DIFOLTA

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

PRALATREXATE

Dostupné z:

RAFA LABORATORIES LTD

ATC kód:

L01BA05

Forma lieku:

SOLUTION FOR INJECTION

Zloženie:

PRALATREXATE 20 MG/ML

Spôsob podávania:

I.V

Typ predpisu:

Required

Výrobca:

ANDERSON BRECON (UK) LTD (TRADING AS PCI PHARMA SERVICES), UK

Terapeutické skupiny:

PRALATREXATE

Terapeutické oblasti:

PRALATREXATE

Terapeutické indikácie:

For the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

Dátum Autorizácia:

2023-02-28

Príbalový leták

1
לע העדוה
לע העדוה
לע העדוה
( הרמחה
( הרמחה
( הרמחה
עדימ
עדימ
עדימ
)תוחיטב
)תוחיטב
)תוחיטב
רשוא
–
01.01
ךיראת
:
21
ב
י
ו
נ
י
2101
תילגנאב רישכת םש
:
tion
jec
for In
Solution
A
FOLT
I
D
םושיר רפסמ
:
684
33
31
49
1
םושירה לעב םש
:
מ"עב אפר תודבעמ
ץראב רשואמה ןולעל סחיב יתוחיטב עדימב
םייוניש
םינמוסמ
עבצב
-
בוהצ
=
הפסוה
,
קורי
=
הקיחמ
.
ל ןולעב
ל ןולעב
ל ןולעב
אפור
אפור
אפור
ןולעב קרפ
שדח טסקט
Dosage and
Administration
Difolta 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.
…
For patients with severe renal impairment (eGFR 15 to < 30 mL/min/1.73
m
2
), the
recommended dose of Difolta is 15 mg/m
2
.
---
_MONITORING _
…
Monitor complete blood cell counts and severity of mucositis at
baseline and weekly….
_DOSE MODIFICATION RECOMMENDATIONS _
…
For patients with severe renal impairment (eGFR 15 to < 30 mL/min/1.73
m
2
), the
recommended starting dose of Difolta is 15 mg/m
2
with dose modification to 10 mg/m
2
for the toxicities specified in Tables 1, 2 and 3.
TABLE 1
DIFOLTA DOSE MODIFICATIONS FOR MUCOSITIS
DOSE UPON RECOVERY IN
PATIENTS WITH SEVERE RENAL
IMPAIRMENT
DOSE UPON RECOVERY
TO
 GRADE 1
ACTION
MUCOSITIS GRADE
A ON
DAY OF TREATMENT
dose
Continue prior
Continue prior dose
Omit dose
Grade 2
2
mg/m
10
20 mg/m
2
Omit dose
Grade 2 recurrence
2
mg/m
10
20 mg/m
2
Omit dose
Grade 3
Stop therapy
Grade 4
2
a
Per National Cancer Institute-Common Terminology Criteria for Adverse
Events (NCI CTCAE,
Version 3.0)
TABLE 2
DIFOLTA DOSE MODIFICATIONS FOR HEMATOLOGIC TOXICITIES
DOSE UPON
IN
RECOVERY
SEVERE
PATIENTS WITH
IMPAIRMENT
RENAL
DOSE UPON
RESTART
ACTION
DURATION OF
TOXICITY
BLOO

Súhrn charakteristických

FULL PRESCRIBING INFORMATION
NAME OF THE MEDICINAL PRODUCT:
DIFOLTA, solution for injection
COMPOSITION:
1 mL contains: 20 mg of pralatrexate (see section 3).
For full list of ingredients see section 11 ("Description").
1
INDICATIONS AND USAGE
Difolta is indicated for the treatment of patients with relapsed or
refractory peripheral T-cell lymphoma (PTCL).
This indication is based on overall response rate. Clinical benefit
such as improvement in progression-free
survival or overall survival has not been demonstrated.
2
DOSAGE AND ADMINISTRATION
2.1 IMPORTANT DOSING INFORMATION
_PRETREATMENT VITAMIN SUPPLEMENTATION _
_Folic Acid:_
Patients should take folic acid 1-1.25 mg orally once daily beginning
10 days before the first dose
of Difolta. Continue folic acid during the full course of therapy and
for 30 days after the last dose of Difolta
[
_see Warnings and Precautions (5.1) (5.2)_
].
_Vitamin B_
_12_
_:_
Administer vitamin B
12
1 mg intramuscularly within 10 weeks prior to the first dose of
Difolta
and every 8-10 weeks thereafter. Subsequent vitamin B
12
injections may be given the same day as treatment
with Difolta [
_see Warnings and Precautions (5.1) (5.2)_
].
_ _
_DOSING AND ADMINISTRATION_
The recommended dose of Difolta is 30 mg/m
2
administered as an intravenous push over 3-5 minutes via the
side port of a free flowing 0.9% Sodium Chloride Injection intravenous
line once weekly for 6 weeks in 7-week
cycles until progressive disease or unacceptable toxicity. The
calculated dose of Difolta should be aseptically
withdrawn into a syringe for immediate use. Do not dilute Difolta.
For patients with severe renal impairment (eGFR 15 to < 30 mL/min/1.73
m
2
), the recommended dose of
Difolta is 15 mg/m
2
.
Difolta is a clear, yellow solution. Parenteral drug products should
be inspected visually for particulate matter
and discoloration prior to administration, whenever solution and
container permit. Do not use any vials
exhibiting particulate matter or discoloration.
2.2 MONITORING AND DOSE MODIFICATIONS FOR ADVER