RADICAVA Edaravone 30mg/20mL concentrated injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

edaravone, Quantity: 30 mg

Available from:

Teva Pharma Australia Pty Ltd

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: edaravone; sodium bisulfite; sodium chloride; sodium hydroxide; cysteine hydrochloride monohydrate; phosphoric acid; water for injections

Administration route:

Intravenous Infusion

Units in package:

10 x 20 mL ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

RADICAVA is indicated in adults with a diagnosis of amyotrophic lateral sclerosis who are independent in activities of daily living with normal respiratory function and where treatment is initiated within two years of disease onset.,Efficacy has not been demonstrated in patients outside of this defined population.

Product summary:

Visual Identification: Clear colorless concentrated injection filled in a clear glass ampoule and diluted before use.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2023-02-15

Patient Information leaflet

RADICAVA
®
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A
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V
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®
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0
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.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING RADICAVA?
RADICAVA contains the active ingredient edaravone, RADICAVA is used to
treat patients with amyotrophic lateral sclerosis (ALS).
For more information, see Section 1. Why am I using RADICAVA? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE RADICAVA?
Do not use if you have ever had an allergic reaction to edaravone 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
RADICAVA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with RADICAVA 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 IS RADICAVA GIVEN?
RADICAVA is a concentrated solution for injection that must be diluted
before use and will be prepared by a health care professional
before it is given to you. RADICAVA will be given slowly into a vein
as an infusion (drip) over 60 minutes.
Usually when you first start using RADICAVA you will receive a dose
each day for 14 days followed by a 14-day drug free period.
Following the first round of treatment, you will usually receive a
dose each day for 10 days out of 14-day periods, followed by 14-day
drug-free periods.
More instructions can be found in Section 4. How is RADICAVA given? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING RADICAVA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, pharmacist or nurse treating you that you
are using RADICAVA.
•
Tell your doctor, hospital pharmacist or nurse before using RADI

Summary of Product characteristics

RADICAVA V1.0
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 – RADICAVA
® EDARAVONE
1
NAME OF THE MEDICINE
Edaravone.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each clear glass ampoule contains 30 mg of edaravone in 20 mL
concentrated injection.
Excipient(s) with known effect: Each ampoule contains sodium
bisulfite.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Concentrated solution for injection filled in a clear glass ampoule.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
_RADICAVA _
_IS _
_INDICATED _
_IN _
_ADULTS _
_WITH _
_A _
_DIAGNOSIS _
_OF _
_AMYOTROPHIC _
_LATERAL _
_SCLEROSIS _
_WHO _
_ARE _
_INDEPENDENT IN ACTIVITIES OF DAILY LIVING WITH NORMAL RESPIRATORY
FUNCTION AND WHERE TREATMENT IS _
_INITIATED WITHIN TWO YEARS OF DISEASE ONSET. _
_EFFICACY HAS NOT BEEN DEMONSTRATED IN PATIENTS OUTSIDE OF THIS
DEFINED POPULATION. _
4.2
D
OSE AND METHOD OF ADMINISTRATION
RADICAVA concentrated injection must be diluted before use and is for
intravenous infusion only.
Promptly discontinue the infusion upon the first observation of any
signs or symptoms consistent with
a hypersensitivity reaction (see Section 4.4 Special warnings and
precautions for use).
The recommended dosage of RADICAVA is 60 mg of edaravone (two
ampoules) diluted with 100 mL
of 0.9% sodium chloride for infusion and administered as an
intravenous infusion over a 60-minute
period according to the following schedule:
•
An initial treatment cycle with daily dosing for 14 days, followed by
a 14-day drug-free
period.
•
Subsequent treatment cycles with daily dosing for 10 days out of
14-day periods, followed
by 14-day drug-free periods.
Radicava is for single _use in one patient only. Discard any residue._
To reduce microbiological hazard, use as soon as practica