MYALEPT- metreleptin injection, powder, lyophilized, for solution United States - English - NLM (National Library of Medicine)

myalept- metreleptin injection, powder, lyophilized, for solution

amryt pharmaceuticals dac - metreleptin (unii: tl60c27rlh) (metreleptin - unii:tl60c27rlh) - metreleptin 11.3 mg in 2.2 ml - myalept (metreleptin) for injection is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. limitations of use - the safety and effectiveness of myalept for the treatment of complications of partial lipodystrophy have not been established. - the safety and effectiveness of myalept for the treatment of liver disease, including nonalcoholic steatohepatitis (nash), have not been established. - myalept is not indicated for use in patients with hiv-related lipodystrophy. - myalept is not indicated for use in patients with metabolic disease, including diabetes mellitus and hypertriglyceridemia, without concurrent evidence of congenital or acquired generalized lipodystrophy. myalept is contraindicated in patients with general obesity not associated with congenital leptin deficiency. myalept has not been shown to be effective in treating general obesity, and the development of anti-metreleptin antibodi

JUXTAPID- lomitapide mesylate capsule United States - English - NLM (National Library of Medicine)

juxtapid- lomitapide mesylate capsule

amryt pharmaceuticals dac - lomitapide mesylate (unii: x4s83cp54e) (lomitapide - unii:82kub0583f) - lomitapide 5 mg - juxtapid is indicated as an adjunct to a low-fat diet and other lipid-lowering treatments, including ldl apheresis where available, to reduce low-density lipoprotein cholesterol (ldl-c), total cholesterol (tc), apolipoprotein b (apo b), and non-high-density lipoprotein cholesterol (non-hdl-c) in patients with homozygous familial hypercholesterolemia (hofh). limitations of use - the safety and effectiveness of juxtapid have not been established in patients with hypercholesterolemia who do not have hofh, including those with heterozygous familial hypercholesterolemia (hefh). - the effect of juxtapid on cardiovascular morbidity and mortality has not been determined. juxtapid is contraindicated in the following conditions: - pregnancy [see warnings and precautions (5.3) and use in specific populations (8.1)] . - concomitant administration of juxtapid with moderate or strong cyp3a4 inhibitors, as this can increase juxtapid exposure [see warnings and precautions (5.6), drug interactions (7.1), and clinical pharmac

Filsuvez European Union - English - EMA (European Medicines Agency)

filsuvez

amryt pharmaceuticals dac - dry extract from birch bark (der 5-10 : 1), extraction solvent n-heptane 95% (w/w) - epidermolysis bullosa dystrophica; epidermolysis bullosa, junctional - preparations for treatment of wounds and ulcers - treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (eb) in patients 6 months and older.

Myalepta European Union - English - EMA (European Medicines Agency)

myalepta

amryt pharmaceuticals dac - metreleptin - lipodystrophy, familial partial - other alimentary tract and metabolism products, - myalepta is indicated as an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (ld) patients:with confirmed congenital generalised ld (berardinelli-seip syndrome) or acquired generalised ld (lawrence syndrome) in adults and children 2 years of age and abovewith confirmed familial partial ld or acquired partial ld (barraquer-simons syndrome), in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control.

Mycapssa European Union - English - EMA (European Medicines Agency)

mycapssa

amryt pharmaceuticals dac - octreotide acetate - acromegaly - pituitary and hypothalamic hormones and analogues - mycapssa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.

Lojuxta European Union - English - EMA (European Medicines Agency)

lojuxta

amryt pharmaceuticals dac - lomitapide - hypercholesterolemia - lipid modifying agents - lojuxta is indicated as an adjunct to a low‑fat diet and other lipid‑lowering medicinal products with or without low-density-lipoprotein (ldl) apheresis in adult patients with homozygous familial hypercholesterolaemia (hofh). genetic confirmation of hofh should be obtained whenever possible. other forms of primary hyperlipoproteinaemia and secondary causes of hypercholesterolaemia (e.g. nephrotic syndrome, hypothyroidism) must be excluded.,

FILSUVEZ- birch triterpenes gel United States - English - NLM (National Library of Medicine)

