RimabotulinumtoxinB Injection

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 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.

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 certain types of migraine, overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination), and anal fissures (a split or tear in the tissue near the rectal area). 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.

HOW should this medicine be used?

RimabotulinumtoxinB injection comes as a liquid to be injected into affected muscles or saliva glands 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.

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), prabotulinumtoxinA-xvfs (Jeuveau), 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, lincomycin (Lincocin), neomycin, polymyxin, streptomycin, and tobramycin; medications for allergies, colds, or sleep; and muscle relaxants. 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. Many other medications may also interact with rimabotulinumtoxinB, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• 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 had surgery on your face, or 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.

• 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?

RimabotulinumtoxinB injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• pain or tenderness in the area where the medication was injected
• back, neck, or joint pain
• headache
• nausea
• heartburn
• dry mouth
• cough

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• itching
• rash
• hives
• swelling of the face, throat, tongue, lips, or eyes
• shortness of breath
• wheezing
• dizziness
• fainting

RimabotulinumtoxinB injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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 at https://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.