RimabotulinumtoxinB (rim-a-bot-ue-LYE-num-tox-in-bee)

Treats the abnormal head position and neck pain that result from cervical dystonia (severe muscle spasms of the neck). Also treats chronic sialorrhea (drooling or excessive salivation). This is a botulinum toxin B type product.

Brand Name(s):

Myobloc

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot into one of your muscles.
• A nurse or other health provider will give you this medicine.
• This medicine works slowly. Improvement often starts within 2 to 4 weeks after the injection. The effects usually last 12 to 16 weeks.
• Your doctor will only use rimabotulinumtoxinB (Myobloc®) to treat your condition. Other botulinum toxin products may not work the same way.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how this medicine works. Tell your doctor if you are using medicine for infection (including amikacin, gentamicin, neomycin, netilmicin, streptomycin, tobramycin) or a muscle relaxant that would be used during surgery (including atracurium, gallamine, pancuronium, tubocurarine, vecuronium).
• If you need to receive an injection of any botulinum toxin product within 4 months after receiving this medicine, tell the doctor when you last received a dose of rimabotulinumtoxinB.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have breathing problems (including asthma, emphysema), bladder problems, bleeding problems, a droopy eyelid, nerve or muscle problems (including amyotrophic lateral sclerosis (ALS, Lou Gehrig's disease), Lambert-Eaton syndrome, myasthenia gravis), or speaking or swallowing problems. Tell your doctor if you have plans to have surgery, or have had surgery on your face.
• This medicine may cause serious muscle reactions (including trouble with swallowing, talking, or breathing), which can be life-threatening.
• One part of this medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made of human blood has been greatly reduced in recent years. Although the risk is low, talk with your doctor if you have concerns.
• This medicine may make your muscles weak and cause vision problems. Avoid driving, using machines, or doing anything else that could be dangerous if you feel weak or are not able to see well.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, double vision, drooping of the eyelids
• Change or loss of voice
• Fever, chills, cough, stuffy or runny nose, sore throat, and body aches
• Loss of bladder control
• Pain in the neck
• Trouble with breathing, speaking, or swallowing
• Unusual muscle weakness or paralysis

If you notice these less serious side effects, talk with your doctor:

• Back or joint pain
• Dizziness, headache
• Dry mouth
• Nausea or stomach upset
• Redness, pain, tenderness, bruising, swelling, or weakness where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088