Varuby

Posology Adults 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:Medicinal product no longer authorised 3 Highly 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 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.

Special populations Elderly people (≥ 65 years) No dose adjustment is necessary for the elderly. Limited data in patients aged 75 years and older are available. 2). Renal impairment 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. 2). Hepatic impairment No dose adjustment is needed in patients with mild or moderate hepatic impairment.

There are no data in patients with severe hepatic impairment. 2). Paediatric population The safety and efficacy of rolapitant in children and adolescents below 18 years of age has not yet been established. No data are available. Medicinal product no longer authorised 4

Summary of safety profile Over 4,375 patients have been treated with Varuby or a comparator across Phase 1, 2, and 3 clinical studies. 5%). The safety profile in the multiple-cycle extensions of highly and moderately emetogenic chemotherapy studies for up to 6 cycles of chemotherapy is similar to the profile observed in Cycle 1.

Tabulated list of adverse reactions The following adverse reactions were observed in a pooled analysis of the Highly Emetogenic Chemotherapy (HEC) and Moderately Emetogenic Chemotherapy (MEC) studies.

Frequencies are defined as:

Very common (≥1/10); common (≥1/100 to < 1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known: frequency cannot be estimated from the available data. Adverse reactions per system organ class System organ class Common Uncommon Rare Infections and infestations Oral fungal infection Candidiasis Oral candidiasis Blood and lymphatic system disorders Neutropenia International Normalised Ratio increased Leukopenia Neutrophil count decreased Thrombocytopenia Immune system disorders Hypersensitivity Metabolism and nutrition disorders Decreased appetite Dehydration Hypomagnesaemia Psychiatric disorders Insomnia Anxiety Bruxism Nervous system disorders Headache Dizziness Disturbance in attention Dysgeusia Somnolence Balance disorder Movement disorder Syncope Ear and labyrinth disorders Hypoacusis Tinnitus Eye disorders Vision blurred Cardiac disorders Heart rate increased Gastrointestinal disorders Constipation Diarrhoea Dyspepsia Nausea Abdominal distension Abdominal pain Stomatitis Abdominal discomfort Change of bowel habit Dry mouth Gastrooesophageal reflux disease Retching Vascular disorders Hypertension Respiratory, thoracic and mediastinal disorders Hiccups Dyspnoea Skin and subcutaneous tissue disorders Alopecia Angioedema Dermatitis acneiform Dry skin Musculoskeletal and connective tissue disorders Myalgia Arthralgia Back pain Muscular weakness RhabdomyolysisMedicinal product no longer authorised 8 Adverse reactions per system organ class System organ class Common Uncommon Rare General disorders and administration site conditions Fatigue Asthenia Gait disturbance Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

2). Varuby should be used with caution in these patients. 8). 2). Varuby should be used with caution in these patients. 8). g. g. g. 5). Lactose Varuby contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

1. 5)