미국 - 영어 - NLM (National Library of Medicine)

vertex pharmaceuticals incorporated - exagamglogene autotemcel (unii: s53l777gm8) (exagamglogene autotemcel - unii:s53l777gm8) - casgevy is indicated for the treatment of patients aged 12 years and older with: - sickle cell disease (scd) with recurrent vaso-occlusive crises - transfusion-dependent β- thalassemia (tdt) none. consider the risks of mobilization and myeloablative conditioning agents in patients with reproductive potential and patients that are pregnant or breastfeeding. risk summary there are no clinical data from the use of exagamglogene autotemcel in pregnant women. no animal reproductive and developmental toxicity studies have been conducted with exagamglogene autotemcel to assess whether it can cause fetal harm when administered to a pregnant woman. casgevy must not be administered during pregnancy because of the risks associated with myeloablative conditioning. pregnancy after casgevy infusion should be discussed with the treating physician. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there are no data on the presence of exagamglogene autotemcel in human or animal milk, the effects on the breastfed child, or the effects on milk production. because of the potential risks associated with myeloablative conditioning, breastfeeding should be discontinued during conditioning. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for casgevy and any potential adverse effects on the breastfed child from casgevy or from the underlying maternal condition. breastfeeding after casgevy infusion should be discussed with the treating physician. pregnancy testing a negative serum pregnancy test must be confirmed prior to the start of each mobilization cycle and re-confirmed prior to myeloablative conditioning. contraception there are insufficient exposure data to provide a precise recommendation on duration of contraception following treatment with casgevy. women of childbearing potential and men capable of fathering a child should use effective method of contraception from start of mobilization through at least 6 months after administration of casgevy. advise patients of the risks associated with conditioning agents. infertility there are no data on the effects of exagamglogene autotemcel on human fertility. effects on male and female fertility have not been evaluated in animal studies. infertility has been observed with myeloablative conditioning therefore, advise patients of fertility preservation options before treatment, if appropriate. the safety and efficacy of casgevy has been established in pediatric patients with scd and tdt aged 12 years and older. use of casgevy in patients aged 12 to less than 18 years is supported by data in 12 patients with scd in trial 1 (6 patients evaluable for the primary efficacy analysis), and 18 patients with tdt in trial 2 (11 patients evaluable for the primary efficacy analysis). the efficacy and safety profile of casgevy in pediatric patients aged 12 years and older were consistent with the efficacy and safety in adult patients [see adverse reactions (6.1) and clinical studies (14.1, 14.2)] . patients with scd the median (min, max) time to platelet engraftment was 45 (23, 81) days in pediatric patients aged 12 years and older and 32 (23, 126) days in adult patients. the median (min, max) time to neutrophil engraftment was 28 (24, 40) days in pediatric patients aged 12 years and older and 26 (15, 38) days in adult patients. patients with tdt the median (min, max) time to platelet engraftment was 45 (20, 199) days in pediatric patients aged 12 years and older and 41.5 (24, 200) days in adult patients. the median (min, max) time to neutrophil engraftment was 30 (19, 56) days in pediatric patients aged 12 years and older and 28.5 (12, 40) days in adult patients. the safety and efficacy of casgevy in pediatric patients aged less than 12 years has not been established. casgevy has not been studied in patients > 65 years of age. hsc transplantation must be appropriate for a patient to be treated with casgevy. casgevy has not been studied in patients with renal impairment, defined as estimated glomerular filtration rate < 60 ml/min/1.73 m2 . patients should be assessed for renal impairment to ensure hsc transplantation is appropriate. casgevy has not been studied in patients with hepatic impairment. patients should be assessed for hepatic impairment to ensure hsc transplantation is appropriate. casgevy has not been studied in patients with hiv-1, hiv-2, hbv or hcv. perform screening for hiv-1, hiv-2, hbv and hcv and any other infectious agents in accordance with local guidelines before collection of cells for manufacturing. casgevy should not be used in patients with active hiv-1, hiv-2, hbv or hcv. casgevy has not been studied in patients who have received a prior allogeneic or autologous hsc transplant. treatment with casgevy is not recommended in these patients.

