Kisplyx

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

lenvatinib mesilate

Available from:

Eisai GmbH

ATC code:

L01XE29

INN (International Name):

lenvatinib

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Carcinoma, Renal Cell

Therapeutic indications:

Kisplyx is indicated for the treatment of adults with advanced renal cell carcinoma (RCC):in combination with pembrolizumab, as first-line treatment (see section 5.1).in combination with everolimus, following one prior vascular endothelial growth factor (VEGF)-targeted therapy.

Product summary:

Revision: 20

Authorization status:

Authorised

Authorization date:

2016-08-25

Patient Information leaflet

45
B. PACKAGE LEAFLET
46
PACKAGE LEAFLET: INFORMATION FOR THE USER
KISPLYX 4 MG HARD CAPSULES
KISPLYX 10 MG HARD CAPSULES
lenvatinib
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Kisplyx is and what it is used for
2.
What you need to know before you take Kisplyx
3.
How to take Kisplyx
4.
Possible side effects
5.
How to store Kisplyx
6.
Contents of the pack and other information
1.
WHAT KISPLYX IS AND WHAT IT IS USED FOR
WHAT KISPLYX IS
Kisplyx is a medicine that contains the active substance lenvatinib.
It is used in combination with
pembrolizumab as the first treatment for adults with advanced kidney
cancer (advanced renal cell
carcinoma). It is also used in combination with everolimus to treat
adults with advanced kidney cancer
where other treatments (so-called “VEGF-targeted therapy”) have
not helped stop the disease.
HOW KISPLYX WORKS
Kisplyx blocks the action of proteins called receptor tyrosine kinases
(RTKs), which are involved in
the development of new blood vessels that supply oxygen and nutrients
to cells and help them to grow.
These proteins can be present in high amounts in cancer cells, and by
blocking their action Kisplyx
may slow the rate at which the cancer cells multiply and the tumour
grows and help to cut off the
blood supply that the cancer needs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KISPLYX
DO NOT TAKE KISPLYX IF:
•
you are allergic to lenvatinib or any of the other ingredients of this
medicine (listed in
section 6).
•
you are breast-feeding (se

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Kisplyx 4 mg hard capsules
Kisplyx 10 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Kisplyx 4 mg hard capsules
Each hard capsule contains 4 mg of lenvatinib (as mesilate).
Kisplyx 10 mg hard capsules
Each hard capsule contains 10 mg of lenvatinib (as mesilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Kisplyx 4 mg hard capsules
A yellowish-red body and yellowish-red cap, approximately 14.3 mm in
length, marked in black ink
with “Є” on the cap, and “LENV 4 mg” on the body.
Kisplyx 10 mg hard capsules
A yellow body and yellowish-red cap, approximately 14.3 mm in length,
marked in black ink with “Є”
on the cap, and “LENV 10 mg” on the body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Kisplyx is indicated for the treatment of adults with advanced renal
cell carcinoma (RCC):
•
in combination with pembrolizumab, as first-line treatment (see
section 5.1).
•
in combination with everolimus, following one prior vascular
endothelial growth factor
(VEGF)-targeted therapy (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and supervised by a healthcare
professional experienced in the use of
anticancer therapies.
Posology
_ _
_Kisplyx in combination with pembrolizumab as first-line treatment_
The recommended dose of lenvatinib is 20 mg (two 10-mg capsules)
orally once daily in combination
with pembrolizumab either 200 mg every 3 weeks or 400 mg every 6 weeks
administered as an
intravenous infusion over 30 minutes. The daily dose of lenvatinib is
to be modified as needed
according to the dose/toxicity management plan. Lenvatinib treatment
should continue until disease
3
progression or unacceptable toxicity. Pembrolizumab should be
continued until disease progression,
unacceptable toxicity or the maximum duration of therapy as specified
for pembrolizumab.
See the Summary of Product Characteristics (SmPC) for pembrolizumab