Canada - English - Health Canada

rhythm pharmaceuticals, inc. - setmelanotide (setmelanotide acetate) - solution - 10mg - setmelanotide (setmelanotide acetate) 10mg

Israel - English - Ministry of Health

medison pharma ltd - setmelanotide - solution for injection - setmelanotide 10 mg / 1 ml - imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed bardet-biedl syndrome (bbs), loss-of-function biallelic pro-opiomelanocortin (pomc), including pcsk1, deficiency or biallelic leptin receptor (lepr) deficiency in adults and children 6 years of age and above.

European Union - English - EMA (European Medicines Agency)

rhythm pharmaceuticals netherlands b.v. - setmelanotide - obesity - antiobesity preparations, excl. diet products - imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed bardet biedl syndrome (bbs), loss-of-function biallelic pro-opiomelanocortin (pomc), including pcsk1, deficiency or biallelic leptin receptor (lepr) deficiency in adults and children 6 years of age and above.

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

rhythm pharmaceuticals, inc - setmelanotide (unii: n7t15v1fuy) (setmelanotide - unii:n7t15v1fuy) - imcivree is indicated for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to: - pro-opiomelanocortin (pomc), proprotein convertase subtilisin/kexin type 1 (pcsk1), or leptin receptor (lepr) deficiency as determined by an fda-approved test demonstrating variants in pomc, pcsk1, or lepr genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (vus) [see dosage and administration (2.1) - bardet-biedl syndrome (bbs) [see dosage and administration (2.2)]. limitations of use: imcivree is not indicated for the treatment of patients with the following conditions as imcivree would not be expected to be effective: - obesity due to suspected pomc, pcsk1, or lepr deficiency with pomc , pcsk1 , or lepr variants classified as benign or likely benign - other types of obesity not related to pomc, pcsk1 or lepr deficiency or bbs, including obesity associated with other genetic syndromes and general (polygenic) obe

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

clinuvel pharmaceuticals ltd - afamelanotide acetate, quantity: 18 mg - implant - excipient ingredients: polyglactin - scenesse is indicated for prevention of phototoxicity in adult patients with erythropoietic protoporphyria (epp)

