欧州連合 - 英語 - EMA (European Medicines Agency)

pfizer europe ma eeig  - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - immunostimulants, - filgrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia.the safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.filgrastim is indicated for the mobilisation of peripheral blood progenitor cells (pbpcs).in patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (anc) of ≤0.5 x 109/l and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.filgrastim is indicated for the treatment of persistent neutropenia (anc ≤1.0 x 109/l) in patients with advanced hiv infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - filgrastim, quantity: 960 microgram/ml - injection, solution - excipient ingredients: sodium; sorbitol; polysorbate 80; acetate; water for injections - to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs in doses not usually requiring bone marrow transplantation. for reducing the duration of neutropenia and clinical sequelae in patients undergoing induction and consolidation chemotherapy for acute myeloid leukaemia. for the mobilisation of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy, in order to accelerate neutrophil and platelet recovery by infusion of such cells after myeloablative of myelosuppressive therapy in patients with non-myeloid malignancies. for the mobilisation of peripheral blood progenitor cells, in normal volunteers, for use in allogeneic peripheral blood progenitor cell transplantation. in patients receiving myeloablative chemotherapy, for reducing the duration of neutropenia and clinical sequelae following autologous or allogeneic bone marrow transplantation. for chronic administration to increase neutrophil counts and to reduce the incidence and duration of infections in patients with severe chronic neutropenia. in patients with hiv infection, for reversal of clinically significant neutropenia and subsequent maintenance of adequate neutrophil counts during treatment with antiviral and/or other myelosuppressive medications

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - filgrastim, quantity: 600 microgram/ml - injection, solution - excipient ingredients: water for injections; sodium; acetate; sorbitol; polysorbate 80 - to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs in doses not usually requiring bone marrow transplantation. for reducing the duration of neutropenia and clinical sequelae in patients undergoing induction and consolidation chemotherapy for acute myeloid leukaemia. for the mobilisation of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy, in order to accelerate neutrophil and platelet recovery by infusion of such cells after myeloablative of myelosuppressive therapy in patients with non-myeloid malignancies. for the mobilisation of peripheral blood progenitor cells, in normal volunteers, for use in allogeneic peripheral blood progenitor cell transplantation. in patients receiving myeloablative chemotherapy, for reducing the duration of neutropenia and clinical sequelae following autologous or allogeneic bone marrow transplantation. for chronic administration to increase neutrophil counts and to reduce the incidence and duration of infections in patients with severe chronic neutropenia. in patients with hiv infection, for reversal of clinically significant neutropenia and subsequent maintenance of adequate neutrophil counts during treatment with antiviral and/or other myelosuppressive medications

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - filgrastim, quantity: 300 microgram/ml - injection, solution - excipient ingredients: polysorbate 80; water for injections; sorbitol; acetate; sodium - to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs in doses not usually requiring bone marrow transplantation. for reducing the duration of neutropenia and clinical sequelae in patients undergoing induction and consolidation chemotherapy for acute myeloid leukaemia. for the mobilisation of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy, in order to accelerate neutrophil and platelet recovery by infusion of such cells after myeloablative of myelosuppressive therapy in patients with non-myeloid malignancies. for the mobilisation of peripheral blood progenitor cells, in normal volunteers, for use in allogeneic peripheral blood progenitor cell transplantation. in patients receiving myeloablative chemotherapy, for reducing the duration of neutropenia and clinical sequelae following autologous or allogeneic bone marrow transplantation. for chronic administration to increase neutrophil counts and to reduce the incidence and duration of infections in patients with severe chronic neutropenia. in patients with hiv infection, for reversal of clinically significant neutropenia and subsequent maintenance of adequate neutrophil counts during treatment with antiviral and/or other myelosuppressive medications

