DARZALEX 120 MGML S.C. 1800 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DARATUMUMAB

Available from:

J-C HEALTH CARE LTD

ATC code:

L01XC24

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

DARATUMUMAB 120 MG / 1 ML

Administration route:

S.C

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 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.

Authorization date:

2021-04-11

Patient Information leaflet

PATIENT CARD
IN CASE OF EMERGENCY, OR IF YOU
FIND THIS CARD, PLEASE CONTACT
THE DOCTOR LISTED BELOW:
Doctor’s Name/Clinic, Center or Hospital Name:
Telephone number:
IMPORTANT
MEDICAL INFORMATION
INSIDE
DARZALEX 20 MG/ML IV
DARZALEX 120 MG/ML SC, 1800 MG
Patient Card
DAR P-ID-ENG-CARD SH010821
DARZALEX PATIENTS: PROVIDE THIS CARD TO HEALTHCARE
PROVIDERS BEFORE BLOOD TRANSFUSION AND CARRY IT FOR 6
MONTHS AFTER TREATMENT HAS ENDED. FOR FURTHER INFORMATION
PLEASE REFER TO THE PATIENT INFORMATION LEAFLET
PATIENT ID CARD FOR DARZALEX
Name: _____________________________________________
I AM TAKING THE FOLLOWING MEDICATION:
Daratumumab antibody product for the treatment
of multiple myeloma
Stopped taking this medication ______
_
_ / ________ / ________
DD MM YYYY
DEAR HEALTHCARE PROVIDER,
Daratumumab is associated with the risk of interference with
blood typing.
The Indirect Coombs test may show positive results in patients
taking daratumumab, even in the absence of antibodies to minor
blood antigens in the patient’s serum.
The chance of this disturbance can persist for up to 6 months
after the last dose of daratumumab. The determination of a
patient’s ABO and Rh blood type
are not impacted.
If an emergency transfusion is required, non-cross-matched,
ABO/RhD-compatible RBCs can be given per local blood
bank practices.
BEFORE STARTING DARATUMUMAB MY BLOOD TEST RESULTS
COLLECTED ON _______ / _______ / _______ WERE:
DD MM YYYY
Blood type:
□ A □ B □ AB □ O □ Rh+ □ Rh-
INDIRECT COOMBS TEST (ANTIBODY SCREEN) WAS:
□ Negative
□
Positive for the following antibodies:
________________________________________________
Contact details of the institution where the blood tests were
performed: _______________________________________
The format and the content of this card were updated and approved by
the
Ministry of Health in July 2021. For further information, read the
patient leaflet.
Side effects can be reported to the Ministry of Health by using an
online form
for reporting side effects found on the Ministr

Summary of Product characteristics

DARZALEX 120 mg/ml S.C 08_2023_sub
1.
NAME OF THE MEDICINAL PRODUCT
DARZALEX 120 MG/ML S.C. 1,800 MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 15 mL vial of solution for injection contains 1,800 mg of
daratumumab (120 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 15 mL vial of solution for injection contains 735.1 mg of
sorbitol (E420).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
The solution is clear to opalescent, colourless to yellow.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
DARZALEX 120MG/ML S.C. 1,800MG 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 120MG/ML S.C. 1,800MG subcutaneous formulation is not
intended for intravenous
administration and should be given by subcutaneous injection only,
using the doses specified.
DARZALEX 120MG/ML S.C. 1,800MG should be administered by a healthcare
professional, and the
first dose should be administered in an environment where
resuscitation facilities are ava