Varuby
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
02-03-2020
Charakterystyka produktu
(SPC)
02-03-2020
Sprawozdanie z oceny publicznego
(PAR)
02-03-2020
Składnik aktywny:
rolapitant
Dostępny od:
TESARO Bio Netherlands B.V.
Kod ATC:
A04AD
INN (International Nazwa):
rolapitant
Grupa terapeutyczna:
Antiemetics and antinauseants,
Dziedzina terapeutyczna:
Vomiting; Nausea; Cancer
Wskazania:
Prevention of delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults.Varuby is given as part of combination therapy.
Podsumowanie produktu:
Revision: 3
Status autoryzacji:
Withdrawn
Data autoryzacji:
2017-04-19
Ulotka dla pacjenta
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
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Charakterystyka produktu
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-
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