DAXXIFY
Generic: BOTULINUM TOXIN TYPE A
Basic Information
Manufacturer
Revance Therapeutics, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAMUSCULAR
FDA Set ID
3aaa6e14-a3f7-4fb2-b9f9-d3a9c3ae1f74
Indications & Usage
1 INDICATIONS AND USAGE DAXXIFY is an acetylcholine release inhibitor and neuromuscular-blocking agent indicated for: Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/ or procerus muscle activity in adult patients.
( 1.1 ) The treatment of cervical dystonia in adult patients.
( 1.2 ) 1.1 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.
1.2 Cervical Dystonia DAXXIFY is indicated for the treatment of cervical dystonia in adult patients.
( 1.1 ) The treatment of cervical dystonia in adult patients.
( 1.2 ) 1.1 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.
1.2 Cervical Dystonia DAXXIFY is indicated for the treatment of cervical dystonia in adult patients.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Spread of Toxin Effect [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] Cardiovascular System Adverse Reactions [see Warnings and Precautions (5.5) ] Increased Neuromuscular Compromise in Patients with Pre-Existing Neuromuscular Disorders [see Warnings and Precautions (5.6) ] Dysphagia and Breathing Difficulties [see Warnings and Precautions (5.7) ] Ophthalmic Adverse Reactions in Patients Treated for Glabellar Lines [see Warnings and Precautions (5.9) ] The most commonly observed adverse reactions are: Glabellar Lines (≥1%): headache (6%), eyelid ptosis (2%), and facial paresis (1%).
( 6.1 ) Cervical Dystonia (≥5%): headache (9%), injection site pain (8%), injection site erythema (5%), muscular weakness (5%), and upper respiratory tract infection (5%).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Revance Therapeutics, Inc.
at 1-877-373-8669 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 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 [including injection site pain (4%), injection site erythema (3%), injection site oedema (3%), injection site bruising (1%), injection site papule (<1%), and injection site pruritus (<1%)], 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%).
( 6.1 ) Cervical Dystonia (≥5%): headache (9%), injection site pain (8%), injection site erythema (5%), muscular weakness (5%), and upper respiratory tract infection (5%).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Revance Therapeutics, Inc.
at 1-877-373-8669 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 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 [including injection site pain (4%), injection site erythema (3%), injection site oedema (3%), injection site bruising (1%), injection site papule (<1%), and injection site pruritus (<1%)], 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%).