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

pfizer australia pty ltd - lenograstim -

USA - engelsk - NLM (National Library of Medicine)

evive biotechnology singapore pte. ltd. - efbemalenograstim alfa (unii: 5upw5hjw3o) (efbemalenograstim alfa - unii:5upw5hjw3o) - ryzneuta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. limitations of use ryzneuta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. ryzneuta is contraindicated in patients with a history of serious allergic reactions to granulocyte stimulating factors such as efbemalenograstim alfa-vuxw, pegfilgrastim, or filgrastim products [see warnings and precautions ( 5.3)] . risk summary although available data with ryzneuta use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to other human g csf products. these studies have not established an association of g-csf product use during pregnancy with major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, no evidence of reproductive/developmental toxicity occurred in the offspring of pregnant rats and rabbits that received cumulative doses of efbemalenograstim alfa-vuxw approximately 2.6 and 0.7 times, respectively, the recommended human dose (based on body surface area). 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 risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data three studies were conducted in pregnant rats dosed with efbemalenograstim alfa-vuxw at cumulative doses up to approximately 2.6 times the recommended human dose at the following stages of gestation: during the period of organogenesis, from mating through the first half of pregnancy, and from the first trimester through delivery and lactation. no evidence of fetal loss or structural malformations was observed in any study. growth and learning were also unaffected. pregnant rabbits were dosed with efbemalenograstim alfa-vuxw every other day during organogenesis at cumulative doses up to 0.7 times the recommended human dose showed no signs of fetal loss or structural malformations. maternal toxicity (decreased weight gain or weight loss and/or death) was observed when higher cumulative doses of efbemalenograstim alfa-vuxw were used in an early dose-ranging study in rabbits. risk summary there are no data on the presence of efbemalenograstim alfa-vuxw or its metabolite in either human or animal milk, the effects on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for efbemalenograstim alfa-vuxw and any potential adverse effects on the breastfed child from efbemalenograstim alfa-vuxw or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. clinical studies of ryzneuta did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience with ryzneuta has not identified differences in responses between the elderly and younger patients.

Irland - engelsk - HPRA (Health Products Regulatory Authority)

chugai pharma uk ltd - lenograstim - pdr+solv for soln for inf/inj - 13 million iu/ml

Irland - engelsk - HPRA (Health Products Regulatory Authority)

chugai pharma uk ltd - lenograstim - pdr+solv for soln for inf/inj - 34 million iu/ml

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - lenograstim 13.4 miu - powder for injection - 13.4 miu - active: lenograstim 13.4 miu excipient: arginine hydrochloric acid mannitol methionine phenylalanine polysorbate 20

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - lenograstim 33.6 miu - powder for injection - 33.6 miu - active: lenograstim 33.6 miu excipient: arginine hydrochloric acid mannitol methionine phenylalanine polysorbate 20

Irland - engelsk - HPRA (Health Products Regulatory Authority)

chugai pharma uk ltd - lenograstim - pdr+solv for soln for inf/inj - 13 million iu/ml

Irland - engelsk - HPRA (Health Products Regulatory Authority)

chugai pharma uk ltd - lenograstim - pdr+solv for soln for inf/inj - 34 million iu/ml

Singapore - engelsk - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - lenograstim - injection, powder, for solution - 263 mcg/ml

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

hospira australia pty ltd - lenograstim -