Varuby 90mg tablets

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Rolapitant hydrochloride monohydrate

Fáanlegur frá:

Tesaro UK Ltd

ATC númer:

A04AD14

INN (Alþjóðlegt nafn):

Rolapitant hydrochloride monohydrate

Skammtar:

90mg

Lyfjaform:

Tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 04060000

Upplýsingar fylgiseðill

Taking Varuby before chemotherapy prevents
sickness and feelings of sickness. Do not
take this medicine in the days after you have
chemotherapy - unless you are about to have
another chemotherapy cycle. Do not take
Varuby more than once every two weeks.
IF YOU TAKE MORE VARUBY THAN YOU SHOULD
The usual dose is two tablets. If you think you
may have taken more than you should, tell your
doctor straight away.
IF YOU FORGET TO TAKE VARUBY
If you have forgotten to take your dose, tell
your doctor straight away.
IF YOU STOP TAKING VARUBY
Varuby helps prevent feeling sick and being
sick when you have chemotherapy. If you do
not want to take this medicine, discuss this with
your doctor.
If you have any further questions on the use of
this medicine, ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
TELL YOUR DOCTOR, PHARMACIST OR NURSE IF YOU
NOTICE ANY OF THE FOLLOWING SIDE EFFECTS:
SERIOUS SIDE EFFECTS:
Rare: may affect up to 1 in 1,000 people
If you have symptoms of an allergic reaction,
such as sudden shortness of breath, swelling
of the lips or tongue or change in taste,
swelling of skin or tissue or sudden rash or
fever, or faster heartbeats, TELL YOUR DOCTOR
OR NURSE IMMEDIATELY. They will provide
appropriate treatment.
OTHER SIDE EFFECTS:
Common: may affect up to 1 in 10 people
-
headache
-
constipation
-
feeling tired
Uncommon: may affect up to 1 in 100 people
-
sore or painful muscles
-
feeling dizzy, difficulty concentrating, lack
of energy, feeling sleepy (somnolence) or
trouble sleeping (insomnia)
-
stomach problems including stomach
discomfort, bloating, nausea, pain,
indigestion, and diarrhoea
-
low levels of white blood cells which fight
infections (shown in blood tests)
-
infection in the mouth
-
mouth sores
-
decreased appetite
-
hiccups
-
weakness
Rare: may affect up to 1 in 1,000 people
-
thrush in the mouth or skin
-
a reduction in number of platelets (shown in
blood tests)
-
increased risk of ble

Vara einkenni

OBJECT 1
VARUBY 90 MG FILM-COATED TABLETS- SUMMARY OF
PRODUCT CHARACTERISTICS
Summary of Product Characteristics Updated 24-May-2017 | Tesaro UK
Limited
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:
_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
Ch