Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: TESARO Bio Netherlands B.V., Joop Geesinkweg 901, 1114 AB Amsterdam-Duivendrecht, Netherlands
Prevention of delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults.
Varuby is given as part of combination therapy (see section 4.2).
Varuby is given as part of a regimen that includes dexamethasone and a 5-HT3 receptor antagonist.
180 mg (two tablets) should be administered within 2 hours prior to initiation of each chemotherapy cycle but at no less than 2-week intervals.
There is no medicinal product interaction between rolapitant and dexamethasone, so no dosage adjustment for dexamethasone is required.
The following regimens are recommended for the prevention of nausea and vomiting associated with emetogenic cancer therapy:
Highly emetogenic chemotherapy regimen:
| Day 1 | Day 2 | Day 3 | Day 4 | |
|---|---|---|---|---|
| Varuby | 180 mg orally; Within 2 hours prior to chemotherapy | Καμία | ||
| Dexamethasone | 20 mg orally; 30 min prior to chemotherapy | 8 mg orally twice daily | 8 mg orally twice daily | 8 mg orally twice daily |
| 5-HT3 receptor antagonist | Standard dose of 5-HT3 receptor antagonist. See the Summary of Product Characteristics for the co-administered 5-HT3 receptor antagonist for appropriate dosing information. | None | ||
Moderately emetogenic chemotherapy regimen:
| Day 1 | Day 2 | Day 3 | Day 4 | |
|---|---|---|---|---|
| Varuby | 180 mg orally; Within 2 hours prior to chemotherapy | None | ||
| Dexamethasone | 20 mg orally; 30 min prior to chemotherapy | None | ||
| 5-HT3 receptor antagonist | Standard dose of 5-HT3 receptor antagonist. See the Summary of Product Characteristics for the co-administered 5-HT3 receptor antagonist for appropriate dosing information. | See the Summary of Product Characteristics for the co-administered 5-HT3 receptor antagonist for appropriate dosing information. | ||
No dose adjustment is necessary for the elderly. Limited data in patients aged 75 years and older are available. Varuby should be used with caution in these patients (see section 5.2).
No dose adjustment is necessary for patients with mild or moderate renal impairment. There are limited data in patients with severe renal impairment and no data in patients with end stage renal disease undergoing haemodialysis. Varuby should be used with caution in these patients (see section 5.2).
No dose adjustment is needed in patients with mild or moderate hepatic impairment. There are no data in patients with severe hepatic impairment. Varuby should be used with caution in these patients (see sections 4.4 and 5.2).
The safety and efficacy of rolapitant in children and adolescents below 18 years of age has not yet been established. No data are available.
The tablets should be swallowed whole, with some water and may be taken with or without food.
Rolapitant doses up to 720 mg have been used in clinical studies without any safety concerns. In case of overdose, the medicinal product should be discontinued and general supportive treatment and monitoring should be provided. Because of the antiemetic activity of rolapitant, emesis induced by a medicinal product may not be effective. Dialysis studies have not been performed.
Shelf life: 4 years.
This medicinal product does not require any special storage conditions.
Polyvinyl chloride/polychlorotrifluoroethylene/aluminium foil twinned blister.
Pack size of two tablets.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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