LENALIDOMIDE S.K. 10 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LENALIDOMIDE

Available from:

K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL

ATC code:

L04AX04

Pharmaceutical form:

HARD CAPSULE

Composition:

LENALIDOMIDE 10 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

LOTUS PHARMACEUTICAL CO., LTD NANTOU PLANT, TAIWAN

Therapeutic area:

LENALIDOMIDE

Therapeutic indications:

Multiple Myeloma (MM)Lenalidomide S.K. is indicated for the treatment of multiple myeloma. Myelodysplastic Syndromes Lenalidomide S.K. is indicated for patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Lenalidomide S.K. 7.5 mg is not indicated for treatment in MDS. Mantle Cell Lymphoma Lenalidomide S.K. is indicated for the treatment of adult patients with relapsed and/or refractory mantle cell lymphoma (MCL). Follicular lymphomaLenalidomide S.K. in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma.

Authorization date:

2020-06-22

Patient Information leaflet

2
Contents
Page
Introduction
3
Personal Information
4
Summary
6
You must never take Lenalidomide S.K. if
7
Info for women who are able to become pregnant
8
Info for women who are not able to become pregnant 11
Information for men
12
Pregnancy Prevention Program Initiation & Reports 13
Prescription information
14
End of Treatment Requirements
15
Additional information
16
3
Lenalidomide S.K. was found to be harmful to foetuses or
cause birth defects in animals and is likely to have similar
effects in humans.
Your doctor has registered you to a Risk Management Plan
(RMP), Pregnancy Prevention Program (PPP).
The aim of
this program is to assist your doctor to inform
you
regarding
the
risks
related
to
an
unborn
child
associated with Lenalidomide S.K. treatment and to ensure
that you are aware of the precautions you need to take
before, during and after the treatment.
You
must
understand
and
consent
to
the
program
conditions to receive the treatment with Lenalidomide S.K.
Disclaimer:
This
information
pack
only
refers
to
Risk
Management Plan (RMP), Pregnancy Prevention Program
(PPP). To find out more about the medication, side-effects
and
warnings
please
speak
with
your
healthcare
professional and read the patient information leaflet.
4
Personal Information
Information for patients, doctors, caregivers & pharmacists about
the
use
of
personal
information
– risk
management
program
relating to the administration of the drug Lenalidomide
K.S. Kim International Ltd. (hereinafter: “K.S. Kim” or “we”)
respects
your right to privacy. Your ability to make informed decisions about
the use of information belonging to you is important to us. In this
document, we specify the information that we collect from you, how
we protect it and what uses we make of the information.
Information that we collect
“Personal information” is information that can be attributed to a
person or entity, such as a name, address or medical information.
The personal information that we collect from patients includes
name/ initials, identity car