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Drug overview for XEOMIN (incobotulinumtoxina):
Generic name: INCOBOTULINUMTOXINA (BOT-ue-LYE-num)
Drug class: Neuromuscular Blockers
Therapeutic class: Locomotor System
IncobotulinumtoxinA, a type A botulinum toxin produced by Clostridium botulinum, is a neuromuscular blocking agent and inhibitor of acetylcholine release peripheral cholinergic and ganglionic autonomic nerve terminals.
IncobotulinumtoxinA is used for the treatment or improvement of upper limb spasticity, cervical dystonia, and blepharospasm in patients previously treated with onabotulinumtoxinA, and for temporary improvement in the appearance of moderate to severe glabellar facial lines associated with corrugator and/or procerus muscle activity. Currently, 3 botulinum toxin type A preparations (abobotulinumtoxinA (Dysport(R)), incobotulinumtoxinA (Xeomin(R)), and onabotulinumtoxinA (Botox(R), Botox(R) Cosmetic)) and one botulinum toxin type B preparation (rimabotulinumtoxinB (Myobloc(R))) are commercially available in the US . Because the assay method used to determine potency of each botulinum toxin is specific to the individual manufacturer and/or preparation, units of biologic activity of incobotulinumtoxinA cannot be compared to or converted into units of any other botulinum toxin (e.g., abobotulinumtoxinA, onabotulinumtoxinA, rimabotulinumtoxinB), and these preparations are not interchangeable.
IncobotulinumtoxinA differs from other commercially available botulinum toxin preparations in that it contains pure neurotoxin without any complexing proteins (hemagglutinins and nonhemaglutinins). Whether this formulation difference is associated with therapeutic benefit compared with other botulinum toxin preparations has not been established.
Generic name: INCOBOTULINUMTOXINA (BOT-ue-LYE-num)
Drug class: Neuromuscular Blockers
Therapeutic class: Locomotor System
IncobotulinumtoxinA, a type A botulinum toxin produced by Clostridium botulinum, is a neuromuscular blocking agent and inhibitor of acetylcholine release peripheral cholinergic and ganglionic autonomic nerve terminals.
IncobotulinumtoxinA is used for the treatment or improvement of upper limb spasticity, cervical dystonia, and blepharospasm in patients previously treated with onabotulinumtoxinA, and for temporary improvement in the appearance of moderate to severe glabellar facial lines associated with corrugator and/or procerus muscle activity. Currently, 3 botulinum toxin type A preparations (abobotulinumtoxinA (Dysport(R)), incobotulinumtoxinA (Xeomin(R)), and onabotulinumtoxinA (Botox(R), Botox(R) Cosmetic)) and one botulinum toxin type B preparation (rimabotulinumtoxinB (Myobloc(R))) are commercially available in the US . Because the assay method used to determine potency of each botulinum toxin is specific to the individual manufacturer and/or preparation, units of biologic activity of incobotulinumtoxinA cannot be compared to or converted into units of any other botulinum toxin (e.g., abobotulinumtoxinA, onabotulinumtoxinA, rimabotulinumtoxinB), and these preparations are not interchangeable.
IncobotulinumtoxinA differs from other commercially available botulinum toxin preparations in that it contains pure neurotoxin without any complexing proteins (hemagglutinins and nonhemaglutinins). Whether this formulation difference is associated with therapeutic benefit compared with other botulinum toxin preparations has not been established.
