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BTB (Generic RimabotulinumtoxinB Injection)

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WARNING

An injection of rimabotulinumtoxinB may cause symptoms of botulism, such as severe or life-threatening difficulty breathing or swallowing, to spread from the injection site. People who experience swallowing problems while using this drug may continue to experience them for several months. To prevent food or liquid from entering their lungs, they might need to be fed through a feeding tube. RimabotulinumtoxinB injections might cause symptoms to appear right away or up to several weeks later. People of any age receiving treatment for any ailment may experience symptoms, but youngsters receiving treatment for spasticity probably run the largest risk (muscle stiffness and tightness). Inform your doctor if you have or have ever had any breathing or swallowing issues, such as asthma or emphysema, or any conditions that affect your muscles or nerves, such as amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig’s disease; condition in which the nerves that control muscle movement slowly die, resulting in the muscles shrinking and weakening), motor neuropathy (condition in which the muscles weaken over time), or myasthenia grav (condition that causes muscle weakness that may improve with activity). Call your doctor right away if you have any of the following symptoms: the inability to control urination, loss of strength or muscle weakness throughout the body, double or blurred vision, drooping eyelids, difficulty breathing, speaking, or eating.

As soon as you start receiving rimabotulinumtoxinB injections for therapy and after each injection, your doctor will give you the medication guide provided by the manufacturer. If you have any questions after reading the material, see your doctor or pharmacist. For more information about the Medication Guide, go to the Food and Drug Administration (FDA) website or the manufacturer’s website.

Why is this medication prescribed?

Injections of rimabotulinumtoxinB are used to treat cervical dystonia symptoms (spasmodic torticollis; uncontrollable tightening of the neck muscles that may cause neck pain and abnormal head positions). Additionally, chronic sialorrhea is treated by rimabotulinumtoxinB injection (ongoing drooling or excessive salivation). A group of drugs known as neurotoxins includes ribabotulinumtoxinB injection. RimabotulinumtoxinB injection functions by obstructing the nerve signals that result in the muscles’ uncontrolled tightness and movement. By inhibiting the nerve signals that lead to excessive salivation, rimabotulinumtoxinB acts when injected into salivary glands.

How should this medicine be used?

A doctor must administer rimabotulinumtoxinB injection as a liquid into the afflicted muscles or salivary glands. To treat your disease, your doctor will determine the ideal location to inject the drug. Depending on your condition and the length of time the effects of the treatment continue, you might require further rimabotulinumtoxinB injections every 3 to 4 months.

RimabotulinumtoxinB injection will likely be administered to you by your doctor at first at a low dose, and when you respond to the drug, your doctor will gradually increase the dose.

It is not possible to switch from one botulinum toxin brand or kind to another.

Other uses for this medicine

The injection of rimabotulinumtoxinB is also occasionally used to treat various disorders in which pain, odd motions, or other symptoms are brought on by aberrant muscular tension. Other conditions that can be treated with rimabotulinumtoxinB injection include anal fissures, overactive bladder (a condition in which the bladder muscles contract involuntarily and cause frequent urination, an urgent need to urinate, and inability to control urination), and specific types of migraine (a split or tear in the tissue near the rectal area). The dangers of using this drug for your illness should be discussed with your doctor.

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before receiving rimabotulinumtoxinB injection,

  • 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, let your doctor and pharmacist know right once For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Incorporate any of the following: Amikacin, clindamycin (Cleocin), colistimethate (Coly-Mycin), gentamicin, lincomycin (Lincocin), neomycin, polymyxin, streptomycin, and tobramycin, as well as drugs for allergies, colds, or sleep, and muscle relaxants. Additionally, let your doctor know whether you’ve recently had any injections of botulinum toxin-containing products. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects. Tell your doctor about all the drugs you are taking, even any not on this list, since many other drugs may also interact with rimabotulinumtoxinB.
  • Swelling or other indications of infection in the location where rimabotulinumtoxinB will be injected should be reported to your doctor. The drug won’t be injected into an infection by your doctor.
  • Inform your doctor if you’ve undergone facial surgery, have ever experienced a botulinum toxin adverse effect, or have any bleeding issues.
  • Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. Call your doctor right away if you find out you’re pregnant while having rimabotulinumtoxinB injection.
  • Inform the surgeon or dentist that you are receiving a rimabotulinumtoxinB injection if you are undergoing surgery, including dental surgery.
  • You should be aware that rimabotulinumtoxinB injection can impair vision or result in a loss of strength or muscle weakness throughout the body. Do not operate machinery, drive a car, or engage in any other risky activity if you have any of these symptoms.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What side effects can this medication cause?

The injection of rimabotulinumtoxinB may have adverse effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • The place where the injection of the medicine caused pain or tenderness
  • Back ache
  • Headache
  • Nausea
  • Heartburn
  • Mouth ache
  • Cough

Some adverse effects can be very harmful. Call your doctor right away if you have any of these signs or any of those in the IMPORTANT WARNING section:

  • Itching
  • Rash
  • Hives
  • Swelling of the lips, eyes, tongue, cheeks, or throat
  • Breathing difficulties
  • Wheezing
  • Dizziness
  • Fainting

Other side effects after rimabotulinumtoxinB injection are possible. If you have any strange side effects while taking this medicine, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs typically do not show up right away after the injection. Tell your doctor straight away if you received too much rimabotulinumtoxinB or if you swallowed the drug. Also let them know if you suffer any of the following symptoms during the following few weeks:

  • Weakness
  • Any difficulty moving your body in any direction
  • Having trouble breat

What other information should I know?

Keep all of your doctor’s appointments.

If you have any inquiries regarding rimabotulinumtoxinB injection, ask your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Myobloc®
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