Everolimus TAD 2.5 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Everolimus

Available from:

TAD Pharma GmbH

ATC code:

L01XE; L01XE10

INN (International Name):

Everolimus

Dosage:

2.5 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

Protein kinase inhibitors; everolimus

Authorization status:

Not marketed

Authorization date:

2019-11-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EVEROLIMUS TAD 2.5 MG TABLETS
EVEROLIMUS TAD 5 MG TABLETS
EVEROLIMUS TAD 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 TAD is and what it is used for
2.
What you need to know before you take Everolimus TAD
3.
How to take Everolimus TAD
4.
Possible side effects
5.
How to store Everolimus TAD
6.
Contents of the pack and other information
1.
WHAT EVEROLIMUS TAD IS AND WHAT IT IS USED FOR
Everolimus TAD 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 TAD is used to treat adult patients with:
-
advanced tumours called neuroendocrine tumours that originate from the
pancreas. It is given if
the tumours are inoperable and do not overproduce specific hormones or
other related natural
substances.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EVEROLIMUS TAD
Everolimus TAD will only be prescribed for you by a doctor with
experience in cancer treatment.
Follow all the doctor’s instructions carefully. They may differ from
the general information contained
in this leaflet. If you have any questions about Everolimus TAD or why
it has been prescribed for you,
ask your doctor.
DO NOT TAKE EVEROLIMUS TAD
-
if you are
ALLERGIC TO
everolimus, to related substances such as sirolimus or temsirolimus,
or to
any of the other ingredients of this medicine (listed in section 6).
If you think you may be allergi

Summary of Product characteristics

Health Products Regulatory Authority
30 June 2023
CRN00D4T0
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Everolimus TAD 2.5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg everolimus.
Excipient with known effect
Each tablet contains 73.94 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off white oval biconvex tablets (approximately 10 x 5 mm),
debossed with E9VS on one side and 2.5 on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Neuroendocrine tumours of pancreatic origin
Everolimus TAD is indicated for the treatment of unresectable or
metastatic, well- or moderately-differentiated neuroendocrine
tumours of pancreatic origin in adults with progressive disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Everolimus TAD should be initiated and supervised by a
physician experienced in the use of anticancer
therapies.
Posology
For the different dose regimens Everolimus TAD is available as 2.5 mg,
5 mg and 10 mg tablets.
The recommended dose is 10 mg everolimus once daily. Treatment should
continue as long as clinical benefit is observed or
until unacceptable toxicity occurs.
If a dose is missed, the patient should not take an additional dose,
but take the next prescribed dose as usual.
_ _
_Dose adjustment due to adverse reactions_
Management of severe and/or intolerable suspected adverse reactions
may require dose reduction and/or temporary
interruption of Everolimus TAD therapy. For adverse reactions of Grade
1, dose adjustment is usually not required. If dose
reduction is required, the recommended dose is 5 mg daily and must not
be lower than 5 mg daily.
Table 1 summarises the dose adjustment recommendations for specific
adverse reactions (see also section 4.4).
Table 1 Everolimus TAD dose adjustment recommendations
ADVERSE REACTION
SEVERITY
1
​
EVEROLIMUS TAD DOSE ADJUSTMENT
Non-infectious
pneumonitis
Grade 2
​
Consider interruption of therapy until sympt