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How to Inject Daxxify®: a Beginner’s Guide(daxibotulinumtoxinA-lanm)

What is Daxxify®?

DAXXIFY is a botulinum toxin type A produced by the bacteria Clostridium botulinum. It is designed for the temporary improvement in the appearance of moderate to severe glabellar lines, or frown lines between the eyebrows, in adult patients. Daxxify comes in single-use vials containing 50 units per vial. Ingredients include daxibotulinumtoxinA-lanm, human serum albumin, trehalose, and polysorbate 20.

DAXXIFY works by interfering with acetylcholine release from nerve endings at the neuromuscular junction. The neurotoxin binds to the nerve terminal and cleaves a protein called SNAP25, which is essential for the release of acetylcholine. Over time, new nerve endings form, re-establishing nerve signal transmission.

Daxxify was FDA-approved in 2022 for aesthetic use in the glabellar lines. Most patients will see the full effect within days 3 to 7, and muscle relaxation may last up to 6 months, which is longer compared to other neurotoxins.

Contraindication

Daxxify is contraindicated in the following patients:

• Known hypersensitivity to botulinum toxin or other components in the formulation.
• Infection at the site of injection.

Safety Information

The package insert for Daxxify indicates that post-marketing safety data suggest the spread of botulinum toxin beyond the site of local injection. Various symptoms such as asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties have been observed from hours to weeks following the injection. There have been reports of death related to the spread of botulinum toxin from swallowing or breathing difficulties. Patients must be warned to seek immediate medical attention if swallowing, speech, or respiratory disorders occur. In severe cases, patients have required either feeding tubes or intubation.

Patients with peripheral motor neuropathy diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) are at increased risk and should be avoided.

Hypersensitivity Reactions

Hypersensitivity reactions such as anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea have been reported. If a patient experiences any of these symptoms, immediate medical attention is required. Any hypersensitivity to neurotoxin, human albumin, or other ingredients can lead to life-threatening anaphylaxis.

Injection Techniques

To minimize the risk of ptosis, avoid injection near the levator palpebrae and ensure that corrugator injections are placed at least 1 cm above the bony ridge. Corneal exposure, ulceration, or ectropion has been reported due to loss of orbicularis muscle function, leading to complications. It is not recommended to inject Daxxify into the medial lower eyelid area. Due to the risk of ecchymosis in the soft tissue of the eyelid, it is recommended to apply gentle pressure.

Albumin Content

Daxxify contains albumin, which is a derivative of human blood. Therefore, there is a theoretical risk of viral diseases, Creutzfeldt-Jakob Disease (CJD), or variant Creutzfeldt-Jakob Disease (vCJD), although none has ever been reported.

Clinical Trials

Clinical studies enrolled healthy patients (≥18 years old) with glabellar lines of at least moderate severity at maximum frown. Subjects received 40 units of Daxxify and were followed up for 36 weeks. Data on day 30 showed that 74% to 80% of subjects rated at least a 2-grade improvement from baseline. The duration of effect was observed up to 6 months in many patients.

Reconstitution and Handling

The package insert recommends that sterile, preservative-free 0.9% Sodium Chloride Injection is used for reconstitution. Draw up with a 20-27 gauge needle. Using alcohol, clean the rubber stopper of the vial. Insert the needle vertically through the rubber stopper, and the vacuum will automatically draw the saline from the syringe into the vial. After removing the needle, mix Daxxify carefully by swirling and inverting the vial. Vigorous shaking is not recommended. The package insert advises that Daxxify should be used for only one injection session for only one patient and within 24 hours after dilution. After dilution, it should be stored in a refrigerator at 2°C – 8°C (36°F – 46°F).

It should be noted that preserved (bacteriostatic) 0.9% Sodium Chloride will increase the activity of the Daxxify protein for up to 6 weeks when stored at 4°C. Additionally, the general practice consensus is that Daxxify is used as a multiple-dose vial for more than one patient.

Additional dilution options will be discussed during your hands-on Daxxify certification and training class.

Patient Consultation

All patients must receive a thorough consultation about their concerns before any injections. Obtain a complete past medical history, including any history related to the use of botulinum toxin. Assess information regarding previous use, last injection, and any complications. Manage your patient’s expectations and discuss their current status with empathy and honesty. Address any asymmetry and discuss the limitations of the treatment. Ensure your patient signs all the necessary forms, such as informed consent. Document a photo of your patient to record a “before” picture in case there are any complications.

Glabella (Frown Lines) Daxxify Certification

Muscles Involved

The procerus and corrugator muscles comprise the two main muscle groups in the glabellar area. The procerus originates from the nasal bone and attaches to the medial forehead and skin of the brow.  Procerus muscle moves the medial brow down inferiorly.  The corrugator originates from the medial superciliary arch and inserts into the skin of the medial forehead.  The corrugator moves the brow medially and inferiorly.  

Injection Technique 

Aim your needle perpendicular to the skin.  At the 90 degrees angle, insert the needle deep into the subcutaneous space near the periosteum.  Since the frontalis muscle lies superficial to the glabellar muscles, the injection must be deep intramuscular.  A superficial injection can cause the eyebrows to feel heavy on your patient.  However, an injection that is too deep will dull the needle if you hit the skull.  

Landmarks:

Medial corrugator injection = 1 cm above the bony orbital rim and vertical to the medial canthus

Lateral corrugator injections = 1 cm above the bony orbital rim and around 0.5cm medial to the vertical mid-pupillary line

Procerus injection = immediately above the crossing point of the X formed by drawing a line from the medial eyebrow to the contralateral medial canthus.

