Darzalex

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Daratumumab

Available from:

Janssen-Cilag International N.V.

ATC code:

L01FC01

INN (International Name):

daratumumab

Therapeutic group:

monoclonal antibodies and antibody drug conjugates, Antineoplastic agents

Therapeutic area:

Multiple Myeloma

Therapeutic indications:

Multiple MyelomaDarzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5.1).as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.AL AmyloidosisDARZALEX is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis.

Product summary:

Revision: 21

Authorization status:

Authorised

Authorization date:

2016-05-20

Patient Information leaflet

85
B. PACKAGE LEAFLET
86
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DARZALEX 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
daratumumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What DARZALEX is and what it is used for
2.
What you need to know before you are given DARZALEX
3.
How DARZALEX is given
4.
Possible side effects
5.
How to store DARZALEX
6.
Contents of the pack and other information
1.
WHAT DARZALEX IS AND WHAT IT IS USED FOR
WHAT DARZALEX IS
DARZALEX is a cancer medicine that contains the active substance
daratumumab. It belongs to a
group of medicines called “monoclonal antibodies”. Monoclonal
antibodies are proteins that have
been designed to recognise and attach to specific targets in the body.
Daratumumab has been designed
to attach to specific cancer cells in your body, so that your immune
system can destroy the cancer
cells.
WHAT DARZALEX IS USED FOR
DARZALEX is used in adults 18 years or older, who have a type of
cancer called “multiple
myeloma”. This is a cancer of your bone marrow.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DARZALEX
YOU MUST NOT BE GIVEN DARZALEX
-
if you are allergic to daratumumab or any of the other ingredients of
this medicine (listed in
section 6).
Do not use DARZALEX if the above applies to you. If you are not sure,
talk to your doctor or nurse
before you are given DARZALEX.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before you are given DARZALEX.
Infusion-related reactions
DARZALEX is given as an infusion (drip) into a vein. Before and after
each infusion of DARZALEX,
you will be given medicines which help to lower the chance of
infusion-related reactions (see
“Medicines given during tre

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
DARZALEX 20 mg/mL concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL vial contains 100 mg of daratumumab (20 mg daratumumab per
mL).
Each 20 mL vial contains 400 mg of daratumumab (20 mg daratumumab per
mL).
Daratumumab is a human monoclonal IgG1κ antibody against CD38
antigen, produced in a
mammalian cell line (Chinese Hamster Ovary) using recombinant DNA
technology.
Excipient with known effect
Each 5 mL vial of solution for infusion contains 273.3 mg of sorbitol
(E420).
Each 20 mL vial of solution for infusion contains 1093 mg of sorbitol
(E420).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
The solution is colourless to yellow.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DARZALEX is indicated:

in combination with lenalidomide and dexamethasone or with bortezomib,
melphalan and
prednisone for the treatment of adult patients with newly diagnosed
multiple myeloma who are
ineligible for autologous stem cell transplant.

in combination with bortezomib, thalidomide and dexamethasone for the
treatment of adult
patients with newly diagnosed multiple myeloma who are eligible for
autologous stem cell
transplant.

in combination with lenalidomide and dexamethasone, or bortezomib and
dexamethasone, for
the treatment of adult patients with multiple myeloma who have
received at least one prior
therapy.

as monotherapy for the treatment of adult patients with relapsed and
refractory multiple
myeloma, whose prior therapy included a proteasome inhibitor and an
immunomodulatory
agent and who have demonstrated disease progression on the last
therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
DARZALEX should be administered by a healthcare professional, in an
environment where
resuscitation facilities are available.
Pre- and post-infusion medicinal products should be administered to
reduce the risk of infusion-related
reacti