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

juniper biologics pty ltd - netupitant, quantity: 300 mg; palonosetron hydrochloride, quantity: 0.56 mg (equivalent: palonosetron, qty 0.5 mg) - capsule - excipient ingredients: microcrystalline cellulose; sucrose laurate; povidone; croscarmellose sodium; purified water; silicon dioxide; sodium stearylfumarate; magnesium stearate; glyceryl caprylate/caprate; glycerol; polyglyceryl-3 dioleate; butylated hydroxyanisole; nitrogen; gelatin; titanium dioxide; iron oxide yellow; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; ethanol absolute; iron oxide black; sorbitol; 1,4-sorbitan; mannitol - akynzeo is indicated in adult patients for: prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.

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

juniper biologics pty ltd - fosnetupitant chloride hydrochloride, quantity: 260 mg (equivalent: fosnetupitant, qty 235 mg); palonosetron hydrochloride, quantity: 280 microgram (equivalent: palonosetron, qty 250 microgram) - injection, concentrated - excipient ingredients: sodium hydroxide; mannitol; disodium edetate; hydrochloric acid; water for injections - indicated in adult patients for:,prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy.,prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.

United States - English - NLM (National Library of Medicine)

eisai inc. - netupitant (unii: 7732p08tir) (netupitant - unii:7732p08tir) - netupitant 300 mg

United States - English - NLM (National Library of Medicine)