20 units are the standard FDA approved injection for the Glabellar lines as found in the Daxxify® package insert.  

Please note that patients with strong glabellar muscles may require 1-2 additional units per injection site. Additional clinical pearls will be discussed during your hands-on Daxxify certification and Daxxify Training class.

Complication

According to Daxxify®, adverse reaction included the following:

• Headache 6%
• Brow ptosis 0.7%
• Hematoma 0.6%
• Pain 0.2%
• Eyelid edema 0.4%
• Blepharospasm 0.2%
• Eye disorder 0.2%
• Eyelid ptosis 0.2%

Lid ptosis is a cosmetically dangerous complication.  An injection that is lateral to the mid-pupillary line may cause the botulinum toxin to spread to the levator palpebrae.  An injection near the orbital rim may also cause this complication.  Lid ptosis can be seen 2 to 7 days after the initial injection.  The effects may last up to 4 – 8 weeks.  When this complication occurs, Iopidine 0.5% drop, one drop to affected eye TID may be prescribed to minimize the ptosis.

Frontalis (Horizontal Forehead Lines) Daxxify Training

Muscle involved

The frontalis muscle is a common muscle that beginners have difficulty injecting properly.  The size and shape vary from v-shaped or rectangle-shaped, short or tall, and narrow or broad.  Relying solely on the wrinkle pattern on the skin will cause you to miss the muscle if you don’t use your fingers to palpate the borders of the muscle.  

The frontalis muscle originates at the galea aponeurosis and inserts into the muscles of the glabellar complex. The frontalis lifts the eyebrows superiorly and moves the scalp anteriorly.  While the wrinkles are horizontal, the muscle fibers run vertically.

Injection Technique

When injecting the frontalis, you can angle your needle at a shallow angle like a subcutaneous injection.  This is due to the fact that the skin is typically thin and there are no other major structures or muscle groups that overlap in the forehead.  Place your injections at least 2 cm apart.  You may see a small wheel form under the skin.  The lower 3 – 4 cm of the forehead should be avoided to prevent brow ptosis.  In some patients with v-shaped frontalis, there are no muscle fibers in the middle, and injection here will yield no benefits. 

Allergan states in their package insert that 4 units should be injected in 5 injection spots.  An article from 2004 titled “Consensus recommendations on the use of botulinum toxin type A in facial aesthetics” recommends that we start with a lower dose of Botox®: 2 units per injection site.  Many injectors will avoid injecting too much botulinum toxin here to avoid a frozen forehead or brow ptosis.  

Complication

According to Allergan, Botox® was used on 665 patients and the complication rates are as follows:

• Headache (9%)
• Eyelid ptosis  (2%)
• Brow ptosis (2%)
• Skin tightness (2%)

Brow ptosis typically occurs due to over injection of the frontalis.  An injection that is too low can also cause this.  Some patients who do not want the glabellar injection with the frontalis will experience this as well.  Finally, a hyperfunctional frontalis muscle, that contracts whenever the person opens their eyes, will experience heaviness due to the inability to move the frontalis.  

A Spock brow or Mephisto sign is caused by inadequate injections along the lateral fibers of the frontalis muscle.  In treating the touch-up, inject 1 -2 units into the strongest portion of the muscle fiber.  

Orbicularis Oculi (Crow’s Feet) Daxxify Certification

Muscles Involved

The orbicularis oculi is a single circumferential muscle that outlines the orbit.  It originates from the medial palpebral ligament and inserts into the lateral palpebral raphe, corrugator, frontalis, and depressor supercili.  The orbicularis oculi pull the skin of the forehead, temple, and cheek towards the medial angle of the orbit.  

Injection Technique

Similar to the frontalis injection, the needle can be inserted at a low angle like a subcutaneous injection.  However, it is still an intramuscular injection as you need to affect the muscle to have an effect.  Inject 1 cm outside of the orbital rim to avoid injecting the ocular muscles.  Place at least 3 injections at least 2 cm apart in a triangular shape. 

Allergan states in their package insert that 4 units should be injected in 6 injection spots.  An article from 2004 titled “Consensus recommendations on the use of botulinum toxin type a in facial aesthetics” recommends that we start with a lower dose of Botox®: 3 units per injection site.  

Complication

According to Allergan, Botox® was used on 526 patients and the complication rates are as follows:

• Eyelid edema (1%)

Rare side effects, such as asymmetrical smile or diplopia, are caused by migration. All injections should be high above the zygomatic arch.  

Daxxify Certification & Daxxify Training Course

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Statement of Responsibility

Cosmetic Medical Training recognizes that many of the techniques and recommendations are for procedures that are considered off-label use.  Our recommendations are based on many textbooks, published articles, seminars, and practical knowledge and experience.  The authors have attempted to maintain up to date knowledge and information in this training manual with the current standard of care.  However, due to the continuing flow of new research and information relating to the drugs being used in this course, we recommend that you check with the manufacturer for any changes in the package inserts, warnings, and precautions.  All information and tools presented within this site are intended for educational purposes. We do not guarantee that the information will be completely accurate and up to date; therefore the authors will not be held responsible for any errors, omissions, or inaccuracies published.  Application of the knowledge is ultimately the responsibility of the practitioner.

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Originally published at Daxxify Training in Pittsburgh