DaxibotulinumtoxinA Monograph for Professionals - Drugs.com

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# DaxibotulinumtoxinA

Brand name: Daxxify
Drug class: Other Miscellaneous Therapeutic Agents

Medically reviewed by Drugs.com on Sep 29, 2022. Written by ASHP.

### Warning

WARNING: DISTANT SPREAD OF TOXIN EFFECT

See full prescribing information for complete boxed warning.

The effects of daxibotulinumtoxinA-lanm 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. DaxibotulinumtoxinA-lanm is not approved for the treatment of spasticity or any conditions other than glabellar lines.

## Introduction

DaxibotulinumtoxinA-lanm is an acetylcholine release inhibitor and neuromuscular blocking agent.

## Uses for DaxibotulinumtoxinA

### DaxibotulinumtoxinA-lanm has the following uses:

DaxibotulinumtoxinA-lanm is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.

## DaxibotulinumtoxinA Dosage and Administration

### General

DaxibotulinumtoxinA-lanm is available in the following dosage form(s) and strength(s):

For injection: 50 units or 100 units sterile lyophilized powder in a single-dose vial for reconstitution.

### Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

#### Adults

Prior to intramuscular injection, reconstitute each vial of daxibotulinumtoxinA-lanm with the required amount of sterile, preservative-free 0.9% sodium chloride injection to obtain a reconstituted solution at a concentration of 8 units/0.1 mL. See full prescribing information for instructions on preparation and administration.

##### Dosage and Administration

Recommended dosage: 0.1 mL (8 units) by intramuscular injection into each of five sites, for a total dose of 40 units.

DaxibotulinumtoxinA-lanm should be administered no more frequently than every three months. Consideration of the cumulative dose is necessary when treating adult patients with daxibotulinumtoxinA-lanm. Physicians should be aware of whether patients are receiving treatment with other botulinum toxin products for other indications.

Detailed DaxibotulinumtoxinA dosage information

## Related/similar drugs

onabotulinumtoxinA, Botox Cosmetic, Daxxify, Jeuveau, prabotulinumtoxinA

## Cautions for DaxibotulinumtoxinA

### Contraindications

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

- Infection at the injection sites.

### Warnings/Precautions

#### Spread of Toxin Effect

Postmarketing safety data from other approved botulinum toxins suggest that botulinum toxin effects may be observed beyond the site of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and 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 related to the spread of toxin effects. The risk of symptoms is greatest in children treated for spasticity, but symptoms can occur in adults treated for spasticity and other conditions, and particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including upper limb spasticity in children and approved indications, symptoms consistent with spread of toxin effect have been reported at doses comparable to or lower than the maximum recommended total dose. DaxibotulinumtoxinA-lanm is not approved for treatment of spasticity or any conditions other than glabellar lines. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech or respiratory difficulties occur.

Although no serious adverse reactions of distant spread of toxin effect associated with daxibotulinumtoxinA-lanm have been reported in clinical studies of 40 units for glabellar lines, these reactions are possible.

#### Lack of Interchangeability Between Botulinum Toxin Products

The potency units of daxibotulinumtoxinA-lanm are specific to the preparation and assay method utilized. They are not interchangeable with other preparation of botulinum toxin products therefore, units of biological activity of daxibotulinumtoxinA-lanm cannot be compared to or converted to units of any other botulinum toxin products assessed with any other specific assay method.

#### Serious Adverse Reactions with Unapproved Use

Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received botulinum toxin injections for unapproved uses. In these cases, the adverse reactions may have resulted from the administration of botulinum toxin products to the site of injection and/or adjacent structures. In some cases, patients had pre-existing dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of botulinum toxin products.

#### Hypersensitivity Reactions

Serious and/or immediate hypersensitivity reactions have been reported for botulinum toxin products. These reactions include anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea. If such a reaction occurs, discontinue further injection of daxibotulinumtoxinA-lanm and immediately institute appropriate medical therapy. The use of daxibotulinumtoxinA-lanm in patients with a known hypersensitivity to any botulinum toxin preparation or any of its formulation components could lead to a life threatening allergic reaction.

#### Cardiovascular System

There have been reports following administration of botulinum toxins of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.

#### Pre-existing Neuromuscular Disorders

Monitor patients with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) for increased neuromuscular compromise following botulinum toxin treatment. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia and respiratory compromise from typical doses of daxibotulinumtoxinA-lanm.

#### Dysphagia and Breathing Difficulties

Treatment with botulinum toxin products, including daxibotulinumtoxinA-lanm, can result in swallowing or breathing difficulties. These reactions can occur within hours to weeks after injection with botulinum toxin. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or swallowing. When distant effects occur, additional respiratory mechanisms may be involved.

Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin products. Dysphagia may persist for several months. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised. Treatment with botulinum toxins, including daxibotulinumtoxinA-lanm, may weaken neck muscles that serve as accessory muscles of ventilation. This may result in a critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles. There have been postmarketing reports from other botulinum toxin products of serious breathing difficulties, including respiratory failure.

Patients treated with botulinum toxin may require immediate medical attention should they develop problems with swallowing, speech, or respiratory disorders.

