LEDAGA chlormethine (as hydrochloride) 160 microgram/g topical gel tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

chlormethine hydrochloride, Quantity: 0.2 mg/g (Equivalent: chlormethine, Qty 0.16 mg/g)

Available from:

Juniper Biologics Pty Ltd

Pharmaceutical form:

Gel

Composition:

Excipient Ingredients: butylated hydroxytoluene; disodium edetate; diethylene glycol monoethyl ether; isopropyl alcohol; hyprolose; lactic acid; propylene glycol; glycerol; menthol; sodium chloride

Administration route:

Topical

Units in package:

1 x 60 g tube

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Ledaga is indicated for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL) in adult patients.

Product summary:

Visual Identification: Ledaga is a clear, colourless gel provided in a white aluminium tube with an inner lacquer and an aluminium seal and a white polypropylene screw cap.; Container Type: Tube; Container Material: Epoxy-coated Al; Container Life Time: 48 Months; Container Temperature: Store below minus 15 degrees Celsius (deep freeze); Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2021-06-22

Patient Information leaflet

CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
1.
WHY AM I USING LEDAGA?
2.
WHAT SHOULD I KNOW BEFORE I USE LEDAGA?
3.
WHAT IF I AM TAKING OTHER MEDICINES?
4.
HOW DO I USE LEDAGA?
5.
WHAT SHOULD I KNOW WHILE USING LEDAGA?
6.
ARE THERE ANY SIDE EFFECTS?
LEDAGA
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
Ledaga contains the active ingredient chlormethine. Ledaga is an
anti-cancer medicine used on the skin to treat mycosis
fungoides-type cutaneous T-cell lymphoma (MF-type CTCL).
For more information, see Section 1. Why am I using Ledaga? in the
full CMI.
Do not use if you have ever had an allergic reaction to chlormethine
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
Ledaga? in the full CMI.
Tell your doctor or pharmacist if you are taking, have recently taken,
or might take any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription
from your pharmacy, supermarket or health food
shop.
•
The recommended dose is application as a thin film once a day to the
affected areas.
•
If you are a caregiver that is applying the gel to a patient, you must
wear disposable nitrile gloves when applying this
medicine to avoid contact with the medicine (this is a special type of
glove; ask your doctor or pharmacist if you are not
sure). Patients applying the gel themselves do not need to wear gloves
but should wash their hands with soap and water
immediately after applying.
More instructions can be found in Section 4. How do I use Ledaga? in
the full CMI.
THINGS YOU
SHOULD DO
•
Remind any doctor or pharmacist you visit that you are using Ledaga.
•
Tell you

Summary of Product characteristics

LEDAGA PI Ver 3.0
1
▼
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION – LEDAGA
®
(CHLORMETHINE HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Chlormethine hydrochloride
2.
QUALITIATIVE AND QUANTITATIVE COMPOSITION
Each gram of gel contains chlormethine hydrochloride equivalent to 160
micrograms of
chlormethine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gel.
Clear, colourless gel.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ledaga is indicated for the topical treatment of mycosis
fungoides-type cutaneous T-cell
lymphoma (MF-type CTCL) in adult patients.
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment with Ledaga should be initiated by an appropriately
experienced physician.
POSOLOGY
A thin film of Ledaga should be applied once daily to affected areas
of the skin.
Treatment with Ledaga should be stopped for any grade of skin
ulceration or blistering, or
moderately severe or severe dermatitis (e.g., marked skin redness with
oedema). Upon
improvement, treatment with Ledaga can be restarted at a reduced
frequency of once every 3
days. If reintroduction of treatment is tolerated for at least 1 week,
the frequency of application
can be increased to every other day for at least 1 week and then to
once-daily application if
tolerated.
_Elderly _
_ _
The dosing recommendation for elderly patients ( ≥ 65 years old) is
the same as for younger
adult patients (see section 4.8).
_Paediatric population _
_ _
The safety and efficacy of Ledaga in children aged 0 to 18 years have
not been established. No
data are available.
LEDAGA PI Ver 3.0
2
METHOD OF ADMINISTRATION
Ledaga is for topical application to the skin.
The following instructions should be followed by patients or
caregivers when applying Ledaga:
•
Patients must wash hands thoroughly with soap and water im