What is Varuby - Rolapitant used for and what is it used for?
Varuby is a medicine used to prevent nausea (feeling sick) and vomiting in adult cancer patients treated with chemotherapy (anticancer therapy). Because the potential for nausea and vomiting varies with chemotherapy drugs, Varuby is used in patients undergoing moderately or highly emetogenic chemotherapy (which induces vomiting).
Varuby acts against delayed nausea and vomiting (ie when symptoms occur 24 hours or more after cancer therapy) and is given with other medicines that help control the more immediate nausea and vomiting.
Varuby contains the active ingredient rolapitant.
How is Varuby - Rolapitant used?
Varuby can only be obtained with a prescription and is available as 90 mg tablets. Two tablets should be taken on the first day of each chemotherapy cycle, at (almost) two hours from the start of chemotherapy. Varuby is given in combination with dexamethasone and a 5-HT3 receptor antagonist (two other types of medicines that prevent nausea and vomiting), but their mode of administration depends on the type of chemotherapy.
For more information, see the summary of product characteristics (included with EPAR).
How does Varuby - Rolapitant work?
The active substance present in Varuby, rolapitant, works by blocking the receptors of neurchinin 1 (NK1). Chemotherapy can release into the body a substance (substance P) that binds to these receptors by stimulating delayed nausea and vomiting. By blocking these receptors, Varuby is able to prevent this effect. When administered together with medicines acting through other mechanisms to prevent immediate nausea and vomiting, Varuby may promote prolonged control of these symptoms after the chemotherapy session.
What benefit has Varuby - Rolapitant shown during the studies?
In two main studies Varuby was more effective than placebo (a dummy treatment) in preventing delayed nausea and vomiting after highly emetogenic chemotherapy sessions. In both studies, one of 532 patients and the other of 555 patients, participants were also given dexamethasone and granisetron (a 5-HT3 receptor antagonist). Combining the results of both studies, nausea and vomiting were not detected within 24-120 hours after chemotherapy treatment in 71% of patients (382 out of 535) treated with Varuby compared to 60% of patients treated with placebo (322 of 535).
Also in a third main study it was found that Varuby is more effective than placebo when combined with dexamethasone and granisetron in patients undergoing moderately emetogenic chemotherapy. Delayed nausea and vomiting were not observed in 71% of patients treated with Varuby (475 out of 666) compared with 62% of patients treated with placebo (410 out of 666).
What are the risks associated with Varuby - Rolapitant?
The most common side effects with Varuby (which can affect between 1 and 2 people in 100) are fatigue and headache. Patients taking Varuby should not use St. John's wort (a herbal medicine for mild depression) since it can reduce the therapeutic effect of Varuby.
For the full list of all side effects reported with Varuby, see the package leaflet.
Why has Varuby - Rolapitant been approved?
Varuby improves the control of delayed nausea and vomiting in combination with other standard therapies. In addition, any side effects have been shown to be manageable and similar to those observed with medicines indicated for nausea and vomiting. Although various drugs for the control of nausea and vomiting induced by chemotherapy treatments are approved in the EU, many patients continue to report these effects and the control of nausea in particular remains a challenge. Overall, Varuby's benefits outweigh the risks and it was recommended that it be approved for use in the EU
What measures are being taken to ensure the safe and effective use of Varuby - Rolapitant?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Varuby have been included in the summary of product characteristics and the package leaflet.
More information on Varuby - Rolapitant
The full EPAR for Varuby can be found on the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Varuby therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
