Nplate

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

Romiplostim

Prieinama:

Amgen Australia Pty Ltd

Klasė:

Medicine Registered

Pakuotės lapelis

NPLATE
®

_Romiplostim (rbe) ro''-mi''p-lo''-sti''m_
CONSUMER MEDICINE INFORMATION (CMI)

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Nplate.
It does not contain all the available
information.
It does not take the place of talking to
your doctor, nurse or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Nplate against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT NPLATE IS USED
FOR
Nplate is used to treat low blood
platelet counts in people with
immune (idiopathic)
thrombocytopenic purpura (called
ITP). ITP is a disease in which your
immune system destroys your
platelets.
Platelets are the cells in your blood
that help seal cuts and form blood
clots. If you have too few platelets
you could bruise more easily than
normal. You could also bleed for a
long time after being injured. If your
platelet count is very low, you may
be at risk of serious, life-threatening
bleeding.
This medicine works by increasing
the number of platelets made by your
body. Nplate makes your bone
marrow produce more platelets. This
helps to prevent bruising and
bleeding.
Your doctor, however, may prescribe
Nplate for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE NPLATE IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
romiplostim
•
any of the ingredients listed at the
end of this leaflet
•
any medicines that are produced
using the bacteria E.coli.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT USE IT AFT

Prekės savybės

Nplate
®
 (romiplostim) Product Information     
Page 1 of 16 
NAME OF THE MEDICINE 
Nplate
®
 is the Amgen Inc. trademark for romiplostim (rbe). 

DESCRIPTION 
Romiplostim, a member of the thrombopoietin
(TPO) mimetic class,  is an Fc-peptide 
fusion protein (peptibody) that signals and activates intracellular transcriptional 
pathways via the TPO receptor (also
known as  c-Mpl) to increase platelet production.  
The peptibody molecule is comprised of a human immunoglobulin IgG1
Fc domain, with 
each  single-chain subunit covalently linked at the
C-terminus to a peptide chain 
containing two thrombopoietin receptor-binding domains.  Romiplostim is produced by 
recombinant DNA technology in _Escherichia
coli_ (_E. coli_).   

Nplate  is a sterile, white, preservative-free, lyophilised powder for reconstitution and 
administration as a subcutaneous (SC) injection.   

For a full list of excipients see PRESENTATION AND
STORAGE CONDITIONS. 

PHARMACOLOGY 
PHARMACODYNAMICS 
Romiplostim  increases platelet production through binding and activation of the 
thrombopoietin receptor, a mechanism analogous to endogenous thrombopoietin 
(eTPO).  The TPO receptor is predominately expressed on cells of the
myeloid lineage 
such as megakaryocyte progenitor cells, megakaryocytes and
platelets.   
Nplate
®
 (romiplostim) Product Information     
Page 2 of 16 
In clinical studies, treatment with  Nplate  resulted in
dose-dependent increases in 
platelet count. The peak platelet counts  in immune (idiopathic) thrombocytopenic 
purpura (ITP) patients who received a single subcutaneous dose
of 1 to 10 µg/kg 
Nplate  were  1.3 to 14.9 times greater than the baseline
platelet count over  a  2  to 3 
week period;  the
response was variable among patients.   The platelet counts of ITP 
patients wh