Țară: Uniunea Europeană
Limbă: engleză
Sursă: EMA (European Medicines Agency)
rolapitant
TESARO Bio Netherlands B.V.
A04AD
rolapitant
Antiemetics and antinauseants,
Vomiting; Nausea; Cancer
Prevention of delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults.Varuby is given as part of combination therapy.
Revision: 3
Withdrawn
2017-04-19
25 B. PACKAGE LEAFLET Medicinal product no longer authorised 26 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VARUBY 90 MG FILM-COATED TABLETS Rolapitant This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, or pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Varuby is and what it is used for 2. What you need to know before you take Varuby 3. How to take Varuby 4. Possible side effects 5. How to store Varuby 6. Contents of the pack and other information 1. WHAT VARUBY IS AND WHAT IT IS USED FOR WHAT VARUBY IS Varuby contains the active substance rolapitant. WHAT VARUBY IS USED FOR Varuby is used to help prevent adults with cancer feeling sick (nauseous) or being sick (vomiting) while having cancer treatment chemotherapy. HOW VARUBY WORKS Chemotherapy can cause the body to release “substance P.” Substance P attaches to nerve cells in the brain’s vomiting centre and makes you feel sick or be sick. Rolapitant, the active substance in Varuby, blocks substance P from attaching to these nerve cells and this helps prevent nausea and vomiting. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VARUBY _ _ DO NOT TAKE VARUBY: - if you are allergic to rolapitant or any of the other ingredients of this medicine (listed in section 6). - if you take an herbal medicine called St John’s wort _(Hypericum performatum)_ , used to tre Citiți documentul complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Varuby 90 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 90 mg of rolapitant (as hydrochloride monohydrate). Excipient(s) with known effect This medicinal product contains 230 mg of lactose (as monohydrate) per dose (two tablets). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Tablets are blue, debossed with T0101 on one side and 100 on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ Varuby is given as part of a regimen that includes dexamethasone and a 5-HT 3 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-HT 3 receptor antagonist Standard dose of 5-HT 3 receptor antagonist. See the Summary of Product Characteristics for the co- Citiți documentul complet