DARZALEX

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Bahan aktif:

DARATUMUMAB

Tersedia dari:

SOHO INDUSTRI PHARMASI - Indonesia

INN (Nama Internasional):

DARATUMUMAB

Dosis:

20 MG/ML

Bentuk farmasi:

KONSENTRAT INJEKSI

Unit dalam paket:

DUS, 1 VIAL @ 5 ML (100 MG)

Diproduksi oleh:

CILAG CHEMIE - Switzerland

Tanggal Otorisasi:

2019-03-20

Karakteristik produk

PI DARZALEX (daratumumab) (CCDS 21Dec18 v.07+TD 28Sep18+deletion RRMM)
1
DARZALEX™
Daratumumab.
Concentrate for solution for infusion
DOSAGE FORMS AND STRENGTHS
Daratumumab is an immunoglobulin G1 kappa (IgG1κ) human monoclonal
antibody against CD38 antigen,
produced in a mammalian cell line (Chinese Hamster Ovary [CHO]) using
recombinant DNA technology.
DARZALEX is available as a colorless to yellow preservative free
liquid concentrate for intravenous infusion after
dilution.
Each mL contains 20 mg daratumumab.
5 mL vial: Each single-use vial contains 100 mg of daratumumab.
20 mL vial: Each single-use vial contains 400 mg of daratumumab.
For excipients, see _List of Excipients_.
CLINICAL INFORMATION
INDICATIONS
DARZALEX is indicated as monotherapy for the treatment of patients
with multiple myeloma who have received
at least three prior lines of therapy including a proteasome inhibitor
(PI) and an immunomodulatory agent or
who are double refractory to a PI and an immunomodulatory agent.
POSOLOGY AND METHOD OF ADMINISTRATION
DARZALEX should be administered by a healthcare professional, in an
environment where resuscitation facilities
are available.
Posology
Pre- and post-infusion medications should be administered to reduce
the risk of infusion-related reactions (IRRs)
with daratumumab. See below “Recommended concomitant medications”,
“Management of infusion-related
reactions” and _Warnings and Precautions_.
_Dose _
Standard dosing for monotherapy (4-week cycle regimen):
The recommended dose is DARZALEX 16 mg/kg body weight administered as
an intravenous infusion according
to the following dosing schedule in Table 1.
TABLE 1: STANDARD DARZALEX DOSING SCHEDULE FOR MONOTHERAPY (4-WEEK
CYCLE DOSING REGIMEN)
WEEKS
SCHEDULE
Weeks 1 to 8
weekly (total of 8 doses)
Weeks 9 to 24
a
every two weeks
(total of 8 doses)
Week 25 onwards until disease progression
b
every four weeks
a
First dose of the every-2 week-dosing schedule is given at Week 9
b
First dose of the every-4 week-dosing schedule is given at Week 25