Daxxify (daxibotulinumtoxinA-lanm)

Assay methods used to determine potency of various botulinum toxin preparations are specific to each individual preparation; units of biologic activity of daxibotulinumtoxin A-lanm cannot be compared with or converted to units of other botulinum toxin preparations.

Individualize dosage according to patient response and particular condition treated.

Do not exceed the recommended dose and frequency; excessive and/or unintended neuromuscular weakness may occur if higher than recommended dosages are given. Use minimum effective dosage whenever possible to reduce risk of adverse effects.

Consider the cumulative dose when treating patients with daxibotulinumtoxinA-lanm. Physicians should be aware of whether patients are receiving treatment with other botulinum toxin products for other indications.

DaxibotulinumtoxinA-lanm is administered by IM injection into affected muscles. The drug is commercially available as a lyophilized powder in single-dose 50- or 100-unit vials. The lyophilized powder must be reconstituted prior to administration. Instructions for reconstitution and administration are specific to each vial size and indication; the manufacturer's labeling should be consulted for detailed instructions regarding reconstitution, preparation, and administration.

Store unopened vials of daxibotulinumtoxinA-lanm at room temperature (20-25degreesC) or in a refrigerator (2-8degreesC) in the original carton to protect the drug from light.

When used for temporary improvement in the appearance of glabellar facial lines in adults, daxibotulinumtoxinA-lanm lyophilized powder is reconstituted by adding 0.6 mL of preservative-free 0.9% sodium chloride injection to a vial labeled as containing 50 units of daxibotulinumtoxinA-lanm, or adding 1.2 mL of preservative-free 0.9% sodium chloride injection to a vial labeled as containing 100 units of daxibotulinumtoxinA-lanm; the resulting solution with either method contains 8 units per 0.1 mL.

When used for cervical dystonia in adults, daxibotulinumtoxin A-lanm lyophilized powder is reconstituted by adding 1 mL of preservative-free 0.9% sodium chloride injection to a vial labeled as containing 100 units of the drug to provide a solution containing 10 units per 0.1 mL. Alternatively, 2 mL of preservative-free 0.9% sodium chloride injection can be added to a vial labeled as containing 100 units of daxibotulinumtoxin A-lanm to provide a solution containing 5 units per 0.1 mL.

When reconstituting the lyophilized drug, the required amount of preservative-free 0.9% sodium chloride injection should be slowly injected in the vial. A partial vacuum will draw the diluent into the vial; vials should not be used if the vacuum is absent. Following addition of diluent, vials should be gently rotated until the lyophilized drug is completely dissolved. Use each vial for only one injection session and for only one patient; discard any remaining solution in vial immediately after use.

Daxibotulinumtoxin A-lanm should be administered within 72 hours of reconstitution; during this time period, the reconstituted solution can be stored in a refrigerator (2-8degreesC), protected from light.

Injection sites in patients with glabellar facial lines can be readily identified by palpating for areas of tense muscle mass in the lateral corrugator and vertical procerus muscles while the patient is frowning; location, size, and use of such muscles may vary considerably among individuals. To minimize the risk of ptosis, injections near the levator palpebrae superioris should be avoided, especially in individuals with larger brow-depressor complexes. Risk of dysphagia may be decreased by limiting the total dose injected into the sternocleidomastoid muscle. Do not inject daxibotulinumtoxin A-lanm less than 1 centimeter above the superior orbital rim. Each injection is administered using a 30- to 33-gauge needle. While advancing the needle through the skin, digital pressure should be applied to the superior medial orbital rim.

In patients with cervical dystonia, the total dose per treatment session should be administered as several injections divided among affected muscles.

No dosing information is available for this tab.

No dosing information is available for this tab.

No formal drug interaction studies have been conducted with daxibotulinumtoxinA-lanm.

There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Neuromuscular Blocking Agents/General Anesthetics (Inhl)

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.

Neuromuscular Blocking Agents/Misc Antibiotics

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.

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.

Moderate Interaction: Assess the risk to the patient and take action as needed.

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.

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.

Neuromuscular Blocking Agents/Trimethaphan

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Additive pharmacologic effects.