DRUG IMAGES
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The following indications for XEOMIN (incobotulinumtoxina) have been approved by the FDA:
Indications:
Blepharospasm
Glabellar lines
Horizontal forehead lines
Lateral canthal lines
Sialorrhea
Spasmodic torticollis
Upper limb spasticity
Professional Synonyms:
Blepharospasmus
Brow furrow
Cervical dystonia
Dystonia of neck muscles
Dystonic torticollis
Excessive saliva secretion
Excessive salivation
Forehead lines due to frontalis muscle activity
Horizontal lateral canthal rhytides
Horizontal rhytides of forehead
Increased salivation
Ptyalism
Rhytides of glabellar skin
Rotatory spasm
Rotatory tic
Salivary hypersecretion
Upper limb muscle spasticity
Indications:
Blepharospasm
Glabellar lines
Horizontal forehead lines
Lateral canthal lines
Sialorrhea
Spasmodic torticollis
Upper limb spasticity
Professional Synonyms:
Blepharospasmus
Brow furrow
Cervical dystonia
Dystonia of neck muscles
Dystonic torticollis
Excessive saliva secretion
Excessive salivation
Forehead lines due to frontalis muscle activity
Horizontal lateral canthal rhytides
Horizontal rhytides of forehead
Increased salivation
Ptyalism
Rhytides of glabellar skin
Rotatory spasm
Rotatory tic
Salivary hypersecretion
Upper limb muscle spasticity
The following dosing information is available for XEOMIN (incobotulinumtoxina):
Dosage of incobotulinumtoxinA is expressed in units of biologic activity; each unit is equivalent to the median intraperitoneal lethal dose (LD50) in mice. Assay methods used to determine potency of various botulinum toxin preparations are specific to each individual preparation; therefore, units of biologic activity of incobotulinumtoxinA cannot be compared with or converted to units of other botulinum toxin preparations.
Dosage of incobotulinumtoxinA should be individualized according to patient response and the particular condition being treated. The manufacturer states that the maximum cumulative dose per treatment session for any indication is 400 units. Other factors such as disease severity (degree of spasticity/dystonia), number and location of muscles involved, muscle mass, body weight, and previous response to other botulinum toxin therapy also should be considered.
The first onset of effect of incobotulinumtoxinA occurs within a median of 7 days after injection. The effects of incobotulinumtoxinA usually last for up to 3 months, but may persist for considerably longer or shorter periods depending on the individual.
If the patient receives an overdose of incobotulinumtoxinA or the drug is injected into the wrong muscle (i.e., misinjection), the local or state health department should be contacted to process a request for botulism antitoxin through the US Centers for Disease Control and Prevention (CDC) Drug Service. If a response is not received within 30 minutes, the CDC Emergency Operations Center should be contacted directly at 770-488-7100. Information about the antitoxin is available at the following CDC website: http://www.cdc.gov/laboratory/drugservice/formulary.html.
Botulism antitoxin will not reverse any botulinum toxin-induced muscle weakness already evident at the time of antitoxin administration but may stabilize the deficits.
Dosage of incobotulinumtoxinA should be individualized according to patient response and the particular condition being treated. The manufacturer states that the maximum cumulative dose per treatment session for any indication is 400 units. Other factors such as disease severity (degree of spasticity/dystonia), number and location of muscles involved, muscle mass, body weight, and previous response to other botulinum toxin therapy also should be considered.
The first onset of effect of incobotulinumtoxinA occurs within a median of 7 days after injection. The effects of incobotulinumtoxinA usually last for up to 3 months, but may persist for considerably longer or shorter periods depending on the individual.
If the patient receives an overdose of incobotulinumtoxinA or the drug is injected into the wrong muscle (i.e., misinjection), the local or state health department should be contacted to process a request for botulism antitoxin through the US Centers for Disease Control and Prevention (CDC) Drug Service. If a response is not received within 30 minutes, the CDC Emergency Operations Center should be contacted directly at 770-488-7100. Information about the antitoxin is available at the following CDC website: http://www.cdc.gov/laboratory/drugservice/formulary.html.
Botulism antitoxin will not reverse any botulinum toxin-induced muscle weakness already evident at the time of antitoxin administration but may stabilize the deficits.
No enhanced Administration information available for this drug.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for XEOMIN (incobotulinumtoxina):
There are 0 contraindications.
