Nerlynx

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

neratinib

Available from:

Pierre Fabre Medicament

ATC code:

L01EH02

INN (International Name):

neratinib

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Breast Neoplasms

Therapeutic indications:

Nerlynx is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy.

Product summary:

Revision: 13

Authorization status:

Authorised

Authorization date:

2018-08-31

Patient Information leaflet

27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NERLYNX 40 MG FILM-COATED TABLETS
neratinib
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 Nerlynx is and what it is used for
2.
What you need to know before you take Nerlynx
3.
How to take Nerlynx
4.
Possible side effects
5.
How to store Nerlynx
6.
Contents of the pack and other information
1.
WHAT NERLYNX IS AND WHAT IT IS USED FOR
WHAT NERLYNX IS
Nerlynx contains the active substance ‘neratinib’. It belongs to a
group of medicines called ‘tyrosine
kinase inhibitors’ used to block cancer cells and treat breast
cancer.
WHAT NERLYNX IS USED FOR
Nerlynx is used for patients who have early stage breast cancer which:
-
is hormone receptor positive (HR-positive) and human epidermal growth
factor receptor 2-
positive (HER2-positive), and
-
has previously been treated with another medicine called
‘trastuzumab’.
The ‘HER2 receptor’ is a protein found on the surface of cells in
the body. It helps control how a
healthy breast cell grows. In HER2-positive breast cancer, the cancer
cells have a large amount of
HER2 receptors on their surface. This results in the cancer cells
dividing and growing faster.
‘Hormone receptors’ are also proteins expressed inside the cells
of some specific tissues. Estrogens
and progesterone bind to these proteins and regulate cell activity. In
HR-positive breast cancer, tumor
cell division and growth can be enhanced by estrogens and/or
progesterone.
Before Nerlynx is used, your cancer mus

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Nerlynx 40 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains neratinib maleate, equivalent to 40
mg neratinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Oval, red film-coated tablet with ‘W104’ debossed on one side.
Tablet dimensions are 10.5 mm x
4.3 mm with thickness of 3.1 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
Nerlynx is indicated for the extended adjuvant treatment of adult
patients with early-stage hormone
receptor positive HER2-overexpressed/amplified breast cancer and who
completed adjuvant
trastuzumab-based therapy less than one year ago.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Nerlynx treatment should be initiated and supervised by a physician
experienced in the administration
of anti-cancer medicinal products.
Posology
The recommended dose of Nerlynx is 240 mg (six 40 mg tablets) taken
orally once daily,
continuously for one year. Nerlynx should be taken with food,
preferably in the morning. Patients
should initiate treatment within 1 year after completion of
trastuzumab therapy.
_Dose modifications for adverse reactions_
Nerlynx dose modification is recommended based on individual safety
and tolerability. Management
of some adverse reactions may require dose interruption and/or dose
reduction as shown in Table 1,
Table 2, Table 3, and Table 4.
Nerlynx should be discontinued for patients who:
•
Fail to recover to Grade 0 to 1 from treatment-related toxicity,
•
For toxicities that result in a treatment delay > 3 weeks, or
•
For patients that are unable to tolerate 120 mg daily
Additional clinical situations may result in dose adjustments as
clinically indicated (e.g. intolerable
toxicities, persistent Grade 2 adverse reactions, etc.).
3
TABLE 1:
NERLYNX DOSE MODIFICATIONS FOR ADVERSE REACTIONS
DOSE LEVEL
NERLYNX DOSE
Recommended starting dose
240 mg daily
First dose reduction
200 mg daily
Second do