Istodax (romidepsin) 10mg powder for injection vial, and solvent for reconstitution vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

romidepsin, Quantity: 10 mg

Available from:

Celgene Pty Ltd

INN (International Name):

Romidepsin

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: povidone; dilute hydrochloric acid

Administration route:

Intravenous Infusion

Units in package:

single-use powder for injection vial, with solvent vial

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Istodax is indicated for the treatment of peripheral T-cell lymphoma in patients who have received at least one prior systemic therapy.

Product summary:

Visual Identification: Romidepsin is a white to off-white lyophilised sterile powder for concentrate for solution for infusion.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-08-07

Patient Information leaflet

ISTODAX
®
_POWDER FOR INJECTION_
_(romidepsin 10 mg)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Istodax.
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 Istodax
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT ISTODAX IS
USED FOR
Istodax contains an active ingredient
called romidepsin.
It is a type of anti-cancer (anti-
neoplastic) medicine that belongs to
a group of medicines known as
histone deacetylase or HDAC
inhibitors.
Istodax is used to treat a type of
cancer called peripheral T-cell
lymphoma, or PTCL, in patients who
have received at least one previous
treatment for this condition.
PTCL is a disease in which a type of
white blood cell from your immune
system, called T-cells, grows
abnormally. Istodax works by
slowing or stopping the growth of
these cancer cells. This medicine has
also been shown to kill cancer cells.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Istodax for another reason.
Istodax is not addictive.
This medicine is available only with
a doctor's prescription.
The safe and effective use of Istodax
has not been established in children
or adolescents (under 18 years of
age).
BEFORE YOU ARE
GIVEN ISTODAX
_WHEN YOU MUST NOT BE GIVEN_
_ISTODAX_
DO NOT TAKE ISTODAX IF:
•
YOU ARE ALLERGIC TO ROMIDEPSIN
OR ANY OF THE INGREDIENTS LISTED
AT THE END OF THIS LEAFLET (SEE
PRODUCT DESCRIPTION).
Some of the symptoms of an allergic
reaction may include:
-
shortness of breath
-
wheezing or difficulty breathing
-
swelling of the face, lips, tongue
or other parts of the body
-
rash, itching or hives on the skin.
_BEFORE YOU ARE GIVEN ISTODAX_
TELL YOUR DOCTOR IF YOU HAVE

Summary of Product characteristics

Istodax
®
(romidepsin) Powder of Injection – AU Product Information Celgene
V2.0 – 1 February 2022 (CCDS V9)
AUSTRALIAN PRODUCT INFORMATION
ISTODAX
® (ROMIDEPSIN) 10MG POWDER OF INJECTION
1
NAME OF THE MEDICINE
Australian approved name: Romidepsin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 11 mg of romidepsin (inclusive of 10% overfill).
For the full list of excipients, see Section 6.1 (List of Excipients).
Description
Romidepsin is a white to off-white powder, with a melting point of
272ºC. Romidepsin is generally more
soluble in organic solvents and is very slightly soluble in water
(about 0.3 mg/mL). The partition
coefficient (n-octanol/water) is approximately 1.9.
3
PHARMACEUTICAL FORM
Istodax is supplied in a composite pack including a sterile 10 mg
single-use vial containing 10 mg of
lyophilised romidepsin and 20 mg of povidone, and a second sterile
vial containing 2.2 mL of solvent.
The solvent vial contains 80% propylene glycol and 20% anhydrous
ethanol. Both romidepsin and solvent
vials contain an overfill to ensure the recommended volume can be
withdrawn at a concentration of 5
mg/mL.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Istodax is indicated for the treatment of peripheral T-cell lymphoma
in patients who have received at least
one prior systemic therapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
4.2.1
DOSAGE
The recommended dose is 14 mg/m
2
administered intravenously over a 4-hour period on Days 1, 8 and 15
of a 28-day cycle. Cycles should be repeated every 28 days provided
that the patient continues to benefit
from and tolerates the therapy.
4.2.2
METHOD OF ADMINISTRATION
Istodax should be administered under the supervision of a physician
qualified in the use of
chemotherapeutic agents. Serum potassium and magnesium should be
within the normal range before
each administration of Istodax.
Istodax
®
(romidepsin) Powder of Injection – AU Product Information Celgene
V2.0 – 1 February 2022 (CCDS V9)
Istodax is an anti-neoplastic agent and, as with other potentially