There are 3 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Misc Antibiotics/Neuromuscular Blocking Agents SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Aminoglycosides, bacitracin, clindamycin, lincomycin, and polymyxins may enhance the pharmacologic effects of neuromuscular blocking agents. CLINICAL EFFECTS: May see an increase in the pharmacologic effects of neuromuscular blocking agents, including prolonged respiratory depression and apnea. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: If it is necessary to administer these drugs concurrently, do so with extreme caution. Monitor neuromuscular function and adjust the dose of the neuromuscular blocking agent accordingly. DISCUSSION: Concomitant administration of aminoglycosides, bacitracin, clindamycin, lincomycin, and polymixins with neuromuscular blocking agents has been shown to produce synergism of the effects on skeletal muscles. Concurrent administration of these drugs has been associated with prolonged respiratory depression, respiratory paralysis, and fatal apnea. The interaction usually occurs when the antibiotic is given prior to or concurrently with the neuromuscular blocking drug, but it may also occur when given after administration. Any antibiotic dosage or route of administration may produce respiratory depression. |
AMIKACIN SULFATE, BETHKIS, COLISTIN SULFATE, GENTAMICIN SULFATE, GENTAMICIN SULFATE IN NS, HUMATIN, KANAMYCIN SULFATE, KITABIS PAK, NEOMYCIN SULFATE, PAROMOMYCIN SULFATE, STREPTOMYCIN SULFATE, TIGECYCLINE, TOBI, TOBI PODHALER, TOBRAMYCIN, TOBRAMYCIN SULFATE, TYGACIL |
| General Anesthetics (Inhl)/Neuromuscular Blocking Agents SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: General anesthetics enhance the pharmacologic effects of nondepolarizing muscle relaxants. CLINICAL EFFECTS: May see an increase in the neuromuscular blocking effects of the nondepolarizing muscle relaxant including respiratory depression, bradycardia, hypotension, flushing, or muscle weakness. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: It may be necessary to decrease the dose of the nondepolarizing muscle relaxant. Monitor neuromuscular function and adjust the dose of the nondepolarizing muscle relaxant accordingly. DISCUSSION: Concomitant administration of general anesthetics and nondepolarizing muscle relaxants has been shown to produce synergistic neuromuscular blocking effects of nondepolarizing muscle relaxants. |
DESFLURANE, FORANE, ISOFLURANE, SEVOFLURANE, SUPRANE, TERRELL, ULTANE |
| Neuromuscular Blocking Agents/Quinine Derivatives SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Synergistic or additive pharmacologic activity. CLINICAL EFFECTS: May see an increase in the neuromuscular blocking effects, including profound sedation, respiratory depression, coma, and/or death. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Avoid concurrent administration of neuromuscular blocking agents and quinine derivatives during the first several hours of postoperative period. If administered, respiratory support may be needed. If concurrent use is necessary, monitor patients for unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. DISCUSSION: Administration of quinidine during the immediate postoperative period has been associated with respiratory paralysis and apnea. |
NUEDEXTA, QUALAQUIN, QUINIDINE GLUCONATE, QUINIDINE SULFATE, QUININE HCL, QUININE SULFATE |
There are 3 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Neuromuscular Blocking Agents/Polypeptide Antibiotics SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Synergistic pharmacologic activity. Polymyxin B affects neuromuscular transmission by blocking acetylcholine receptors. Its action is thus post-synaptic and the neuromuscular block has no antagonists. Polymyxin B causes neostigmine resistance to d-tubocurarine blockade and calcium resistance to the blockade evoked by aminoglycoside antibiotics (1,2,3,4). A pre-synaptic mechanism may also be involved with decreased release of acetylcholine. CLINICAL EFFECTS: May see an increase in the neuromuscular blocking effects, including profound sedation, respiratory depression, coma, and/or death. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: If it is necessary to administer these drugs concurrently, do so with extreme caution. Monitor neuromuscular function and adjust the dose of the neuromuscular blocking agent accordingly. If concurrent use is necessary, monitor patients for unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. DISCUSSION: Concomitant administration of polypeptide antibiotics and neuromuscular blocking agents has been shown to produce synergism of the effects on skeletal muscles. Concurrent administration of these drugs has been associated with prolonged respiratory depression, respiratory paralysis, and apnea. This interaction has been documented with colistimethate, polymyxin B, bacitracin, and vancomycin. |