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - filgrastim, quantity: 300 microgram/ml - injection, solution - excipient ingredients: acetate; sorbitol; water for injections; polysorbate 80; sodium - to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs in doses not usually requiring bone marrow transplantation. for reducing the duration of neutropenia and clinical sequelae in patients undergoing induction and consolidation chemotherapy for acute myeloid leukaemia. for the mobilisation of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy, in order to accelerate neutrophil and platelet recovery by infusion of such cells after myeloablative of myelosuppressive therapy in patients with non-myeloid malignancies. for the mobilisation of peripheral blood progenitor cells, in normal volunteers, for use in allogeneic peripheral blood progenitor cell transplantation. in patients receiving myeloablative chemotherapy, for reducing the duration of neutropenia and clinical sequelae following autologous or allogeneic bone marrow transplantation. for chronic administration to increase neutrophil counts and to reduce the incidence and duration of infections in patients with severe chronic neutropenia. in patients with hiv infection, for reversal of clinically significant neutropenia and subsequent maintenance of adequate neutrophil counts during treatment with antiviral and/or other myelosuppressive medications

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - filgrastim (unii: pvi5m0m1gw) (filgrastim - unii:pvi5m0m1gw) - nivestym is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever [see clinical studies (14.1)] . nivestym is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (aml) [see clinical studies (14.2)] . nivestym is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation [see clinical studies (14.3)]. nivestym is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis [see clinical studies (14.4)] . nivestym is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia [see clinical studies (14.5)] . nivestym is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products [see warnings and precautions (5.3)] . risk summary available data from published studies, including several observational studies of pregnancy outcomes in women exposed to filgrastim products and those who were unexposed, have not established an association with filgrastim products use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . reports in the scientific literature have described transplacental passage of filgrastim in pregnant women when administered ≤ 30 hours prior to preterm delivery (≤ 30 weeks gestation). in animal reproduction studies, effects of filgrastim on prenatal development have been studied in rats and rabbits. no malformations were observed in either species. no maternal or fetal effects were observed in pregnant rats at doses up to 58 times the human doses. filgrastim has been shown to have adverse effects in pregnant rabbits at doses 2 to 10 times higher than the human doses (see data) . the estimated background risk of major birth defects and miscarriage for the indicated populations 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 human data several observational studies based on the severe chronic neutropenia international registry (scnir) described pregnancy outcomes in women with severe chronic neutropenia (scn) who were exposed to filgrastim products during pregnancy and women with scn who were unexposed. no major differences were seen between treated and untreated women with respect to pregnancy outcome (including miscarriage and preterm labor), newborn complications (including birth weight) and infections. methodological limitations of these studies, include small sample size, and lack of generalizability due to the underlying maternal condition. animal data effects of filgrastim on prenatal development have been studied in rats and rabbits. no malformations were observed in either species. filgrastim has been shown to have adverse effects in pregnant rabbits at doses 2 to 10 times higher than the human doses. in pregnant rabbits showing signs of maternal toxicity, reduced embryo-fetal survival (at 20 and 80 mcg/kg/day) and increased abortions (at 80 mcg/kg/day) were observed. in pregnant rats, no maternal or fetal effects were observed at doses up to 575 mcg/kg/day, which is approximately 58 times higher than the human dose of 10 mcg/kg/day. offspring of rats administered filgrastim during the peri-natal and lactation periods exhibited a delay in external differentiation and growth retardation (≥ 20 mcg/kg/day) and slightly reduced survival rate (100 mcg/kg/day). risk summary there is published literature documenting transfer of filgrastim into human milk. there are a few case reports describing the use of filgrastim in breastfeeding mothers with no adverse effects noted in the infants. there are no data on the effects of filgrastim products on milk production. other filgrastim products are secreted poorly into breast milk, and filgrastim products are not absorbed orally by neonates. