RimabotulinumtoxinB

RimabotulinumtoxinB, also known as botulinum toxin type B, comes from the bacteria that causes botulism. Botulinum toxin prevents nerves from working in the muscles, leading to a temporary decrease in muscle activity.

RimabotulinumtoxinB is used in adults to treat unusual head position and neck pain caused by cervical dystonia.

RimabotulinumtoxinB is also used in adults to treat chronic drooling (sialorrhea).

RimabotulinumtoxinB may also be used for reasons not mentioned in this medication guide.

RimabotulinumtoxinB is injected into a muscle or a gland by a healthcare provider. Your doctor will decide when you should get your next dose.

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

Your doctor may change your dose from time to time until they find the best dose for you.

Your doctor may need to check how you are doing regularly, and your next dose may change based on how you respond to treatment.

Call your doctor if your symptoms do not get better, or if they get worse.

Do not get botulinum toxin injections from more than one medical professional at the same time. If you change healthcare providers, make sure to tell your new provider how long it has been since your last botulinum toxin injection.

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

The botulinum toxin in rimabotulinumtoxinB can move to other parts of the body beyond the injection site. This can lead to serious and life-threatening side effects.

Contact your doctor immediately if you experience a hoarse voice, droopy eyelids, vision issues, severe muscle weakness, loss of bladder control, or difficulties with breathing, talking, or swallowing. Some of these effects may appear up to several weeks after receiving a botulinum toxin injection.

You should not be treated with rimabotulinumtoxinB if you are allergic to it or to any other botulinum toxin injection, such as onabotulinumtoxinA, abobotulinumtoxinA, or incobotulinumtoxinA, or if you have an infection in the area where the medicine will be injected.

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

Tell your doctor if you have or have ever had:

• a nerve-muscle disorder, such as myasthenia gravis, ALS (Lou Gehrig's disease), or Lambert-Eaton syndrome;
• a breathing disorder or problems such as asthma or emphysema;
• droopy eyelids;
• problems with swallowing;
• bleeding problems;
• surgery on your face;
• a planned surgery; or
• received other botulinum toxin injection in the past 4 months.

RimabotulinumtoxinB 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.

It is not known if rimabotulinumtoxinB will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using rimabotulinumtoxinB.

Get emergency medical help if you notice signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

The botulinum toxin in rimabotulinumtoxinB can move to other areas of the body beyond where it was injected. This has led to side effects in some people after receiving botulinum toxin injections, even for cosmetic reasons. Problems with swallowing and breathing can be very serious and life-threatening, especially in children with certain muscle issues.

Call your doctor right away if you experience any of these side effects (which can happen up to several hours or weeks after an injection):

• unusual or severe muscle weakness (especially in a part of the body that did not receive the injection);
• trouble breathing, talking, or swallowing;
• hoarse voice, droopy eyelids, blurred vision, double vision, or other vision issues; or
• loss of bladder control.

Common side effects of rimabotulinumtoxinB may include:

• pain or discomfort at the injection site;
• headache;
• dry mouth; or
• trouble swallowing.

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

Usual Adult Dose for Cervical Dystonia:

For patients who have demonstrated tolerability to botulinum toxin: Initial dose: 2500 to 5000 Units IM divided among affected musclesFor patients who have not demonstrated tolerability to botulinum toxin: -Lower initial doses are recommendedSubsequent dosing should be optimized according to patient's response -Duration of effect: 12 to 16 weeks (at doses of 5000 to 10,000 Units)Comments:-This drug should be administered by physicians familiar and experienced in the assessment and management of patients with cervical dystonia. Use: To reduce the severity of abnormal head position and neck pain associated with cervical dystonia.

Usual Adult Dose for Sialorrhea:

Initial dose: 1500 to 3500 Units divided among the parotid and submandibular glands:--Parotid: 500 to 1500 Units per gland--Submandibular: 250 Units per gland Subsequent dosing should be based on patient's response; typical duration of effect for each treatment is up to 3 months, but may vary in individual patientsFrequency of treatment: Generally, no more frequent than every 12 weeks Comments: -Consult package labeling for additional administration guidance including illustration of gland placement. -In clinical trials, both anatomical landmarks and ultrasound guidance were used for gland location; both methods produced similar reduction in the unstimulated salivary flow rate.Use: For the treatment of chronic sialorrhea.

Call your doctor for instructions if you miss an appointment for your RimabotulinumtoxinB injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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.

RimabotulinumtoxinB may impair your reactions and may cause weakness, loss of strength, or vision changes. Avoid driving or hazardous activity until you know how rimabotulinumtoxinB will affect you.

Tell your doctor about all your other medicines, especially:

• a muscle relaxer;
• an injectable antibiotic;
• sleep medicine;
• botulinum toxin such as Dysport, Xeomin, Botox, Botox cosmetic;
• 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 rimabotulinumtoxinB. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

• What is botulinum toxin used to treat?