Malta - English - Medicines Authority

anfarm hellas s.a. 4 achaias str. & trizinias 14564 kifissia, attiki, greece - palonosetron hydrochloride - solution for injection - palonosetron hydrochloride - antiemetics and antinauseants

New Zealand - English - Medsafe (Medicines Safety Authority)

mundipharma new zealand ltd - palonosetron hydrochloride 50 µg/ml - solution for injection - 250µg/5ml - active: palonosetron hydrochloride 50 µg/ml excipient: citric acid monohydrate disodium edetate dihydrate hydrochloric acid mannitol sodium citrate dihydrate sodium hydroxide water for injection - aloxi is indicated for prevention of nausea and vomiting induced by cytotoxic chemotherapy.

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

juniper biologics pty ltd - palonosetron hydrochloride, quantity: 56 microgram/ml (equivalent: palonosetron, qty 50 microgram/ml) - injection, solution - excipient ingredients: sodium hydroxide; disodium edetate; hydrochloric acid; sodium citrate dihydrate; mannitol; water for injections; citric acid monohydrate - aloxi is indicated for: - prevention of nausea and vomiting induced by cytotoxic chemotherapy. - prevention of postoperative nausea and vomiting (ponv) for up to 24 hours following surgery.

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

meitheal pharmaceuticals inc. - palonosetron hydrochloride (unii: 23310d4i19) (palonosetron - unii:5d06587d6r) - palonosetron hydrochloride injection is indicated in adults for prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (mec). - acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (hec). - postoperative nausea and vomiting (ponv) for up to 24 hours following surgery. efficacy beyond 24 hours has not been demonstrated. as with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients where nausea and vomiting must be avoided during the postoperative period, palonosetron hydrochloride injection is recommended even where the incidence of postoperative nausea and/or vomiting is low. palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of: - acute nausea and vomiting associated with initial

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

fresenius kabi usa, llc - palonosetron hydrochloride (unii: 23310d4i19) (palonosetron - unii:5d06587d6r) - palonosetron hydrochloride injection is indicated in adults for prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (mec). - acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (hec). - postoperative nausea and vomiting (ponv) for up to 24 hours following surgery. efficacy beyond 24 hours has not been demonstrated. as with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients where nausea and vomiting must be avoided during the postoperative period, palonosetron hydrochloride injection is recommended even where the incidence of postoperative nausea and/or vomiting is low. palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of: - acute nausea and vomiting associated with initial

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

fresenius kabi usa, llc - palonosetron hydrochloride (unii: 23310d4i19) (palonosetron - unii:5d06587d6r) - palonosetron hydrochloride injection is indicated in adults for prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (mec). - acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (hec). palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of: - acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy. palonosetron hydrochloride injection is contraindicated in patients known to have hypersensitivity to palonosetron [see warnings and precautions (5.1)] . risk summary there are no available data on palonosetron hcl use in pregnant women to inform a drug-associated risk. in animal reproduction studies, no effects on embryo-fetal development were observed with the administration of oral palonosetron hcl during

