, your doctor will likely start you on a low dose of incobotulinumtoxinA injection and gradually increase it.

It is not possible to interchange one brand or variety of botulinum toxin for another.

An injection of incobotulinumtoxinA might help manage your condition, but it won’t heal it. Your body may need a few days or even weeks to fully respond to an incobotulinumtoxinA injection.

Other uses for this medicine

Ask your doctor or pharmacist for more information if you think this medicine could be recommended for something else.

What special precautions should I follow?

Regarding special precautions for IncobotulinumtoxinA injection, it’s crucial to follow these guidelines:

• Any allergy to incobotulinumtoxinA, abobotulinumtoxinA (Dysport), onabotulinumtoxinA (Botox), prabotulinumtoxinA-xvfs (Jeuveau), rimabotulinumtoxinB (Myobloc), any other drug, or any of the substances in incobotulinumtoxinA injection should be reported to your doctor and pharmacist. For an ingredient list, consult the Medication Guide or ask your pharmacist.
• Inform your physician and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal remedies you now take or intend to use. Additionally, let your doctor know if, during the last four months, you have had any injections of botulinum toxin. Your doctor might need to carefully monitor you for any negative effects or adjust the dosages of your medications.
• Medications for allergies, colds, or sleep disorders are among the over-the-counter or herbal drugs that may interact with incobotulinum toxica injection. Prior to having incobotulinumtoxinA injection, make sure your pharmacist and doctor are aware that you are taking these medications. While getting an injection of incobotulinumtoxinA, do not begin any of these medications without first talking to your healthcare professional.
• If you experience any swelling or other infection-related symptoms near the injection site for incobotulinumtoxinA, let your doctor know. The drug will not be injected by your doctor into an infected region.
• Inform your physician if you have experienced bleeding issues in the past or present, as well as any negative effects from using botulinum toxin products or having surgery on your face or eyes.
• Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. Inform your physician if you become pregnant after receiving an injection of incobotulinumtoxin A.
• Inform the physician or dentist that you are receiving an injection of incobotulinumtoxinA if you are undergoing surgery, including dental surgery.
• As you well aware, incobotulinumtoxinAn injection can result in visual impairment, muscle weakness, or loss of strength throughout the body. Do not operate machinery, drive a car, or engage in any other risky activity if you have any of these symptoms.
• Consult your doctor about increasing your activities following your treatment if you are receiving incobotulinumtoxinA injections for a condition that has restricted your activities. As your body responds to the effects of your medication, your doctor will likely want you to gradually increase your activities.

By following these precautions and guidelines, you can help ensure the safe and effective use of IncobotulinumtoxinA injection for your specific medical or cosmetic needs.

What special dietary instructions should I follow?

Regarding special dietary instructions, there are typically no specific dietary restrictions associated with IncobotulinumtoxinA injection. However, maintaining a healthy and balanced diet can contribute to overall well-being and may support the effectiveness of the treatment. If you have any concerns or questions about dietary considerations, discuss them with your healthcare provider.

What should I do if I forget a dose?

If you forget a dose of IncobotulinumtoxinA injection, contact your healthcare provider or clinic as soon as possible to reschedule the appointment. It’s essential to adhere to the recommended treatment schedule to achieve the desired results. Missing a dose may delay the onset of the effects or affect the longevity of the treatment’s benefits. Your healthcare provider can advise you on the appropriate course of action based on your individual circumstances.

What side effects can this medication cause?

IncobotulinumtoxinA injections, commonly known as Botox injections, can cause several side effects, although not everyone experiences them. These side effects can vary in severity and may include:

• Pain, tenderness, or bruising in the place where you received the injection
• Nasal congestion, sore throat, or runny nose
• Headache
• Dry mouth
• Problems with your teeth or gums
• Diarrhea
• Joint, bone, or muscle pain
• Dry eyes
• Reduced blinking or effectiveness of blinking

Certain adverse effects may be dangerous. Contact your physician right once if you encounter any of the following symptoms, as well as those mentioned in the IMPORTANT WARNING section:

• Vision changes
• Eyelid swelling
• Eye pain or irritation
• Seizures
• Neck pain
• Shortness of breath
• Fainting
• Dizziness
• Rash
• Hives
• Itching
• Swelling of the hands, feet, ankles, or lower legs

It’s essential to discuss the potential side effects of incobotulinumtoxinA injections with your healthcare provider before undergoing the procedure. They can provide personalized advice and recommendations based on your individual medical history and circumstances. Additionally, report any unusual or concerning symptoms to your healthcare provider promptly.

What should I know about storage and disposal of this medication?

Storage and disposal of IncobotulinumtoxinA injection are important considerations to ensure its effectiveness and safety:

• Storage: IncobotulinumtoxinA injection should be stored in the refrigerator at a temperature of 2°C to 8°C (36°F to 46°F). Do not freeze the medication. Keep it in the original packaging and protect it from light. Do not use the medication if it has been frozen or if the solution appears discolored or contains particles.
• Disposal: Unused or expired the medication should be disposed of properly according to local regulations for hazardous waste disposal. Do not dispose of Botox in household trash or flush it down the toilet or drain. Consult your healthcare provider or pharmacist for guidance on safe disposal methods.

In case of emergency/overdose

In case of emergency or overdose of IncobotulinumtoxinA injection, seek immediate medical attention or contact your local poison control center. Symptoms of overdose may include excessive muscle weakness, difficulty breathing, difficulty swallowing, or severe allergic reactions. It’s essential to inform healthcare professionals about the specific circumstances of the overdose for appropriate management.

What other information should I know?

• Duration of Effect: The effects of the medication are temporary and typically last for several months, after which repeat treatments may be necessary to maintain the desired results.
• Avoiding Certain Activities: After receiving injections, it’s advisable to avoid rubbing or massaging the treated area and to refrain from strenuous exercise, excessive sun exposure, or lying down for several hours to prevent the toxin from spreading to unintended muscles.
• Follow-up Appointments: Follow up with your healthcare provider as scheduled to monitor the effectiveness of the treatment and address any concerns or questions you may have.
• Informing Healthcare Providers: Make sure to inform other healthcare providers, such as dentists or surgeons, about any treatments you have received, as it may affect other medical procedures or medications.
• Pregnancy and Breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential risks and benefits of IncobotulinumtoxinA injection treatment with your healthcare provider, as its safety during pregnancy and breastfeeding has not been fully established.

By adhering to these guidelines and communicating openly with your healthcare provider, you can ensure safe and effective use of IncobotulinumtoxinA injection for your specific medical or cosmetic needs.