Rimabotulinumtoxinb
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From MedlinePlus, U.S. National Library of Medicine
Specialty pharmacy: therapy management checklist, storage and cold chain, dosing calendar, Medicare Part D coverage.
Boxed warning
WARNING: DISTANT SPREAD OF TOXIN EFFECT 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. Swallowing and breathing difficulties can be life threatening and there have been reports of death.
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 occurred at doses comparable to those used to treat cervical dystonia and at lower doses [see Warnings and Precautions (5.1) ]. WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete boxed warning.
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 symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have an underlying condition that would predispose them to these symptoms ( 5.1 ).
Acetylcholine Release Inhibitor
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Instructions for Safe Use The potency units of MYOBLOC are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and cannot be compared to or converted into units of any other botulinum toxin products [see Warnings and Precautions , Description ] .
Each single-dose vial should only be used during one session and only for one patient. Discard any remaining solution in the vial. MYOBLOC is ready to use; no reconstitution required. MYOBLOC may be diluted with 0.9% Sodium Chloride Injection. Once diluted, the product must be used within 4 hours as the formulation does not contain a preservative.
Drug interactions
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- Rimabotulinumtoxinb
Label text (5 paragraphs)
Co-administration with aminoglycosides or other agents interfering with neuromuscular transmission may potentiate effects of MYOBLOC ( 7.1 ) Co-administration or overlapping of botulinum toxin serotypes (within 4 months) may potentiate neuromuscular paralysis ( 7.3 )
7.1 Aminoglycosides and Other Agents Interfering with Neuromuscular Transmission Co-administration of MYOBLOC and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated.
7.2 Anticholinergic Drugs Use of anticholinergic drugs after administration of MYOBLOC may potentiate systemic anticholinergic effects.
7.3 Other Botulinum Neurotoxin Products The effect of administering different botulinum toxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.
7.4 Muscle Relaxants Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of MYOBLOC.
Contraindications
4 CONTRAINDICATIONS MYOBLOC is contraindicated in patients with: A known hypersensitivity to any botulinum toxin product or to any of the components in the formulation [see Warnings and Precautions (5.3) , Description (11) ] Infection at the proposed injection site(s) MYOBLOC is contraindicated in patients with: Known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation ( 4 , 5.3 ) Infection at the proposed injection site(s) ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for rimabotulinumtoxinb. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risks associated with the use of MYOBLOC in pregnant women. No developmental toxicity was observed in pregnant rats administered MYOBLOC by intramuscular injection during gestation and lactation, at doses producing maternal toxicity. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.
Data Animal Data When MYOBLOC was administered by intramuscular injection to pregnant rats (0, 300, 1000, or 3000 Units/kg/day) or rabbits (0, 0.03, 0.1, 0.3, or
1.0 Units/kg/day) throughout gestation, no adverse effects on embryofetal development were observed. The highest dose tested in rat, which was associated with maternal toxicity, was 36 times the maximum recommended human dose (MRHD) for cervical dystonia (5000 Units) on a body weight (Units/kg) basis. The highest dose tested in rabbit was substantially less than the MRHD for cervical dystonia on a Units/kg basis; maternal toxicity was observed at all but the lowest dose tested.
Breastfeeding (LactMed)
No data exist on the medical use of rimabotulinumtoxinB during breastfeeding. However, it is not detectable systemically after intramuscular use, thus excretion into breast milk is considered unlikely. The closely related drug, onabotulinumtoxinA was not detectable in the milk of two women and detectable in only minute amounts in 5 others after 40 to 92 units injected into the face. Many mothers have breastfed their infants after injection of onabotulinumtoxinA for migraine. An international guideline considers onabotulinumtoxinA acceptable in breastfeeding women with chronic migraine. No special precautions are required.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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