Varubi (rolapitant) Tablets is a substance P/neurokinin 1 (NK1) receptor antagonist indicated in combination with other antiemetic (antinausea) agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic (nausea-causing) cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.
The recommended dosage of Varubi is 180 mg administered approximately 1 to 2 hours prior to the start of chemotherapy, administered in combination with dexamethasone and a 5-HT3 receptor antagonist.
What Drugs, Substances, or Supplements Interact with Varubi?
Varubi may interact with thioridazine, pimozide, methotrexate, topotecan, irinotecan, digoxin, and rifampin. Tell your doctor all medications and supplements you use.
Varubi During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before receiving Varubi; it is unknown if it would harm a fetus. It is unknown if Varubi passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Varubi (rolapitant) Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Varubi Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
pain or burning when you urinate;
low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
low white blood cell counts--fever, swollen gums, painful mouth sores, skin sores, cold or flu symptoms, cough, trouble breathing.
Common side effects may include:
low blood cell counts;
painful urination;
mouth sores;
hiccups;
dizziness; or
stomach pain, indigestion, loss of appetite.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following adverse reactions are discussed in greater detail in other sections of the labeling:
Interaction with CYP2D6 Substrates [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS]
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 2 and Table 3.
Table 2: 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 3: 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.
&Copy; Varubi Patient Information is supplied by Cerner Multum, Inc. and Varubi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
