DaxibotulinumtoxinA

What is DaxibotulinumtoxinA?

• DaxibotulinumtoxinA (Daxxify) is an acetylcholine release inhibitor and neuromuscular blocking agent. DaxibotulinumtoxinA-lanm is a 150 kDa botulinum toxin without accessory proteins purified from the bacterium Clostridium botulinum type A.

Botulinum Toxin Mechanism

Botulinumtoxin surface 3BTA

Doctor performing Botox injection

What are the uses of this medicine?

• DaxibotulinumtoxinA (Daxxify) is a prescription medicine for adults that is injected into muscles to temporarily improve the look of moderate to severe frown lines between the eyebrows (glabellar lines).

How does this medicine work?

• DaxibotulinumtoxinA (Daxxify) blocks cholinergic transmission at the neuromuscular junction by inhibiting the release of acetylcholine.
• When injected into skeletal muscle, Daxxify 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 Daxxify.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to Daxxify or any of the ingredients in Daxxify.
• had an allergic reaction to any other botulinum toxin product such as rimabotulinumtoxinB (MYOBLOC), onabotulinumtoxinA (BOTOX, BOTOX COSMETIC), abobotulinumtoxinA (DYSPORT), incobotulinumtoxinA (XEOMIN) or prabotulinumtoxinA-xvfs (JEUVEAU).
• have a skin infection at the planned injection site.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any if you:

• have received any other botulinum toxin product in the last 4 months.
• have received injections of botulinum toxin such as rimabotulinumtoxinB (MYOBLOC), onabotulinumtoxinA (BOTOX, BOTOX COSMETIC), abobotulinumtoxinA (DYSPORT), prabotulinumtoxinA (JEUVEAU) and incobotulinumtoxinA, (XEOMIN) in the past. Be sure your healthcare provider knows exactly which product you received.

Is this medicine FDA approved?

• Initial U.S. Approval: 2022

How should this medicine be used?

Recommended dosage:

• The total recommended dose is 40 Units per treatment session divided into five equal intramuscular injections of 8 Units each (two injections in each corrugator muscle and one injection in the procerus muscle).

Administration:

• Daxxify is an injection that your healthcare provider will give you.
• Daxxify is injected into your affected muscles. Your healthcare provider may change your dose of Daxxify, until you and your healthcare provider find the best dose for you.
• Daxxify should not be received more than 1 time every 3 months.
• Your healthcare provider will tell you how often you will receive your dose of Daxxify injections.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: 50 Units or 100 Units sterile lyophilized powder in a single-dose vial.

This medicine is available in fallowing brand namesː

• Daxxify

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• eyelid drooping
• loss of the ability to move the muscles in your face

Less common, but serious side effects may include:

• Problems swallowing, speaking, or breathing
• Spread of toxin effects
• Heart problems
• Eye problems
• Allergic reactions

What special precautions should I follow?

• 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. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech or respiratory difficulties occur.
• Daxxify cannot be interchangeable with other preparation of botulinum toxin products therefore, Units of biological activity of Daxxify cannot be compared to or converted to Units of any other botulinum toxin products assessed with any other specific assay method.
• 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.
• Serious and/or immediate hypersensitivity reactions have been reported for botulinum toxin products. If such a reaction occurs, discontinue further injection of Daxxify and immediately institute appropriate medical therapy.
• Adverse event reports have been received involving the cardiovascular system with botulinum toxin products, some with fatal outcomes. Use caution when administering to patients with pre-existing cardiovascular disease.
• 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.
• Treatment with botulinum toxin products, including Daxxify, can result in swallowing or breathing difficulties. Patients treated with botulinum toxin may require immediate medical attention should they develop problems with swallowing, speech or respiratory disorders.
• Use caution when administering Daxxify 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, 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.
• Dry eye has been reported with the use of botulinum toxin products in the treatment of glabellar lines. If symptoms of dry eye (e.g., eye irritation, photophobia, or visual changes) persist, consider referring patient to an ophthalmologist.
• 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.
• It is not known if Daxxify passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Daxxify.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• neuromuscular weakness

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• In the event of overdose, the patient should be medically monitored for symptoms or excessive muscle weakness or muscle paralysis.
• Symptomatic treatment may be necessary.
• Respiratory support may be required where excessive doses cause paralysis of the respiratory muscles.

Can this medicine be used in pregnancy?

• There are no available data on Daxxify use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• Safety and effectiveness of Daxxify in patients less than 18 years of age have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: daxibotulinumtoxinA-lanm
• Inactive ingredients: L-histidine, L-histidine-HCl monohydrate, polysorbate 20, RTP004 peptide, trehalose dihydrate

Who manufactures and distributes this medicine?

Manufactured by:

• Revance Therapeutics, Inc.
• Newark, CA

What should I know about storage and disposal of this medication?

• Unopened Daxxify vials should be stored at room temperature 20°C to 25°C (68°F to 77°F) or refrigerated at 2°C to 8° C (36°F to 46°F) in the original carton to protect from light.

• Dailymed label info on DaxibotulinumtoxinA
• FDA DaxibotulinumtoxinA

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