USA - engelska - NLM (National Library of Medicine)

amgen inc - filgrastim (unii: pvi5m0m1gw) (filgrastim - unii:pvi5m0m1gw) - filgrastim 300 ug in 1 ml - neupogen 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)] . neupogen 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)] . neupogen 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)] . neupogen is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis [see clinical studies (14.4)] . neupogen is indicated for chronic administ

Australien - engelska - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - pegfilgrastim, quantity: 6 mg - injection, solution - excipient ingredients: sodium; polysorbate 20; acetate; sorbitol; water for injections - for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infection, as manifested by febrile neutropenia.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - pegfilgrastim, quantity: 6 mg - injection, solution - excipient ingredients: sodium; polysorbate 20; acetate; sorbitol; water for injections - for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infection, as manifested by febrile neutropenia.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - pegfilgrastim, quantity: 6 mg - injection, solution - excipient ingredients: sodium; polysorbate 20; acetate; sorbitol; water for injections - for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infection, as manifested by febrile neutropenia.

USA - engelska - NLM (National Library of Medicine)

amgen inc - trastuzumab (unii: p188anx8ck) (trastuzumab - unii:p188anx8ck) - kanjinti is indicated for adjuvant treatment of her2 overexpressing node positive or node negative (er/pr negative or with one high risk feature [see clinical studies ( 14.1 )] ) breast cancer - as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel - as part of a treatment regimen with docetaxel and carboplatin - as a single agent following multi-modality anthracycline-based therapy. select patients for therapy based on an fda-approved companion diagnostic for a trastuzumab product [ see dosage and administration ( 2.1 ) ] . kanjinti is indicated: - in combination with paclitaxel for first-line treatment of her2-overexpressing metastatic breast cancer - as a single agent for treatment of her2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease. select patients for therapy based on an fda-approved companion diagnostic for a trastuzumab product [see dosage and administration ( 2.1 )] kanjinti is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with her2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease. select patients for therapy based on an fda-approved companion diagnostic for a trastuzumab product [see dosage and administration ( 2.1 )] . none. risk summary trastuzumab products can cause fetal harm when administered to a pregnant woman. in post-marketing reports, use of trastuzumab during pregnancy resulted in cases of oligohydramnios and of oligohydramnios sequence, manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death [see data]. apprise the patient of the potential risks to a fetus. there are clinical considerations if trastuzumab products are used in a pregnant woman or if a patient becomes pregnant within 7 months following the last dose of a trastuzumab product [see clinical   considerations]. the estimated 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. clinical   considerations fetal/neonatal adverse reactions monitor women who received kanjinti during pregnancy or within 7 months prior to conception for oligohydramnios. if oligohydramnios occurs, perform fetal testing that is appropriate for gestational age and consistent with community standards of care. data human data in post-marketing reports, use of trastuzumab during pregnancy resulted in cases of oligohydramnios and of oligohydramnios sequence, manifesting in the fetus as pulmonary hypoplasia, skeletal abnormalities and neonatal death. these case reports described oligohydramnios in pregnant women who received trastuzumab either alone or in combination with chemotherapy. in some case reports, amniotic fluid index increased after trastuzumab was stopped. in one case, trastuzumab therapy resumed after amniotic index improved, and oligohydramnios recurred. animal data in studies where trastuzumab was administered to pregnant cynomolgus monkeys during the period of organogenesis at doses up to 25 mg/kg given twice weekly (up to 25 times the recommended weekly human dose of 2 mg/kg), trastuzumab crossed the placental barrier during the early (gestation days 20 to 50) and late (gestation days 120 to 150) phases of gestation. the resulting concentrations of trastuzumab in fetal serum and amniotic fluid were approximately 33% and 25%, respectively, of those present in the maternal serum but were not associated with adverse developmental effects. risk summary there is no information regarding the presence of trastuzumab products in human milk, the effects on the breastfed infant, or the effects on milk production. published data suggest human igg is present in human milk but does not enter the neonatal and infant circulation in substantial amounts. trastuzumab was present in the milk of lactating cynomolgus monkeys but not associated with neonatal toxicity [ see data ].   consider the developmental and health benefits of breastfeeding along with the mother's clinical need for kanjinti treatment and any potential adverse effects on the breastfed child from kanjinti or from the underlying maternal condition. this consideration should also take into account the trastuzumab product wash out period of 7 months [see clinical pharmacology ( 12.3 )]. data in lactating cynomolgus monkeys, trastuzumab was present in breast milk at about 0.3% of maternal serum concentrations after pre- (beginning gestation day 120) and post-partum (through post-partum day 28) doses of 25 mg/kg administered twice weekly (25 times the recommended weekly human dose of 2 mg/kg of trastuzumab products). infant monkeys with detectable serum levels of trastuzumab did not exhibit any adverse effects on growth or development from birth to 1 month of age. pregnancy testing verify the pregnancy status of females of reproductive potential prior to the initiation of kanjinti. contraception females trastuzumab products can cause embryo-fetal harm when administered during pregnancy. advise females of reproductive potential to use effective contraception during treatment with kanjinti and for 7 months following the last dose of kanjinti [see use in specific populations ( 8.1 )  and clinical pharmacology ( 12.3 )]. the safety and effectiveness of trastuzumab products in pediatric patients have not been established. trastuzumab has been administered to 386 patients who were 65 years of age or over (253 in the adjuvant treatment and 133 in metastatic breast cancer treatment settings). the risk of cardiac dysfunction was increased in geriatric patients as compared to younger patients in both those receiving treatment for metastatic disease in studies 5 and 6, or adjuvant therapy in studies 1 and 2. limitations in data collection and differences in study design of the 4 studies of trastuzumab in adjuvant treatment of breast cancer preclude a determination of whether the toxicity profile of trastuzumab in older patients is different from younger patients. the reported clinical experience is not adequate to determine whether the efficacy improvements (orr, ttp, os, dfs) of trastuzumab treatment in older patients is different from that observed in patients < 65 years of age for metastatic disease and adjuvant treatment. in study 7 (metastatic gastric cancer), of the 294 patients treated with trastuzumab, 108 (37%) were 65 years of age or older, while 13 (4.4%) were 75 and over. no overall differences in safety or effectiveness were observed.