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

bluepoint laboratories - palonosetron hydrochloride (unii: 23310d4i19) (palonosetron - unii:5d06587d6r) - palonosetron hydrochloride injection is indicated in adults for prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (mec). - acute nausea and vomiting associated with initial and repeat course of highly emetogenic cancer chemotherapy (hec). - postoperative nausea and vomiting (ponv) for up to 24 hours following surgery. efficacy beyond 24 hours has not been demonstrated. as with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients where nausea and vomiting must be avoided during the postoperative period, palonosetron hydrochloride is recommended even where the incidence of postoperative nausea and/or vomiting is low. palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of: - acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy. palonosetron hydrochloride is contraindicated in patients known to have hypersensitivity to palonosetron [see  warning and precautions   error! hyperlink reference not valid. )] risk summary there are no available data on palonosetron hcl use in pregnant women to inform a drug-associated risk. in animal reproduction studies, no effects on embryo-fetal development were observed with the administration of oral palonosetron hcl during the period of organogenesis at doses up to 1,894 and 3,789 times the recommended human intravenous dose in rats and rabbits, respectively (see data). 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 risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data in animal reproduction studies, no effects on embryo-fetal development were observed in pregnant rats given oral palonosetron hcl at doses up to 60 mg/kg/day (1,894 times the recommended human intravenous dose based on body surface area) or pregnant rabbits given oral dosed up to 60 mg/kg/day (3,789 times the recommended human intravenous dose based on body surface area) during the period of organogenesis. risk summary there are no data on the presence of palonosetron in human milk, the effects of palonosetron on the breastfed infant, or the effects of palonosetron on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for palonosetron hydrochloride and any potential adverse effect on the breastfed infant from palonosetron or from the underlying maternal condition. chemotherapy-induced nausea and vomiting safety and effectiveness of palonosetron hydrochloride injection have been established in pediatric patients aged 1 month to less than 17 years for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including hec. use is supported by a clinical trial where 165 pediatric patients aged 2 months to less than 17 years were randomized to receive a single dose of palonosetron 20 mcg/kg (maximum 1.5 mg) administered as an intravenous infusion 30 minutes prior to the start of emetogenic chemotherapy [see clinical studies ( 14.2) ]. while this study demonstrated that pediatric patients require a higher palonosetron dose than adults to prevent chemotherapy-induced nausea and vomiting, the safety profile is consistent with the established profile in adults [see adverse reactions ( 6.1) ]. safety and effectiveness of palonosetron hydrochloride injection in neonates (less than 1 month of age) have not been established. postoperative nausea and vomiting studies safety and effectiveness have not been established in pediatric patients for prevention of postoperative nausea and vomiting. two pediatric trials were performed. pediatric study 1, a dose finding study was conducted to compare two doses of palonosetron, 1 mcg/kg (maximum 0.075 mg) versus 3 mcg/kg (maximum 0.25 mg). a total of 150 pediatric surgical patients participated, age range 1 month to less than 17 years. no dose responses were observed. pediatric study 2, a multicenter, double-blind double-dummy, randomized, parallel group, active control, single-dose non-inferiority study, compared intravenous palonosetron hcl (1 mcg/kg, maximum 0.075 mg) versus intravenous ondansetron. a total of 670 pediatric surgical patients participated, age 30 days to less than 17 years. the primary efficacy endpoint, complete response (cr: no vomiting, no retching, and no antiemetic rescue medication) during the first 24 hours postoperatively was achieved in 78.2% of patients in the palonosetron group and 82.7% in the ondansetron group. given the pre-specified non-inferiority margin of -10%, the stratum adjusted mantel-haenszel statistical non-inferiority confidence interval for the difference in the primary endpoint, complete response (cr), was [-10.5, 1.7%], therefore non-inferiority was not demonstrated. adverse reactions to palonosetron were similar to those reported in adults. of the 1374 adult cancer patients in clinical studies of intravenously administered palonosetron hcl, 316 (23%) were 65 years and over, while 71 (5%) were at least 75 years and over. of the 1520 adult patients in clinical studies of intravenously administered palonosetron hcl, 73 (5%) were at least 65 years old [ see clinical studies ( 14.1, 14.3]. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity in some older individuals cannot be ruled out. population pharmacokinetics analysis did not reveal any differences in palonosetron pharmacokinetics between cancer patients 65 years of age and older compared to younger patients [see clinical pharmacology ( 12.3)]. no dose adjustment is required for geriatric patients.

