FOLOTYN® SOLUTION FOR INFUSION 20MGML

国: シンガポール

言語: 英語

ソース: HSA (Health Sciences Authority)

有効成分:

Pralatrexate

から入手可能:

MUNDIPHARMA PHARMACEUTICALS PTE. LTD.

ATCコード:

L01BA05

投薬量:

20mg/ml

医薬品形態:

INFUSION, SOLUTION

構図:

Pralatrexate 20mg/ml

投与経路:

INTRAVENOUS

処方タイプ:

Prescription Only

製:

Baxter Oncology GmbH

認証ステータス:

ACTIVE

承認日:

2014-04-30

情報リーフレット

_FOLOTYN®_ SOLUTION FOR INFUSION 20MG/ML 

INDICATIONS AND USAGE 

_FOLOTYN_
®
 is indicated for the treatment
of patients with relapsed or refractory peripheral T-cell
lymphoma 
(PTCL).  This indication is based on
overall response rate with the view to
induce responses sufficient to allow 
patients to be eligible for stem cell
transplant.  Clinical benefit such as improvement in
progression-free 
survival or overall survival has not been demonstrated.  
In
the pivotal open-label, single-arm, Phase II study, recruited patients were pre-treated
with a median of 3 prior 
systemic therapies. 
DOSAGE AND ADMINISTRATION 

_FOLOTYN_
®
 should be administered under the supervision of a qualified
physician experienced in the use of 
antineoplastic agents.  Appropriate
management of complications is possible only when
adequate diagnostic and 
treatment facilities are readily available. 
PERIPHERAL T-CELL LYMPHOMA  
The recommended dose of _FOLOTYN_
®
 is 30 mg/m
2
 administered as an intravenous (IV) push over 3-5 minutes via 
the side port of a free-flowing 0.9% Sodium Chloride Injection,
USP IV line once weekly for 6 weeks in 
7-week cycles until progressive disease or unacceptable
toxicity.  
VITAMIN SUPPLEMENTATION 
Patients should take low-dose (1.0-1.25 mg) oral folic acid on
a daily basis.  Folic acid should be initiated 
during the 10-day period preceding the first dose of _FOLOTYN_
®
, and dosing should continue during the full course 
of therapy and for 30 days after the last dose of _FOLOTYN_
®
.  Patients should also receive a vitamin B
12
 (1 mg) 
intramuscular injection no more than 10 weeks prior
to the first dose of _FOLOTYN_
®
 and every 8-10 weeks 
thereafter.  Subsequent vitamin B
12 
injections may be given the same day as treatment with _FOLOTYN_
®

[_see Warnings and Precaution

製品の特徴

_FOLOTYN_
® SOLUTION FOR INFUSION 20MG/ML
INDICATIONS AND USAGE
_FOLOTYN_
®
is indicated for the treatment of patients with relapsed or refractory
peripheral T-cell lymphoma
(PTCL). This indication is based on overall response rate with the
view to induce responses sufficient to allow
patients to be eligible for stem cell transplant. Clinical benefit
such as improvement in progression-free
survival or overall survival has not been demonstrated.
In the pivotal open-label, single-arm, Phase II study, recruited
patients were pre-treated with a median of 3 prior
systemic therapies.
DOSAGE AND ADMINISTRATION
_FOLOTYN_
®
should be administered under the supervision of a qualified physician
experienced in the use
of
antineoplastic agents. Appropriate management of complications is
possible only when adequate diagnostic and
treatment facilities are readily available.
PERIPHERAL T-CELL LYMPHOMA
The recommended dose of
_FOLOTYN_
®
is 30 mg/m
2
administered as an intravenous (IV) push over 3-5 minutes via
the side port of a free-flowing 0.9% Sodium Chloride Injection, USP IV
line once weekly for 6 weeks in
7-week cycles until progressive disease or unacceptable toxicity.
For patients with severe renal impairment (eGFR 15 to < 30 mL/min/1.73
m2), the recommended dose of
FOLOTYN is 15 mg/m2.
PRETREATMENT VITAMIN SUPPLEMENTATION
_Folic Acid _
Instruct patients to take 1.0 to1.25 mg orally once daily beginning 10
days before the first dose of
_FOLOTYN_
®
.
Continue folic acid during treatment with
_FOLOTYN_
®
and for 30 days after the last dose of
_FOLOTYN_
®
.
[
_see Warnings and Precautions_
]
_Vitamin B_
_12_
_ _
Administer vitamin B
12
(1 mg) intramuscular injection within 10 weeks prior to the first dose
of
_FOLOTYN_
®
and
every 8-10 weeks thereafter. Subsequent vitamin B
12
injections may be given the same day as treatment with
_FOLOTYN_
®
[
_see Warnings and Precautions_
].
PREPARATION AND ADMINISTRATION PRECAUTIONS
_FOLOTYN_
®
is a cytotoxic anticancer agent. Caution should be exercised in
handling, preparing,