KIMMTRAK tebentafusp 0.1 mg/0.5 mL concentrated solution for infusion vial

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

tebentafusp, Quantity: 0.2 mg/mL

Commercializzato da:

Medison Pharma Australia Pty Ltd

Forma farmaceutica:

Injection, concentrated

Composizione:

Excipient Ingredients: citric acid monohydrate; water for injections; mannitol; trehalose dihydrate; polysorbate 20; dibasic sodium phosphate

Via di somministrazione:

Intravenous Infusion

Confezione:

1 vial

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

KIMMTRAK is indicated for the treatment of HLA-A02 01-positive adult patients with unresectable or metastatic uveal melanoma.

Dettagli prodotto:

Visual Identification: Sterile, preservative-free, clear, colourless to slightly yellowish solution in a single-dose vial.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2022-06-03

Foglio illustrativo

KIMMTRAK CMI
V4.0 06 Jan 2023
1
KIMMTRAK
®
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.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I BEING GIVEN KIMMTRAK?
KIMMTRAK contains the active ingredient tebentafusp. KIMMTRAK is used
to treat rare eye cancer called uveal melanoma.
For more information, see Section 1. Why am I being given KIMMTRAK? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN KIMMTRAK?
Do not use if you have ever had an allergic reaction to KIMMTRAK 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 am
given KIMMTRAK? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with KIMMTRAK 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 WILL I BE GIVEN KIMMTRAK?
KIMMTRAK will be given to you by a healthcare professional in a
hospital or clinic through an infusion (drip) into your vein
(intravenous) over 15-20 minutes.
More instructions can be found in Section 4. How will I be given
KIMMTRAK? in the full CMI.
5.
WHAT SHOULD I KNOW ABOUT BEING GIVEN KIMMTRAK?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, pharmacist or nurse you visit that you
have been given KIMMTRAK.
DRIVING OR USING
MACHINES
•
If you feel unwell whilst being treated with KIMMTRAK, you should not
drive or operate machinery
until you feel well again.
For more information, see Section 5. What should I know about being
given KIMMTRAK? in the full CMI.
6.
ARE THERE ANY SIDE E

Scheda tecnica

Australian PI: KIMMTRAK
V8.0 06 Jan 2023
Page 1 of 15
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
.
WARNING: CYTOKINE RELEASE SYNDROME
Cytokine Release Syndrome (CRS), which may be serious or
life-threatening, can occur in
patients receiving tebentafusp. Only administer in an appropriate
setting. Monitor for at least 16
hours following each of the first three infusions, and then as
clinically indicated.
AUSTRALIAN PRODUCT INFORMATION – KIMMTRAK
®
(TEBENTAFUSP) CONCENTRATED SOLUTION FOR INFUSION
1
NAME OF THE MEDICINE
Tebentafusp
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 0.1 milligrams of tebentafusp in 0.5 mL of
concentrated solution for infusion.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Concentrated solution for infusion
.
Sterile, preservative-free, clear, colourless to slightly yellowish
solution in a single-dose vial.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
KIMMTRAK is indicated for the treatment of HLA-A*02:01-positive adult
patients with
unresectable or metastatic uveal melanoma.
4.2
D
OSE AND METHOD OF ADMINISTRATION
KIMMTRAK should be administered under the supervision of a physician
experienced in the use
of anti-cancer agents.
DOSE
The recommended dose of KIMMTRAK is:
•
20 micrograms on Day 1
•
30 micrograms on Day 8
•
68 micrograms on Day 15
•
68 micrograms once every week thereafter
Give each dose by intravenous infusion over 15-20 minutes. Continue
treatment with
KIMMTRAK until disease progression or unacceptable toxicity occurs.
▼
Australian PI: KIMMTRAK
V8.0 06 Jan 2023
Page 2 of 15
Administer the first three doses of KIMMTRAK in a healthcare setting
with adequate resources
(including 24-hour monitoring, medications and resuscitation
equipment) to manage cytokine
release syndrome (CRS). Monitor patients f