Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 5000units/mL (single-dose vial)
Cervical Dystonia
Indicated for cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia
Prior botulinum toxin injection: 2500-5000 units IM, divided among affected muscles
No prior botulinum toxin injection: Lower initial dose
Determine subsequent dosing based on patient’s individual response
Duration of effect observed in studies between 12-16 weeks at doses 5,000-10,000 units
Chronic Sialorrhea
Indicated for chronic sialorrhea
1,500-3,500 units, divided among parotid and submandibular glands via intraglandular administration
Parotid gland: 500-1,500 units/gland
Submandibular gland: 250 units/gland
Consider patient response to treatment when determining frequency and dose of subsequent treatments; no more frequent than q12Weeks
Duration of effect of each treatment is up to 3 months usually; varies among patients
Other Indications & Uses
Off-label: Spasticity associated with cerebral palsy, chronic anal fissure; sialorrhea associated with ALS or Parkinson disease
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (6)
- abobotulinumtoxinA
rimabotulinumtoxinB, abobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Effect of administering different botulinum toxins simultaneously or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to resolution of the effects of a previously administered botulinum toxin.
- amikacin
amikacin increases effects of rimabotulinumtoxinB by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of apnea.
- amphotericin B deoxycholate
amphotericin B deoxycholate increases effects of rimabotulinumtoxinB by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of respiratory depression.
- capreomycin
capreomycin increases effects of rimabotulinumtoxinB by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of apnea.
- clindamycin
clindamycin increases effects of rimabotulinumtoxinB by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of respiratory depression.
- neomycin PO
neomycin PO, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Anticholinergics may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
Monitor Closely (33)
- anticholinergic/sedative combos
anticholinergic/sedative combos, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Anticholinergics may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- atracurium
atracurium, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Anticholinergics may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- atropine
atropine, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Anticholinergics may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- belladonna alkaloids
belladonna alkaloids, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Anticholinergics may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- benztropine
benztropine and rimabotulinumtoxinB both decrease cholinergic effects/transmission. Use Caution/Monitor.
- carbachol
carbachol increases and rimabotulinumtoxinB decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- chlorpromazine
chlorpromazine, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Anticholinergics may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- clozapine
clozapine increases effects of rimabotulinumtoxinB by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.
- dimenhydrinate
dimenhydrinate, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Anticholinergics may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- droperidol
droperidol increases effects of rimabotulinumtoxinB by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.
- fluphenazine
fluphenazine increases effects of rimabotulinumtoxinB by pharmacodynamic synergism. Use Caution/Monitor. Anticholinergics may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- gentamicin
gentamicin, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Aminoglycosides may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- glycopyrronium tosylate topical
glycopyrronium tosylate topical, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- haloperidol
haloperidol, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Anticholinergics may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- lincomycin
lincomycin, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Aminoglycosides may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- loxapine
loxapine, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Anticholinergics may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- loxapine inhaled
loxapine inhaled, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Anticholinergics may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- magnesium sulfate
magnesium sulfate, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Anticholinergics may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- olanzapine
olanzapine, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Anticholinergics may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- perphenazine
perphenazine, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Anticholinergics may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- pimozide
pimozide, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Anticholinergics may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- prochlorperazine
prochlorperazine, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Anticholinergics may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- quetiapine
quetiapine, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Anticholinergics may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- quinidine
quinidine, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Anticholinergics may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- risperidone
risperidone, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Anticholinergics may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- sodium sulfate/?magnesium sulfate/potassium chloride
sodium sulfate/?magnesium sulfate/potassium chloride increases effects of rimabotulinumtoxinB by Other (see comment). Use Caution/Monitor. Comment: Magnesium may potentiate the effects of the neuromuscular blocking agents.
- sodium sulfate/potassium sulfate/magnesium sulfate
sodium sulfate/potassium sulfate/magnesium sulfate increases effects of rimabotulinumtoxinB by Other (see comment). Use Caution/Monitor. Comment: Magnesium may potentiate the effects of the neuromuscular blocking agents.
- streptomycin
streptomycin, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Aminoglycosides may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- thioridazine
thioridazine, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Anticholinergics may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- thiothixene
thiothixene, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Anticholinergics may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- tobramycin
tobramycin, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Aminoglycosides may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- tobramycin inhaled
tobramycin inhaled increases effects of rimabotulinumtoxinB by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Aminoglycosides may aggravate muscle weakness because of a curare-like effect.
