United States - English - NLM (National Library of Medicine)

allergan, inc. - botulinum toxin type a (unii: e211kpy694) (botulinum toxin type a - unii:e211kpy694) - botulinum toxin type a 100 [usp'u] - overactive bladder botox  for injection is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication. detrusor overactivity associated with a neurologic condition botox  is indicated for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., sci, ms) in adults who have an inadequate response to or are intolerant of an anticholinergic medication. botox is indicated for the treatment of neurogenic detrusor overactivity (ndo) in pediatric patients 5 years of age and older who have an inadequate response to or are intolerant of anticholinergic medication. botox is indicated for the prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer). limitations of use safety and effectiveness have not been established for the prophylaxis of episodic migraine (14 headache days or fewer per month) in seven placebo-controlled studies. botox is indicated for the treatment of spasticity in patients 2 years of age and older. limitations of use   botox has not been shown to improve upper extremity functional abilities, or range of motion at a joint affected by a fixed contracture. botox is indicated for the treatment of adults with cervical dystonia, to reduce the severity of abnormal head position and neck pain associated with cervical dystonia. botox is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents. limitations of use the safety and effectiveness of botox for hyperhidrosis in other body areas have not been established. weakness of hand muscles and blepharoptosis may occur in patients who receive botox for palmar hyperhidrosis and facial hyperhidrosis, respectively. patients should be evaluated for potential causes of secondary hyperhidrosis (e.g., hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease. safety and effectiveness of botox have not been established for the treatment of axillary hyperhidrosis in pediatric patients under age 18. botox is indicated for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or vii nerve disorders in patients 12 years of age and older. botox is contraindicated: - in patients who are hypersensitive to any botulinum toxin product or to any of the components in the formulation [see warnings and precautions ( 5.4 )] .  - in the presence of infection at the proposed injection site(s). - for intradetrusor injection in patients with a urinary tract infection; or in patients with urinary retention or post-void residual (pvr) urine volume >200 ml who are not routinely performing clean intermittent self-catheterization (cic) [see warnings and precautions ( 5.12 , 5.13 )] . risk summary there are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of botox in pregnant women. in animal studies, administration of botox during pregnancy resulted in adverse effects on fetal growth (decreased fetal weight and skeletal ossification) at clinically relevant doses, which were associated with maternal toxicity [see data ]. 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. the background risk of major birth defects and miscarriage for the indicated populations is unknown. data animal data when botox (4, 8, or 16 units/kg) was administered intramuscularly to pregnant mice or rats two times during the period of organogenesis (on gestation days 5 and 13), reductions in fetal body weight and decreased fetal skeletal ossification were observed at the two highest doses. the no-effect dose for developmental toxicity in these studies (4 units/kg) is approximately equal to the human dose of 400 units, on a body weight basis (units/kg). when botox was administered intramuscularly to pregnant rats (0.125, 0.25, 0.5, 1, 4, or 8 units/kg) or rabbits (0.063, 0.125, 0.25, or 0.5 units/kg) daily during the period of organogenesis (total of 12 doses in rats, 13 doses in rabbits), reduced fetal body weights and decreased fetal skeletal ossification were observed at the two highest doses in rats and at the highest dose in rabbits. these doses were also associated with significant maternal toxicity, including abortions, early deliveries, and maternal death. the developmental no-effect doses in these studies of 1 unit/kg in rats and 0.25 units/kg in rabbits are less than the human dose of 400 units, based on units/kg. when pregnant rats received single intramuscular injections (1, 4, or 16 units/kg) at three different periods of development (prior to implantation, implantation, or organogenesis), no adverse effects on fetal development were observed. the developmental no-effect level for a single maternal dose in rats (16 units/kg) is approximately 2 times the human dose of 400 units, based on units/kg. risk summary there are no data on the presence of botox 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 botox and any potential adverse effects on the breastfed infant from botox or from the underlying maternal conditions. detrusor overactivity associated with a neurologic condition the safety and effectiveness of botox for detrusor overactivity associated with a neurologic condition have been established in pediatric patients 5 years of age and older who have an inadequate response to or are intolerant of anticholinergic medication. use of botox in this patient population is based on the results of a randomized, double-blind, parallel group trial in 113 pediatric patients 5 to 17 years of age (inclusive) with detrusor overactivity associated with a neurologic condition (study 191622-120) and a long-term, multicenter, double-blind, long-term extension trial (study 191622-121) [see clinical studies ( 14.3 )]. the most common adverse reactions in this population were urinary tract infection, bacteriuria, hematuria, and leukocyturia [see adverse reactions   ( 6.1 ) ] . the safety and effectiveness of botox have not been established in patients with ndo younger than 5 years of age. overactive bladder the safety and effectiveness of botox for the treatment of overactive bladder have not been established in pediatric patients. efficacy was not demonstrated in a multicenter, randomized, double-blind, parallel-group, multiple-dose clinical study which was conducted to evaluate the efficacy and safety of botox in pediatric patients aged 12 to 17 years with overactive bladder. fifty-five patients who had an inadequate response to or were intolerant of at least one anticholinergic medication were treated with botox. there was not a statistically significant difference in the mean change from baseline in the daily average frequency of daytime urinary incontinence episodes (primary efficacy endpoint) at week 12 post-treatment when a medium and high dose were each compared to a low dose of botox. the adverse reactions in pediatric patients treated with botox were comparable with the known safety profile in adults with overactive bladder.  prophylaxis of headaches in chronic migraine safety and effectiveness in patients below the age of 18 years have not been established. in a 12-week, multicenter, double-blind, placebo-controlled clinical trial, 123 adolescent patients (ages 12 to below 18 years) with chronic migraine were randomized to receive botox 74 units, botox 155 units, or placebo, for one injection cycle. this trial did not establish the efficacy of botox, compared with placebo, for the prophylaxis of headaches in adolescents with chronic migraine. spasticity safety and effectiveness have been established in pediatric patients 2 to 17 years of age [see warnings and precautions ( 5.1 ), adverse reactions ( 6.1 ) , and clinical studies ( 14.6 )] . the safety and effectiveness of botox have been established by evidence from adequate and well-controlled studies of botox in patients 2 to 17 years of age with upper and lower limb spasticity. safety and effectiveness in pediatric patients below the age of 2 years have not been established [see boxed warning and warnings and precautions ( 5.1 )]. axillary hyperhidrosis safety and effectiveness in patients below the age of 18 years have not been established. cervical dystonia safety and effectiveness in pediatric patients below the age of 16 years have not been established. blepharospasm and strabismus safety and effectiveness in pediatric patients below the age of 12 years have not been established. juvenile animal data in a study in which juvenile rats received intramuscular injection of botox (0, 8, 16, or 24 units/kg) every other week from postnatal day 21 for 12 weeks, changes in bone size/geometry associated with decreased bone density and bone mass were observed at all doses, in association with limb disuse, decreased muscle contraction, and decreased body weight gain. impairment of fertility and male reproductive organ histopathology (degeneration of seminiferous tubules of the testis) were observed at the mid and high doses. bone and male reproductive organ effects showed evidence of reversibility after dosing cessation. the no-effect dose for adverse developmental effects in juvenile animals (8 units/kg) is similar to the human dose (400 units) on a body weight (kg) basis. of the 2145 adult patients in placebo-controlled clinical studies of botox for the treatment of spasticity, 33.5% were 65 or older, and 7.7% were 75 years of age or older. no overall differences in safety were observed between elderly patients and adult patients younger than 65 years of age.  in clinical studies of botox across other indications, no overall differences in safety were observed between elderly patients and younger adult patients, with the exception of overactive bladder (see below). other reported clinical experience has not identified differences in responses between the elderly and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out. overactive bladder of 1242 overactive bladder patients in placebo-controlled clinical studies of botox, 41.4% were 65 years of age or older, and 14.7% were 75 years of age or older. adverse reactions of uti and urinary retention were more common in patients 65 years of age or older in both placebo and botox groups compared to younger patients (see table 24). otherwise, there were no overall differences in the safety profile following botox treatment between patients aged 65 years and older compared to adult patients younger than 65 years of age in these studies. observed effectiveness was comparable between these age groups in placebo-controlled clinical studies.