#### Pre-existing Conditions at the Injection Site

Use caution when administering daxibotulinumtoxinA-lanm to patients with surgical alterations to the facial anatomy, marked facial asymmetry, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, inflammation at the injection site(s), pre-existing eyelid or eyebrow ptosis, when excessive weakness or atrophy is present in the target muscles, or the inability to substantially lessen glabellar lines even by physically spreading them apart.

#### Ophthalmic Adverse Reactions

Dry eye has been reported with the use of botulinum toxin products in the treatment of glabellar lines. Reduced tear production, reduced blinking, and corneal disorders may occur with use of botulinum toxins, including daxibotulinumtoxinA-lanm. If symptoms of dry eye (e.g., eye irritation, photophobia, or visual changes) persist, consider referring patient to an ophthalmologist.

#### Specific Populations

##### Pregnancy

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, intramuscular administration of daxibotulinumtoxinA-lanm during pregnancy resulted in adverse effects on fetal growth (decreased fetal body weight and skeletal ossification) at maternally toxic doses approximately equivalent to 40 times the maximum recommended human dose (MRHD).

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Embryofetal development studies were conducted in rats and rabbits with daxibotulinumtoxinA-lanm. For comparison of animal to human doses based on a body weight comparison, the MRHD is set at 40 units/subject (0.67 units/kg for an average 60 kg subject). Intramuscular administration of daxibotulinumtoxinA-lanm (3, 10 or 30 units/kg) to pregnant rats four times during the period of organogenesis (on gestation days 7, 10, 13, and 16) caused decreased fetal body weight and decreased fetal skeletal ossification at the highest dose, which was associated with maternal toxicity. No embryofetal developmental toxicity was noted at doses up to 10 units/kg which is 15 times the MRHD. Intramuscular administration of daxibotulinumtoxinA-lanm (0.02, 0.1, 0.48 or 2.4 units/kg/day) to pregnant rabbits during the period of organogenesis (total of 13 doses) resulted in maternal lethality at 2.4 units/kg/day and significant decreased maternal body weight at 0.48 units/kg/day. No embryofetal developmental toxicity was noted at doses up to 0.48 units/kg/day which is approximately equivalent to the MRHD.

##### Lactation

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.

##### Pediatric Use

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

##### Geriatric Use

Among the 406 subjects treated with daxibotulinumtoxinA-lanm in the placebo-controlled clinical trials, 36 subjects were 65 years or older. There was no increase in the incidence of treatment-related adverse events in patients over 65 years treated with daxibotulinumtoxinA-lanm. Clinical studies of daxibotulinumtoxinA-lanm did not include sufficient numbers of subjects aged 65 and older to determine whether they responded differently from younger subjects.

### Common Adverse Effects

The most commonly observed adverse reactions (≥1%) are headache (6%), eyelid ptosis (2%) and facial paresis (1%).

## Drug Interactions

### Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Aminoglycoside antibiotics, anticholinergic agents or any other agents that interfere with neuromuscular transmission may potentiate the effect of daxibotulinumtoxinA-lanm; co-administer only with caution and close observation.

DaxibotulinumtoxinA drug interactions (more detail)

## Actions

### Mechanism of Action

DaxibotulinumtoxinA-lanm blocks cholinergic transmission at the neuromuscular junction by inhibiting the release of acetylcholine. When injected into skeletal muscle, daxibotulinumtoxinA is internalized into the nerve terminal, translocates into the neuronal cytosol where it cleaves SNAP25, a protein necessary for synaptic vesicle membrane docking and subsequent release of acetylcholine which produces a dose dependent decrease of muscle function. Recovery of activity is gradual and results from the degradation of neurotoxin light chain in the neurons with a contribution from the formation of axonal sprouts. Muscle reinnervation occurs, leading to a slow reversal of the pharmacological effects of daxibotulinumtoxinA.

## Advice to Patients

- Advise the patient to read the FDA-approved patient labeling (Medication Guide).

- Advise patients or caregivers to seek immediate medical care if swallowing, speech or respiratory disorders arise or existing symptoms worsen.

- Advise patients if they develop any unusual symptoms such as loss of strength, muscle weakness, blurred vision, or drooping eyelids occur, they should avoid driving a car or engaging in other potentially hazardous activities.

- Inform patients that daxibotulinumtoxinA-lanm injection may cause eye dryness. Advise patients to report symptoms of eye dryness (e.g., eye pain, eye irritation, photosensitivity, or changes in vision) to their doctor.

## Additional Information

AHFSfirstRelease™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

## Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

DaxibotulinumtoxinA-lanm
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer
--- | --- | --- | --- | ---
Parenteral | For injection | 50 units | Daxxify | Revance Therapeutics
|  | 100 units | Daxxify | Revance Therapeutics

AHFS Drug Information. © Copyright 2023, Selected Revisions September 29, 2022. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

Reload page with references included

## More about daxibotulinumtoxinA

- Check interactions
- Side effects
- Dosage information
- During pregnancy
- Drug class: skeletal muscle relaxants

### Patient resources

- Advanced Reading

### Professional resources

#### Other brands

Daxxify

### Related treatment guides

- Glabellar Lines

Medical Disclaimer