Brand Name(s):

Myobloc^®

Other Name(s):

BoNT-B
BTB
Botulinum Toxin Type B

IMPORTANT WARNING

RimabotulinumtoxinB 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 rimabotulinumtoxinB or as late as several weeks after treatment. Symptoms may occur in people of any age being treated for any condition, but 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 rimabotulinumtoxinB 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?

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 in a class of medications called neurotoxins. It works by blocking the nerve signals that cause uncontrollable tightening and movement of the muscles.

HOW should this medicine be used?

RimabotulinumtoxinB injection comes as a liquid to be injected into affected muscles 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 of rimabotulinumtoxinB every 3 to 4 months, depending on your condition and how long the effects of the treatment last.

Your doctor will probably start you on a low dose of rimabotulinumtoxinB 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.

RimabotulinumtoxinB injection controls cervical dystonia but does not cure it. It may take 5 days or longer before you feel the full benefit of rimabotulinumtoxinB injection.

Are there OTHER USES for this medicine?

RimabotulinumtoxinB injection is also sometimes used to treat other conditions in which abnormal muscle tightening causes pain, abnormal movements, or other symptoms. RimabotulinumtoxinB injection is also sometimes used to treat excessive sweating of the hands, excessive sweating that occurs during or after eating, many types of wrinkles of the face, tremor (uncontrollable shaking of a part of the body), certain types of migraine, and anal fissures (a split or tear in the tissue near the rectal area). The medication is also sometimes used to improve the ability to move in children with cerebral palsy (condition that causes difficulty with movement and balance) or adults who have had a stroke. Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before receiving rimabotulinumtoxinB injection,

tell your doctor and pharmacist if you are allergic to rimabotulinumtoxinB, abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), onabotulinumtoxinA (Botox), any other medications, or any of the ingredients in rimabotulinumtoxinB injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: certain antibiotics such as amikacin, clindamycin (Cleocin), colistimethate (Coly-Mycin), gentamicin, kanamycin, lincomycin (Lincocin), neomycin (Neo-Fradin, Neo-Rx), polymyxin, streptomycin, and tobramycin (Tobi); cholinesterase inhibitors such as ambenonium (Mytelase; no longer available in U.S.), donepezil (Aricept), galantamine (Razadyne), neostigmine (Bloxiverz), physostigmine, pyridostigmine (Mestinon, Regonol), rivastigmine (Exelon), and tacrine (Cognex); magnesium sulfate; medications for allergies, colds, or sleep; muscle relaxants; and quinidine (in Nuedexta). Also tell your doctor if you have received injections of any botulinum toxin product in the past 4 months. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have swelling or other signs of infection in the area where rimabotulinumtoxinB will be injected. Your doctor will not inject the medication into an infected area.
tell your doctor if you have or have ever had any side effect from any botulinum toxin product or bleeding problems.
tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while receiving rimabotulinumtoxinB injection, call your doctor.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving rimabotulinumtoxinB injection.
you should know that rimabotulinumtoxinB injection may cause loss of strength or muscle weakness all over the body or impaired vision. If you have any of these symptoms, do not drive a car, operate machinery, or do other dangerous activities.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

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 rimabotulinumtoxinB 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:

weakness
difficulty moving any part of your body
difficulty breathing

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Ask your pharmacist any questions you have about rimabotulinumtoxinB 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: February 15, 2019.