Everolimus Rowex 2.5mg Tablets

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Everolimus

Dostupné s:

Rowex Ltd

ATC kód:

L01EG02; L01XE; L01XE10

INN (Mezinárodní Name):

Everolimus

Dávkování:

2.5 milligram(s)

Léková forma:

Tablet

Terapeutické oblasti:

everolimus; Protein kinase inhibitors; everolimus

Stav Autorizace:

Not marketed

Datum autorizace:

2019-09-20

Informace pro uživatele

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EVEROLIMUS ROWEX 2.5 MG TABLETS
EVEROLIMUS ROWEX 5 MG TABLETS
EVEROLIMUS ROWEX 10 MG TABLETS
everolimus
_ _
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.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Everolimus Rowex is and what it is used for
2. What you need to know before you take Everolimus Rowex
3. How to take Everolimus Rowex
4. Possible side effects
5. How to store Everolimus Rowex
6. Contents of the pack and other information
1. WHAT EVEROLIMUS ROWEX IS AND WHAT IT IS USED FOR
_ _
Everolimus Rowex is an anticancer medicine containing the active
substance everolimus. Everolimus
reduces the blood supply to the tumour and slows down the growth and
spread of cancer cells.
Everolimus Rowex is used to treat adult patients with:
•
hormone receptor-positive advanced breast cancer in postmenopausal
women, in whom other
treatments (so called “non-steroidal aromatase inhibitors”) no
longer keep the disease under
control. It is given together with a medicine called exemestane, a
steroidal aromatase inhibitor,
which is used for hormonal anticancer therapy.
•
advanced tumours called neuroendocrine tumours that originate from the
stomach, bowels, lung or
pancreas. It is given if the tumours are inoperable and do not
overproduce specific hormones or
other related natural substances.
•
advanced
kidney
cancer
(advanced
renal
cell
carcinoma),
where
other
treatments
(so-called
“VEGF-targeted therapy”) have not helped stop your disease.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
EVEROLIMUS ROWEX

Charakteristika produktu

Health Products Regulatory Authority
16 January 2023
CRN00D8C2
Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Everolimus Rowex 2.5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg of everolimus.
Excipient with known effect
Each tablet contains 74.2 mg of lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to slightly yellow, elongated tablets approximately 10.1 x 4.1
mm with a bevelled edge and no score, engraved with
"LCL" on one side and "NVR" on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hormone receptor-positive advanced breast cancer
Everolimus Rowex is indicated for the treatment of hormone
receptor-positive, HER2/neu negative advanced breast cancer, in
combination with exemestane, in postmenopausal women without
symptomatic visceral disease after recurrence or
progression following a non-steroidal aromatase inhibitor.
Neuroendocrine tumours of pancreatic origin
Everolimus Rowexis indicated for the treatment of unresectable or
metastatic, well- or moderately-differentiated
neuroendocrine tumours of pancreatic origin in adults with progressive
disease.
Neuroendocrine tumours of gastrointestinal or lung origin
Everolimus Rowex is indicated for the treatment of unresectable or
metastatic, well-differentiated (Grade 1 or Grade 2)
non-functional neuroendocrine tumours of gastrointestinal or lung
origin in adults with progressive disease (see sections 4.4
and 5.1).
Renal cell carcinoma
Everolimus Rowex is indicated for the treatment of patients with
advanced renal cell carcinoma, whose disease has progressed
on or after treatment with VEGF-targeted therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Everolimus Rowex should be initiated and supervised by
a physician experienced in the use of anticancer
therapies.
Posology
For the different dose regimens Everolimus Rowex is available as 2.5
mg, 5 mg and 10 mg tablets.
The recommended dose is 10 mg everolimus once daily. Treatm