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for nivestym and any potential adverse effects on the breastfed child from nivestym or from the underlying maternal condition. nivestym prefilled syringe with bd ultrasafe plus™ passive needle guard may not accurately measure volumes less than 0.3 ml due to the needle spring mechanism design. therefore, the direct administration of a volume less than 0.3 ml using nivestym prefilled syringe is not recommended due to the potential for dosing errors. for direct administration of doses less than 0.3 ml (180 mcg) use nivestym single-dose vial. in patients with cancer receiving myelosuppressive chemotherapy‚ 15 pediatric patients median age 2.6 (range 1.2 to 9.4) years with neuroblastoma were treated with myelosuppressive chemotherapy (cyclophosphamide‚ cisplatin‚ doxorubicin‚ and etoposide) followed by subcutaneous filgrastim at doses of 5, 10, or 15 mcg/kg/day for 10 days (n = 5/dose) (study 8). the pharmacokinetics of filgrastim in pediatric patients after chemotherapy were similar to those in adults receiving the same weight-normalized doses, suggesting no age-related differences in the pharmacokinetics of filgrastim. in this population‚ filgrastim was well-tolerated. there was one report of palpable splenomegaly and one report of hepatosplenomegaly associated with filgrastim therapy; however‚ the only consistently reported adverse event was musculoskeletal pain‚ which is no different from the experience in the adult population. the safety and effectiveness of nivestym have been established in pediatric patients with scn [see clinical studies (14.5)] . use of nivestym for this indication is supported by nivestym’s approval as a biosimilar to filgrastim and evidence from a phase 3 study (study 7) to assess the safety and efficacy of filgrastim in the treatment of scn where 123 patients with a median age of 12 years (range 7 months to 76 years) were studied. of the 123 patients, 12 were infants (7 months to 2 years of age), 49 were children (2 to 12 years of age), and 9 were adolescents (12 to 16 years of age). additional information is available from a scn postmarketing surveillance study, which includes long-term follow-up of patients in the clinical studies and information from additional patients who entered directly into the postmarketing surveillance study. of the 731 patients in the surveillance study, 429 were pediatric patients < 18 years of age (range 0.9 to 17) [see indications and usage (1.5), dosage and administration (2.5), and clinical studies (14.5)] . long-term follow-up data from the postmarketing surveillance study suggest that height and weight are not adversely affected in patients who received up to 5 years of filgrastim treatment. limited data from patients who were followed in the phase 3 study for 1.5 years did not suggest alterations in sexual maturation or endocrine function. pediatric patients with congenital types of neutropenia (kostmann's syndrome, congenital agranulocytosis, or schwachman-diamond syndrome) have developed cytogenetic abnormalities and have undergone transformation to mds and aml while receiving chronic filgrastim treatment. the relationship of these events to filgrastim product administration is unknown [see warnings and precautions (5.8) and adverse reactions (6)] . among 855 subjects enrolled in 3 randomized, placebo-controlled trials of filgrastim-treated patients receiving myelosuppressive chemotherapy, there were 232 subjects age 65 or older, and 22 subjects age 75 or older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects. clinical studies of filgrastim in other approved indications (i.e., bmt recipients, pbpc mobilization, and scn) did not include sufficient numbers of subjects aged 65 and older to determine whether elderly subjects respond differently from younger subjects. instructions for use nivestym (neye-ves-tim) (filgrastim-aafi) injection single-dose prefilled syringe important read the patient information for important information you need to know about nivestym before using this instructions for use. before you use a nivestym prefilled syringe, read this important information. storing your prefilled syringe using your prefilled syringe call your healthcare provider if you have any questions. about the nivestym prefilled syringe nivestym prefilled syringe parts (see figure a). nivestym 300 mcg/0.5 ml prefilled syringe is shown as an example.   figure a what you need for your injection included in the carton: not included in the carton (see figure b)   figure b preparing the nivestym prefilled syringe step 1: find a clean, well-lit flat work surface. step 2: take the carton containing the nivestym prefilled syringe out of the refrigerator and leave it unopened on your work surface for at least 30 minutes so that it reaches room temperature. put the original carton with any unused prefilled syringes back in the refrigerator. step 3: wash your hands with soap and water. step 4: remove the prefilled syringe from the carton by the needle guard only. do not remove the prefilled syringe by its plunger or needle cover. see figure c. check to make sure that the needle guard is covering the barrel of the prefilled syringe.   