Inlyta
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
28-09-2021
Summary of Product characteristics
(SPC)
28-09-2021
Public Assessment Report
(PAR)
21-08-2015
Active ingredient:
axitinib
Available from:
Pfizer Europe MA EEIG
ATC code:
L01EK01
INN (International Name):
axitinib
Therapeutic group:
Protein kinase inhibitors
Therapeutic area:
Carcinoma, Renal Cell
Therapeutic indications:
Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.
Product summary:
Revision: 14
Authorization status:
Authorised
Authorization date:
2012-09-03
Patient Information leaflet
45
B. PACKAGE LEAFLET
46
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
INLYTA 1 MG FILM-COATED TABLETS
INLYTA 3 MG FILM-COATED TABLETS
INLYTA 5 MG FILM-COATED TABLETS
INLYTA 7 MG FILM-COATED TABLETS
axitinib
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, 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 Inlyta is and what it is used for
2.
What you need to know before you take Inlyta
3.
How to take Inlyta
4.
Possible side effects
5.
How to store Inlyta
6.
Contents of the pack and other information
1.
WHAT INLYTA IS AND WHAT IT IS USED FOR
Inlyta is a medicine containing the active substance axitinib.
Axitinib reduces the blood supply to the
tumour and slows down the growth of cancer.
Inlyta is indicated for the treatment of advanced kidney cancer
(advanced renal cell carcinoma) in
adults, when another medicine (called sunitinib or a cytokine) is no
longer stopping disease from
progressing.
If you have any questions about how this medicine works or why this
medicine has been prescribed
for you, ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE INLYTA
DO NOT TAKE INLYTA:
If you are allergic to axitinib or any of the other ingredients of
this medicine (listed in section 6).
If you think you may be allergic, ask your doctor for advice.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR NURSE BEFORE TAKING INLYTA
•
IF YOU HAVE HIGH BLOOD PRESSURE.
Inlyta can raise your blood pressure. It is important to check your
blood pressure before you
take this medicine, and regularly while you are taking it. If you have
high blood pressure
Read the complete document
Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Inlyta 1 mg film-coated tablets
Inlyta 3 mg film-coated tablets
Inlyta 5 mg film-coated tablets
Inlyta 7 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Inlyta 1 mg film-coated tablets
Each film-coated tablet contains 1 mg of axitinib.
_ _
Inlyta 3 mg film-coated tablets
Each film-coated tablet contains 3 mg of axitinib.
Inlyta 5 mg film-coated tablets
Each film-coated tablet contains 5 mg of axitinib.
Inlyta 7 mg film-coated tablets
Each film-coated tablet contains 7 mg of axitinib.
_ _
Excipients with known effect
_Inlyta 1 mg film-coated tablet _
Each film-coated tablet contains 33.6 mg of lactose monohydrate.
_Inlyta 3 mg film-coated tablet_
Each film-coated tablet contains 35.3 mg of lactose monohydrate.
_Inlyta 5 mg film-coated tablet _
Each film-coated tablet contains 58.8 mg of lactose monohydrate.
_Inlyta 7 mg film-coated tablet _
Each film-coated tablet contains 82.3 mg of lactose monohydrate.
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Inlyta 1 mg film-coated tablets
Red oval film-coated tablet debossed with “Pfizer” on one side and
“1 XNB” on the other.
Inlyta 3 mg film-coated tablets
Red round film-coated tablet debossed with “Pfizer” on one side
and “3 XNB” on the other.
Inlyta 5 mg film-coated tablets
Red triangular film-coated tablet debossed with “Pfizer” on one
side and “5 XNB” on the other.
Inlyta 7 mg film-coated tablets
Red diamond shaped film-coated tablet debossed with “Pfizer” on
one side and “7 XNB” on the other.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Inlyta is indicated for the treatment of adult patients with advanced
renal cell carcinoma (RCC) after
failure of prior treatment with sunitinib or a cytokine.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Treatment with Inlyta should be conducted by a physician experienced
in the use of anticancer
therapies.
Posology
_ _
The recommended
Read the complete document