BACITRACIN, BACITRACIN MICRONIZED, BACITRACIN ZINC, COLISTIMETHATE, COLISTIMETHATE SODIUM, COLY-MYCIN M PARENTERAL, POLYMYXIN B SULFATE, VANCOMYCIN, VANCOMYCIN HCL, VANCOMYCIN HCL-0.9% NACL, VANCOMYCIN HCL-D5W |
| Neuromuscular Blocking Agents/Lincosamides SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Lincosamides appear to augment the neuromuscular blocking effects of nondepolarizing muscle relaxants. CLINICAL EFFECTS: The effects of nondepolarizing neuromuscular relaxants may be prolonged leading to profound sedation, respiratory depression, coma, and/or death. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Monitor respiratory function of the patient and provide the necessary support. In patients who have received nondepolarizing muscle relaxants, avoid use of lincosamides in the recovery room. If concurrent use is necessary, monitor patients for unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. DISCUSSION: Lincomycin has been reported to augment the neuromuscular blocking effect of pancuronium in seven anesthetized patients. The effect was readily antagonized by neostigmine administration. In a case report, clindamycin produced prolonged neuromuscular blockade in a patient who had received pancuronium. Neostigmine was ineffective in antagonizing the blockade. |
CLEOCIN HCL, CLEOCIN PEDIATRIC, CLEOCIN PHOSPHATE, CLINDAMYCIN (PEDIATRIC), CLINDAMYCIN HCL, CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE-D5W, CLINDAMYCIN-0.9% NACL, LINCOCIN, LINCOMYCIN HCL |
| Hydantoins/Select Neuromuscular Blocking Agents SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: It has been suggested that phenytoin increases end-plate anticholinesterase activity, resulting in higher acetylcholine concentration at the neuromuscular junction.(1) CLINICAL EFFECTS: A higher plasma concentration of the neuromuscular blocking agent was required to effect a given level of neuromuscular blockade in patients receiving phenytoin.(2,3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Patients receiving hydantoin anticonvulsants should be monitored for a decreased response to the neuromuscular blocking agent. The dose of the neuromuscular blocking agent may need to be increased and/or given more frequently.(9) DISCUSSION: In a study, patients receiving phenytoin were administered metocurine, attained 83% of maximum neuromuscular blockade compared with 98% in the control group.(1) In another study, patients maintained on phenytoin for more than one week had a significantly higher pancuronium requirement than those patients not receiving phenytoin.(1) In two separate case reports, patients maintained on phenytoin demonstrated a resistance to pancuronium and a decreased duration of neuromuscular blockade.(3,4) In a study, patients maintained on phenytoin and receiving vecuronium had a significantly shorter total duration and effect of neuromuscular blockade compared to those patients not receiving phenytoin.(5) In contrast, neither the effect nor duration of atracurium's neuromuscular blockade was affected by phenytoin.(5) Two in vitro studies showed that the neuromuscular blockade of curare and tubocurarine was potentiated by the use of phenytoin.(6,7) Ten children received a bolus dose of vecuronium 0.15mg/Kg while on phenytoin and showed a significantly increased clearance of vecuronium compared to the control group, 15.1 and 9.0 ml/Kg/min, respectively.(8) In a case report, a 58 year-old male previously stabilized on phenytoin (400 mg daily) was given an injection of vecuronium (8 mg) to induce muscle blockade during bowel surgery. While monitoring the effectiveness of vecuronium only 75% twitch height blockade was noted after seven minutes. The medication, due to its short duration and impaired effectiveness, had to be given more frequently throughout the surgery in order to maintain adequate muscle block.(9) A separate case report records a decreased response to pancuronium in a 15 year-old male, previously stabilized on phenytoin (350 mg daily), while undergoing surgery to remove a parietal tumor. Pancuronium (0.7 mg/kg) was given as a relaxant during the surgery and monitored using the train-of-four method. Intermittent doses of pancuronium (0.17 mg/kg) were given for the first hour of surgery without successful blockade apparent by the return of all four twitches within ten minutes of each dose. A second attempt at muscular blockade was made with continuous infusion atracurium (0.26-0.55 mg/kg/hour) for the duration of the surgery. Only 16 minutes after stopping the infusion, all four twitches were visible.(10) |
CEREBYX, DILANTIN, DILANTIN-125, FOSPHENYTOIN SODIUM, PHENYTEK, PHENYTOIN, PHENYTOIN SODIUM, PHENYTOIN SODIUM EXTENDED |
The following contraindication information is available for XEOMIN (incobotulinumtoxina):
Drug contraindication overview.
