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Rimabotulinumtoxinb

Also known as: Myobloc

Acetylcholine Release InhibitorAcetylcholine Release Inhibitors

Route: Intramuscular

Check Rimabotulinumtoxinb Interactions →

3 interactions on record⛔ Black Box Warning

Rimabotulinumtoxinb has 3 known drug interactions based on U.S. FDA drug labeling data. 1 are classified as major interactions requiring close medical supervision. Notable interactions include combinations with Botulinum Toxin Type A, Muscle Relaxants, Nephrotoxic Compounds. Patients taking Rimabotulinumtoxinb should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 3
Major: 1
Moderate: 2

Major (1)

Rimabotulinumtoxinb + Botulinum Toxin Type A— Concurrent or overlapping administration (within 4 months) may exacerbate excessive neuromuscular weakness and paralysis…

Moderate (2)

Rimabotulinumtoxinb + Muscle Relaxants— Administration before or after rimabotulinumtoxinb may exaggerate excessive weakness.
Rimabotulinumtoxinb + Nephrotoxic Compounds— Co-administration may potentiate neuromuscular effects of rimabotulinumtoxinb; should be performed with caution.

Rimabotulinumtoxinb + Botulinum Toxin Type A⚠️Major

Concurrent or overlapping administration (within 4 months) may exacerbate excessive neuromuscular weakness and paralysis.

Rimabotulinumtoxinb + Muscle Relaxants🟡Moderate

Administration before or after rimabotulinumtoxinb may exaggerate excessive weakness.

Rimabotulinumtoxinb + Nephrotoxic Compounds🟡Moderate

Co-administration may potentiate neuromuscular effects of rimabotulinumtoxinb; should be performed with caution.

⛔ FDA Black Box 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 ).

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 )

Pregnancy & Breastfeeding

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.

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine, supplemented with a small number of well-established interactions from curated clinical references. For informational purposes only. Always consult your pharmacist or physician.