rimabotulinumtoxinB (Rx)

Brand and Other Names:Myobloc
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

injectable solution

  • 5000 unit/mL
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Cervical Dystonia

Prior botulinum toxin injection: 2500-5000 units IM, divided among affected muscles

No prior botulinum toxin injection: Administer lower dose for initial treatment

Repeat dose: Adjust dose based on response and administer no sooner than 12-16 weeks

Sialorrhea (Off-label)

Second-line agent for drooling associated with ALS or Parkinson disease if inadequate response to anticholinergics

2500 units injected into bilateral parotid and submandibular glands

Other Indications & Uses

Off-label: spasticity associated with cerebral palsy, chronic anal fissure; sialorrhea associated with ALS or Parkinson disease

Safety/efficacy not established

Cervical Dystonia

Prior botulinum toxin injection: 2500-5000 units IM, divided among affected muscles

No prior botulinum toxin injection: Administer lower dose for initial treatment

Repeat dose: Adjust dose based on response and administer no sooner than 12-16 weeks

Sialorrhea (Off-label)

Second-line agent for drooling associated with ALS or Parkinson disease if inadequate response to anticholinergics

2500 units injected into bilateral parotid and submandibular glands

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Interactions

Interaction Checker

and rimabotulinumtoxinB

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            Headache

            Dry mouth

            Dysphagia

            Dyspepsia

            Injection site pain

            Flu-like symptoms

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            Warnings

            Black Box Warnings

            Effects of all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects

            These symptoms 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

            Swallowing and breathing difficulties can be life threatening, and death have been reported

            The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms

            In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses

            Contraindications

            Hypersensitivity

            For IM administration only

            Cautions

            Peripheral motor neuropathic diseases (eg, ALS, motor neuropathy)

            Neuromuscular junctional disorders (eg, myasthenia gravis, Lambert-Eaton syndrome)

            Increased risk for severe dysphagia and respiratory compromise in pts with neuromuscular disorders

            Risk of respiratory compromise & death esp in children treated off-label for cerebral palsy-associated spasticity

            Contains human albumin

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Not known if excreted in breast milk; effect on nursing infant not known

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Neurotoxin from Clostridium botulinum; blocks cholinergic transmission at the neuromuscular junction by inhibiting acetylcholine release from the peripheral cholinergic nerve endings

            Pharmacokinetics

            Duration: 12-16 weeks

            Absorption: Minimal levels in circulation after IM injection

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            Administration

            IM Information

            Preparation

            • May dilute with 0.9% NaCl
            • Once diluted, use within 4 hr (does not contain preservative)

            Storage

            • Refrigeration at 2-8C
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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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