Varuby - Rolapitant

What is Varuby - Rolapitant 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 (cancer therapy). As the potential for nausea and vomiting varies between chemotherapy drugs, Varuby is used in patients undergoing moderately or highly emetogenic (vomiting) chemotherapy.

Varuby works against delayed nausea and vomiting (i.e. when symptoms occur 24 hours or more after anticancer therapy) and is given with other medicines that help control 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, (almost) two hours after 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 how they are given depends on the type of chemotherapy.

For more information, see the Summary of Product Characteristics (included in the EPAR).

How does Varuby - Rolapitant work?

The active substance in Varuby, rolapitant, works by blocking neurchinin 1 (NK1) receptors. Chemotherapy can release a substance (substance P) in the body that binds to these receptors, stimulating delayed nausea and vomiting. By blocking these receptors, Varuby is able to prevent this effect. When given together with medicines that work by other mechanisms. to prevent immediate nausea and vomiting, Varuby can help maintain 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 sessions of highly emetogenic chemotherapy. In both studies, one involving 532 patients and the other involving 555 patients, participants were also given dexamethasone and granisetron (a 5-HT3 receptor antagonist). Combining the results of both studies, no nausea and no nausea were detected. vomiting within 24-120 hours after chemotherapy treatment in 71% of patients (382 out of 535) treated with Varuby compared with 60% of patients treated with placebo (322 out of 535).

A third main study also 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 may affect between 1 and 2 in 100 people) are tiredness and headache. Patients taking Varuby should not use St. John's wort (a herbal medicine for mild depression) as it may reduce the therapeutic effect of Varuby.

For the full list of 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 were manageable and similar to those seen with medicines indicated for nausea and vomiting. Although various medicines for the control of nausea and vomiting induced by chemotherapy treatments are approved in the EU, many patients continue to report such effects and the control of nausea in particular remains a challenge. Overall, the benefits of Varuby are superior. 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?

The recommendations and precautions that healthcare professionals and patients need to observe in order for Varuby to be used safely and effectively have been set out in the summary of product characteristics and package leaflet.

More information about Varuby - Rolapitant

The complete version of Varuby's EPAR can be found on the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Varuby therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.

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