DARZALEX CONCENTRATE FOR SOLUTION FOR INFUSION 400MG20ML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

daratumumab

Available from:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

ATC code:

L01XC24

Pharmaceutical form:

INFUSION, SOLUTION CONCENTRATE

Composition:

daratumumab 20mg/mL

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Vetter Pharma-Fertigung GmbH & Co. KG

Authorization status:

ACTIVE

Authorization date:

2016-10-26

Summary of Product characteristics

1
PRODUCT NAME
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 for the treatment of patients with multiple myeloma:
-
in combination with bortezomib, melphalan and prednisone, or in
combination with
lenalidomide and dexamethasone in newly diagnosed patients who are
ineligible for
autologous stem cell transplant.
-
in combination with bortezomib, thalidomide and dexamethasone in newly
diagnosed
patients who are eligible for autologous stem cell transplant.
-
in
combination
with
lenalidomide
and
dexamethasone,
or
in
combination
with
bortezomib and dexamethasone in patients who have received at least
one prior therapy.
-
in
combination
with
carfilzomib
and
dexamethasone
in
patients
with
relapsed
or
refractory multiple myeloma who have received one to three prior lines
of therapy.
-
as monotherapy, in patients 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.
DOSAGE AND ADMINISTRATION
DARZALEX
®
should be administered by a healthcare professional, with immediate
access to
emergency equipment and appropriate medical support to manage
infusion-related reactions
(IRRs) if they occur.
Pre- and post-infusion medications should be administered (see
_Recommended concomitant _
_medications_
below).
DOSAGE – ADULTS (≥18 YEARS)
_RECOMMENDED DOSE _
The DARZALEX