IncobotulinumtoxinA is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis, serum sickness, urticaria, soft tissue edema, dyspnea) to any botulinum toxin preparation or any ingredient (e.g., albumin, sucrose) in their formulations. The drug also is contraindicated in patients with the infection at the proposed site(s) of injection.
IncobotulinumtoxinA is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis, serum sickness, urticaria, soft tissue edema, dyspnea) to any botulinum toxin preparation or any ingredient (e.g., albumin, sucrose) in their formulations. The drug also is contraindicated in patients with the infection at the proposed site(s) of injection.
There are 2 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Dyspnea |
| Respiratory depression |
There are 15 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Amyotrophic lateral sclerosis |
| Blepharoptosis |
| Blurred vision |
| Botulism |
| Cerebral palsy-associated limb spasticity |
| Dysarthria |
| Dysphagia |
| Eaton-lambert syndrome |
| Muscle spasticity of cerebral origin |
| Muscle spasticity of spinal origin |
| Muscle weakness |
| Myasthenia gravis |
| Peripheral motor neuropathy |
| Polyopia |
| Urinary incontinence |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Predisposition to aspiration |
The following adverse reaction information is available for XEOMIN (incobotulinumtoxina):
Adverse reaction overview.
The most common adverse effects (occurring in at least 2% of patients and more frequently than with placebo) reported in clinical studies of patients with upper limb spasticity treated with 120-400 units of incobotulinumtoxinA were seizure, nasopharyngitis, dry mouth, and upper respiratory tract infection. The most common adverse effects (occurring in at least 5% of patients and more frequently than with placebo) reported in clinical trials of patients with cervical dystonia receiving a single IM dose of incobotulinumtoxinA (120 or 240 units) were dysphagia, neck pain, muscle weakness, injection site pain, and musculoskeletal pain. The most common adverse effects (occurring in at least 5% of patients and more frequently than with placebo) reported in clinical trials of patients with blepharospasm receiving incobotulinumtoxinA were eyelid ptosis, dry eye, dry mouth, diarrhea, headache, visual impairment, dyspnea, nasopharyngitis, and respiratory tract infection. The most common adverse effect reported in more than 1% of individuals receiving incobotulinumtoxinA for cosmetic improvement of glabellar facial lines in clinical trials was headache.
The most common adverse effects (occurring in at least 2% of patients and more frequently than with placebo) reported in clinical studies of patients with upper limb spasticity treated with 120-400 units of incobotulinumtoxinA were seizure, nasopharyngitis, dry mouth, and upper respiratory tract infection. The most common adverse effects (occurring in at least 5% of patients and more frequently than with placebo) reported in clinical trials of patients with cervical dystonia receiving a single IM dose of incobotulinumtoxinA (120 or 240 units) were dysphagia, neck pain, muscle weakness, injection site pain, and musculoskeletal pain. The most common adverse effects (occurring in at least 5% of patients and more frequently than with placebo) reported in clinical trials of patients with blepharospasm receiving incobotulinumtoxinA were eyelid ptosis, dry eye, dry mouth, diarrhea, headache, visual impairment, dyspnea, nasopharyngitis, and respiratory tract infection. The most common adverse effect reported in more than 1% of individuals receiving incobotulinumtoxinA for cosmetic improvement of glabellar facial lines in clinical trials was headache.