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

northstar rx llc - palonosetron hydrochloride (unii: 23310d4i19) (palonosetron - unii:5d06587d6r) - palonosetron hydrochloride injection is indicated in adults for prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (mec). - acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (hec). - postoperative nausea and vomiting (ponv) for up to 24 hours following surgery. efficacy beyond 24 hours has not been demonstrated. as with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients where nausea and vomiting must be avoided during the postoperative period, palonosetron hydrochloride is recommended even where the incidence of postoperative nausea and/or vomiting is low. palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of: - acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy. palonosetron hydrochloride is contraindicated in patients known to have hypersensitivity to palonosetron [see warnings and precautions (5.1)] . risk summary there are no available data on palonosetron hcl use in pregnant women to inform a drug-associated risk. in animal reproduction studies, no effects on embryo-fetal development were observed with the administration of oral palonosetron hcl during the period of organogenesis at doses up to 1,894 and 3,789 times the recommended human intravenous dose in rats and rabbits, respectively (see data). 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 risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data in animal reproduction studies, no effects on embryo-fetal development were observed in pregnant rats given oral palonosetron hcl at doses up to 60 mg/kg/day (1,894 times the recommended human intravenous dose based on body surface area) or pregnant rabbits given oral doses up to 60 mg/kg/day (3,789 times the recommended human intravenous dose based on body surface area) during the period of organogenesis. risk summary there are no data on the presence of palonosetron in human milk, the effects of palonosetron on the breastfed infant, or the effects of palonosetron on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for palonosetron hydrochloride and any potential adverse effect on the breastfed infant from palonosetron or from the underlying maternal condition. chemotherapy-induced nausea and vomiting safety and effectiveness of palonosetron hydrochloride injection have been established in pediatric patients aged 1 month to less than 17 years for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including hec.  use is supported by a clinical trial where 165 pediatric patients aged 2 months to less than 17 years were randomized to receive a single dose of palonosetron hydrochloride injection 20 mcg/kg (maximum 1.5 mg) administered as an intravenous infusion 30 minutes prior to the start of emetogenic chemotherapy [see clinical studies (14.2)] . while this study demonstrated that pediatric patients require a higher palonosetron dose than adults to prevent chemotherapy-induced nausea and vomiting, the safety profile is consistent with the established profile in adults [ see adverse reactions (6.1)] . safety and effectiveness of palonosetron hydrochloride in neonates (less than 1 month of age) have not been established. postoperative nausea and vomiting studies safety and effectiveness have not been established in pediatric patients for prevention of postoperative nausea and vomiting. two pediatric trials were performed. pediatric study 1, a dose finding study was conducted to compare two doses of palonosetron, 1 mcg/kg (maximum 0.075 mg) versus 3 mcg/kg (maximum 0.25 mg). a total of 150 pediatric surgical patients participated, age range 1 month to less than 17 years. no dose response was observed. pediatric study 2, a multicenter, double-blind, double-dummy, randomized, parallel group, active control, single-dose non-inferiority study, compared intravenous palonosetron hcl (1 mcg/kg, maximum 0.075 mg) versus intravenous ondansetron. a total of 670 pediatric surgical patients participated, age 30 days to less than 17 years. the primary efficacy endpoint, complete response (cr: no vomiting, no retching, and no antiemetic rescue medication) during the first 24 hours postoperatively was achieved in 78.2% of patients in the palonosetron group and 82.7% in the ondansetron group. given the pre-specified non-inferiority margin of -10%, the stratum adjusted mantel-haenszel statistical non-inferiority confidence interval for the difference in the primary endpoint, complete response (cr), was [-10.5, 1.7%], therefore non-inferiority was not demonstrated. adverse reactions to palonosetron were similar to those reported in adults. of the 1374 adult cancer patients in clinical studies of intravenously administered palonosetron hcl, 316 (23%) were 65 years and over, while 71 (5%) were at least 75 years and over. of the 1520 adult patients in clinical studies of intravenously administered palonosetron hcl, 73 (5%) were at least 65 years old [see clinical studies (14.1, 14.3)] . no overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity in some older individuals cannot be ruled out.  population pharmacokinetics analysis did not reveal any differences in palonosetron pharmacokinetics between cancer patients 65 years of age and older compared to younger patients [see clinical pharmacology (12.3)] . no dose adjustment is required for geriatric patients.

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

cipla australia pty ltd - palonosetron hydrochloride, quantity: 280.8 microgram (equivalent: palonosetron, qty 250 microgram) - injection, solution - excipient ingredients: mannitol; sodium hydroxide; hydrochloric acid; disodium edetate; citric acid monohydrate; sodium citrate dihydrate; water for injections - indicated for prevention of nausea and vomiting induced by cytotoxic chemotherapy.

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - palonosetron - vomiting; nausea; cancer - antiemetics and antinauseants, - palonosetron accord is indicated in adults for:the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy,the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.palonosetron accord is indicated in paediatric patients 1 month of age and older for:the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.