BLINCYTO blinatumomab (rch) 38.5 microgram powder for injection vial with Intravenous (IV) solution stabiliser

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

blinatumomab, Quantity: 38.5 microgram/g

Available from:

Amgen Australia Pty Ltd

INN (International Name):

blinatumomab

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: citric acid monohydrate; lysine hydrochloride; polysorbate 80; sodium hydroxide; water for injections

Administration route:

Intravenous

Units in package:

1 vial Blincyto and 1 vial IV solution stabiliser for Blincyto supplied in composite pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Blincyto is indicated for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).,Blincyto is indicated for the treatment of minimal residual disease (MRD) positive B-cell precursor acute lymphoblastic leukaemia (ALL) in patients in complete haematological remission.,Note to indication: the indications in Philadelphia positive, MRD positive and paediatric patients were approved based on phase II, non-randomised evidence. An improvement in clinical outcomes by direct prospective comparison in a randomised setting relative to other standard-of-care salvage therapies has not been established.

Product summary:

Visual Identification: Colourless to slightly yellow and clear to slightly opalescent solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 60 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2015-11-09

Patient Information leaflet

WARNING: IN SOME PATIENTS, BLINCYTO MAY CAUSE SERIOUS SIDE EFFECTS
THAT CAN BE SEVERE, LIFE-THREATENING, OR LEAD TO
DEATH. CALL YOUR HEALTHCARE PROFESSIONAL AND GET MEDICAL ATTENTION
IMMEDIATELY IF YOU GET ANY OF THE SYMPTOMS LISTED
BELOW.
•
FEVER, TIREDNESS OR WEAKNESS, DIZZINESS, LOW BLOOD PRESSURE, HEADACHE,
NAUSEA, VOMITING, CHILLS, FACE SWELLING,
WHEEZING OR TROUBLE BREATHING, SKIN RASH.
•
SEIZURES, DIFFICULTY IN SPEAKING OR SLURRED SPEECH, LOSS OF
CONSCIOUSNESS, TROUBLE SLEEPING, CONFUSION, DISORIENTATION,
LOSS OF BALANCE, HEADACHE, DIFFICULTY WITH FACIAL MOVEMENTS/HEARING
/VISION/SWALLOWING.
BLINCYTO
®
_(BLIN-SY-TOH)_
_Blinatumomab (blin-a-toom-oh-mab)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Blincyto. It does not
contain all the available information.
It does not take the place of talking to
your doctor, nurse or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you or your child taking
Blincyto against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT BLINCYTO 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,
adolescents, and children with acute
lymphoblastic leukaemia. Acute
lymphoblastic leukaemia is a cancer
of the blood in which a particular
type 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
BLINCYTO
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT RECEIVE BLINCYTO IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
blinatumomab.
•
any of the ingredien

Summary of Product characteristics

Blincyto
®
(blinatumomab) Product Information
Page 1 of 51
20210312 Blincyto Product Information
AUSTRALIAN PRODUCT INFORMATION – BLINCYTO

(BLINATUMOMAB) POWDER FOR INJECTION
WARNING
THE FOLLOWING HAVE OCCURRED IN PATIENTS RECEIVING BLINCYTO:
•
CYTOKINE RELEASE SYNDROME, WHICH MAY BE LIFE-THREATENING OR FATAL
•
NEUROLOGICAL TOXICITIES, WHICH MAY BE SEVERE, LIFE-THREATENING, OR
FATAL
•
REACTIVATION OF JC VIRAL INFECTION
INTERRUPT OR DISCONTINUE BLINCYTO AS RECOMMENDED IF ANY OF THESE
ADVERSE
EVENTS OCCUR (SEE SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
AND
SECTION 4.2 DOSE AND METHOD OF ADMINISTRATION).
1
NAME OF THE MEDICINE
Blinatumomab
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
Each single-use vial of Blincyto contains 38.5 micrograms
preservative-free blinatumomab.
After reconstitution with 3 mL of preservative-free sterile Water for
Injections, the resulting
total volume of reconstituted solution is 3.1 mL and each mL contains
12.5 micrograms
(mcg) blinatumomab. The extractable amount of blinatumomab per vial is
35 micrograms in
a volume of 2.8 mL reconstituted solution.
EXCIPIENTS
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Lyophilised powder for injection with IV stabiliser solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Blincyto is indicated for the treatment of relapsed or refractory
B-cell precursor acute
lymphoblastic leukaemia (ALL).
Blincyto
®
(blinatumomab) Product Information
Page 2 of 51
20210312 Blincyto Product Information
Blincyto is indicated for the treatment of minimal residual disease
(MRD) positive B-cell
precursor acute lymphoblastic leukaemia (ALL) in patients in complete
haematological
remission.
Note to indication: the indications in Philadelphia positive, MRD
positive and paediatric
patients were approved based on phase II, non-randomised evidence. An
improvement in
clinical outcomes by direct prospective comparison in a randomised
setting relative to other
standard-of-care salvage thera