Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
BOTULINUM TOXIN TYPE A (UNII: E211KPY694) (BOTULINUM TOXIN TYPE A - UNII:E211KPY694)
Revance Therapeutics, Inc.
INTRAMUSCULAR
PRESCRIPTION DRUG
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. DAXXIFY is indicated for the treatment of cervical dystonia in adult patients. DAXXIFY is contraindicated in: - patients with known hypersensitivity to any botulinum toxin preparation, DAXXIFY, or any of the components in the DAXXIFY formulation [see Warnings and Precautions (5.4)]. - the presence of infection at the proposed injection sites. Risk Summary 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. In animal reproduction studies, intramuscular administration of DAXXIFY 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) (see Data ). 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. Data Animal Data Embryofetal development studies were conducted in rats and rabbits with DAXXIFY. 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 DAXXIFY (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 DAXXIFY (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. Risk Summary There are no data on the presence of DAXXIFY 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 DAXXIFY and any potential adverse effects on the breastfed infant from DAXXIFY or from the underlying maternal condition. Safety and effectiveness of DAXXIFY in patients less than 18 years of age have not been established. Glabellar Lines Among the 406 subjects treated with DAXXIFY 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 DAXXIFY. Clinical studies of DAXXIFY did not include sufficient numbers of subjects aged 65 and older to determine whether they responded differently from younger subjects [see Clinical Studies (14)]. Cervical Dystonia Among the 255 patients treated with DAXXIFY in the placebo-controlled clinical trial, 83 patients were 65 years or older. There was no increase in the incidence of treatment-related adverse events in patients over 65 years treated with DAXXIFY. Clinical studies of DAXXIFY did not include sufficient numbers of patients aged 65 and older to determine whether they responded differently from younger patients [see Clinical Studies (14)].
How Supplied DAXXIFY (daxibotulinumtoxinA-lanm) for injection is a sterile lyophilized powder supplied in a single-dose vial in the following sizes: Carton containing one 50 Units/Vial NDC 72960-111-01 Carton containing one 100 Units/Vial NDC 72960-112-01 Storage and Handling 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.
Biologic Licensing Application
Revance Therapeutics, Inc. ---------- MEDICATION GUIDE DAXXIFY® (DAX'-I-FYE) DAXIBOTULINUMTOXINA-LANM FOR INJECTION, FOR INTRAMUSCULAR USE This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 11/2023 What is the most important information I should know about DAXXIFY? DAXXIFY may cause serious side effects that can be life-threatening. Call your healthcare provider or get medical help right away if you have any of these problems after treatment with DAXXIFY: • Problems swallowing, speaking, or breathing. These problems can happen hours, days, or weeks after an injection of DAXXIFY if the muscles that you use to breathe and swallow become weak after the injection. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with DAXXIFY. • People with certain breathing problems may need to use muscles in their neck to help them breathe. These people may be at greater risk for serious breathing problems with DAXXIFY. • Swallowing problems may last for several months. People who cannot swallow well may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving DAXXIFY have the highest risk of getting these problems. • Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include: • loss of strength and muscle weakness all over the body • blurred vision and drooping eyelids • trouble saying words clearly • trouble breathing • double vision • hoarseness or change or loss of voice • loss of bladder control • trouble swallowing These symptoms can happen hours, days, or weeks after you receive an injection of DAXXIFY. These problems could make it unsafe for you to drive a car or do other dangerous activities. See "What shoul Læs hele dokumentet
DAXXIFY- BOTULINUM TOXIN TYPE A INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION REVANCE THERAPEUTICS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DAXXIFY SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DAXXIFY. DAXXIFY (DAXIBOTULINUMTOXINA-LANM) FOR INJECTION, FOR INTRAMUSCULAR USE INITIAL U.S. APPROVAL: 2022 WARNING: DISTANT SPREAD OF TOXIN EFFECT _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ THE EFFECTS OF DAXXIFY 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. THE RISK OF SYMPTOMS IS PROBABLY GREATEST IN CHILDREN TREATED FOR SPASTICITY, AN UNAPPROVED USE FOR DAXXIFY, BUT SYMPTOMS CAN ALSO OCCUR IN ADULTS, PARTICULARLY IN THOSE PATIENTS WHO HAVE AN UNDERLYING CONDITION THAT WOULD PREDISPOSE THEM TO THESE SYMPTOMS. (5.1) RECENT MAJOR CHANGES Boxed Warning 8/2023 Indications and Usage (1) 8/2023 Dosage and Administration (2.1, 2.3, 2.4) 8/2023 Warnings and Precautions (5.1) 8/2023 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) DOSAGE AND ADMINISTRATION Glabellar Lines: the recommended dose is 0.1 mL (8 Units) by intramuscular injection into each of five sites, for a total dose of 40 Units. (2.2) Cervical Dystonia: the recommended dose is 125 Units to 250 Units given intramuscularly as a divided dose among affected muscles. (2.3) DOSAGE FORMS AND STRENGTHS For injection: 50 Units or 100 Units sterile lyophilized powder in a single-dose vial. (3) CONTRAINDICATIONS Known hypersensit Læs hele dokumentet