DARZALEX SC daratumumab 1800 mg/15 mL solution for injection vial

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

daratumumab, Quantity: 1800 mg

MAH:

Janssen-Cilag Pty Ltd

pharmaceutical_form:

Injection, solution

composition:

Excipient Ingredients: vorhyaluronidase alfa; histidine; histidine hydrochloride monohydrate; sorbitol; methionine; polysorbate 20; water for injections

administration_route:

Subcutaneous

units_in_package:

1

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

DARZALEX SC is indicated for the treatment of patients:,? with newly diagnosed multiple myeloma:,- who are eligible for autologous stem cell transplant. For use in combination with:-bortezomib, thalidomide, and dexamethasone.,- who are ineligible for autologous stem cell transplant. For use in combination with: - bortezomib, melphalan and prednisone, or - lenalidomide and dexamethasone.,? with multiple myeloma who have received: - at least one prior therapy. For use in combination with: - bortezomib and dexamethasone, or - lenalidomide and dexamethasone.,- at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are refractory to both a PI and an immunomodulatory agent. For use as: - monotherapy.,DARZALEX SC in combination with bortezomib, cyclophosphamide and dexamethasone, is indicated for the treatment of patients with light chain AL amyloidosis.

leaflet_short:

Visual Identification: Colourless to yellow, clear to opalescent, preservative-free solution; 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

authorization_status:

Registered

authorization_date:

2020-09-08

PIL

DARZALEX SC (211208) ACMI
1
DARZALEX
® SC
_SOLUTION FOR INJECTION _
_Daratumumab _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DARZALEX SC
Solution for injection. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given
DARZALEX SC against the benefits
this medicine is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN DARZALEX SC ASK
YOUR DOCTOR.
KEEP THIS LEAFLET WHILE YOU ARE
BEING TREATED WITH DARZALEX
SC.
You may need to read it again.
WHAT DARZALEX SC
IS USED FOR
DARZALEX SC is an anti-cancer
medicine and contains the active
substance daratumumab. This
belongs to a group of medicines
called “monoclonal antibodies”. One
of the ways monoclonal antibodies
work is by attaching themselves to
specific abnormal blood cells in your
body, so your immune system can
destroy them.
DARZALEX SC is used to treat
adults with multiple myeloma
(cancer of the bone marrow).
DARZALEX SC is also used to treat
adults with AL amyloidosis (also
known as light chain amyloidosis, a
type of blood disorder). In AL
amyloidosis, abnormal blood cells
make excessive amounts of abnormal
proteins that deposit in various
organs, causing these organs to not
function properly.
Your doctor may have prescribed
DARZALEX SC for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY DARZALEX
SC HAS BEEN PRESCRIBED FOR YOU.
THIS MEDICINE IS AVAILABLE ONLY
WITH A DOCTOR'S PRESCRIPTION.
BEFORE YOU ARE GIVEN
DARZALEX SC
_WHEN YOU MUST NOT USE IT: _
DO NOT USE DARZALEX SC IF:
•
you know you are allergic
(hypersensitive) to daratumumab
or other ingredients of
DARZALEX SC. See Product
Description at the end of this
leaflet for a list of ingredients.
SYMPTOMS OF AN ALLERGIC REACTION
MAY INCLUDE RASH, ITCHING OR HIVES
ON THE SKIN, SHORTNESS OF BREATH,
WHEEZING OR DIFFICULTY BREATHING,
SWELLING OF THE FACE, LIPS,

SPC

_ _
CCDSv10 210413
1
DARZALEX SC (211116) API
DARZALEX
®
SC
DARATUMUMAB SOLUTION FOR INJECTION
AUSTRALIAN PRODUCT INFORMATION
1.
NAME OF THE MEDICINE
Daratumumab.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
15 mL vial: Each single-use vial contains 1800 mg of daratumumab (120
mg/mL).
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.
Recombinant human hyaluronidase (rHuPH20; vorhyaluronidase alfa) is an
endoglycosidase
used to increase the dispersion and absorption of co-administered
drugs when administered
subcutaneously. It is produced by mammalian CHO cells containing a DNA
plasmid encoding
for a soluble fragment of human hyaluronidase (PH20). It is a
glycosylated single-chain protein
with an approximate molecular weight of 61 kD.
For a full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
DARZALEX SC is available as a colourless to yellow, clear to
opalescent, preservative-free
solution for subcutaneous administration.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DARZALEX SC is indicated for the treatment of patients:
•
with newly diagnosed multiple myeloma:
-
who are eligible for autologous stem cell transplant. For use in
combination with:

bortezomib, thalidomide, and dexamethasone.
-
who are ineligible for autologous stem cell transplant. For use in
combination with:

bortezomib, melphalan and prednisone, or

lenalidomide and dexamethasone.
•
with multiple myeloma who have received:
-
at least one prior therapy. For use in combination with:

bortezomib and dexamethasone, or

lenalidomide and dexamethasone.
-
at least three prior lines of therapy including a proteasome inhibitor
(PI) and an
immunomodulatory agent or who are refractory to both a PI and an
immunomodulatory agent. For use as:

monotherapy.
_ _
CCDSv10 210413
2
DARZALEX SC (211116) API
DARZALEX SC in combination with bortezomib, cyclophospha