Blincyto 38.5micrograms powder for concentrate and solution for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Blinatumomab

Available from:

Amgen Ltd

ATC code:

L01XC19

INN (International Name):

Blinatumomab

Dosage:

38.5microgram

Pharmaceutical form:

Powder for solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08020300; GTIN: 8715131009922

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BLINCYTO 38.5 MICROGRAMS POWDER FOR CONCENTRATE AND SOLUTION FOR
SOLUTION FOR INFUSION
blinatumomab
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
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. This belongs to a
group of medicines called
antineoplastic agents which target cancer cells.
BLINCYTO is used to treat adults with acute lymphoblastic leukaemia.
Acute lymphoblastic
leukaemia is a cancer of the blood in which a particular kind of white
blood cell called “B-
lymphocyte” is growing out of control. This medicine works by
enabling your immune system to
attack and destroy these abnormal white blood cancer cells.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BLINCYTO
_ _
DO NOT USE BLINCYTO:
-
if you are allergic to blinatumomab or any of the other ingredients of
this medicine (listed in
section 6).
-
if you are breast-feeding.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR, PHARMACIST OR NURSE BEFORE USING BLINCYTO
if any of these apply to you.
BLINCYTO may not be suitable for you:

if you have ever had neurological problems, for example, shaking (or
tremor), abnormal
sensations, seizures, memory loss, confusion

Summary of Product characteristics

OBJECT 1
BLINCYTO
Summary of Product Characteristics Updated 20-Jun-2018 | Amgen Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
BLINCYTO 38.5 micrograms powder for concentrate and solution for
solution for infusion.
2. Qualitative and quantitative composition
One vial of powder contains 38.5 micrograms blinatumomab.
Reconstitution with water for injections results in a final
blinatumomab concentration of 12.5
micrograms/mL.
Blinatumomab is produced in Chinese hamster ovary cells by recombinant
DNA technology.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for concentrate and solution for solution for infusion.
BLINCYTO powder (powder for concentrate): White to off-white powder.
Solution (stabiliser): Colourless-to-slightly yellow, clear solution
with a pH of 7.0.
4. Clinical particulars
4.1 Therapeutic indications
BLINCYTO is indicated for the treatment of adults with Philadelphia
chromosome negative relapsed or
refractory B-precursor acute lymphoblastic leukaemia (ALL).
4.2 Posology and method of administration
Treatment should be initiated under the direction of and supervised by
physicians experienced in the
treatment of haematological malignancies.
Hospitalisation is recommended for initiation at a minimum for the
first 9 days of the first cycle and the
first 2 days of the second cycle.
In patients with a history or presence of clinically relevant central
nervous system (CNS) pathology (see
section 4.4), hospitalisation is recommended at a minimum for the
first 14 days of the first cycle. In the
second cycle, hospitalisation is recommended at a minimum for 2 days,
and clinical judgment should be
based on tolerance to BLINCYTO in the first cycle. Caution should be
exercised as cases of late
occurrence of first neurological events in the