rimabotulinumtoxinB (Myobloc)

What is the most important information I should know about Myobloc?

The botulinum toxin contained in this medication can spread to other body areas beyond where it was injected. This can cause serious life-threatening side effects.

What is rimabotulinumtoxinB (Myobloc)?

RimabotulinumtoxinB (Myobloc), also called botulinum toxin type B, is made from the bacteria that causes botulism. Botulinum toxin blocks nerve activity in the muscles, causing a temporary reduction in muscle activity.

Myobloc is used to treat cervical dystonia (severe spasms in the neck muscles).

Myobloc is also used to treat chronic drooling (sialorrhea).

Myobloc may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before I receive Myobloc?

Tell your doctor if you have ever had a side effect after receiving a botulinum toxin in the past.

Tell your doctor if you have ever had:

• other botulinum toxin injections such as Botox Dysport, or Xeomin (especially in the last 4 months);
• amyotrophic lateral sclerosis (ALS, or "Lou Gehrig's disease");
• myasthenia gravis;
• Lambert-Eaton syndrome;
• a breathing problem such as asthma or emphysema;
• droopy eyelids;
• problems with swallowing;
• bleeding problems;
• surgery on your face; or
• if you are planning to have any type of surgery.

Myobloc is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

How is Myobloc given?

This medicine is injected into a muscle or into a gland. A healthcare provider will give you this injection once every 12 to 16 weeks. Myobloc injections should be spaced at least 3 months apart.

Your injections may be given into more than one area at a time, depending on the condition being treated.

The effects of a Myobloc injection are temporary. Your symptoms may return completely within 3 months after an injection. After repeat injections, it may take less and less time before your symptoms return, especially if your body develops antibodies to the botulinum toxin.

Using this medicine more often than prescribed will not make it more effective and may result in serious side effects.

What happens if I miss a dose?

Since botulinum toxin has a temporary effect and is given at widely spaced intervals, missing a dose is not likely to be harmful.

What happens if I overdose?

Overdose symptoms may not appear right away, but can include muscle weakness, trouble swallowing, weak or shallow breathing, or loss of movement in any part of your body.

What should I avoid after receiving Myobloc?

Myobloc may impair your vision or depth perception. Be careful if you drive or do anything that requires you to be able to see clearly.

What are the possible side effects of Myobloc?

The botulinum toxin contained in this medicine can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulinum toxin injections, even for cosmetic purposes.

• unusual or severe muscle weakness (especially in a body area that was not injected with the medication);
• trouble breathing, talking, or swallowing;
• hoarse voice, drooping eyelids;
• blurred vision, double vision;
• loss of bladder control;
• problems with vision; or
• chest pain.

Common side effects may include:

• pain or discomfort where the medicine was injected;
• headache;
• dry mouth; or
• trouble swallowing.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Myobloc?

Tell your doctor about all your other medicines, especially:

• a muscle relaxer;
• medicine to treat an infection;
• medicine to treat depression, anxiety, mood disorders, or mental illness;
• cold or allergy medicine (Benadryl and others);
• medicine to treat Parkinson's disease;
• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;
• medicine to treat overactive bladder; or
• bronchodilator asthma medication.

This list is not complete and many other drugs may affect Myobloc. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about Myobloc (rimabotulinumtoxinB).