DARZALEX 20 MGML I.V

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DARATUMUMAB

Available from:

J-C HEALTH CARE LTD

ATC code:

L01XC24

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

DARATUMUMAB 20 MG / 1 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

CILAG AG, SWITZERLAND

Therapeutic area:

DARATUMUMAB

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 st em 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

Authorization date:

2022-01-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
This medicine is dispensed with a doctor’s prescription only
Darzalex
®
20 mg/ml I.V
Concentrate for solution for infusion
The active ingredient and its concentration
Daratumumab 20 mg/ml
For a list of the inactive and allergenic ingredients in this
preparation – see section 6 “Further Information”.
See also “Important information about some of the ingredients of the
medicine” in section 2.
Read this leaflet carefully in its entirety before using the medicine.
This leaflet contains concise
information about the medicine. If you have further questions, refer
to the doctor or pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it on to others. It may
harm them, even if it seems to you that their ailment is similar.
Patient Information Card:
In addition to this leaflet, Darzalex 20 mg/ml I.V is provided with a
Patient Safety Information Card. This
card contains important safety information you should be aware of
before starting and during treatment
with Darzalex 20 mg/ml I.V, and adhere to.
Read the Patient Safety Information Card and the patient leaflet
before you start using the preparation.
Keep the card for further reading, if necessary.
1.
WHAT IS THE MEDICINE INTENDED FOR?
•
Darzalex 20 mg/ml I.V in combination with lenalidomide and
dexamethasone, or in combination with
bortezomib, melphalan and prednisone, is intended for the treatment of
adult patients with newly
diagnosed multiple myeloma, which is a cancer of the bone marrow, and
who are ineligible for
autologous stem cell transplant.
•
Darzalex 20 mg/ml I.V in combination with bortezomib, thalidomide and
dexamethasone is intended
for the treatment of adult patients with newly diagnosed multiple
myeloma, who are eligible for
autologous stem cell transplant.
•
Darzalex 20 mg/ml I.V in combination with lenalidomide and
dexamethasone, or in combination with
bortezomib and dexamethasone, is intended for th

Summary of Product characteristics

Darzalex 20mg-ml IV-100mg_400mg_ concentrate for solution for
infusion_SPC_02_2023_sub
1.
NAME OF THE MEDICINAL PRODUCT
DARZALEX 20 mg/mL I.V.
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 and 20 mL vial of DARZALEX 20MG/ML I.V contains 0.4 mmol and
1.6 mmol (9.3 mg
and 37.3 mg) sodium, respectively.
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 20MG/ML I.V 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 20MG/ML I.V 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
reaction