原产地英文商品名：Akynzeo for Injection 235mg/0.25mg/vial
原产地英文药品名：fosnetupitant and palonosetron
胶囊：300mgnetupitant/0.5mg帕洛诺司琼注射剂：235mg fosnetupitant /帕洛诺司琼为0.25mg冻干粉末在单一剂量小瓶用于重构。
AKYNZEO(300mg netupitant/0.5mg palonosetron)胶囊：硬明胶胶囊，白色身体和焦糖帽，身上印有“HE1”。它们提供如下：NDC#69639-101-01：在一个水泡中包装一个胶囊NDC#69639-101-04：四粒胶囊(每个水泡条两粒胶囊)。存储AKYNZEO胶囊应储存在20°C至25°C(68°F至77°F)的温度下;15°C至30°C(59°F至86°F)[见USP受控室温]。用于注射用于注射的AKYNZEO(235mg
AKYNZEO(fosnetupitant and palonosetron) for injection, for intravenous useNDC: 69639-102-01Drug Name: Akynzeo for InjectionCommon name: fosnetupitant and palonosetronActive substance: FOSNETUPITANT; PALONOSETRON HYDROCHLORIDEDose: 235mg; 0.25mgDosage form / dosage: Injectable; InjectionIndications: Nausea/Vomiting, Chemotherapy InducedLicensee: Helsinn Healthcare SA c/o August Consulting, Inc.Licensee Address: 515 Capital of Texas Highway, Suite 150 Austin, TX 78746Manufacturer: Helsinn Healthcare SA c/o August Consulting, Inc.Manufacturer Address: 515 Capital of Texas Highway, Suite 150 Austin, TX 78746Market Status: PrescriptionTE code: NoneRLD: TBDRS: NoApproved application number: NDA210493Whether it is an orphan drug: NoApproval time: 2011.04.19Approval of the instrument:PDFInstructions:PDF—————————————————-Helsinn Group announces the FDA approval of the IV formulation of AKYNZEO® (fosnetupitant/palonosetron) in the United StatesU.S. Food and Drug Administration (FDA) has approved the intravenous formulation of AKYNZEO® (NEPA, a fixed antiemetic combination of fosnetupitant, 235mg, and palonosetron, 0.25mg) as an alternative treatment option for patients experiencing CINV.The FDA has approved AKYNZEO® IV 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 has not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy.Oral AKYNZEO® was previously approved by the FDA as a fixed combination oral agent in 2014 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® is an oral fixed 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.The bioequivalence of the IV with the oral formulation of netupitant was demonstrated and the safety of IV NEPA was established through a repeated dose safety study in cancer patients to potentially uncover adverse drug reactions that may appear during subsequent clinical practice. No anaphylactic and injection site reactions related to IV NEPA were reported in this study.Currently a repeated dose safety study is ongoing in patients receiving anthracycline plus cyclophosphamide to further establish the safety profile in this setting.The prevention of CINV has been refined in treatment guidelines over the past several decades. Currently the combination treatment of antiemetic medicines with different mechanisms of actions are recommended for the prevention of CINV.The approval of AKYNZEO® in IV formulation will offer to US patients and healthcare providers an alternative route of administration of the only fixed antiemetic combination targeting two distinct CINV pathways in a single dose.Riccardo Braglia, Helsinn Group Vice Chairman and CEO, commented: “The approval of the intravenous formulation of AKYNZEO® paves the way to bring this important therapeutic option to more patients in a new formulation, and we are delighted that we are now able to push ahead with launching this product in the United States in May 2018”About Akynzeo®INDICATIONAKYNZEO® (netupitant 300mg/palonosetron 0.5mg) capsules was approved in October 2014 in the United States and 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® (fosnetupitant 235mg/palonosetron 0.25) for injection was approved in April 2018 in the United States and 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 highly emetogenic cancer chemotherapy.Limitations of UsAKYNZEO for injection has not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy.AKYNZEO is a combination of palonosetron, a serotonin-3 (5-HT3) receptor antagonist, and netupitant or fosnetupitant, substance P/neurokinin-1 (NK-1) receptor antagonists: palonosetron prevents nausea and vomiting during the acute phase and netupitant/fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.IMPORTANT SAFETY INFORMATIONWarnings and Precautions•Hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving palonosetron, one of the components of AKYNZEO, with or without known hypersensitivity to other 5-HT3 receptor antagonists.•Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs. Serotonin syndrome can be life threatening. Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes, autonomic instability, neuromuscular symptoms, seizures, and gastrointestinal symptoms. Patients should be monitored for the emergence of serotonin syndrome, and if symptoms occur, discontinue AKYNZEO and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if AKYNZEO is used concomitantly with other serotonergic drugs.Adverse Reactions•Most common adverse reactions for AKYNZEO capsules and injection: headache, asthenia, dyspepsia, fatigue, constipation and erythemaDrug Interactions•Use with caution in patients receiving concomitant medications primarily metabolized by CYP3A4. The plasma concentrations of CYP3A4 substrates can increase when co-administered with AKYNZEO. The inhibitory effect on CYP3A4 can last for multiple days◦Dexamethasone doses should be reduced when given with AKYNZEO. A more than two-fold increase in the systemic exposure of dexamethasone was observed 4 days after a single dose of netupitant or a single infusion of fosnetupitant◦Consider the potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) when administering with AKYNZEO. When administered with netupitant, the systemic exposure to midazolam was significantly increased•Avoid concomitant use of AKYNZEO in patients on chronic use of a strong CYP3A4 inducer such as rifampin as this may decrease the efficacy of AKYNZEOUse in Specific Populations•Avoid use of AKYNZEO in patients with severe hepatic impairment, severe renal impairment, or end-stage renal disease•Avoid use in pregnancy, limited data is available, may cause fetal harm.