RimabotulinumtoxinB

What is RimabotulinumtoxinB?

• RimabotulinumtoxinB (Myobloc) is an acetylcholine release inhibitor used to relieve the symptoms of cervical dystonia (spasmodic torticollis; uncontrollable tightening of the neck muscles that may cause neck pain and abnormal head positions) and chronic sialorrhea (ongoing drooling or excessive salivation).

Botulinum toxin 3BTA

What are the uses of this medicine?

RimabotulinumtoxinB (Myobloc) is a prescription medicine used in adults that is injected into:

• muscles and used to treat the abnormal head position and neck pain that happens with cervical dystonia (CD).
• glands that make saliva and is used to treat long-lasting (chronic) drooling (sialorrhea).

How does this medicine work?

Botulinum Toxin Mechanism

• Myobloc blocks cholinergic transmission at the neuromuscular and salivary neuroglandular junction by inhibiting the release of acetylcholine from peripheral cholinergic nerved terminals.
• This inhibition occurs according to the following sequence: neurotoxin binding to cholinergic nerve terminals, internalization of the neurotoxin into the nerve terminal, translocation of the light-chain part of the molecule into the cytosol of the nerve terminal, and enzymatic cleavage of synaptic Vesicle Associated Membrane Protein (VAMP, also known as synaptobrevin), a presynaptic target protein essential for the release of acetylcholine.
• In both muscles and glands, impulse transmission is re-established by the formation of new nerve endings.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to Myobloc or any of the ingredients in Myobloc.
• had an allergic reaction to any other botulinum toxin product such as BOTOX® , BOTOX® Cosmetic (onabotulinumtoxinA), DYSPORT® (abobotulinumtoxinA), or XEOMIN® (incobotulinumtoxinA).
• have a skin infection at the planned injection site.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• Certain antibiotics such as amikacin, clindamycin (Cleocin), colistimethate (Coly-Mycin), gentamicin, lincomycin (Lincocin), neomycin, polymyxin, streptomycin, and tobramycin
• medications for allergies, colds, or sleep
• muscle relaxants

• Also tell your doctor if you have received injections of any botulinum toxin product in the past 4 months.

Is this medicine FDA approved?

• Initial U.S. Approval: 2000

How should this medicine be used?

Recommended dosage: For Cervical Dystonia:

• For patients with demonstrated tolerance of botulinum toxin injection, recommended total dosage is 2,500 Units to 5,000 Units divided among effected muscles.

For Chronic Sialorrhea:

• The recommended dosage is 1,500 Units to 3,500 Units; 500 Units to 1,500 Units per parotid gland and 250 Units per submandibular gland; no more frequent than every 12 weeks.

Administration:

• Myobloc is a shot (injection) that your doctor will give you.
• Myobloc is injected into your affected muscles or glands.
• Your doctor may give you another dose of Myobloc after 12 weeks or longer, if it is needed.
• Your doctor may change your dose of Myobloc, until you and your doctor find the best dose for you.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 2,500 Units/0.5 mL; 5,000 Units/mL; or 10,000 Units/2 mL (5,000 Units/mL) in a single-dose vial

This medicine is available in fallowing brand namesː

• Myobloc

What side effects can this medication cause?

The most common side effects of Myobloc in people with cervical dystonia include:

• dry mouth
• injection site discomfort or pain
• trouble swallowing (dysphagia)
• headache

The most common side effects of Myobloc in people with sialorrhea include:

• dry mouth
• trouble swallowing (dysphagia)

Myobloc may cause serious side effects that can be life threatening which may include:

• Problems swallowing, speaking, or breathing
• Spread of toxin effects
• allergic reactions

What special precautions should I follow?

• One brand or type of botulinum toxin cannot be substituted for another.
• Myobloc may cause loss of strength or general muscle weakness or vision problems within hours to weeks of receiving Myobloc. If this happens, do not drive a car, operate machinery or do other dangerous activities.
• Advise patients to inform their healthcare provider if they develop any unusual symptoms, including difficulty with swallowing, speaking or breathing, or if any existing symptom worsens. Inform patients of the risk of aspiration.
• Postmarketing reports indicate that the effects of Myobloc and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection.
• Serious hypersensitivity reactions have been reported with botulinum toxin products. Angioedema, urticaria, and rash have occurred with Myobloc treatment. If serious and/or immediate hypersensitivity reactions occur, discontinue further injection of Myobloc and institute appropriate medical therapy immediately.
• This product contains albumin, a derivative of human blood. There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would be considered extremely remote.
• Tell your doctor if you have had surgery on your face, or if you have or have ever had any side effect from any botulinum toxin product or bleeding problems.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Excessive doses of Myobloc may be expected to produce neuromuscular weakness with a variety of symptoms.
• Respiratory support may be required where excessive doses cause paralysis of respiratory muscles.
• Symptoms of overdose are likely not to be present immediately following injection. Should accidental injection or oral ingestion occur, the person should be medically supervised for several weeks for signs and symptoms of excessive muscle weakness or muscle paralysis.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• In the event of overdose, the patient should be medically monitored for symptoms of excessive muscle weakness or muscle paralysis.
• Symptomatic treatment may be necessary.

Can this medicine be used in pregnancy?

• There are no adequate data on the developmental risks associated with the use of Myobloc in pregnant women.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: botulinum toxin type B
• Inactive ingredients: albumin human, sodium chloride and sodium succinate.

Who manufactures and distributes this medicine?

• Manufactured by: Solstice Neurosciences, LLC, Rockville MD

What should I know about storage and disposal of this medication?

• Store under refrigeration at 2°C to 8°C (36°F- 46°F) in the original carton to protect from light.
• DO NOT FREEZE. DO NOT SHAKE.
• All vials of expired Myobloc and equipment used in the administration of Myobloc should be carefully discarded according to standard medical waste practices.
• Do not use after the expiration date stamped on the vial.

• Dailymed label info on RimabotulinumtoxinB
• FDA RimabotulinumtoxinB

RimabotulinumtoxinB Resources
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