United States - English - NLM (National Library of Medicine)

evolus, inc. - botulinum toxin type a (unii: e211kpy694) (botulinum toxin type a - unii:e211kpy694) - jeuveau 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. jeuveau is contraindicated in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation [see warnings and precautions (5.4) ]. jeuveau is contraindicated in the presence of infection at the proposed injection site(s). the limited available data on jeuveau use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. an embryofetal developmental study conducted with jeuveau in pregnant rats revealed no treatment-related effects to the developing fetus when jeuveau was administered intramuscularly during organogenesis at doses up to 12 times the maximum recommended human dose (mrhd) (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. animal data in an embryofetal developmental study, intramuscular doses up to 4 unit/kg jeuveau were administered to pregnant rats once daily during organogenesis (gestation days 6 to 16). no maternal or embryofetal toxicities were observed at doses up to 4 unit/kg (12 times the mrhd of 20 units, based on unit/kg comparison). there is no information regarding the presence of prabotulinumtoxina-xvfs in human or animal milk, its effects on the breastfed infant, or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for jeuveau and any potential adverse effects on the breastfed infant from jeuveau or from the underlying maternal condition safety and effectiveness in pediatric patients have not been established. the two clinical trials of jeuveau included 68 subjects age 65 and greater. although no differences in safety or efficacy were observed between older and younger subjects, clinical studies of jeuveau did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

United States - English - NLM (National Library of Medicine)

revance therapeutics, inc. - botulinum toxin type a (unii: e211kpy694) (botulinum toxin type a - unii:e211kpy694) - 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)].

Australia - English - Department of Health (Therapeutic Goods Administration)

evolus australia pty ltd - prabotulinumtoxina, quantity: 100 u - solution, powder for - excipient ingredients: sodium chloride; albumin - nuceiva is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients.