IMJUDO CONCENTRATE FOR SOLUTION FOR INFUSION 20MGML

Ország: Szingapúr

Nyelv: angol

Forrás: HSA (Health Sciences Authority)

Aktív összetevők:

Tremelimumab

Beszerezhető a:

ASTRAZENECA SINGAPORE PTE LTD

ATC-kód:

L01FX20

Gyógyszerészeti forma:

INFUSION, SOLUTION CONCENTRATE

Összetétel:

Tremelimumab 20 mg/mL

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

Prescription Only

Gyártó:

Vetter Pharma-Fertigung GmbH & Co. KG

Engedélyezési státusz:

ACTIVE

Engedély dátuma:

2023-08-25

Termékjellemzők

1
IMJUDO
®
(TREMELIMUMAB)
1.
NAME OF THE MEDICINAL PRODUCT
•
IMJUDO
CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML, 25 mg (25
mg/1.25 mL) for intravenous infusion.
•
IMJUDO
CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML, 300 mg (300
mg/15 mL) for intravenous infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 20 mg of tremelimumab.
Each vial of 1.25 mL contains 25 mg of tremelimumab.
Each vial of 15 mL contains 300 mg of tremelimumab.
IMJUDO is a human anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4)-
immunoglobulin G2
(IgG2a) monoclonal antibody produced in murine myeloma cells by
recombinant DNA
technology.
For a full list of excipient(s), see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate
for solution
for infusion; 20 mg/mL in a single-dose
vial for
intravenous
administration.
Sterile, preservative-free, clear to slightly opalescent, colourless
to slightly yellow solution, free
from or practically free from visible particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HEPATOCELLULAR CARCINOMA (HCC)
IMJUDO in combination with durvalumab is indicated for the treatment
of patients with
unresectable hepatocellular carcinoma (uHCC) who have not received
prior systemic therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose of IMJUDO is presented in Table 1.
IMJUDO is administered as an intravenous infusion over 1 hour.
TABLE 1
RECOMMENDED DOSAGE OF IMJUDO
2
INDICATION
RECOMMENDED IMJUDO
DOSAGE
DURATION OF COMBINATION
THERAPY
uHCC
Single Tremelimumab
Regular Interval Durvalumab
(STRIDE): 300 mg
a
as a
single priming dose in
combination with durvalumab
1500 mg
a,b
at Cycle 1/Day 1,
followed by durvalumab
monotherapy every 4 weeks
Until disease progression or
until unacceptable toxicity
a
Patients with a body weight of 30 kg or less must receive weight-based
dosing, equivalent to IMJUDO 4 mg/kg
and durvalumab 20 mg/kg until weight is greater than 30 kg.
b
Administer IMJUDO prior to durvalumab on the same day. Refer to the
Prescribing Information for durvalumab
dosing infor