DARZALEX daratumumab 400 mg/20 mL concentrated solution for infusion vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

daratumumab, Quantity: 400 mg

Available from:

Janssen-Cilag Pty Ltd

INN (International Name):

daratumumab

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: glacial acetic acid; sodium acetate trihydrate; sodium chloride; mannitol; polysorbate 20; water for injections

Administration route:

Intravenous

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

DARZALEX 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.

Product summary:

Visual Identification: DARZALEX is a colourless to yellow liquid concentrate; 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:

Licence status A

Authorization date:

2017-07-17

Patient Information leaflet

DARZALEX (211208) ACMI
1
DARZALEX
®
_CONCENTRATE FOR SOLUTION FOR INFUSION _
_Daratumumab _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DARZALEX
Concentrate for Solution for
Infusion. 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 against the benefits this
medicine is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN DARZALEX ASK YOUR
DOCTOR.
KEEP THIS LEAFLET WHILE YOU ARE
BEING TREATED WITH DARZALEX.
You may need to read it again.
WHAT DARZALEX IS
USED FOR
DARZALEX 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 cancer cells in your body, so
your immune system can destroy
them.
DARZALEX is used to treat adults
with multiple myeloma (cancer of the
bone marrow).
Your doctor may have prescribed
DARZALEX for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY DARZALEX
HAS BEEN PRESCRIBED FOR YOU.
THIS MEDICINE IS AVAILABLE ONLY
WITH A DOCTOR'S PRESCRIPTION.
BEFORE YOU ARE GIVEN
DARZALEX
_WHEN YOU MUST NOT USE IT: _
DO NOT USE DARZALEX IF:
•
you know you are allergic
(hypersensitive) to daratumumab
or other ingredients of
DARZALEX. 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, TONGUE OR
OTHER PARTS OF THE BODY.
DARZALEX SHOULD NOT BE GIVEN
TO CHILDREN OR YOUNG PEOPLE BELOW
18 YEARS OF AGE. THIS IS BECAUSE IT IS
NOT KNOWN HOW THE MEDICINE WILL
AFFECT THEM.
_BEFORE YOU START TO USE IT: _
TELL YOUR DOCTOR IF YOU HAVE OR
HAVE HAD ANY MEDICAL CONDITIONS,
ESPECIALLY THE FOLLOWING:
•
bl

Summary of Product characteristics

_ _
CCDSv16 210413
1
DARZALEX (211116) API
DARZALEX
®
DARATUMUMAB CONCENTRATED SOLUTION FOR INFUSION
AUSTRALIAN PRODUCT INFORMATION
1.
NAME OF THE MEDICINE
Daratumumab.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 mL vial: Each single-use vial contains 100 mg of daratumumab.
20 mL vial: Each single-use vial contains 400 mg of daratumumab.
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.
For a full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
DARZALEX concentrated solution for infusion is supplied as a
colourless to yellow preservative
free liquid concentrate for intravenous infusion after dilution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DARZALEX 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.
4.2 DOSE AND METHOD OF 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.
_ _
CCDSv16 210413
2
DARZALEX (211116) API
Before DARZALEX therapy is commenced, clinicians should arrange for
extended red cell
phenotyping of patients (see section 4.4 Special warnings and
pr