- |||||||||| Decadron (dexamethasone) / Merck (MSD), Varubi IV (rolapitant IV) / TerSera Therap, GSK
Clinical, PK/PD data, Journal: Pharmacokinetics, Safety, and Tolerability of Rolapitant Administered Intravenously Following Single Ascending and Multiple Ascending Doses in Healthy Subjects. (Pubmed Central) - Apr 10, 2020
The most common rolapitant-related treatment-emergent adverse events were headache, dry mouth, and dizziness, which were predominantly mild in severity. Overall, the pharmacokinetic and safety profiles of IV rolapitant were consistent with those of the oral formulation.
- |||||||||| ondansetron / Generic mfg., olanzapine / Generic mfg., Xpovio (selinexor) / Ono Pharma, Karyopharm, Antengene
Symptom management for patients with relapsed and refractory multiple myeloma receiving therapy with selinexor (Xpovio™) (Henry B. Gonzalez Convention Center - Tower View Registration) - Feb 17, 2020 - Abstract #ONS2020ONS_397;
Patient education should include discussion of common toxicities and appointments for evaluation/supportive care measures. Optimization of supportive care and oral adherence is critical to maintain patients on treatment longer to get better response rates in this triple class refractory population.
- |||||||||| Varubi (rolapitant oral) / TerSera Therap, GSK, Varubi IV (rolapitant IV) / TerSera Therap, GSK
Journal: Infusion reactions following administration of intravenous rolapitant at an academic medical center. (Pubmed Central) - Nov 28, 2019
Due to the quick onset of the infusion-related hypersensitivity reactions with intravenous rolapitant, interpatient differences in pharmacokinetics or pharmacodynamics are unlikely to be the cause. An objective assessment utilizing the Naranjo Causality Scale rates these infusion-related hypersensitivity reactions as definite adverse drug reactions.
- |||||||||| olanzapine / Generic mfg., netupitant (Ro 67-3189) / Helsinn, Otsuka
Clinical, Journal: Ten-Year Trends in Antiemetic Prescribing in Patients Receiving Highly Emetogenic Chemotherapy. (Pubmed Central) - Sep 28, 2019
Receipt of olanzapine, rolapitant, and netupitant was minimal throughout the study period.Dexamethasone and 5-HT3RAs were used by most patients receiving HEC, in accordance with guideline recommendations. NK1RA use was less adherent with guidelines.
- |||||||||| Review, Journal, CINV: Evolving role of neurokinin 1-receptor antagonists for chemotherapy-induced nausea and vomiting. (Pubmed Central) - Oct 18, 2018
To examine pharmacologic and clinical characteristics of neurokinin 1 (NK)-receptor antagonists (RAs) for preventing chemotherapy-induced nausea and vomiting (CINV) following highly or moderately emetogenic chemotherapy, a literature search was performed for clinical studies in patients at risk of CINV with any approved NK RAs in the title or abstract: aprepitant (capsules or oral suspension), HTX019 (intravenous [IV] aprepitant), fosaprepitant (IV aprepitant prodrug), rolapitant (tablets or IV), and fixed-dose tablets combining netupitant or fosnetupi-tant (IV netupitant prodrug) with the 5-hydroxytryptamine type 3 (5HT) RA palonosetron (oral or IV)...Adding an NK RA to 5HT RA and dexamethasone significantly improves CINV control vs the two-drug regimen. Newer NK RAs offer more formulation options, higher acute-phase plasma levels, or improved tolerability, and increase clinicians' opportunities to maximize benefits of this important class of antiemetics.
- |||||||||| Journal: Prevention of chemotherapy-induced nausea: the role of neurokinin-1 (NK1) receptor antagonists. (Pubmed Central) - Oct 20, 2017
Aprepitant has not shown consistent superiority over a two-drug (ondansetron-dexamethasone) combination in nausea control after cisplatin- or anthracycline-cyclophosphamide (AC)-based highly emetogenic chemotherapy (HEC)...The potential impact of the new NK1RAs rolapitant and netupitant (oral fixed combination with palonosetron, as NEPA) in CIN prophylaxis is discussed...Recently, NK1RAs have been challenged by olanzapine, with olanzapine showing superior efficacy in nausea prevention after HEC. Fixed antiemetic combinations (such as NEPA) or new antiemetics with a long half-life that may be given once per chemotherapy cycle (rolapitant or NEPA) may improve patient compliance with antiemetic treatment.
- |||||||||| Varubi IV (rolapitant IV) / TerSera Therap, GSK
Trial completion: A Phase 1, 2-Part, Single Ascending Dose Assessment of the Safety, Tolerability, and Pharmacokinetics of Rolapitant Intravenous in Healthy Volunteers (clinicaltrials.gov) - Aug 25, 2015
P1, N=100, Completed,
Addition of rolapitant to 5-HT3RA and dexamethasone therapy significantly improved CR, no nausea, no emesis, and CP in pts with GI/CRC receiving emetogenic chemotherapy. Active, not recruiting --> Completed
- |||||||||| Varubi IV (rolapitant IV) / TerSera Therap, GSK
Trial completion: An Open Label, Single Dose, Three Part Study to Assess the Effects of Rolapitant (2 mg/mL IV Solution) on the Pharmacokinetics of Digoxin; Sulfasalazine; and the Cooperstown Cocktail (Midazolam, Omeprazole, Warfarin, Caffeine, and Dextromethorphan in Healthy Subjects (clinicaltrials.gov) - Aug 25, 2015
P1, N=102, Completed,
Active, not recruiting --> Completed Recruiting --> Completed
- |||||||||| Varubi IV (rolapitant IV) / TerSera Therap, GSK
Enrollment open, Enrollment change: An Open Label, Single Dose, Three Part Study to Assess the Effects of Rolapitant (2 mg/mL IV Solution) on the Pharmacokinetics of Digoxin; Sulfasalazine; and the Cooperstown Cocktail (Midazolam, Omeprazole, Warfarin, Caffeine, and Dextromethorphan in Healthy Subjects (clinicaltrials.gov) - Jun 18, 2015
P1, N=108, Recruiting,
Recruiting --> Completed Not yet recruiting --> Recruiting | N=90 --> 108
- |||||||||| Varubi IV (rolapitant IV) / TerSera Therap, GSK
Enrollment closed: A Phase 1, 2-Part, Single Ascending Dose Assessment of the Safety, Tolerability, and Pharmacokinetics of Rolapitant Intravenous in Healthy Volunteers (clinicaltrials.gov) - Jun 17, 2015
P1, N=100, Active, not recruiting,
Not yet recruiting --> Recruiting | N=90 --> 108 Recruiting --> Active, not recruiting
- |||||||||| Varubi IV (rolapitant IV) / TerSera Therap, GSK
New P1 trial: An Open Label, Single Dose, Three Part Study to Assess the Effects of Rolapitant (2 mg/mL IV Solution) on the Pharmacokinetics of Digoxin; Sulfasalazine; and the Cooperstown Cocktail (Midazolam, Omeprazole, Warfarin, Caffeine, and Dextromethorphan in Healthy Subjects (clinicaltrials.gov) - May 5, 2015
P1, N=90, Not yet recruiting,
|