- trifluoperazine
trifluoperazine, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Anticholinergics may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
Minor (3)
- acetazolamide
acetazolamide decreases effects of rimabotulinumtoxinB by pharmacodynamic antagonism. Minor/Significance Unknown.
- clonazepam
clonazepam decreases effects of rimabotulinumtoxinB by pharmacodynamic antagonism. Minor/Significance Unknown.
- nimodipine
nimodipine increases effects of rimabotulinumtoxinB by pharmacodynamic synergism. Minor/Significance Unknown. Ca Channel Blockers interfere w/Ach release from prejunctional axon.
Adverse Effects
Frequency Not Defined
Headache
Dry mouth
Dysphagia
Dyspepsia
Injection site pain
Flu-like symptoms
Angioedema
Urticaria
Rash
Constipation
Dry eye
Accommodation disorder
Warnings
Black Box Warnings
Distant spread of toxin effect
- Effects of rimabotulinumtoxinB and all botulinum toxin products may spread from injection area to produce symptoms consistent with botulinum toxin effects
- Symptoms have been reported hours to weeks after injection
- Swallowing and breathing difficulties can be life threatening and death have been reported
- Risk of symptoms may be greatest in children treated for spasticity but symptoms can also occur in adults, particularly in patients with an underlying condition which 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 to any botulinum toxin product or to any of the components in the formulation
Infection at proposed injection site
Cautions
Postmarketing safety data and other approved botulinum toxins suggest that botulinum toxin effects may, in some cases, be observed beyond the local injection site
Potency units are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of rimabotulinumtoxinB cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method
Serious hypersensitivity reaction (eg, angioedema, urticaria, rash) have been reported with botulinum toxin products have occurred
Product contains albumin; based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease
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
Drug interaction overview
- Coadministration with aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) may potentiate effects of the toxin; use with caution
- Use of anticholinergic drugs after administration of rimabotulinumtoxinB may potentiate systemic anticholinergic effects
- Excessive weakness may be exaggerated by administration of a muscle relaxant before or after administration of rimabotulinumtoxinB
-
Other botulinum neurotoxin products
- 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
Pregnancy & Lactation
Pregnancy
There are no adequate data on the developmental risks associated with use in pregnant women
No developmental toxicity was observed in pregnant rats administered rimabotulinumtoxinB by IM during gestation and lactation, at doses producing maternal toxicity
Lactation
There are no data on the presence of rimabotulinumtoxinB in human milk, the effects on the breastfed infant, or the effects on milk production
Consider developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed infant or from the underlying maternal condition
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.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
Using currently available analytical technology, drug was not detectable in peripheral blood following IM or intraglandular injection at recommended doses
Administration
Administration
Cervical dystonia: IM administration
Chronic sialorrhea: Intraglandular administration
Ready to use; no reconstitution required
May dilute with 0.9% NaCl; once diluted, product must be used within 4 hr
Discard any remaining solution in vial
Storage
Refrigerate at 2-8ºC
Protect from light
Do not freeze; do not shake
Do not use after expiration date stamped on vial
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Myobloc intramuscular - | 5,000 unit/mL vial |  | |
| Myobloc intramuscular - | 2,500 unit/0.5 mL vial |  | |
| Myobloc intramuscular - | 10,000 unit/2 mL vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
rimabotulinumtoxinB intramuscular
BOTULINUM TOXIN - INJECTION
(BOT-ue-LYE-num)
WARNING: See also Uses section.This medication can spread to other parts of the body after your injection, causing serious (possibly fatal) side effects. These can occur hours or even weeks after the injection. However, the chances of such serious side effects occurring when this medication is used for migraines or skin conditions such as wrinkles, eye spasm, or excessive sweating are extremely unlikely.Children being treated for muscle stiffness/spasms have the greatest risk of these effects, as well as anyone that has certain medical conditions (see Precautions section). Discuss the risks and benefits of this medication with your doctor.Get medical help right away if any of these very serious side effects occur: chest pain, difficulty breathing, excessive muscle weakness, irregular heartbeat, severe difficulty swallowing or speaking, loss of bladder control.