USA - engelska - NLM (National Library of Medicine)

amgen inc - erenumab (unii: i5i8vb78vt) (erenumab - unii:i5i8vb78vt) - aimovig is indicated for the preventive treatment of migraine in adults. aimovig is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aimovig during pregnancy. patients should be encouraged to enroll by calling 1-833-244-4083 or visiting https://www.genesispregnancyregistry.com/. risk summary there are no adequate data on the developmental risk associated with the use of aimovig in pregnant women. no adverse effects on offspring were observed when pregnant monkeys were administered erenumab-aooe throughout gestation [see data]. serum erenumab-aooe exposures in pregnant monkeys were greater than those in humans at clinical doses. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recogni

USA - engelska - NLM (National Library of Medicine)

amgen inc - etelcalcetide hydrochloride (unii: 72pt5993du) (etelcalcetide - unii:60me133fjb) - etelcalcetide 2.5 mg in 0.5 ml - parsabiv is indicated for the treatment of secondary hyperparathyroidism (hpt) in adult patients with chronic kidney disease (ckd) on hemodialysis. limitations of use: parsabiv has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with chronic kidney disease who are not on hemodialysis and is not recommended for use in these populations. hypersensitivity parsabiv is contraindicated in patients with known hypersensitivity to etelcalcetide or any of its excipients. hypersensitivity reactions, including face edema and anaphylactic reaction, have occurred with parsabiv [see adverse reactions (6)] . risk summary there are no available data on the use of parsabiv in pregnant women. in animal reproduction studies, effects were seen at doses associated with maternal toxicity that included hypocalcemia. in a pre- and post-natal study in rats administered etelcalcetide during organogenesis through delivery and weaning, there was a slight increase in perinatal pup mortality,

