KORSUVA difelikefalin (as acetate) 50 microgram/1 mL solution for injection vial

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

difelikefalin acetate, Quantity: 55 microgram (Equivalent: difelikefalin, Qty 50 microgram)

Disponible des:

Seqirus Pty Ltd

formulario farmacéutico:

Injection, solution

Composición:

Excipient Ingredients: sodium chloride; sodium acetate trihydrate; acetic acid; water for injections

Vía de administración:

Intravenous

Unidades en paquete:

12 vials, 3 vials

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Korsuva is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients on haemodialysis.

Resumen del producto:

Visual Identification: Clear, colourless solution, free from particles.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Estat d'Autorització:

Registered

Data d'autorització:

2022-11-10

Informació per a l'usuari

2022-11-10 Korsuva_AUS_CMI
1
KORSUVA
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 KORSUVA?
Korsuva contains the active ingredient difelikefalin. Korsuva is used
to treat itchy skin in adults with chronic kidney disease
who need dialysis to clean their blood.
For more information, see Section 1. Why am I using Korsuva? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE KORSUVA?
Do not use if you have ever had an allergic reaction to difelikefalin
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
Korsuva? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Korsuva 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 KORSUVA?
•
The doctor will determine the recommended dose for Korsuva based on
your body weight. It will be given as an injection
into a vein by a doctor or nurse at the end of your dialysis treatment
through the tube that connects you to the dialysis
machine.
More instructions can be found in Section 4. How do I use Korsuva? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING KORSUVA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Korsuva.
THINGS YOU
SHOULD NOT DO
NA
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how Korsuva affects you.
Certain symptoms such as dizziness and drowsiness may affect your
ability to drive or operate
machinery.
DRINKING
ALCOHOL
•
Tell your doctor if you drink alcohol

Fitxa tècnica

1
2022-11-10_Korsuva_AUS_PI
▼ 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
KORSUVA (DIFELIKEFALIN [AS ACETATE]) SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
Difelikefalin acetate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of 1 mL contains 50 micrograms difelikefalin (as acetate).
Excipients with known effect
This medicinal product contains less than 1 mmol sodium per vial, that
is to say essentially
sodium-free.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution, free from particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Korsuva is indicated for the treatment of moderate-to-severe
_ _
pruritus associated with chronic
kidney disease in adult patients on haemodialysis.
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dose of Korsuva is 0.5 micrograms/kg dry body weight
(ie, the target
postdialysis weight) by intravenous bolus injection three times per
week. The total dose
volume (mL) required from the vial should be calculated as follows:
0.01 x prescription dry
body weight (kg), rounded to the nearest tenth (0.1 mL). Recommended
doses are detailed in
the
TABLE 1
below:
2
2022-11-10_Korsuva_AUS_PI
TABLE 1: RECOMMENDED KORSUVA DOSE
WEIGHT RANGE*
(Dry Body Weight in kg)
DOSE**
(mL)
40 - 44
0.4
45 - 54
0.5
55 - 64
0.6
65 - 74
0.7
75 - 84
0.8
85 - 94
0.9
95 - 104
1.0
105 - 114
1.1
115 - 124
1.2
125 - 134
1.3
135 - 144
1.4
145 - 154
1.5
155 - 164
1.6
165 - 174
1.7
175 - 184
1.8
185 - 194
1.9
195 - 204
2.0
*The recommended dose for patients with a dry body weight above 204 kg
should be calculated as in above text.
** More than 1 vial may be necessary if a dose of more than 1 mL is
required
_Missed doses _
_ _
If a regu