rimabotulinumtoxinB 5,000 unit/mL intramuscular solution

Generic name:
Botulinum toxin - injection

Pronunciation
(BOT-ue-LYE-num)

See also Uses section.

This medication can spread to other parts of the body after your injection, causing serious (possibly fatal) side effects. These can occur hours or even weeks after the injection. However, the chances of such serious side effects occurring when this medication is used for migraines or skin conditions such as wrinkles, eye spasm, or excessive sweating are extremely unlikely.

Children being treated for muscle stiffness/spasms have the greatest risk of these effects, as well as anyone that has certain medical conditions (see Precautions section). Discuss the risks and benefits of this medication with your doctor.

Get medical help right away if any of these very serious side effects occur: chest pain, difficulty breathing, excessive muscle weakness, irregular heartbeat, severe difficulty swallowing or speaking, loss of bladder control.

There are different types of botulinum toxin products (toxin A and B) with different uses (eye problems, muscle stiffness/spasms, migraines, cosmetic, overactive bladder). Different brands of this medication deliver different amounts of medication. Your doctor will choose the correct product for you.

Botulinum toxin is used to treat certain eye disorders such as crossed eyes (strabismus) and uncontrolled blinking (blepharospasm), to treat muscle stiffness/spasms or movement disorders (such as cervical dystonia, torticollis), and to reduce the cosmetic appearance of wrinkles or vertical neck bands connecting the jaw and neck (platysma bands). It is also used to prevent headaches in people with very frequent migraines. Botulinum toxin relaxes muscle by blocking the release of a chemical called acetylcholine.

Botulinum toxin is also used to treat overactive bladder by patients who do not respond to or who cannot tolerate the side effects of other medications. It helps to reduce leaking of urine, feeling of needing to urinate right away, and frequent trips to the bathroom.

It is also used to treat severe underarm sweating and drooling/excess saliva. Botulinum toxin works by blocking the chemicals that turn on the sweat and salivary glands.

Botulinum toxin is not a cure, and your symptoms will gradually return as the medication wears off.

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get an injection. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection by an experienced health care professional. It is injected into the affected muscles when treating eye disorders, muscle stiffness/spasms, platysma bands, and wrinkles. When used to prevent migraines, it is injected into the muscles of the head and neck. It is injected into the skin for the treatment of excessive sweating. For the treatment of drooling/excess saliva, this medication is injected into the salivary glands. When treating overactive bladder, it is injected into the bladder.

The dosage, the number of injections, the site of injections, and how often you receive the medication will be determined by your condition and your response to treatment. Children's dosage is also based on weight. Most people start to see an effect within a few days to 2 weeks, and the effect usually lasts 3 to 6 months.

See also Warning section.

Because this medication is given at the site of your condition, most of the side effects occur close to where the medication is injected. Redness, bruising, infection, and pain at the injection site may occur.

Dizziness, mild difficulty swallowing, respiratory infections such as cold or flu, pain, nausea, headache, and muscle weakness may occur when this medication is used to relax muscles. Double vision, drooping or swollen eyelid, eye irritation, dry eyes, tearing, reduced blinking, and increased sensitivity to light may also occur.

If any of these effects last or get worse, notify your doctor or pharmacist promptly. You may require protective eye drops/ointments, an eye patch, or other treatment.

When this medication is used to prevent migraines, side effects such as headache, neck pain, and drooping eyelid may occur.

When this medication is used for excessive sweating, side effects such as non-underarm sweating, respiratory infections such as cold or flu, headache, fever, neck or back pain, and anxiety may occur.

When this medication is used for overactive bladder, side effects such as urinary tract infections, burning/painful urination, fever, or difficulty urinating may occur.

If any of these effects last or get worse, notify your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• itching/swelling (especially of the face/tongue/throat)
• rash
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as cow's milk protein found in some products), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor your medical history, especially of:

• bleeding problems
• eye surgery
• certain eye problem (glaucoma)
• heart disease
• diabetes
• signs of swelling/weakness/infection near the injection site
• urinary tract infection
• inability to urinate
• muscle/nerve disorders (such as Lou Gehrig's disease-ALS, myasthenia gravis)
• seizures
• trouble swallowing (dysphagia)
• breathing problems (such as asthma, emphysema, aspiration-type pneumonia)
• treatment with any botulinum toxin product (especially in the last 4 months)

This drug may make cause muscle weakness, droopy eyelids, or blurred vision. Do not drive, use machinery, or do anything that needs alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Some brands of this medication contain albumin made from human blood. Even though the blood is carefully tested, and this medication goes through a special manufacturing process, there is an extremely small chance that you may get serious infections from the medication. Consult your doctor or pharmacist for more information.

Older adults using this drug for overactive bladder may be more sensitive to the side effects of this drug, especially urinary effects.

Children using this drug for muscle spasms may be more sensitive to the side effects of this drug, including difficulty breathing or swallowing. See also Warning section. Discuss the risks and benefits with the doctor.

This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• certain antibiotics (including aminoglycosides such as gentamicin, polymyxin)
• anticoagulants (such as warfarin)
• Alzheimer's disease drugs (such as galantamine, rivastigmine, tacrine)
• myasthenia gravis drugs (such as ambenonium, pyridostigmine)
• quinidine

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. An antitoxin is available but must be used before symptoms of overdose become apparent. Symptoms of overdose may be delayed, and may include serious muscle weakness, breathing problems and paralysis.

It is important to understand the risks and benefits of this therapy. Discuss any questions or concerns with your health care professional.

Not applicable.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.