USA - engelska - NLM (National Library of Medicine)

amgen inc - denosumab (unii: 4eqz6yo2hi) (denosumab - unii:4eqz6yo2hi) - denosumab 120 mg in 1.7 ml - xgeva is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. xgeva is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity [see clinical trials ( 14.2 )] . xgeva is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. pre-existing hypocalcemia must be corrected prior to initiating therapy with xgeva [s ee warnings and precautions ( 5.3 )] . xgeva is contraindicated in patients with known clinically significant hypersensitivity to xgeva [see   warnings and precautions ( 5.2 ) and   adverse reactions ( 6.2 )] . risk summary based on findings in animals and its mechanism of action, xgeva can cause fetal harm when administered to a pregnant woman [see clinical pharmacology ( 12.1 )] . there are insufficient data with denosumab use in pregnant women to inform any drug associated risks for adverse developmental outcomes. in utero denosumab exposure from cynomolgus monkeys dosed monthly with denosumab throughout pregnancy at a dose 25-fold higher than the recommended human dose of xgeva based on body weight resulted in increased fetal loss, stillbirths, and postnatal mortality; and absent lymph nodes, abnormal bone growth, and decreased neonatal growth [ see data ] .   apprise pregnant women of the potential risk to the fetus.   the background rate of major birth defects and miscarriage is unknown for the indicated population. 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. data animal data the effects of denosumab on prenatal development have been studied in both cynomolgus monkeys and genetically engineered mice in which rank ligand (rankl) expression was turned off by gene removal (a “knockout mouse”). in cynomolgus monkeys dosed subcutaneously with denosumab throughout pregnancy starting at gestational day 20 and at a pharmacologically active dose 25-fold higher than the recommended human dose of xgeva based on body weight, there was increased fetal loss during gestation, stillbirths, and postnatal mortality. other findings in offspring included absence of axillary, inguinal, mandibular, and mesenteric lymph nodes; abnormal bone growth, reduced bone strength, reduced hematopoiesis, dental dysplasia, and tooth malalignment; and decreased neonatal growth. at birth out to one month of age, infants had measurable blood levels of denosumab (22-621% of maternal levels). following a recovery period from birth out to 6 months of age, the effects on bone quality and strength returned to normal; there were no adverse effects on tooth eruption, though dental dysplasia was still apparent; axillary and inguinal lymph nodes remained absent, while mandibular and mesenteric lymph nodes were present, though small; and minimal to moderate mineralization in multiple tissues was seen in one recovery animal. there was no evidence of maternal harm prior to labor; adverse maternal effects occurred infrequently during labor. maternal mammary gland development was normal. there was no fetal noael (no observable adverse effect level) established for this study because only one dose of 50 mg/kg was evaluated. mammary gland histopathology at 6 months of age was normal in female offspring exposed to denosumab in utero ; however, development and lactation have not been fully evaluated. in rankl knockout mice, absence of rankl (the target of denosumab) also caused fetal lymph node agenesis and led to postnatal impairment of dentition and bone growth.  pregnant rankl knockout mice showed altered maturation of the maternal mammary gland, leading to impaired lactation [see use in specific populations ( 8.3 ) and nonclinical toxicology ( 13.2 )] . risk summary there is no information regarding the presence of xgeva (denosumab) in human milk, the effects on the breastfed child, or the effects on milk production. denosumab was detected in the maternal milk of cynomolgus monkeys  up to 1 month after the last dose of denosumab (≤ 0.5% milk:serum ratio) and maternal mammary gland development was normal, with no impaired lactation. however, pregnant rankl knockout mice showed altered maturation of the maternal mammary gland, leading to impaired lactation [see use in specific populations ( 8.1 ) and nonclinical toxicology ( 13.2 )] . consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for xgeva treatment and any potential adverse effects on the breastfed child from xgeva or from the underlying maternal condition. based on findings in animals and its mechanism of action, xgeva can cause fetal harm when administered to a pregnant woman [see use in specific populations ( 8.1 )] . pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating xgeva