Daxxify Drug Information
Generic name: BOTULINUM TOXIN TYPE A
Acetylcholine Release Inhibitor [EPC] Neuromuscular Blocker [EPC]
Uses of Daxxify
Glabellar Lines
DAXXIFY 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.
Cervical Dystonia
DAXXIFY is indicated for the treatment of cervical dystonia in adult patients.
Dosage & Administration of Daxxify
Side Effects of Daxxify
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common side effects from treatment with DAXXIFY usually occur within one to two weeks after injection and, while generally transient, may have a duration of several weeks or months. Glabellar Lines In the two randomized, placebo-controlled, Phase 3 clinical trials that assess the use of DAXXIFY for the temporary improvement in the appearance of moderate to severe glabellar lines, GL-1 and GL-2, 406 subjects received a single-dose treatment of 40 Units DAXXIFY, and 203 subjects received placebo.
The most frequent adverse reactions are presented in Table 3. TABLE 3: Most Common Adverse Reactions ≥1% and More Frequent than Placebo in Pooled Double- Blind, Placebo-Controlled Trials for Glabellar Lines Adverse Reaction DAXXIFY N=406 n (%) Placebo N=203 n (%) Headache 26 (6%) 4 (2%) Eyelid ptosis 9 (2%) 0 (0%) Facial paresis Facial paresis, including facial asymmetry. 5 (1%) 0 (0%) Injection site reactions were reported in 6% of subjects treated with DAXXIFY and in 6% of subjects treated with placebo (these reactions included injection site pain, injection site erythema, injection site oedema, injection site bruising, injection site hematoma, injection site papule, and injection site pruritus). In an 84-week, open-label, repeat-dose safety study in glabellar lines, 2691 subjects were treated with 40 Units of DAXXIFY. Of these, 2380 subjects received one treatment with DAXXIFY, 882 received two treatments with DAXXIFY, and 568 subjects received three treatments with DAXXIFY. Adverse reactions were reported in 535 of the 2691 subjects (20%). The adverse reaction profile was similar to that reported in single-dose trials. Injection site reactions were the most common adverse reactions, reported in 9% of subjects, followed by headache (5%), edema (2%), erythema (2%), and eyelid ptosis in 1% of subjects. The incidence of these adverse reactions did not increase with multiple re- treatments.
Cervical Dystonia In the randomized, placebo-controlled, Phase 3 clinical trial to assess the use of DAXXIFY for the treatment of cervical dystonia, 255 patients received a dose of DAXXIFY (n=125 for 125 Units and n=130 for 250 Units), and 46 patients received placebo. Table 4 lists adverse reactions that occurred in ≥2% of patients treated with DAXXIFY and more frequently than placebo. TABLE 4: Most Common Adverse Reactions ≥2% and More Frequent than Placebo in the Phase 3 Double-Blind, Placebo-Controlled Clinical Trial for Cervical Dystonia Adverse Reaction DAXXIFY 125 Units N=125 n (%) DAXXIFY 250 Units N = 130 n (%) Placebo N=46 n (%) Headache 11 (9%) 9 (7%) 1 (2%) Injection site pain 10 (8%) 7 (5%) 2 (4%) Injection site erythema 6 (5%) 3 (2%) 1 (2%) Muscular weakness 6 (5%) 3 (2%) 0 (0%) Musculoskeletal pain 5 (4%) 5 (4%) 0 (0%) Nasopharyngitis 4 (3%) 3 (2%) 0 (0%) Arthralgia 3 (2%) 1 (1%) 0 (0%) Upper respiratory tract infection 2 (2%) 7 (5%) 2 (4%) Spinal pain 3 (2%) 4 (3%) 1 (2%) Atrioventricular block first degree 2 (2%) 0 (0%) 0 (0%) Urinary tract infection 3 (2%) 0 (0%) 0 (0%) Dysphagia 2 (2%) 5 (4%) 0 (0%) In a 52-week, open-label, repeat-dose safety study in cervical dystonia, 357 subjects (271 from the randomized trial, 86 newly enrolled) received up to 4 treatments with DAXXIFY. Of these, 28 subjects received one treatment with DAXXIFY, 95 subjects received two treatments, 169 received three treatments, and 65 received four treatments with DAXXIFY. Adverse reactions were reported in 138 patients (20%).
Warnings & Cautions for Daxxify
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, an unapproved use for DAXXIFY, 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.
Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory difficulties occur.
