Revlimid

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

Lenalidomide

Доступно од:

Celgene Australia Pty Ltd

Класа:

Medicine Registered

Информативни летак

REVLIMID
®

_(lenalidomide)_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Revlimid. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Revlimid
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT REVLIMID IS
USED FOR
Revlimid belongs to a group of
medicines called immunomodulating
agents.
•
Revlimid is used in combination
with another drug called
dexamethasone to treat adult
patients who have been diagnosed
with Multiple Myeloma or MM
(cancer of the bone marrow). It is
prescribed for patients whose
disease has progressed after one
therapy.
•
Revlimid is also used to treat
patients who have conditions
called myelodysplastic
syndromes (MDS) in whom the
bone marrow does not produce
enough mature blood cells. This
causes a lack of healthy blood
cells that can function properly in
the body. There are different
types of MDS. Revlimid is
approved to treat a type of MDS
where part of chromosome 5 is
missing. This type of MDS is
known as deletion 5q MDS.
Patients with this type of MDS
often have low red blood cell
counts that require treatment with
blood transfusions and it is hoped
that the use of Revlimid will
reduce the need for these.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT HOW REVLIMID
WORKS, OR WHY THIS MEDICINE HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
Revlimid will only be prescribed to
you by a doctor who has experience
in medicines to treat cancers of the
blood.
BEFORE YOU TAKE
REVLIMID
_WHEN YOU MUST NOT TAKE IT:_
If any of these apply to you, tell your
doctor before you take Revlimid:
•
If you are allergic to lenalidomide
or any of t

Карактеристике производа

Revlimid
®
 (lenalidomide) capsules – Product Information 
Celgene v2.5 – August 2012 
1 
REVLIMID
®
 (LENALIDOMIDE) CAPSULES PRODUCT INFORMATION 

TERATOGENIC EFFECTS: 
REVLIMID (LENALIDOMIDE)  IS STRUCTURALLY RELATED TO THALIDOMIDE.
THALIDOMIDE IS A KNOWN HUMAN 
TERATOGEN THAT CAUSES SEVERE LIFE-THREATENING HUMAN BIRTH DEFECTS.
IF LENALIDOMIDE IS TAKEN DURING 
PREGNANCY, IT MAY CAUSE BIRTH DEFECTS OR DEATH TO AN UNBORN
BABY. WOMEN SHOULD BE ADVISED TO 
AVOID PREGNANCY WHILST TAKING REVLIMID (LENALIDOMIDE) AND
FOR 4 WEEKS AFTER STOPPING THE DRUG. 

I)   
NAME OF THE MEDICINE 
Revlimid (lenalidomide),  3-(4’-amino-1,3-dihydro-1-oxo-2H-isoindol-2-yl)-2,6-piperidinedione, is
an 
immunomodulatory agent  with anti-angiogenic and anti-neoplastic
properties. The Chemical Abstract 
Service (CAS) registry
number for lenalidomide is 191732-72-6 and
the ATC code is L04 AX04. The 
trade name for lenalidomide is Revlimid
® 
(lenalidomide) capsules. 

The chemical structure of lenalidomide is as follows: 

II)   
DESCRIPTION 
Lenalidomide has an empirical formula of C
13
H
13
N
3
O
3
 and a molecular weight of 259.25. It is an off-
white to pale-yellow solid, with
a melting point of approximately 265ºC to
270ºC.  Lenalidomide is 
generally more soluble in organic solvents but exhibits the greatest
solubility in 0.1N HCl buffer. The 
solubility of lenalidomide in water and
at pH 1.21 is < 1.5 mg/mL and 18 mg/mL, respectively. 

LIST OF EXCIPIENTS 
Revlimid capsules contain
the following excipients: lactose, anhydrous; cellulose, microcrystalline; 
croscarmellose sodium; magnesium stearate. 

The capsule shell is composed of gelatin and
titanium dioxide, and may also contain indigo carmine 
CI73015 and iron oxide yellow CI77492
(10 mg capsules), or indigo carmine CI73015 (15 mg 
capsules). The printing ink is composed o