treatment. contraception   females advise females of reproductive potential to use effective contraception during therapy, and for at least 5 months after the last dose of xgeva. the safety and efficacy of xgeva have not been established in pediatric patients except in skeletally mature adolescents (aged 12–16 years) with giant cell tumor of bone. xgeva is recommended only for treatment of skeletally mature adolescents (aged 12–16 years) with giant cell tumor of bone [see indications and usage ( 1.2 )] . clinically significant hypercalcemia after treatment discontinuation has been reported in pediatric patients with growing skeletons who received denosumab for giant cell tumor of bone or for unapproved indications [see adverse reactions ( 6.2 ) and warnings and precautions ( 5.6 )]. xgeva was studied in an open-label trial that enrolled a subset of 19 adolescent patients (aged 12-16 years) with giant cell tumor of bone who had reached skeletal maturity, defined by at least 1 mature long bone (e.g., closed epiphyseal growth plate of the humerus), and had a body weight ≥ 45 kg [see indications and usage ( 1.2 ) and clinical trials ( 14.3 )]. a total of one of five (20%) evaluable adolescent patients had an objective response by retrospective independent assessment of radiographic response according to modified response evaluation criteria in solid tumors (recist 1.1). the adverse reaction profile and efficacy results appeared to be similar in skeletally mature adolescents and adults [see adverse reactions ( 6.1 ) and clinical trials ( 14.3 )] . animal data treatment with xgeva may impair bone growth in children with open growth plates and may inhibit eruption of dentition. in neonatal rats, inhibition of rankl (the target of xgeva therapy) with a construct of osteoprotegerin bound to fc (opg-fc) at doses ≤ 10 mg/kg was associated with inhibition of bone growth and tooth eruption. adolescent primates treated with denosumab at doses 5 and 25 times (10 and 50 mg/kg dose) higher than the recommended human dose of 120 mg administered once every 4 weeks, based on body weight (mg/kg), had abnormal growth plates, considered to be consistent with the pharmacological activity of denosumab. cynomolgus monkeys exposed in utero to denosumab exhibited bone abnormalities, reduced hematopoiesis, tooth malalignment, decreased neonatal growth, and an absence of axillary, inguinal, mandibular, and mesenteric lymph nodes. some bone abnormalities recovered once exposure was ceased following birth; however, axillary and inguinal lymph nodes remained absent 6 months post-birth [see   use in specific populations ( 8.1 ) ] . of the total number of patients in clinical studies that received xgeva (n = 2841) in studies 20050136, 20050244, and 20050103, 1271 (44%) were ≥ 65 years old, while 473 patients (17%) were ≥ 75 years old. of the 859 patients in study 20090482 that received xgeva, 387 patients (45%) were ≥ 65 years old, while 141 patients (16%) were ≥ 75 years old. no overall differences in safety or efficacy were observed between older and younger patients. two clinical trials were conducted in patients without cancer and with varying degrees of renal function. in one study, patients (n = 55) with varying degrees of renal function (ranging from normal through end-stage renal disease requiring dialysis) received a single 60 mg subcutaneous dose of denosumab. in a second study, patients (n = 32) with severe renal dysfunction (creatinine clearance less than 30 ml/min and/or on dialysis) were given two 120 mg subcutaneous doses of denosumab. in both studies, greater risk of developing hypocalcemia was observed with increasing renal impairment, and with inadequate/no calcium supplementation. hypocalcemia was mild to moderate in severity in 96% of patients. monitor calcium levels and calcium and vitamin d intake [see warnings and precautions ( 5.3 ), adverse reactions ( 6.1 ), and clinical pharmacology ( 12.3 )] .

Australien - engelska - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - denosumab, quantity: 60 mg/ml - injection, solution - excipient ingredients: acetate; water for injections; polysorbate 20; sodium hydroxide; sorbitol - the treatment of osteoporosis in postmenopausal women. prolia significantly reduces the risk of vertebral, non-vertebral and hip fractures.,treatment to increase bone mass in men with osteopaenia receiving androgen deprivation therapy for non-metastatic prostate cancer (see clinical trials).,treatment to increase bone mass in men with osteoporosis at increased risk of fracture.,treatment to increase bone mass in women and men at increased risk of fracture due to long-term systemic glucocorticoid therapy.

Australien - engelska - 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