OPDUALAG nivolumab 240mg and relatlimab 80mg in 20mL concentrate solution for IV infusion vial

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

nivolumab, Quantity: 255.6 mg; relatlimab, Quantity: 85.2 mg

Saatavilla:

Bristol-Myers Squibb Australia Pty Ltd

Lääkemuoto:

Injection, concentrated

Koostumus:

Excipient Ingredients: histidine hydrochloride monohydrate; water for injections; pentetic acid; sucrose; polysorbate 80; histidine

Antoreitti:

Intravenous Infusion

Kpl paketissa:

1 Vial per pack

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

OPDUALAG is indicated for the treatment of patients with unresectable or metastatic melanoma who are at least 12 years old.

Tuoteyhteenveto:

Visual Identification: Colorless to slightly yellow liquid, clear to opalescent, essentially free of visible particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Child resistant closure

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2022-10-07

Pakkausseloste

OPDUALAG™
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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 GIVEN OPDUALAG?
OPDUALAG is a medicine that contains two active ingredients, nivolumab
and relatlimab, in a single vial. OPDUALAG is used to
treat advanced melanoma (a type of skin cancer) in adults and in
adolescents (12 years of age and older weighing at least 40 kg)
For more information, see Section 1. Why am I using OPDUALAG? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN OPDUALAG?
Do not take this medicine if you are allergic to the active ingredient
in OPDUALAG (nivolumab and relatlimab) 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 OPDUALAG? in the full
CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Tell your doctor if you are taking or have recently taken any other
medicines. Do not take any other medicines during your treatment
without talking to your doctor first. A list of these medicines is in
Section 3. What if I am taking other medicines? in the full CMI.
4.
HOW AM I GIVEN OPDUALAG?
You will receive treatment with OPDUALAG in a hospital or clinic,
under the supervision of an experienced healthcare professional.
OPDUALAG will be given to you as an infusion (a drip) into a vein
(intravenously). Your doctor will continue giving you OPDUALAG
for as long as you keep benefitting from it or until you no longer
tolerate the treatment. More information can be found in Section 4.
How you will be given OPDUALAG? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING OPDUALAG?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visi

Valmisteyhteenveto

AU_PI_OPDUALAG_2.0_Clean
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
OPDUALAG
™
(NIVOLUMAB/RELATLIMAB)
1
NAME OF THE MEDICINE
nivolumab/relatlimab
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
OPDUALAG 240
mg nivolumab/80
mg relatlimab concentrate for solution for infusion.
Each mL of concentrate for solution for infusion contains 12 mg
nivolumab and 4 mg relatlimab .
One vial of 20 mL contains 240 mg nivolumab and 80 mg relatlimab .
Relatlimab (rch) and nivolumab (rch) are human immunoglobulin G4
(IgG4) monoclonal antibodies
(HuMAb) produced in Chinese hamster ovary cells by recombinant DNA
technology.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear to opalescent, colourless to slightly yellow liquid that is
essentially free of particles.
The solution has a pH of approximately 5.8 and an osmolality of
approximately 310 mOsm/kg.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
OPDUALAG is indicated for the treatment of patients with unresectable
or metastatic melanoma who
are at least 12 years old.
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment must be initiated and supervised by physicians experienced
in the treatment of cancer.
The recommended dose of OPDUALAG for
adult patients, or for paediatric patients who are 12 years
or older and weigh at least 40 kg, is 480 mg nivolumab and 160 mg
relatlimab administered as a 30-
minute intravenous infusion once every 4 weeks, until disease
progression or unacceptable toxicity.
Dose escalation or reduction is not recommended. In general, withhold
OPDUALAG for severe (Grade
3) immune-related adverse reactions. Permanently discontinue OPDUALAG
for life-threatening
(Grade 4) immune-related adverse reactions, recurrent severe (Grad