BLINCYTO INFUSION (PARENTERAL)

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Amgen South Africa (Pty)Ltd

Dosage:

See ingredients

Pharmaceutical form:

INFUSION (PARENTERAL)

Composition:

EACH VIAL CONTAINS BLINATUMOMAB 38,5 ug

Authorization status:

Registered

Patient Information leaflet

Applicant:
Amgen (Pty) Ltd
Product:
BLINCYTO
®
Date of
registration:
30 November 2021
Strength and Dosage
Form:
38,5 µg Lyophilised Powder for Reconstitution and Solution for
Infusion
Page 1 of 12
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S4
BLINCYTO
® POWDER FOR CONCENTRATE AND SOLUTION FOR INFUSION
Blinatumomab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN BLINCYTO
®
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse
or other health care provider.
•
If you experience any side effects, talk to your doctor or nurse. This
includes any possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1.
WHAT BLINCYTO
® IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BLINCYTO
®
3.
HOW TO USE BLINCYTO
®
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE BLINCYTO
®
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT BLINCYTO
® IS AND WHAT IT IS USED FOR
The active ingredient in BLINCYTO
®
is blinatumomab.
BLINCYTO
®
is used to treat adults, adolescents, and children with acute
lymphoblastic leukaemia. Acute lymphoblastic leukaemia is a cancer of
the
blood in which a particular kind of white blood cell is growing out of
control. This
medicine works by enabling your immune system to attack and destroy
these
abnormal white blood cancer cells.
Applicant:
Amgen (Pty) Ltd
Product:
BLINCYTO
®
Date of
registration:
30 November 2021
Strength and Dosage
Form:
38,5 µg Lyophilised Powder for Reconstitution and Solution for
Infusion
Page 2 of 12
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BLINCYTO
®
BLINCYTO
®
should not be administered to you:
•
if you are hypersensitive (allergic) to blinatumomab or any of the
other
ingredients of BLINCYTO
®
(listed in section 6).
•
if you are breast-feeding.
WARNINGS AND PRECAUTIONS
Tell your doctor or health care provider before being given the
infusion: if you
have ever had NEUROLOGICAL PROBLEMS (e.g., seizures, memory loss,
confusion,
disorientation, loss of bal

Summary of Product characteristics

Applicant:
Amgen (Pty) Ltd
Product:
BLINCYTO
®
Date of
Registration:
30 November 2021
Strength and Dosage
Form:
38,5 µg Lyophilised Powder for Reconstitution and Solution for
Infusion
Page 1 of 47
PROFESSIONAL INFORMATION
SCHEDULING STATUS: S4_ _
_ _
1.
NAME OF MEDICINE
BLINCYTO
®
38,5 µg of lyophilized powder for reconstitution and solution for
infusion.
2.
QUALITATIVE AND QUATITATIVE COMPOSITION
Each single-use vial contains 38,5 µg preservative-free blinatumomab.
After reconstitution with 3 ml of preservative-free sterile Water for
Injection, the
resulting total volume of reconstituted solution is 3 ml and each ml
contains
12.5 µg blinatumomab.
Blinatumomab is produced in Chinese hamster ovary cells by recombinant
DNA
technology.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
•
One BLINCYTO
®
38,5 µg single-dose vial containing a sterile, preservative-
free, white to off-white lyophilized powder
•
One IV Solution Stabilizer 10 ml single-dose glass vial containing a
sterile,
preservative-free, colourless to slightly yellow, clear solution.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
MRD-POSITIVE B-CELL PRECURSOR ALL
BLINCYTO
®
is indicated for the treatment of B-cell precursor acute lymphoblastic
leukaemia (ALL) in first or second complete remission (CR) with
minimal residual
disease (MRD) greater than or equal to 0,1 % in adults and children.
Applicant:
Amgen (Pty) Ltd
Product:
BLINCYTO
®
Date of
Registration:
30 November 2021
Strength and Dosage
Form:
38,5 µg Lyophilised Powder for Reconstitution and Solution for
Infusion
Page 2 of 47
RELAPSED OR REFRACTORY B-CELL PRECURSOR ALL
BLINCYTO
®
is indicated for the treatment of relapsed or refractory B-cell
precursor
acute lymphoblastic leukaemia (ALL) in adults and children
.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under the direction of and supervision
of physicians
experienced in the treatment of haematological malignancies.
POSOLOGY
MRD-positive B-cell Precursor ALL
•
A treatment