There are 21 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Dysphagia Dyspnea Hypertension Lagophthalmos Muscle weakness Seizure disorder |
Accidental fall Diplopia Infection |
| Rare/Very Rare |
|---|
|
Acute respiratory distress syndrome Anaphylaxis Blinking decreased Botulism Dysarthria Ectropion General weakness Herpes zoster Hypersensitivity drug reaction Respiration changes Serum sickness Urinary incontinence |
There are 27 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Blepharoptosis Diarrhea Dry eye Headache disorder Injection site sequelae Neck pain Pharyngitis Upper respiratory infection Xerostomia |
Allergic dermatitis Back pain Bronchitis Ecchymosis Eyelid edema Musculoskeletal pain Nausea Pruritus of skin Skin rash Visual changes Voice change |
| Rare/Very Rare |
|---|
|
Blurred vision Edema Erythema Flu-like symptoms Muscle spasm Myalgia Urticaria |
The following precautions are available for XEOMIN (incobotulinumtoxina):
Safety and efficacy of incobotulinumtoxinA have not been established in patients younger than 18 years of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Category C. (See Users Guide.) There are no adequate and well-controlled clinical studies of incobotulinumtoxinA in pregnant women. In animal reproductive studies, increased rate of abortion and embryotoxic effects (e.g., decreased fetal body weight, skeletal ossification) in relation to maternal toxicity were observed in rats and rabbits treated with incobotulinumtoxinA at dosages exceeding the maximum recommended human dose for cervical dystonia. IncobotulinumtoxinA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether incobotulinumtoxinA is distributed into human milk. Because many drugs are distributed into milk, caution is advised if the drug is used in nursing women.
Among the total number of patients included in clinical studies of incobotulinumtoxinA for upper limb spasticity, 70 patients were older than 65 years of age and 7 patients were older than 75 years of age. Although no overall differences in efficacy or safety were observed between geriatric and younger patients and other clinical experience has revealed no evidence of age-related differences the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out. Among the total number of patients included in the phase 3 study of cervical dystonia, 29 were older than 65 years of age; of the 19 geriatric patients who received incobotulinumtoxinA, 53% experienced an adverse event (most commonly dysphagia and asthenia) compared with 40% of those receiving placebo.
Among the total number of patients included in the phase 3 study of blepharospasm, 41 were older than 65 years of age; of the 29 geriatric patients who received incobotulinumtoxinA, 76% experienced an adverse event compared with 58% of those receiving placebo. Clinical studies of incobotulinumtoxinA for cosmetic improvement of glabellar lines included only a limited (4%) number of individuals 65 years of age or older. Effectiveness was demonstrated in 20% of these individuals and there was no increase in the incidence of treatment-related adverse effects.
Among the total number of patients included in the phase 3 study of blepharospasm, 41 were older than 65 years of age; of the 29 geriatric patients who received incobotulinumtoxinA, 76% experienced an adverse event compared with 58% of those receiving placebo. Clinical studies of incobotulinumtoxinA for cosmetic improvement of glabellar lines included only a limited (4%) number of individuals 65 years of age or older. Effectiveness was demonstrated in 20% of these individuals and there was no increase in the incidence of treatment-related adverse effects.
The following prioritized warning is available for XEOMIN (incobotulinumtoxina):
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.
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.
The following icd codes are available for XEOMIN (incobotulinumtoxina)'s list of indications:
| Blepharospasm | |
| G24.5 | Blepharospasm |
| Glabellar lines | |
| L98.8 | Other specified disorders of the skin and subcutaneous tissue |
| Horizontal forehead lines | |
| L98.8 | Other specified disorders of the skin and subcutaneous tissue |
| Lateral canthal lines | |
| L90.8 | Other atrophic disorders of skin |
| L98.8 | Other specified disorders of the skin and subcutaneous tissue |
| Sialorrhea | |
| K11.7 | Disturbances of salivary secretion |
| Spasmodic torticollis | |
| G24.3 | Spasmodic torticollis |
| Upper limb spasticity | |
| G04.1 | Tropical spastic paraplegia |
| G11.4 | Hereditary spastic paraplegia |
| G80.0 | Spastic quadriplegic cerebral palsy |
| G80.1 | Spastic diplegic cerebral palsy |
| G80.2 | Spastic hemiplegic cerebral palsy |
| G81.1 | Spastic hemiplegia |
| G81.10 | Spastic hemiplegia affecting unspecified side |
| G81.11 | Spastic hemiplegia affecting right dominant side |
| G81.12 | Spastic hemiplegia affecting left dominant side |
| G81.13 | Spastic hemiplegia affecting right nondominant side |
| G81.14 | Spastic hemiplegia affecting left nondominant side |
| M62.838 | Other muscle spasm |
Formulary Reference Tool