filsuvez- birch triterpenes gel

amryt pharmaceuticals dac - birch triterpenes (unii: bx09b0rqr0) (birch triterpenes - unii:bx09b0rqr0) - filsuvez is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa (eb) in adult and pediatric patients 6 months of age and older. none. risk summary there are no available data with use of filsuvez in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in an animal reproduction study, oral administration of birch triterpenes to pregnant rats during the period of organogenesis had no effects on reproductive or fetal parameters (see data) . systemic absorption of filsuvez in humans is low following topical administration of filsuvez, and maternal use is not expected to result in fetal exposure to the drug [see pharmacokinetics (12.3)] . 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 miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data in an embryofetal development study, birch triterpenes were orally administered to pregnant rats at doses of 10, 30, or 100 mg/kg/day during the period of organogenesis. birch triterpenes did not cause maternal toxicity or fetal malformations at doses up to 100 mg/kg/day. in a prenatal and postnatal development study, birch triterpenes were orally administered to pregnant rats at doses of 10, 30, or 100 mg/kg/day from gestation day 5 through lactation day 20. birch triterpenes did not affect development at doses up to 100 mg/kg/day. the available data do not support relevant comparisons of systemic birch triterpenes exposures achieved in the animal studies to exposures observed in humans after topical use of filsuvez. risk summary there are no data on the presence of birch triterpenes or metabolites in human milk, the effects on the breastfed infant, or the effect on milk production. no effects on the breastfed infant are anticipated since the systemic exposure of the breastfeeding woman to filsuvez would be low. therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for filsuvez and any potential adverse effects on the breastfed infant from filsuvez or from the underlying maternal condition [see pharmacokinetics (12.3)]. the safety and effectiveness of filsuvez for the treatment of wounds associated with dystrophic and junctional eb have been established in pediatric patients 6 months of age and older. use of filsuvez in this age group is supported by evidence from a single randomized, placebo-controlled trial in 156 subjects 6 months to 17 years of age [see clinical studies (14)] . the safety and effectiveness of filsuvez have not been established in pediatric patients younger than 6 months of age. clinical studies of filsuvez did not include sufficient numbers of eb subjects 65 years of age and older to determine whether they respond differently from younger subjects. important information: filsuvez is for use on the skin (topical use) only. do not use filsuvez in or around your eyes or mucous membranes (for example, the mouth, vagina, or anus). this instructions for use contains information on how to apply filsuvez. read this instructions for use before you start using filsuvez. ask your healthcare provider if you have any questions. important information you need to know before applying filsuvez - use filsuvez exactly as your healthcare provider tells you to use it. - apply filsuvez directly to the wound or to the dressing surface that will be in contact with the wound. - clean wounds before applying filsuvez as instructed by your healthcare provider. - apply filsuvez with a clean or gloved hand. - apply filsuvez at each dressing change until the wound is completely healed. - do not get filsuvez in or apply around the eyes, or mucous membranes (for example, mouth, vagina, or anus). if you get filsuvez in your eyes or mucous membranes, rinse with clean water right away. contact your healthcare provider if you have any discomfort. - wash hands after applying filsuvez and caring for wounds. - the tube of filsuvez is for one-time use only. after the tube has been opened, apply the filsuvez gel right away. throw away any remaining gel and the tube after use. - check the expiration date on the filsuvez tube. do not use filsuvez if the expiration date has passed. call your pharmacist or healthcare provider for instructions. gather your supplies - a new tube of filsuvez - gloves (if using) - sterile, non-adhesive dressing applying filsuvez - wash your hands with soap and water or wear gloves. - open a new tube of filsuvez. apply the gel right away. - you can apply filsuvez in 2 ways, either directly to the wound or to the non-adhesive dressing surface that will be in contact with the wound. option 1: apply filsuvez directly to wound. apply a 1 mm layer of filsuvez to the wound (see step 1). cover the entire wound surface with a 1 mm layer of filsuvez (step 2). do not rub in the gel. cover the wound with a sterile, non-adhesive wound dressing (see step 3). step 1 step 2 step 3 or option 2: apply filsuvez directly to sterile, non-adhesive dressing. apply a generous layer of filsuvez directly to the sterile, non-adhesive dressing (see step 1). cover the entire non-adhesive dressing with filsuvez (step 2). cover the wound with the dressing so that the gel is in direct contact with the wound (see step 3). secure the non-adhesive wound dressing as directed by your healthcare provider . step 1 step 2 step 3 - apply a 1 mm layer of filsuvez to the wound (see step 1). cover the entire wound surface with a 1 mm layer of filsuvez (step 2). do not rub in the gel. cover the wound with a sterile, non-adhesive wound dressing (see step 3). - apply a generous layer of filsuvez directly to the sterile, non-adhesive dressing (see step 1). cover the entire non-adhesive dressing with filsuvez (step 2). cover the wound with the dressing so that the gel is in direct contact with the wound (see step 3). secure the non-adhesive wound dressing as directed by your healthcare provider . how should i store filsuvez? store filsuvez at room temperature between 68°f to 77°f (20°c to 25°c). do not freeze. keep filsuvez and all medicines out of the reach of children. how should i throw away (dispose of) filsuvez? throw away (dispose of) any remaining filsuvez and the tube right away after use in household trash or through a drug take-back option, if available. go to www.fda.gov/drugdisposal for more information on drug disposal. manufactured by: lichtenheldt gmbh, pharmazeutische fabrik, werk 1, industriestr. 7-11, 23812 wahlstedt, germany for more information, call 1-855-303-2347 or go to www.filsuvez.com this instructions for use has been approved by the u.s. food and drug administration. approved: december-2023