YERVOY INJECTION CONCENTRATE 5MGML

Ország: Szingapúr

Nyelv: angol

Forrás: HSA (Health Sciences Authority)

Aktív összetevők:

Ipilimumab

Beszerezhető a:

BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.

ATC-kód:

L01XC11

Adagolás:

5g

Gyógyszerészeti forma:

INJECTION, SOLUTION, CONCENTRATE

Összetétel:

Ipilimumab 5mg/ml

Az alkalmazás módja:

INTRAVENOUS DRIP

Recept típusa:

Prescription Only

Gyártó:

Baxter Pharmaceutical Solution, LLC

Engedélyezési státusz:

ACTIVE

Engedély dátuma:

2014-08-29

Betegtájékoztató

YERVOY
®

(IPILIMUMAB) 

YERVOY INJECTION CONCENTRATE 5MG/ML 
WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS 
YERVOY CAN RESULT IN SEVERE AND FATAL IMMUNE-MEDIATED ADVERSE
REACTIONS DUE TO T-CELL 
ACTIVATION AND PROLIFERATION. THESE
IMMUNE-MEDIATED REACTIONS MAY INVOLVE ANY ORGAN 
SYSTEM; HOWEVER, THE MOST COMMON SEVERE IMMUNE-MEDIATED ADVERSE
REACTIONS ARE 
ENTEROCOLITIS, HEPATITIS, DERMATITIS (INCLUDING TOXIC EPIDERMAL
NECROLYSIS), NEUROPATHY, AND 
ENDOCRINOPATHY. THE MAJORITY OF THESE IMMUNE-MEDIATED REACTIONS
INITIALLY MANIFESTED 
DURING TREATMENT; HOWEVER, A MINORITY OCCURRED WEEKS
TO MONTHS AFTER DISCONTINUATION OF 
YERVOY.  
PERMANENTLY DISCONTINUE YERVOY AND INITIATE SYSTEMIC
HIGH-DOSE CORTICOSTEROID THERAPY 
FOR SEVERE IMMUNE-MEDIATED REACTIONS. _[SEE DOSAGE AND
ADMINISTRATION (2.2).] _
ASSESS PATIENTS FOR SIGNS AND SYMPTOMS OF ENTEROCOLITIS,
DERMATITIS, NEUROPATHY, AND 
ENDOCRINOPATHY AND EVALUATE CLINICAL CHEMISTRIES INCLUDING LIVER FUNCTION
TESTS AND THYROID 
FUNCTION TESTS AT BASELINE AND BEFORE EACH DOSE. _[SEE WARNINGS
AND PRECAUTIONS (5.1, 5.2, 5.3, _
_5.4, 5.5).]_ 
1 INDICATIONS 
AND 
USAGE 
YERVOY (ipilimumab) is indicated for the treatment
of unresectable or metastatic melanoma. 
2 DOSAGE 
AND 
ADMINISTRATION 
2.1 RECOMMENDED 
DOSING 
The recommended dose of YERVOY is 3 mg/kg
administered intravenously over 90 minutes 
every 3 weeks for a total of 4 doses. 
Liver function tests (LFTs) and thyroid function tests should be
evaluated at baseline and before 
each dose of YERVOY. In addition,
any signs or symptoms of immune-related adverse 
reactions, including diarrhoea
and colitis, must be assessed during treatment with YERVOY. 
2.2 
RECOMMENDED DOSE MODIFICATIONS 
•
  Withhold scheduled dose
of YERVOY for any moderate immune-mediated adverse reactions 
or for symptomatic endocrinopathy. For
patients with complete or 

Termékjellemzők

YERVOY
®
(IPILIMUMAB)
YERVOY INJECTION CONCENTRATE 5MG/ML
WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS
YERVOY CAN RESULT IN SEVERE AND FATAL IMMUNE-MEDIATED ADVERSE
REACTIONS DUE TO T-CELL
ACTIVATION AND PROLIFERATION. THESE IMMUNE-MEDIATED REACTIONS MAY
INVOLVE ANY ORGAN
SYSTEM;
HOWEVER,
THE
MOST
COMMON
SEVERE
IMMUNE-MEDIATED
ADVERSE
REACTIONS
ARE
ENTEROCOLITIS, HEPATITIS, DERMATITIS (INCLUDING TOXIC EPIDERMAL
NECROLYSIS), NEUROPATHY, AND
ENDOCRINOPATHY. THE MAJORITY OF THESE IMMUNE-MEDIATED REACTIONS
INITIALLY MANIFESTED
DURING TREATMENT; HOWEVER, A MINORITY OCCURRED WEEKS TO MONTHS AFTER
DISCONTINUATION OF
YERVOY.
PERMANENTLY DISCONTINUE YERVOY AND INITIATE SYSTEMIC HIGH-DOSE
CORTICOSTEROID THERAPY
FOR SEVERE IMMUNE-MEDIATED REACTIONS. _[SEE DOSAGE AND ADMINISTRATION
(2.2).] _
ASSESS
PATIENTS
FOR
SIGNS
AND
SYMPTOMS
OF
ENTEROCOLITIS,
DERMATITIS,
NEUROPATHY,
AND
ENDOCRINOPATHY AND EVALUATE CLINICAL CHEMISTRIES INCLUDING LIVER
FUNCTION TESTS AND THYROID
FUNCTION TESTS AT BASELINE AND BEFORE EACH DOSE. _[SEE WARNINGS AND
PRECAUTIONS (5.1, 5.2, 5.3, _
_5.4, 5.5).]_
1
INDICATIONS AND USAGE
YERVOY (ipilimumab) is indicated for the treatment of unresectable or
metastatic melanoma.
2
DOSAGE AND ADMINISTRATION
2.1
RECOMMENDED DOSING
The recommended dose of YERVOY is 3 mg/kg administered intravenously
over 30-90 minutes
every 3 weeks for a total of 4 doses.
Liver function tests (LFTs) and thyroid function tests should be
evaluated at baseline and before
each
dose
of
YERVOY.
In
addition,
any
signs
or
symptoms
of
immune-related
adverse
reactions, including diarrhoea and colitis, must be assessed during
treatment with YERVOY.
2.2
RECOMMENDED DOSE MODIFICATIONS
•
Withhold scheduled dose of YERVOY for any moderate immune-mediated
adverse reactions
or for symptomatic endocrinopathy. For patients with complete or
partial resolution of
adverse reactions (Grade 0–1), and who are receiving less than 7.5
mg prednisone or
equivalent
per
day,
resume
YERVOY
at
a
dose
of
3
mg/kg
every
3
weeks
until
administration of all 4 planned do