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

palatin technologies - bremelanotide acetate (unii: pv2wi7495p) (bremelanotide - unii:6y24o4f92s) - vyleesi is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (hsdd), as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to: - a co-existing medical or psychiatric condition, - problems with the relationship, or - the effects of a medication or drug substance. acquired hsdd refers to hsdd that develops in a patient who previously had no problems with sexual desire. generalized hsdd refers to hsdd that occurs regardless of the type of stimulation, situation or partner. limitations of use - vyleesi is not indicated for the treatment of hsdd in postmenopausal women or in men. - vyleesi is not indicated to enhance sexual performance. vyleesi is contraindicated in patients who have uncontrolled hypertension or known cardiovascular disease [see warnings and precautions (5.1)]. pregnancy exposure registry there will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to vyleesi during pregnancy. pregnant women exposed to vyleesi and healthcare providers are encouraged to call the vyleesi pregnancy exposure registry at (800) 972-5220. risk summary the few pregnancies in women exposed to vyleesi in clinical trials are insufficient for determining whether there is a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. based on findings in animal studies, the use of vyleesi in pregnant women may be associated with the potential for fetal harm. in animal reproduction and development studies, daily subcutaneous administration of bremelanotide to pregnant dogs during the period of organogenesis at exposures greater than or equal to 16 times the maximum recommended dose (based on area under the concentration-time curve or auc) produced fetal harm. in mice subcutaneously dosed with bremelanotide during pregnancy and lactation, developmental effects were observed in the offspring at greater than or equal to 125-times the maximum recommended dose (based on auc) [see data ]. however, the lowest bremelanotide dose associated with fetal harm has not been identified for either species. for this reason, women should use effective contraception while taking vyleesi and discontinue vyleesi if pregnancy is suspected. 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. data human data there were 7 pregnancies reported in the clinical trials of more than 1057 patients treated with vyleesi for up to 12 months. among these 7 pregnancies, no major congenital anomalies were reported. there was one spontaneous abortion (miscarriage), five full-term live births, and one outcome was unknown due to loss to follow-up. animal data an embryofetal development study was conducted in the dog and a pre- and postnatal development study was conducted in the mouse to inform developmental risk. these two species are not routinely used for reproductive toxicity assessment but were the only two species that could be successfully dosed by the subcutaneous route during gestation. bremelanotide was administered subcutaneously to pregnant dogs (8/dose) at 2, 8, or 20 mg/kg from gestation day (gd) 18-35, corresponding to the period from implantation to late embryogenesis in the dog. embryofetal toxicity, as measured by post-implantation loss, was elevated approximately 3 to 8-fold compared to controls across all treated groups but was not dose-dependent. a developmental no-observed-effect level (noel) was not set. at the low dose of 2 mg/kg/day in the dog, exposure was approximately 16 times the human exposure based on auc. in a pre- and postnatal development study, female mice (30/dose) were dosed subcutaneously at 0, 30, 75, and 150 mg/kg/day from gd 6 through lactation day (ld) 28, and two generations of offspring were assessed (f1 and f2). there were no effects on reproductive parameters in parental (f0) or f1 generation animals at doses up to 150 mg/kg/day (approximately 760 times the human auc). however, developmental delays were observed in the f1 generation mice at ≥ 30 mg/kg/day (approximately 125 times the human auc). for that reason, a developmental noel was not set. there were no significant effects on the growth and development of f2 generation pups. risk summary there is no information on the presence of bremelanotide or its metabolites in human 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 vyleesi and any potential adverse effects on the breastfed child from vyleesi or from the underlying maternal condition. contraception use of vyleesi during pregnancy is not recommended [see use in specific populations (8.1)]. advise females of reproductive potential to use effective contraception while taking vyleesi, and to discontinue vyleesi if pregnancy is suspected. the safety and effectiveness of vyleesi have not been established in pediatric patients. the safety and effectiveness of vyleesi have not been established in geriatric patients. no dosing adjustments are recommended for patients with mild to moderate (egfr 30-89 ml/min/1.73 m2 ) renal impairment. use with caution in patients with severe (egfr <30 ml/min/1.73 m2 ) renal impairment, because these patients may have an increase in the incidence and severity of adverse reactions (e.g., nausea and vomiting) [see clinical pharmacology (12.3)] . no dosing adjustments are recommended for patients with mild to moderate (child-pugh a and b; score 5-9) hepatic impairment. vyleesi has not been evaluated in patients with severe hepatic impairment. use with caution in patients with severe (child-pugh c; score 10-15) hepatic impairment, because these patients may have an increase in the incidence and severity of adverse reactions (e.g., nausea and vomiting) [see clinical pharmacology (12.3)]. - do not use more than 1 dose of vyleesi in 24 hours. - do not use more than 8 doses of vyleesi within a month. - use 1 autoinjector for your dose of vyleesi. throw away (dispose of) the autoinjector after giving your injection. see step 6: throw away (dispose of) the vyleesi autoinjector. - inject vyleesi into the skin of the stomach area (abdomen) or thigh only. - do not pull off the clear cap from the vyleesi autoinjector until you are ready to inject vyleesi. - 1 alcohol wipe (not included in carton) - 1 vyleesi autoinjector - 1 cotton ball or gauze (not included in carton) - 1 adhesive bandage (not included in carton) - 1 sharps disposal container for vyleesi autoinjector disposal. see step 6: throw away (dispose of) the vyleesi autoinjector. - do not try to recap the autoinjector. - the autoinjector should be used or thrown away right after the cap is removed. see step 6: throw away (dispose of) the vyleesi autoinjector. - do not inject into skin that is irritated, sore, bruised, red, hard, or scarred. - do not inject through your clothes. - choose a different site each time you give yourself an injection. - made of heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - a cotton ball or gauze can be used initially to apply pressure after the injection if there is bleeding. an adhesive bandage should be applied after this, if needed. - apply an adhesive bandage if needed. - do not rub the injection site.

European Union - English - EMA (European Medicines Agency)

clinuvel europe limited - afamelanotide - protoporphyria, erythropoietic - emollients and protectives - prevention of phototoxicity in adult patients with erythropoietic protoporphyria (epp).

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

amag pharmaceuticals, inc. - bremelanotide acetate (unii: pv2wi7495p) (bremelanotide - unii:6y24o4f92s) - vyleesi is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (hsdd), as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to: - a co-existing medical or psychiatric condition, - problems with the relationship, or - the effects of a medication or drug substance. acquired hsdd refers to hsdd that develops in a patient who previously had no problems with sexual desire. generalized hsdd refers to hsdd that occurs regardless of the type of stimulation, situation or partner. limitations of use - vyleesi is not indicated for the treatment of hsdd in postmenopausal women or in men. - vyleesi is not indicated to enhance sexual performance. vyleesi is contraindicated in patients who have uncontrolled hypertension or known cardiovascular disease [see warnings and precautions (5.1)]. pregnancy exposure registry there will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed t

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

clinuvel inc. - afamelanotide (unii: qw68w3j66u) (afamelanotide - unii:qw68w3j66u) - scenesse® is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (epp). none.

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

csm clinical supplies management europe gmbh - afamelanotide (unii: qw68w3j66u) (afamelanotide - unii:qw68w3j66u) - scenesse® is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (epp). none. the safety and effectiveness of scenesse have not been established in pediatric patients. there were 10 subjects 65 years old and over in the clinical studies for epp [see clinical studies (14)]. of the 125 subjects treated with scenesse in these studies, 4 (3%) were 65 years of age and older. clinical studies of scenesse did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients.