FOLOTYN pralatrexate 40 mg in 2 mL injection, intravenous infusion vial

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

pralatrexate, Quantity: 20 mg/mL

Tillgänglig från:

Mundipharma Pty Ltd

INN (International namn):

Pralatrexate

Läkemedelsform:

Injection, intravenous infusion

Sammansättning:

Excipient Ingredients: hydrochloric acid; sodium hydroxide; sodium chloride; water for injections

Administreringssätt:

Intravenous

Enheter i paketet:

2 mL

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

FOLOTYN is indicated for the treatment of adult patients with peripheral T-cell lymphoma (nodal, extranodal, and leukaemic/disseminated) who have progressed after at least one prior therapy.

Produktsammanfattning:

Visual Identification: Clear, yellow aqueous solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Bemyndigande status:

Licence status A

Tillstånd datum:

2015-02-26

Bipacksedel

FOLOTYN® SOLUTION FOR INFUSION
1
FOLOTYN
®
solution for infusion
Pralatrexate
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common
questions about FOLOTYN solution
for infusion. It does not contain all
the available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking FOLOTYN
against the benefits they expect it
will have for you.
If you have any concerns about
taking this medicine, ask your
doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What FOLOTYN is
used for
FOLOTYN solution for infusion
contains pralatrexate. Pralatrexate is
an anti-cancer (chemotherapy)
medicine that belongs to a group of
medicines called antifolates.
FOLOTYN is used to treat patients
aged 18 years or older with
peripheral T-cell lymphoma (PTCL)
after previous treatments have not
worked or have stopped working.
PTCL is a rare type of non-Hodgkin's
lymphoma (a cancer of the lymphatic
system). It occurs when T-cells, a
type of white blood cell, multiply too
quickly. PTCL may be found in the
lymph nodes, skin, bone marrow, the
liver, or spleen.
FOLOTYN works by slowing or
stopping the growth of cancer cells.
Your doctor, however, may prescribe
it for another purpose.
Ask your doctor if you have any
questions about why it has been
prescribed for you.
This medicine is only available with
a doctor's prescription.
Before FOLOTYN is
given
When you must not be given
it
FOLOTYN solution for infusion
should not be given to you if you
are allergic to pralatrexate or any
of the ingredients listed at the end
of this leaflet.
FOLOTYN solution for infusion
should not be given to you if you
are breastfeeding.
It is not known if FOLOTYN
solution for infusion passes into
breast milk, which may harm your
baby. You and your doctor should
decide whether you will be treated
with FOLOTYN solution for infusion
or whether you will breast feed your
baby, but you should not do b

Produktens egenskaper

FOLOTYN® INTRAVENOUS INFUSION INJECTION
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION
FOLOTYN
®
(PRALATREXATE) SOLUTION FOR INFUSION
1
NAME OF THE MEDICINE
Pralatrexate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pralatrexate is an off-white to yellow solid.
Each 1 mL of solution contains 20 mg of pralatrexate.
20 mg in 1 mL: Each vial contains 20 mg of pralatrexate in 1 mL of
solution.
40 mg in 2 mL*: Each vial contains 40 mg of pralatrexate in 2 mL of
solution.
*Not available
The inactive ingredients in the solution for infusion are sodium
chloride (approximately 6.3 mg in 1 mL
of solution), a sufficient quantity of sodium hydroxide and
hydrochloric acid if needed, to adjust and
maintain the pH at 7.5-8.5, and water for injections.
3
PHARMACEUTICAL FORM
Pralatrexate solution for infusion is a preservative-free, sterile,
isotonic, non-pyrogenic clear
yellow aqueous parenteral solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
FOLOTYN is indicated for the treatment of adult patients with
peripheral T-cell lymphoma
(nodal, extranodal, and leukaemic/disseminated) who have progressed
after at least one prior
therapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Treatment should only be administered under the supervision of a
physician experienced in the
use of anticancer chemotherapy. FOLOTYN vials contain no antimicrobial
preservative and are
for use in one patient on one occasion only.
Premedication regimen
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 B12 (1 mg) intramuscular
injection no more than 10
weeks prior to the first dose of FOLOTYN and every 8-10 weeks
thereafter. Subsequent vitamin
FOLOTYN® INTRAVENOUS INFUSION INJECTION
Page 2 of 17
B12 injections may be given the same day as treatment with FOLOTYN.
The premedication
regimen sh