helsinn therapeutics (u.s.), inc. - netupitant (unii: 7732p08tir) (netupitant - unii:7732p08tir), palonosetron (unii: 5d06587d6r) (palonosetron - unii:5d06587d6r) - netupitant 300 mg - - akynzeo capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. akynzeo capsules is a combination of palonosetron and netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. - akynzeo for injection and akynzeo injection are indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. akynzeo for injection is a combination of palonosetron and fosnetupitant, a prodrug of netupitant: palonosetron prevents nausea and vomiting during the acute phase and fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. limitations of use akynzeo for injection and akynzeo injection have not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy. none. risk summary limited available data with akynzeo use in pregnant women are insufficient to inform a drug- associated risk of adverse developmental outcomes. in animal reproduction studies with netupitant, no effects on embryo-fetal development were observed following daily oral administration in pregnant rats during the period of organogenesis at doses up to 3.7 times the human auc (area under the plasma concentration-time curve) at the recommended single dose to be given with each cycle of chemotherapy. however, a dose-dependent increase in adverse effects on embryo-fetal development was observed following daily oral administration of netupitant in pregnant rabbits during the period of organogenesis with doses at least 0.2 times the human auc at the recommended single dose to be given with each cycle of chemotherapy. daily oral administration of netupitant in rats up to 3.7 times the human auc at the recommended dose during organogenesis through lactation produced no adverse effects in the offspring (see data). in animal reproduction studies with fosnetupitant, delayed ossification of pubis occurred after intravenous administration in rats during the period of organogenesis at a dose 3 times the human auc for netupitant at the recommended single dose to be given with each cycle of chemotherapy. in pregnant rabbits, an increase in resorptions was observed with daily intravenous administration of fosnetupitant during the period of organogenesis at doses up to 9 times the human auc for fosnetupitant and 0.4 times the human auc for netupitant at the recommended single dose to be given with each cycle of chemotherapy. daily intravenous administration of fosnetupitant (3 times the human auc for netupitant at the recommended single dose to be given with each cycle of chemotherapy) in rats during organogenesis through lactation produced lower bodyweight in offspring at birth through maturation, and delayed physical development (see data). in animal reproduction studies with palonosetron, no effects on embryo-fetal development were observed following oral administration during the period of organogenesis at doses up to 921 and 1841 times the recommended oral dose in rats and rabbits, respectively (see data). based on animal data from netupitant studies, advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 netupitant daily oral administration of up to 30 mg/kg netupitant in rats (3.7 times the human auc at the recommended single dose to be given with each cycle of chemotherapy) during the period of organogenesis produced no effects on embryo-fetal development. however, an increased incidence of external and skeletal abnormalities in rabbit fetuses was observed following daily oral administration of netupitant in rabbits at 10 mg/kg/day and higher (0.2 times the human auc at the recommended single dose to be given with each cycle of chemotherapy) during the period of organogenesis. these abnormalities included positional abnormalities in the limbs and paws, and fused sternebrae. reduction in fetal rabbit weight occurred at 30 mg/kg/day. maternal toxicity in rabbits (i.e., loss of bodyweight during the treatment period) was also observed at 30 mg/kg/day. daily oral administration of up to 30 mg/kg netupitant (3.7 times the human auc at the recommended dose) in rats during organogenesis through lactation produced no adverse effects in the offspring. fosnetupitant daily intravenous administration of 39 mg/kg/day fosnetupitant in rats (3 times the human auc for netupitant at the recommended single dose to be given with each cycle of chemotherapy) during the period of organogenesis produced delayed ossification of pubis.  no effects on embryo-fetal development were observed with daily administration of up to 13 mg/kg fosnetupitant in rats (2 times the human auc for netupitant at the recommended single dose to be given with each cycle of chemotherapy).  due to the limited systemic exposure to fosnetupitant in pregnant rats, it is not possible to provide an auc-based comparison of fosnetupitant exposure in rats and humans.  an increase in resorptions was observed with daily intravenous administration of fosnetupitant at 6 mg/kg/day and higher in rabbits (9 times the human auc for fosnetupitant and 0.4 times the human auc for netupitant at the recommended single dose to be given with each cycle of chemotherapy) during the period of organogenesis.  no effects were observed in rabbits at 3 mg/kg/day (5.4 times the human auc for fosnetupitant and 0.4 times the human auc for netupitant at the recommended single dose to be given with each cycle of chemotherapy).  daily intravenous administration of 39 mg/kg fosnetupitant in rats (3 times the auc for netupitant at the recommended single dose to be given with each cycle of chemotherapy) during organogenesis through lactation produced lower bodyweight in offspring at birth through maturation, and delayed physical development (pinna detachment, eye opening, and preputial separation).  these effects were associated with maternal toxicity (reduced weight gain and food consumption).  no effects occurred in offspring or dams at 13 mg/kg/day (2 times the human auc for netupitant at the recommended single dose to be given with each cycle of chemotherapy). palonosetron in animal reproduction studies with palonosetron, no effects on embryo-fetal development were observed in pregnant rats given oral doses up to 60 mg/kg/day (921 times the recommended oral dose based on body surface area) or pregnant rabbits given oral doses up to 60 mg/kg/day (1841 times the recommended oral dose based on body surface area) during the period of organogenesis. risk summary there are no data on the presence of netupitant (or fosnetupitant) or palonosetron in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for akynzeo and any potential adverse effect on the breastfed child from akynzeo or from the underlying maternal condition. the safety and effectiveness of akynzeo in patients below the age of 18 years have not been established. of the 1169 adult cancer patients treated with akynzeo capsules in clinical studies, 18% were aged 65 and over, while 2% were aged 75 years and over. the nature and frequency of adverse reactions were similar in elderly and younger patients. exploratory analyses of the impact of age on efficacy were performed in the two trials that compared akynzeo to palonosetron [see clinical studies ( 14 )]. in study 1 in patients treated with cisplatin chemotherapy, among the patients less than age 65 years, 115 were treated with akynzeo and 116 were treated with palonosetron alone.  among the patients 65 years or older, 20 were treated with akynzeo and 20 were treated with palonosetron alone. the difference in complete response (cr) rates between akynzeo and palonosetron alone was similar between the two age groups in both the acute and delayed phases. in study 2 in patients treated with anthracyclines plus cyclophosphamide chemotherapy, among the patients less than age 65 years, 608 were treated with akynzeo and 602 were treated with palonosetron alone. among the patients 65 years or older, 116 were treated with akynzeo and 123 were treated with palonosetron alone. the difference in cr rates between akynzeo and palonosetron alone (4% in <65 years and 2% in > 65 years) was similar between the two age groups in the acute phase. in the delayed phase, the difference in cr rates between akynzeo and palonosetron alone (9% in <65 years and 1% in ≥ 65 years) was numerically higher in patients <65 years. this difference between age groups in the delayed phase of study 2 may be explained, in part, by higher cr in the delayed phase associated with palonosetron alone in the older age group (81%) relative to the younger patients treated with palonosetron alone (67%). of the 239 adult cancer patients treated with akynzeo for injection in clinical studies, 36% were aged 65 and over, while 4% were aged 75 years and over. the nature and frequency of adverse reactions were similar in elderly and younger patients. in general, use caution when dosing elderly patients as they have a greater frequency of decreased hepatic, renal or cardiac function and concomitant disease or other drug therapy. no dosage adjustment for akynzeo is necessary for patients with mild to moderate hepatic impairment (child-pugh score 5 to 8). limited data are available with akynzeo in patients with severe hepatic impairment (child-pugh score greater than 9). avoid use of akynzeo in patients with severe hepatic impairment [see overdosage (10), clinical pharmacology (12.3) ] . no dosage adjustment for akynzeo is necessary in patients with mild to moderate renal impairment (creatinine clearance of 30 to 60 ml/min). the pharmacokinetics and safety of netupitant have not been studied in patients with severe renal impairment.  severe renal impairment (creatinine clearance < 30 ml/min) did not substantially affect pharmacokinetics of palonosetron. the pharmacokinetics for netupitant and palonosetron were not studied in patients with end-stage renal disease requiring hemodialysis. avoid use of akynzeo in patients with severe renal impairment or end-stage renal disease [see clinical pharmacology (12.3) ] .

Philippines - English - FDA (Food And Drug Administration)

mundipharma distribution gmbh (philippine branch); distributor: mundipharma distribution gmbh (philippine branch) - netupitant/palonosetron hcl - capsule - 300mg/500mcg

Singapore - English - HSA (Health Sciences Authority)

juniper healthcare pte ltd - netupitant; palonosetron hcl 0.56mg eqv to palonosetron - capsule, gelatin coated - netupitant 300mg; palonosetron hcl 0.56mg eqv to palonosetron 0.50mg

Canada - English - Health Canada

knight therapeutics inc. - palonosetron (palonosetron hydrochloride); netupitant - capsule - 0.5mg; 300mg - palonosetron (palonosetron hydrochloride) 0.5mg; netupitant 300mg - antiemetics

European Union - English - EMA (European Medicines Agency)

helsinn birex pharmaceuticals ltd - netupitant, palonosetron hydrochloride - vomiting; neoplasms; nausea; cancer - antiemetics and antinauseants, - akynzeo is indicated in adults for the:prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy.prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

Israel - English - Ministry of Health

rafa laboratories ltd - netupitant; palonosetron as hydrochloride - capsules - netupitant 300 mg; palonosetron as hydrochloride 0.50 mg - palonosetron, combinations - prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

juniper biologics sdn. bhd. - palonosetron hydrochloride; netupitant -