Lack of Interchangeability between Botulinum Toxin Products
The potency units of DAXXIFY are specific to the preparation and assay method utilized. They are not interchangeable with other preparations 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 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 DAXXIFY and immediately institute appropriate medical therapy.
The use of DAXXIFY in patients with a known hypersensitivity to any botulinum toxin preparation, DAXXIFY, or any of its formulation components could lead to a life-threatening allergic reaction.
Cardiovascular System Adverse Reactions
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.
Increased Neuromuscular Compromise in Patients with 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 DAXXIFY.
Dysphagia and Breathing Difficulties Treatment with botulinum toxin products, including
DAXXIFY, 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 DAXXIFY, 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.
Facial Anatomy in the Treatment of Glabellar Lines 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(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 in Patients Treated for Glabellar Lines 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 DAXXIFY. If symptoms of dry eye (e.g., eye irritation, photophobia, or visual changes) persist, consider referring patient to an ophthalmologist.
Drug Interactions with Daxxify
No formal drug interaction studies have been conducted with DAXXIFY. However, the potential for certain drugs to potentiate the effects of DAXXIFY warrants consideration given the potential risks involved and should be used with caution. Aminoglycosides or other agents interfering with neuromuscular transmission Anticholinergic drugs Botulinum neurotoxin products Muscle relaxants Aminoglycoside antibiotics, anticholinergic agents, or any other agents that interfere with neuromuscular transmission may potentiate the effect of DAXXIFY; co-administer only with caution and close observation.
Pregnancy Safety for Daxxify
Units/kg/day) to pregnant rabbits during the period of organogenesis (total of 13
doses) resulted in maternal lethality at
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.
Pediatric Use of Daxxify
Pediatric Use Safety and effectiveness of DAXXIFY in patients less than 18 years of age have not been established.
Contraindications for Daxxify
is contraindicated in: patients with known hypersensitivity to any botulinum toxin preparation, DAXXIFY, or any of the components in the DAXXIFY formulation. the presence of infection at the proposed injection sites. Known hypersensitivity to any botulinum toxin preparation, DAXXIFY, or any of the components in the DAXXIFY formulation. Infection at the injection sites.
Overdosage Information for Daxxify
Excessive doses of DAXXIFY may be expected to produce neuromuscular weakness with a variety of symptoms. Respiratory support may be required where excessive doses cause paralysis of the respiratory muscles. 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.
Symptoms of overdose are not likely to be present immediately following injection. Should accidental injection or oral ingestion occur, the person should be medically supervised for several weeks for signs and symptoms of excessive muscle weakness or paralysis. In the event of overdose, antitoxin raised against botulinum toxin is available from the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. However, the antitoxin will not reverse any botulinum toxin-induced effects already apparent by the time of antitoxin administration.
In the event of suspected or actual cases of botulinum toxin poisoning, please contact your local or state Health Department to process a request for antitoxin through the CDC. If you do not receive a response within 30 minutes, please contact the CDC directly at 1-770-488-7100.
Clinical Studies of Daxxify
Glabellar Lines Two randomized, double-blind, multi-center, placebo-controlled clinical trials, Studies GL-1 and
GL-2, were conducted to evaluate DAXXIFY for use in the temporary improvement of moderate-to-severe glabellar lines in adults. The 2 trials enrolled a total of 609 subjects (≥18 years old) with glabellar lines of at least moderate severity at maximum frown. A total of 405 subjects were randomized and 406 were treated with 40 Units of DAXXIFY and 204 subjects were randomized and 203 were treated with an equal volume of placebo.
