Rolapitant

(Varubi®)

Rolapitant

Drug updated on 12/11/2024

Dosage FormTablet (oral; 90 mg)
Drug ClassSubstance P/neurokinin-1 (NK-1) receptor antagonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

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Summary
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  • This summary is based on the review of one systematic review/meta-analysis. [1]
  • Highly Emetogenic Chemotherapy (HEC): For complete control of vomiting during days 1-5, fosnetupitant + palonosetron was the most effective combination with 810 of 1000 participants achieving control (relative risk (RR) 1.15, 95% confidence interval (CI) 0.97-1.37; moderate certainty), followed by aprepitant + palonosetron with 753 of 1000 participants (RR 1.07, 95% CI 0.98-1.18; low certainty).
  • Moderately Emetogenic Chemotherapy (MEC): Rolapitant + granisetron achieved higher vomiting control in MEC patients with 660 of 1000 participants (RR 1.19, 95% CI 1.06-1.33; high certainty), while aprepitant + palonosetron also showed efficacy with 716 of 1000 participants (RR 1.29, 95% CI 1.00-1.66; low certainty).
  • Comparative Efficacy: In HEC, netupitant + palonosetron and fosaprepitant + granisetron demonstrated similar efficacy to aprepitant + granisetron, with 704 and 697 of 1000 participants achieving vomiting control, respectively (RR 1.00, 95% CI 0.93-1.08 for netupitant and RR 0.99, 95% CI 0.93-1.06 for fosaprepitant; high certainty).
  • HEC: Fosaprepitant + ondansetron, casopitant + ondansetron, and netupitant + palonosetron were associated with fewer serious adverse events (SAEs), with occurrences of 8 to 9 per 1000 participants (RRs between 0.23 to 0.27, low certainty) compared to aprepitant + granisetron. Rolapitant + granisetron had a slightly higher rate of SAEs at 20 per 1000 participants (RR 0.57, 95% CI 0.19 to 1.70; low certainty).
  • Moderately Emetogenic Chemotherapy (MEC): Rolapitant + granisetron was associated with a higher rate of SAEs compared to granisetron alone, occurring in 176 of 1000 participants (RR 1.15, 95% CI 0.88 to 1.50; low certainty).
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Varubi (rolapitant) Prescribing Information.2020TerSera Therapeutics LLC, Deerfield, IL

Systematic Reviews / Meta-Analyses