USES: There are different types of botulinum toxin products (toxin A and B) with different uses (eye problems, muscle stiffness/spasms, migraines, cosmetic, overactive bladder). Different brands of this medication deliver different amounts of medication. Your doctor will choose the correct product for you.Botulinum toxin is used to treat certain eye disorders such as crossed eyes (strabismus) and uncontrolled blinking (blepharospasm), to treat muscle stiffness/spasms or movement disorders (such as cervical dystonia, torticollis), and to reduce the cosmetic appearance of wrinkles. It is also used to prevent headaches in people with very frequent migraines. Botulinum toxin relaxes muscle by blocking the release of a chemical called acetylcholine.Botulinum toxin is also used to treat overactive bladder by patients who do not respond to or who cannot tolerate the side effects of other medications. It helps to reduce leaking of urine, feeling of needing to urinate right away, and frequent trips to the bathroom.It is also used to treat severe underarm sweating and drooling/excess saliva. Botulinum toxin works by blocking the chemicals that turn on the sweat and salivary glands.Botulinum toxin is not a cure, and your symptoms will gradually return as the medication wears off.
HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get an injection. If you have any questions regarding the information, consult your doctor or pharmacist.This medication is given by injection by an experienced health care professional. It is injected into the affected muscles (intramuscularly) when treating eye disorders, muscle stiffness/spasms, and wrinkles. When used to prevent migraines, it is injected into the muscles of the head and neck. It is injected into the skin (intradermally) for the treatment of excessive sweating. For the treatment of drooling/excess saliva, this medication is injected into the salivary glands. When treating overactive bladder, it is injected into the bladder.Your dose, the number of injections, the site of injections, and how often you receive the medication will be determined by your condition and your response to therapy. For children, the dose is also based on weight. Most people start to see an effect within a few days to 2 weeks, and the effect usually lasts 3 to 6 months.
SIDE EFFECTS: See also Warning section.Because this medication is given at the site of your condition, most of the side effects occur close to where the medication is injected. Redness, bruising, infection, and pain at the injection site may occur.Dizziness, mild difficulty swallowing, respiratory infections such as cold or flu, pain, nausea, headache, and muscle weakness may occur when this medication is used to relax muscles. Double vision, drooping or swollen eyelid, eye irritation, dry eyes, tearing, reduced blinking, and increased sensitivity to light may also occur.If any of these effects last or get worse, notify your doctor or pharmacist promptly. You may require protective eye drops/ointments, an eye patch, or other treatment.When this medication is used to prevent migraines, side effects such as headache, neck pain, and drooping eyelid may occur.When this medication is used for excessive sweating, side effects such as non-underarm sweating, respiratory infections such as cold or flu, headache, fever, neck or back pain, and anxiety may occur.When this medication is used for overactive bladder, side effects such as urinary tract infections, burning/painful urination, fever, or difficulty urinating may occur.If any of these effects last or get worse, notify your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: itching/swelling (especially of the face/tongue/throat), rash, severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as cow's milk protein found in some products), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor your medical history, especially of: bleeding problems, eye surgery, certain eye problem (glaucoma), heart disease, diabetes, signs of infection near the injection site, urinary tract infection, inability to urinate, muscle/nerve disorders (such as Lou Gehrig's disease-ALS, myasthenia gravis), seizures, trouble swallowing (dysphagia), breathing problems (such as asthma, emphysema, aspiration-type pneumonia), treatment with any botulinum toxin product (especially in the last 4 months).This drug may make cause muscle weakness, droopy eyelids, or blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.Before having surgery, tell your doctor or dentist that you are using this medication.Some brands of this medication contain albumin made from human blood. Even though the blood is carefully tested, and this medication goes through a special manufacturing process, there is an extremely small chance that you may get serious infections from the medication. Consult your doctor or pharmacist for more information.Older adults using this drug for overactive bladder may be more sensitive to the side effects of this drug, especially urinary effects.Children using this drug for muscle spasms may be more sensitive to the side effects of this drug, including difficulty breathing or swallowing. See Warning section. Discuss the risks and benefits with the doctor.This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Use for the cosmetic treatment of wrinkles is not recommended during pregnancy.It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: certain antibiotics (including aminoglycosides such as gentamicin, polymyxin), anticoagulants (such as warfarin), Alzheimer's disease drugs (such as galantamine, rivastigmine, tacrine), myasthenia gravis drugs (such as ambenonium, pyridostigmine), quinidine.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. An antitoxin is available but must be used before symptoms of overdose become apparent. Symptoms of overdose may be delayed, and may include serious muscle weakness, breathing problems and paralysis.
NOTES: It is important to understand the risks and benefits of this therapy. Discuss any questions or concerns with your health care professional.
MISSED DOSE: Not applicable.
STORAGE: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.
Information last revised December 2021. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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