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: Available data indicate that the neuromuscular blocking effects of tubocurarine and trimethaphan may be additive.

Select Neuromuscular Blocking Agents/Hydantoins

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)

*Known hypersensitivity to any botulinum toxin preparation, daxibotulinumtoxinA-lanm, or any of the components in the formulation.

*Infection at the injection sites.

There are no contraindication contraindications for this drug.

• Amyotrophic lateral sclerosis
• Atherosclerotic cardiovascular disease
• Dysphagia
• Eaton-lambert syndrome
• Myasthenia gravis
• Neuromuscular disease
• Peripheral motor neuropathy
• Respiratory depression

There are no moderate contraindications for this drug.

The most common adverse effects reported in patients receiving daxibotulinumtoxinA-lanm for cosmetic treatment of glabellar lines (>=1%) were headache, eyelid ptosis, and facial paresis.

The most common adverse effects reported in patients receiving daxibotulinumtoxinA-lanm for the treatment of cervical dystonia (>=5%) were headache, injection site pain, injection site erythema, muscular weakness, and upper respiratory tract infection.

More Frequent

• Dysphagia
• Lagophthalmos
• Muscle weakness
• Voice change

Less Frequent

• Diplopia
• Fever
• Infection

Rare or Very Rare

• Acute myocardial infarction
• Acute respiratory distress syndrome
• Anaphylaxis
• Aspiration pneumonia
• Atrioventricular block
• Botulism
• Brachial plexus disorder
• Cardiac arrhythmia
• Corneal ulcer
• Dysarthria
• Dyspnea
• Entropion
• Erythema
• Erythema multiforme
• Hearing loss
• Hematoma
• Hypersensitivity drug reaction
• Keratitis
• Muscle atrophy
• Pneumonia
• Respiratory depression
• Seizure disorder
• Serum sickness
• Urinary incontinence

More Frequent

• Back pain
• Blepharoptosis
• Bronchitis
• Cough
• Dysuria
• Ecchymosis
• Eyelid edema
• Fatigue
• Headache disorder
• Influenza
• Injection site infection
• Injection site sequelae
• Nausea
• Neck pain
• Ocular irritation
• Pharyngitis
• Rhinitis
• Upper respiratory infection
• Urinary retention
• Urinary tract infection
• Xerostomia

Less Frequent

• Pruritus of skin
• Skin rash
• Visual changes

Rare or Very Rare

• Acute abdominal pain
• Alopecia
• Anorexia
• Arthralgia
• Blurred vision
• Chest pain
• Diarrhea
• Dizziness
• Dry eye
• Edema
• Excessive granulation tissue
• Eyes vertical deviation
• Facial palsy
• Flu-like symptoms
• Gait abnormality
• General weakness
• Heavy feeling
• Hematuria
• Hyperhidrosis
• Hypertonia
• Hypoesthesia
• Madarosis of eyelid
• Malaise
• Muscle fasciculation
• Musculoskeletal pain
• Myalgia
• Paresthesia
• Peripheral neuropathy
• Photophobia
• Psoriasiform eruption
• Retrobulbar hemorrhage
• Sinusitis
• Stinging of skin
• Strabismus
• Symptoms of anxiety
• Syncope
• Tinnitus
• Urticaria
• Vertigo
• Vomiting

No enhanced messaging available.

Safety and effectiveness of daxibotulinumtoxinA-lanm in patients less than 18 years of age have not been established.

There are no available data on daxibotulinumtoxinA-lanm use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, administration of daxibotulinumtoxinA-lanm during pregnancy resulted in adverse effects on fetal growth (e.g., decreased fetal body weight and skeletal ossification) at maternally toxic doses approximately equivalent to 40 times the maximum recommended human dose (MRHD).

There are no data on the presence of daxibotulinumtoxinA-lanm in human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for daxibotulinumtoxinA-lanm and any potential adverse effects on the breastfed infant from the drug or underlying maternal condition.

No increase in the incidence of treatment-related adverse events have been observed in patients older than 65 years of age treated with daxibotulinumtoxinA-lanm. Clinical studies of daxibotulinumtoxinA-lanm did not include sufficient numbers of patients 65 years of age and older to determine whether they responded differently from younger subjects.