캐나다 - 영어 - Health Canada

jubilant hollisterstier llc - pollen - solution - 40000unit - pollen 40000unit - allergenic extracts

미국 - 영어 - NLM (National Library of Medicine)

bluebird bio, inc. - lovotibeglogene autotemcel (unii: 2c6a9nh2z8) (lovotibeglogene autotemcel - unii:2c6a9nh2z8) - lyfgenia is indicated for the treatment of patients 12 years of age or older with sickle cell disease and a history of vaso-occlusive events. limitations of use following treatment with lyfgenia, patients with α-thalassemia trait (-α3.7/-α3.7) may experience anemia with erythroid dysplasia that may require chronic red blood cell transfusions [see adverse reactions (6.1)] . lyfgenia has not been studied in patients with more than two α-globin gene deletions. none. risk summary there are no available data on lyfgenia administration in pregnant women. consider the risks associated with myeloablative conditioning agents on pregnancy and fertility. no reproductive and developmental toxicity studies in animals have been conducted with lyfgenia to assess whether it can cause fetal harm when administered to a pregnant woman. it is not known whether lyfgenia has the potential to be transferred to the fetus. therefore, lyfgenia should not be administered to women who are pregnant, and pregnancy after lyfgenia infusion should be discussed with the treating physician. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. risk summary there is no information regarding the presence of lyfgenia in human milk, the effect on the breastfed infant, and the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for lyfgenia and any potential adverse effects on the breastfed child from lyfgenia. therefore, lyfgenia is not recommended for women who are breastfeeding, and breastfeeding after lyfgenia infusion should be discussed with the treating physician. pregnancy testing a negative serum pregnancy test must be confirmed prior to the start of mobilization and re‑confirmed prior to conditioning procedures and before lyfgenia administration. contraception there are insufficient exposure data to provide a precise recommendation on duration of contraception following treatment with lyfgenia. women of childbearing potential and men capable of fathering a child should use an effective method of contraception (intra-uterine device or combination of hormonal and barrier contraception) from start of mobilization through at least 6 months after administration of lyfgenia. advise patients of the risks associated with conditioning agents. infertility there are no data on the effects of lyfgenia on fertility. data are available on the risk of infertility with myeloablative conditioning. advise patients of the risks and the options for fertility preservation. the safety and efficacy of lyfgenia have been established in pediatric patients 12 years of age and older with sickle cell disease, including 8 adolescents (age 12 years to less than 18) [see clinical studies (14)]. no clinically meaningful differences in efficacy or safety were observed between the adult and pediatric subgroups. the safety and efficacy of lyfgenia in children less than 12 years of age have not been established. no data are available. lyfgenia has not been studied in patients 65 years of age and older. autologous hematopoietic stem cell (hsc) transplantation must be appropriate for a patient to be treated with lyfgenia. lyfgenia has not been studied in patients with hiv-1 or hiv-2. a negative serology test for hiv is necessary prior to apheresis. patients with a positive test for hiv will not be accepted for lyfgenia treatment. lyfgenia has not been studied in patients with renal impairment (defined as creatinine clearance ≤ 70 ml/min/1.73 m2 ). patients' renal function should be assessed for renal impairment to ensure autologous hsc transplantation is appropriate. lyfgenia has not been studied in patients with advanced hepatic disease. patients' hepatic function should be assessed for hepatic impairment to ensure autologous hsc transplantation is appropriate.

아일랜드 - 영어 - HPRA (Health Products Regulatory Authority)

almirall hermal gmbh - mometasone furoate - ointment - 1 mg/g - mometasone

아일랜드 - 영어 - HPRA (Health Products Regulatory Authority)

almirall hermal gmbh - mometasone furoate - cream - 1 milligram(s)/gram - corticosteroids, potent (group iii); mometasone

아일랜드 - 영어 - HPRA (Health Products Regulatory Authority)

almirall hermal gmbh - mometasone furoate - cutaneous emulsion - 1 milligram(s)/gram - corticosteroids, potent (group iii); mometasone