WARNING

RimabotulinumtoxinB injection have the potential to extend beyond the injection site and result in severe or fatal botulism symptoms, such as difficulty breathing or swallowing. 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 rimabotulinumtoxin B, symptoms may appear hours later or even weeks later. People receiving treatment for any age may experience symptoms, but youngsters receiving treatment for spasticity (tight and stiff muscles) are likely at the highest 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. Make a quick contact to your doctor if you encounter any of the following symptoms: All over body weakness or loss of strength; double or blurred vision; drooping eyelids; trouble speaking, breathing, or eating; or inability to control urination.

When you start therapy with rimabotulinumtoxinB injection and every time you get treatment, your doctor will provide you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, make sure you thoroughly read the material and consult your physician or pharmacist.

Why is this medication prescribed?

RimabotulinumtoxinB injection is used to relieve the symptoms of cervical dystonia (spasmodic torticollis; uncontrollable tightening of the neck muscles that may cause neck pain and abnormal head positions). RimabotulinumtoxinB injection is also used to treat chronic sialorrhea (ongoing drooling or excessive salivation). RimabotulinumtoxinB injection is in a class of medications called neurotoxins. When rimabotulinumtoxinB injection is injected into a muscle, it works by blocking the nerve signals that cause uncontrollable tightening and movement of the muscles. When rimabotulinumtoxinB is injected into saliva glands, it works by blocking the nerve signals that cause excessive saliva production.

How should this medicine be used?

RimabotulinumtoxinB injection comes as a liquid to be injected into affected muscles or saliva glands by a doctor. Depending on your condition and the length of time the treatment’s effects endure, you could need further injections of rimabotulinumtoxinB every three to four months.

Most likely, your doctor will start you on a low dose of rimabotulinumtoxin B injection and progressively increase it based on how the drug affects you.

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

Other uses for this medicine

RimabotulinumtoxinB injections are occasionally used to treat other illnesses where aberrant muscular tightness results in discomfort, strange motions, or other symptoms. Anal fissures, a split or tear in the tissue near the rectal area, and overactive bladder, a condition in which the bladder muscles contract uncontrollably and cause frequent urination, an urgent need to urinate, and an inability to control urination, are other conditions that are occasionally treated with rimabotulinumtoxinB injection. Discuss the risks of using this medication for your illness with your doctor.

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 RimabotulinumtoxinB injection, it’s crucial to follow these guidelines:

• If you have an allergy to rimabotulinumtoxinB, abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), onabotulinumtoxinA (Botox), prabotulinumtoxinA-xvfs (Jeuveau), any other medications, or any of the substances in rimabotulinumtoxinB injection, make sure your doctor and pharmacist know. For an ingredient list, ask your pharmacist or consult the Medication Guide.
• 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. Make careful to bring up any of the following: prescription drugs for allergies, colds, or insomnia; muscle relaxants; and specific antibiotics such amikacin, clindamycin (Cleocin), colistimethate (Coly-Mycin), gentamicin, lincomycin (Lincocin), neomycin, polymyxin, streptomycin, and tobramycin. 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. Make sure your doctor is aware of all the medications you take, even ones not on this list, as many other medications may also interact with rimabotulinumtoxinB.
• If you experience any swelling or other infection-related symptoms near the injection site for rimabotulinumtoxin B, let your doctor know. The drug will not be injected by your doctor into an infected region.
• Inform your physician about any facial surgery you have had, any bleeding issues you are experiencing, or if you have ever experienced any ill effects from using products containing botulinum toxin.
• 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 rimabotulinumtoxin B.
• Inform the physician or dentist that you are receiving an injection of rimabotulinumtoxin B if you are undergoing surgery, including dental surgery.
• You should be aware that an injection of rimabotulinumtoxinB may result in eyesight impairment or a generalized loss of strength or muscle weakness. Do not operate machinery, drive a car, or engage in any other risky activity if you have any of these symptoms.

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

What special dietary instructions should I follow?

• There are no specific dietary restrictions associated with RimabotulinumtoxinB Injection. However, if you experience difficulty swallowing, your healthcare provider may recommend modifications to your diet to reduce the risk of choking or aspiration.
• Stay hydrated and maintain a balanced diet to support overall health and well-being.

What should I do if I forget a dose?

• If you miss a dose of RimabotulinumtoxinB Injection, contact your healthcare provider to reschedule your appointment.
• Do not double the dose to make up for a missed one.
• It’s essential to maintain a consistent dosing schedule as prescribed by your healthcare provider to achieve optimal treatment outcomes.

What side effects can this medication cause?

RimabotulinumtoxinB 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 or tenderness in the area where the medication was injected
• Back, neck, or joint pain
• Headache
• Nausea
• Heartburn
• Dry mouth
• Cough

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:

• Itching
• Rash
• Hives
• Swelling of the face, throat, tongue, lips, or eyes
• Shortness of breath
• Wheezing
• Dizziness
• Fainting

It’s essential to discuss the potential side effects of RimabotulinumtoxinB 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:

• • Store RimabotulinumtoxinB Injection vials in the refrigerator at a temperature between 2°C to 8°C (36°F to 46°F).
  • Keep the medication away from light.
  • Do not freeze the medication.
  • Keep RimabotulinumtoxinB Injection out of the reach of children and pets.
  • Follow your healthcare provider’s instructions on how to properly dispose of unused RimabotulinumtoxinB Injection. Dispose of it in accordance with local regulations for hazardous waste disposal.

In case of emergency/overdose

• In case of an overdose or emergency, contact your healthcare provider, local poison control center, or emergency room immediately.
• Symptoms of overdose may include muscle weakness, difficulty swallowing or speaking, drooping eyelids, blurred vision, and respiratory difficulties.

What other information should I know?

• Inform your healthcare provider about any allergies you have, especially to botulinum toxin products or to any ingredients in RimabotulinumtoxinB Injection.
• Inform your healthcare provider about all the medications you are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• Follow your healthcare provider’s instructions carefully regarding the dosage and administration of RimabotulinumtoxinB Injection.
• Do not receive RimabotulinumtoxinB Injection if you are pregnant or breastfeeding unless specifically instructed by your healthcare provider.
• Be aware of the potential side effects of RimabotulinumtoxinB Injection, which may include muscle weakness, difficulty swallowing, neck pain, headache, and injection site reactions. If you experience any severe or concerning side effects, contact your healthcare provider.

Always consult your healthcare provider or pharmacist for specific guidance and recommendations regarding the storage, disposal, and emergency procedures for RimabotulinumtoxinB Injection, as individual circumstances may vary.