Difference between revisions of "Rolapitant (Varubi)"
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<br>Extravasation: n/a | <br>Extravasation: n/a | ||
| − | For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as | + | For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, or the prescribing information. |
==Patient drug information== | ==Patient drug information== | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2015-09-01: Initial FDA approval "in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting sssociated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy." |
| − | *10 | + | *2017-10-25: IV formulation FDA approved |
| + | ==History of changes in EMA indication== | ||
| + | *2017-04-20: Initial authorization as Varuby | ||
| + | *2020-01-23: Withdrawn at the manufacturer's request, for commercial reasons | ||
==Pivotal studies== | ==Pivotal studies== | ||
| − | # Rapoport BL, Chasen MR, Gridelli C, Urban L, Modiano MR, Schnadig ID, Poma A, Arora S, Kansra V, Schwartzberg LS, Navari RM. Safety and efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting after administration of cisplatin-based highly emetogenic chemotherapy in patients with cancer: two randomised, active-controlled, double-blind, phase 3 trials. Lancet Oncol. 2015 Sep;16(9):1079-89. Epub 2015 Aug 10. [https:// | + | # Rapoport BL, Chasen MR, Gridelli C, Urban L, Modiano MR, Schnadig ID, Poma A, Arora S, Kansra V, Schwartzberg LS, Navari RM. Safety and efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting after administration of cisplatin-based highly emetogenic chemotherapy in patients with cancer: two randomised, active-controlled, double-blind, phase 3 trials. Lancet Oncol. 2015 Sep;16(9):1079-89. Epub 2015 Aug 10. [https://pubmed.ncbi.nlm.nih.gov/26272769/ PubMed] |
| − | # Schwartzberg LS, Modiano MR, Rapoport BL, Chasen MR, Gridelli C, Urban L, Poma A, Arora S, Navari RM, Schnadig ID. Safety and efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting after administration of moderately emetogenic chemotherapy or anthracycline and cyclophosphamide regimens in patients with cancer: a randomised, active-controlled, double-blind, phase 3 trial. Lancet Oncol. 2015 Sep;16(9):1071-8. Epub 2015 Aug 10. [https:// | + | # Schwartzberg LS, Modiano MR, Rapoport BL, Chasen MR, Gridelli C, Urban L, Poma A, Arora S, Navari RM, Schnadig ID. Safety and efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting after administration of moderately emetogenic chemotherapy or anthracycline and cyclophosphamide regimens in patients with cancer: a randomised, active-controlled, double-blind, phase 3 trial. Lancet Oncol. 2015 Sep;16(9):1071-8. Epub 2015 Aug 10. [https://pubmed.ncbi.nlm.nih.gov/26272768/ PubMed] |
==Also known as== | ==Also known as== | ||
| − | *'''Code names:''' | + | *'''Code names:''' SCH-619734 |
| − | *'''Brand names:''' Varubi, Varubi IV | + | *'''Brand names:''' Varubi, Varubi IV, Varuby |
[[Category:Drugs]] | [[Category:Drugs]] | ||
| Line 26: | Line 29: | ||
[[Category:Neurokinin 1 (NK1) antagonists]] | [[Category:Neurokinin 1 (NK1) antagonists]] | ||
[[Category:FDA approved in 2015]] | [[Category:FDA approved in 2015]] | ||
| + | [[Category:EMA approved in 2017]] | ||
| + | [[Category:EMA withdrawn in 2020]] | ||
Latest revision as of 00:06, 6 July 2024
General information
Class/mechanism: Substance P/neurokinin 1 (NK1) receptor antagonist.
Route: PO, IV
Extravasation: n/a
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, or the prescribing information.
Patient drug information
History of changes in FDA indication
- 2015-09-01: Initial FDA approval "in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting sssociated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy."
- 2017-10-25: IV formulation FDA approved
History of changes in EMA indication
- 2017-04-20: Initial authorization as Varuby
- 2020-01-23: Withdrawn at the manufacturer's request, for commercial reasons
Pivotal studies
- Rapoport BL, Chasen MR, Gridelli C, Urban L, Modiano MR, Schnadig ID, Poma A, Arora S, Kansra V, Schwartzberg LS, Navari RM. Safety and efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting after administration of cisplatin-based highly emetogenic chemotherapy in patients with cancer: two randomised, active-controlled, double-blind, phase 3 trials. Lancet Oncol. 2015 Sep;16(9):1079-89. Epub 2015 Aug 10. PubMed
- Schwartzberg LS, Modiano MR, Rapoport BL, Chasen MR, Gridelli C, Urban L, Poma A, Arora S, Navari RM, Schnadig ID. Safety and efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting after administration of moderately emetogenic chemotherapy or anthracycline and cyclophosphamide regimens in patients with cancer: a randomised, active-controlled, double-blind, phase 3 trial. Lancet Oncol. 2015 Sep;16(9):1071-8. Epub 2015 Aug 10. PubMed
Also known as
- Code names: SCH-619734
- Brand names: Varubi, Varubi IV, Varuby