figure c do not push the needle guard over the needle cover before the injection. this may activate or lock the needle guard. see figure d that shows a needle guard that has not yet been activated. this is how the prefilled syringe looks before use.   figure d if the needle guard is covering the needle that means it has been activated. see figure e that shows a needle guard that has been activated. this is how the prefilled syringe looks after use. do not use the nivestym prefilled syringe. get another prefilled syringe that has not been activated and is ready to use.   figure e step 5: check the expiration date on the nivestym prefilled syringe. do not use the nivestym prefilled syringe if the expiration date has passed. step 6: inspect the medicine and prefilled syringe. turn the prefilled syringe so you can see the medicine and markings in the window. make sure that you look at the medicine only through the viewing window on the prefilled syringe (see figure f). do not inspect the medicine through the plastic of the needle guard. make sure the medicine in the prefilled syringe is clear and colorless.   figure f step 7: choose the injection site figure g step 8: clean your injection site with an alcohol wipe. see figure h.   figure h step 9: hold the prefilled syringe by the needle guard with the needle cover pointing up. carefully pull the needle cover straight off and away from your body. throw away the needle cover. do not recap the needle. see figure i.   figure i your healthcare provider has prescribed either a "full" syringe dose or a "partial" syringe dose. partial dosing step 10: point the needle up and tap gently until the air rises to the top. see figure j.   figure j step 11: holding the prefilled syringe as shown, slowly push up on the plunger rod to push out the extra air and medicine until the end of the conical base (edge) of the plunger stopper lines up with the syringe marking for your prescribed dose. see figure k for an example of a dose of 0.3 ml. your dose may be different than the example shown. be careful not to activate the needle guard before use. do not use a nivestym prefilled syringe that has been activated. see figure e above. check again to make sure the correct dose of nivestym is in the prefilled syringe.   figure k giving the nivestym prefilled syringe injection step 12: with one hand, gently pinch a fold of skin at the injection site. hold the pinch. see figure l.   figure l step 13: with your other hand, hold the prefilled syringe like you would hold a pencil. use a quick "dart-like" motion to insert the needle at a 45 to 90 degree angle into the skin as shown. see figure m.   figure m step 14: using slow and constant pressure, press down on the plunger rod until it reaches the bottom. see figure n.   figure n step 15: keep the plunger rod fully pressed down while you carefully pull the needle straight out from the injection site. see figure o.   figure o step 16: as you let go of the plunger rod, the needle guard will automatically slide over the needle until the needle is completely covered and the needle guard locks into place. do not recap the needle. see figure p.   figure p step 17: there may be a small amount of blood at the injection site. you can press a cotton ball or gauze over the injection site and hold it for 10 seconds. do not rub the injection site. you may cover the injection site with a small adhesive bandage, if needed. see figure q.   figure q step 18: throw away (dispose of) the syringe as instructed by your healthcare provider or by following the instructions below. see figure r.   figure r disposing of (throw away) used nivestym prefilled syringes this instructions for use has been approved by the u.s. food and drug administration. manufactured by: hospira, inc., a pfizer company lake forest, il 60045 usa us license no. 1974 distributed by pfizer labs, division of pfizer inc., new york, ny 10001 usa lab-0938-6.0 for more information go to www.pfizer.com or call 1-800-438-1985. revised: february 2024 instructions for use nivestym (neye-ves-tim) (filgrastim-aafi) injection single-dose vial important read the patient information for important information you need to know about nivestym before using these instructions for use. before you use a nivestym vial, read this important information: storing your nivestym vial keep nivestym and all medicines out of the reach of children. using your vial call your healthcare provider if you have any questions. step 1: prepare step 2: get ready pull back on the plunger and draw air into the syringe that is the same amount (ml) as the dose of nivestym that your healthcare provider prescribed. important: throw away the needle cap into the sharps disposal container. do not recap the needle. step 3: select and prepare the injection site you can use: step 4: subcutaneous (under the skin) injection step 5: finish this instructions for use has been approved by the u.s. food and drug administration. manufactured by: hospira, inc., a pfizer company lake forest, il 60045 usa us license no. 1974 distributed by pfizer labs, division of pfizer inc., new york, ny 10001 usa lab-0937-5.0 for more information go to www.pfizer.com or call 1-800-438-1985. revised: august 2023

日本 - 英語 - すりの適正使用協議会 RAD-AR Council, Japan

nippon kayaku - filgrastim(genetical recombination) [filgrastim biosimilar2] - injection

日本 - 英語 - すりの適正使用協議会 RAD-AR Council, Japan

nippon kayaku - filgrastim(genetical recombination) [filgrastim biosimilar2] - injection

日本 - 英語 - すりの適正使用協議会 RAD-AR Council, Japan

nippon kayaku - filgrastim(genetical recombination) [filgrastim biosimilar2] - injection

日本 - 英語 - すりの適正使用協議会 RAD-AR Council, Japan

nippon kayaku - filgrastim(genetical recombination) [filgrastim biosimilar2] - injection