RAPAMUNE TABLET 1MG

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

SIROLIMUS

Boleh didapati daripada:

PFIZER (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

SIROLIMUS

Unit dalam pakej:

30Tablet Tablets; 100Tablet Tablets

Dikeluarkan oleh:

PFIZER IRELAND PHARMACEUTICALS

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
RAPAMUNE
_®_
Sirolimus (1 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Rapamune is used for
2.
How Rapamune works
3.
Before you use Rapamune
4.
How to use Rapamune
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
Rapamune
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of Revision
11. Serial Number
WHAT RAPAMUNE IS USED FOR
Rapamune is a medicine used to
prevent rejection (anti-rejection
medicine) in people who have
received a kidney transplant.
Rejection is when your body’s
immune system recognizes the new
organ as a “foreign” threat and
attacks it.
You will be determined if you have a
low to moderate immunological risk
or high immunological risk.
IF YOU BELONG TO LOW TO MODERATE
IMMUNOLOGICAL RISK, you will be
asked to take Rapamune initially in a
regimen with cyclosporine and
corticosteroids.
Cyclosporine will be withdrawn 2 to
4 months after transplantation, and
the Rapamune dose will be increased
to reach recommended blood
concentrations.
IF YOU BELONG TO HIGH IMMUNOLOGIC
RISK (defined as Black transplant
recipients and/or repeat kidney
transplant recipients who lost a
previous transplant for immunologic
reason and/or individuals with high-
panel reactive antibodies (PRA; peak
PRA level > 80%), you will be asked
to take Rapamune in combination
with tacrolimus and corticosteroids or
cyclosporine and corticosteroids for
the first year following
transplantation. Whether these
combinations are safe and effective in
high-risk renal transplant patients
have not been studied beyond one
year. Therefore, after the first year
following transplantation, any
adjustments to these regimens will be
considered on the basis of your
clinical status.
HOW RAPAMUNE WORKS
Rapamune inhibits the activation and
increase in the number or amount of a
type of white blood cell called T-
lymphocyte. Your body produces T-
lymphocytes to fight against infection
or foreign substances which have
entered the body. Rapamune also
inhibits antib

Ciri produk

WARNING: IMMUNOSUPPRESSION, USE IS NOT RECOMMENDED IN LIVER OR LUNG
TRANSPLANT PATIENTS

INCREASED SUSCEPTIBILITY TO INFECTION AND THE POSSIBLE DEVELOPMENT OF
LYMPHOMA AND OTHER
MALIGNANCIES MAY RESULT FROM IMMUNOSUPPRESSION
INCREASED SUSCEPTIBILITY TO INFECTION AND THE POSSIBLE DEVELOPMENT OF
LYMPHOMA MAY RESULT FROM
IMMUNOSUPPRESSION.
ONLY
PHYSICIANS
EXPERIENCED
IN
IMMUNOSUPPRESSIVE
THERAPY
AND
MANAGEMENT OF RENAL TRANSPLANT PATIENTS SHOULD USE RAPAMUNE FOR
PROPHYLAXIS OF ORGAN REJECTION
IN PATIENTS RECEIVING RENAL TRANSPLANTS. PATIENTS RECEIVING THE DRUG
SHOULD BE MANAGED IN FACILITIES
EQUIPPED AND STAFFED WITH ADEQUATE LABORATORY AND SUPPORTIVE MEDICAL
RESOURCES. THE PHYSICIAN
RESPONSIBLE FOR MAINTENANCE THERAPY SHOULD HAVE COMPLETE INFORMATION
REQUISITE FOR THE FOLLOW-UP
OF THE PATIENT.

THE SAFETY AND EFFICACY OF RAPAMUNE (SIROLIMUS) AS IMMUNOSUPPRESSIVE
THERAPY HAVE NOT
BEEN ESTABLISHED IN LIVER OR LUNG TRANSPLANT PATIENTS, AND THEREFORE,
SUCH USE IS NOT
RECOMMENDED.

LIVER TRANSPLANTATION – EXCESS MORTALITY, GRAFT LOSS, AND HEPATIC
ARTERY THROMBOSIS
(HAT)
THE USE OF RAPAMUNE IN COMBINATION WITH TACROLIMUS WAS ASSOCIATED WITH
EXCESS MORTALITY AND
GRAFT LOSS IN A STUDY IN _DE NOVO_ LIVER TRANSPLANT PATIENTS. MANY OF
THESE PATIENTS HAD EVIDENCE OF
INFECTION AT OR NEAR THE TIME OF DEATH.
IN THIS AND ANOTHER STUDY IN _DE NOVO_ LIVER TRANSPLANT PATIENTS, THE
USE OF RAPAMUNE IN COMBINATION
WITH CYCLOSPORINE OR TACROLIMUS WAS ASSOCIATED WITH AN INCREASE IN
HAT; MOST CASES OF HAT
OCCURRED WITHIN 30 DAYS POST-TRANSPLANTATION AND MOST LED TO GRAFT
LOSS OR DEATH.

LUNG TRANSPLANTATION – BRONCHIAL ANASTOMOTIC DEHISCENCE
CASES OF BRONCHIAL ANASTOMOTIC DEHISCENCE, MOST FATAL, HAVE BEEN
REPORTED IN _ DE NOVO_ LUNG
TRANSPLANT PATIENTS WHEN RAPAMUNE HAS BEEN USED AS PART OF AN
IMMUNOSUPPRESSIVE REGIMEN.
1.
NAME OF THE MEDICINAL PRODUCT
Rapamune
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sirolimus is a white to off-white powder. It is insoluble in water but
freely soluble in benzyl alcohol,
chloroform, acet