When This Medicine Should Not Be Used:
You should not receive this medicine if you have had an allergic reaction to rimabotulinumtoxinB or any type of botulinum toxin product. You should not receive this medicine if you have an infection in the skin where the shot will be given.

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.

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

• Make sure your doctor knows if you are also using a medicine for infection (such as amikacin, gentamicin, neomycin, netilmicin, streptomycin, tobramycin, Amikin®, Garamycin®, or Netromycin®) or a muscle relaxant that would be used during surgery (such as atracurium, gallamine, pancuronium, tubocurarine, vecuronium, Flaxedil®, Norcuron®, Pavulon®, Tracrium®, or Tubarine®).
• 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:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have breathing problems, bladder problems, a droopy eyelid, nerve or muscle problems, amyotrophic lateral sclerosis (ALS, Lou Gehrig's disease), Lambert-Eaton syndrome (a nerve and muscle disorder), or myasthenia gravis (severe muscle weakness). Tell your doctor if you have trouble with speaking or swallowing.
• 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. This is the result of required testing of human donors for certain viruses, and testing done during the manufacture of these medicines. Although the risk is low, talk with your doctor if you have concerns.
• Serious muscle reactions have been reported within hours to weeks after receiving this medicine. If you start to have muscle weakness or trouble with swallowing, talking, or breathing, call your doctor right away. In some situations, these problems could be life-threatening and may require treatment in a hospital or clinic.
• 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
• 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 (may occur several weeks after you receive this medicine).

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

• Blurred or double vision.
• Change or loss of voice.
• Dizziness.
• Drooping or swelling of the eyelids.
• Dry mouth.
• Headache.
• Lack or loss of strength.
• 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