ROMIDEPSIN-REACH romidepsin 10 mg 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:

Reach Pharmaceuticals Pty Ltd

Pharmaceutical form:

Diluent, not applicable

Composition:

Excipient Ingredients: propylene glycol; ethanol absolute

Administration route:

Intravenous Infusion

Units in package:

1 vial + 1 diluent vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ROMIDEPSIN-REACH 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: ; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2022-12-13

Patient Information leaflet

ROMIDEPSIN‐REACH, V.04
1
ROMIDEPSIN‐REACH
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ROMIDEPSIN‐REACH?
ROMIDEPSIN‐REACH 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.
For more information, see Section 1. Why am I using
ROMIDEPSIN‐REACH? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ROMIDEPSIN‐REACH?
Do not use if you have ever had an allergic reaction to romidepsin or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
ROMIDEPSIN‐REACH? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ROMIDEPSIN‐REACH and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ROMIDEPSIN‐REACH?
• ROMIDEPSIN‐REACH WILL BE GIVEN TO YOU AS AN INTRAVENOUS (IV)
INFUSION INTO YOUR VEIN BY YOUR DOCTOR OR NURSE.
• YOUR DOCTOR WILL CHOOSE THE CORRECT DOSE FOR YOU DEPENDING ON YOUR
HEIGHT, WEIGHT AND BLOOD TEST RESULTS.
More instructions can be found in Section 4. How do I use
ROMIDEPSIN‐REACH? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ROMIDEPSIN‐REACH?
THINGS YOU
SHOULD DO

IF YOU BECOME PREGNANT WHILE BEING GIVEN ROMIDEPSIN‐REACH, TELL YOUR
DOCTOR IMMEDIATELY.

TELL ALL DOCTORS, DENTISTS, AND PHARMACISTS WHO TREAT YOU THAT YOU ARE
BEING GIVEN THIS MEDICINE.

IF YOU ARE GOING TO HAVE SURGERY, TELL THE SURGEON OR ANAESTHETIST
THAT YOU ARE BEING GIVEN
ROMIDEPSIN‐REACH. It may affect other medicines used during or after
the surgery.

DRINK PLENTY OF FLUIDS WHILE TAKING ROMIDEPSIN‐REACH.

Summary of Product characteristics

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AUSTRALIAN PRODUCT INFORMATION
ROMIDEPSIN-REACH (ROMIDEPSIN) POWDER OF INJECTION
1
NAME OF THE MEDICINE
Romidepsin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 11 mg of romidepsin (inclusive of overfill).
Excipients of known effect (solvent vial): ethanol 20% V/V
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
ROMIDEPSIN-REACH is supplied in a composite pack including a sterile
10 mg
single-use vial containing 10 mg of lyophilised romidepsin, and a
second sterile vial
containing 2.0 mL of solvent.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ROMIDEPSIN-REACH 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
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.
METHOD OF ADMINISTRATION
ROMIDEPSIN-REACH 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
ROMIDEPSIN-
REACH.
ROMIDEPSIN-REACH is an anti-neoplastic agent and, as with other
potentially toxic
compounds,
caution
should
be exercised
when
preparing
and
handling
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ROMIDEPSIN-REACH solutions. The use of gloves is recommended.
Any unused product or waste material should be disposed of in
accordance with local
requirements for disposal of cytotoxic compounds.
PREPARATION AND ADMINISTRATION
ROMIDEPSIN-REACH must be reconstituted with the solvent provided and
further
diluted with 0.9% sodium chloride injection before intravenous
infusion using the
following guidelines:
1.
Each 10 mg single-use vial of ROMIDEPSIN-REACH (vial contains overfill
to
11 mg of romidepsin) must be reconstituted with 2.2 mL o