VARUBI SIDE EFFECTS

  • Generic Name: rolapitant tablets
  • Brand Name: Varubi
  • Drug Class: Antiemetic Agents, NK1 Receptor Antagonists
Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 11/16/2021

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • Interaction with CYP2D6 Substrates

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In 4 controlled clinical trials in patients receiving emetogenic cancer chemotherapy, VARUBI was given in combination with a 5-HT3 receptor antagonist and dexamethasone. On Day 1 of Cycle 1 of chemotherapy, 1567 patients were treated with VARUBI and 1198 of these patients continued into the optional multiple cycle extension for up to 6 cycles of chemotherapy. The median number of cycles administered 180 mg of VARUBI was four. VARUBI 180 mg was administered to 1294 patients.

In Cycle 1 adverse reactions were reported in approximately 7% of patients treated with VARUBI compared with approximately 6% of patients treated with control therapy. The most common adverse reactions reported with an incidence of ≥3% and greater than control are listed in Table 1 and Table 2.

Table 1: Most Common Adverse Reactions in Patients Receiving Cisplatin-Based HighlyEmetogenic Chemotherapy (Cycle 1)*

VARUBI Regimen
(VARUBI, Dexamethasone, and5-HT3 Receptor Antagonist)
N = 624
Control
(Placebo, Dexamethasone, and 5-HT3 Receptor Antagonist)
N = 627
Neutropenia 9% 8%
Hiccups 5% 4%
Abdominal Pain 3% 2%
* all reactions occurring at ≥3% in the VARUBI group and for which the rate for VARUBI exceeds the rate for control

 

Table 2: Most Common Adverse Reactions in Patients Receiving Moderately Emetogenic Chemotherapy and Combinations of Anthracycline and Cyclophosphamide (Cycle 1)*

VARUBI Regimen
(VARUBI, Dexamethasone, and5-HT3 Receptor Antagonist)
N = 670
Control
(Placebo, Dexamethasone, and5-HT3 Receptor Antagonist)
N = 674
Decreased appetite 9% 7%
Neutropenia 7% 6%
Dizziness 6% 4%
Dyspepsia 4% 2%
Urinary tract infection 4% 3%
Stomatitis 4% 2%
Anemia 3% 2%
*all reactions occurring at ≥3% in the VARUBI group and for which the rate for VARUBI exceeds the rate for control.

 

Adverse reactions in the multiple-cycle extensions of highly and moderately emetogenic chemotherapy studies for up to 6 cycles of chemotherapy were generally similar to that observed in Cycle 1.

 

SRC: NLM .