Subjects were excluded if they had eyelid ptosis, deep dermal scarring, excessive dermatochalasis, or an inability to lessen glabellar lines by physically spreading them apart. Enrolled subjects were 21 to 75 years old (with a mean age of 50 years), and predominantly female (87%) and Caucasian (86%). The total dose was delivered in 5 equally divided intramuscular injections of 8 Units each to specific sites in the glabella (Figure 1). Subjects were followed for at least 24 weeks after treatment. Efficacy was determined through the assessment by investigators and subjects of frown wrinkle severity at maximum frown using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). The primary efficacy endpoint (treatment success) was defined as achieving a score of 0 or 1 (none or mild) and an improvement of at least 2 points from baseline for both the investigator's and subject's assessments at Week 4. The percentages of subjects with treatment success at Week 4 are presented in Table 5. TABLE 5: Percentage of Subjects Achieving a Score of None or Mild and ≥ 2-Grade Improvement from Baseline on the Investigator and Subject Assessment of Glabellar Line Severity at Maximum Frown at Week 4 STUDY GL-1 STUDY GL-2 DAXXIFY (N=201) n (%) Placebo (N=102) n (%) Treatment Difference and 95% Confidence Interval DAXXIFY (N=205) n (%) Placebo (N=101) n (%) Treatment Difference and 95% Confidence Interval Treatment Success A score of 0 or 1 (none or mild) and ≥ 2-grade improvement from baseline on both the investigator and subject assessment. 148 (74%) 0 (0%) 74% (68%, 80%) 152 (74%) 0 (0%) 74% (68%, 80%) Individual Components Investigator Assessment 172 (86%) 1 (1%) --- 187 (92%) 2 (2%) --- Subject Assessment 152 (76%) 0 (0%) --- 156 (77%) 0 (0%) --- Figure 2 shows the proportion of subjects, over 36 weeks, rated as 0 or 1 (none or mild) by the investigator, 0 or 1 by the subject, and 0 or 1 with at least a 2-point improvement from their baseline based on both the investigator and subject ratings.
Subjects were followed through at least Week 24 and then were discontinued from the study when both the investigator and subject scores returned to baseline. Subjects who returned to baseline levels prior to Week 36 were counted as non-responders following study discontinuation. FIGURE 2: Proportion of subjects rated as 0 or 1 (none or mild) by investigator, 0 or 1 by the subject, and 0 or 1 with at least 2-point improvement from their baseline (based on both the investigator and subject ratings) in Study GL-1 and Study GL-2. Treatment success is defined as a score of 0 or 1 (none or mild) and ≥ 2-grade improvement from baseline on both the investigator and subject assessment.
FIGURE 2 - Study GL-1 FIGURE 2 - Study GL-2
Cervical Dystonia
The efficacy of DAXXIFY was evaluated in a randomized, double-blind, placebo-controlled, multi-center trial in a total of 301 patients (NCT03608397). The mean age of patients was 58 years, 65% were women, and 96% were White. At study baseline, 84% of patients had previously received a botulinum toxin as treatment for cervical dystonia. Patients had a clinical diagnosis of cervical dystonia with baseline Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score ≥ 20, TWSTRS severity score ≥15, TWSTRS disability score ≥3, and TWSTRS pain score ≥1. For patients who had previously received a botulinum toxin treatment for cervical dystonia, the trial required that ≥14 weeks had passed since the most recent botulinum toxin administration.
Patients were randomized (3:3:1) to receive a single administration of 2.5 mL of either DAXXIFY 125 Units (n = 125), DAXXIFY 250 Units (n = 130), or placebo (n = 46), divided amongst the affected muscles as selected by the investigator. Table 6 indicates the treated muscles, along with the number of patients treated and DAXXIFY units. TABLE 6: Summary of Muscles Treated in Each DAXXIFY Treatment Group Unilateral Muscle Injected DAXXIFY 125 Units DAXXIFY 250 Units Number of Patients Median Units (min, max) Number of Patients Median Units (min, max) Levator Scapulae 106 20 105 50 Longissimus Capitis and Cervices 45 15 58 40 Scalenus Complex 55 15 44 30 Splenius Capitis 120 25 127 50 Splenius Cervices 65 20 71 40 Sternocleidomastoid 115 25 121 50 Trapezius 105 20 105 40 The primary efficacy endpoint was the mean change in the TWSTRS total score from baseline averaged over weeks 4 and 6. TWSTRS evaluates the severity of dystonia, patient-perceived disability from dystonia, and pain, with a range of possible scores from 0 to 85. The mean change from baseline in the total TWSTRS score was significantly greater for both dosage groups of DAXXIFY than for placebo (Table 7). TABLE 7: Change in TWSTRS Score Averaged over Weeks 4 and 6 in Patients with Cervical Dystonia TWSTRS Assessment Placebo (N = 46) DAXI 125 Units (N = 125) DAXI 250 Units (N = 130) Baseline mean 45.3 43.1
Least squares mean change from baseline -4.3 -12.7 -10.9 Least squares mean
difference from placebo (95% CI) -8.4 (-12.2, -4.6) -6.6 (-10.4, -2.8) p-value <0.0001 0.0007 A similar pattern of significant improvement versus placebo was observed in the clinician global impression of change (CGIC) and patient global impression of change (PGIC) scales.
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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