LONQUEX lipegfilgrastim (rbe) 6 mg/0.6 mL solution for injection prefilled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lipegfilgrastim, Quantity: 6 mg

Available from:

Teva Pharma Australia Pty Ltd

INN (International Name):

lipegfilgrastim

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: acetic acid; polysorbate 20; sorbitol; sodium hydroxide; water for injections

Administration route:

Subcutaneous

Units in package:

6 mg / 0.6 mL solution for injection

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Lonquex? is indicated for reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes)

Product summary:

Visual Identification: Lonquex is a sterile preservative free aqueous solution for subcutaneous inj presented in a 1 mL prefilled syringe containing 6 mg of lipegfilgrastim/0.6 mL acetate buffer pH 5.0 (based on protein content); Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; 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:

2015-11-12

Patient Information leaflet

LONQUEX
®
_Lipegfilgrastim (rbe)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS BOOKLET
This booklet answers some common
questions about Lonquex.
Please note that this booklet does not
contain everything there is to know
about Lonquex. It does not take the
place of talking to your doctor, nurse
or pharmacist.
All medicines have risks and
benefits. Your doctor has prescribed
Lonquex after considering its likely
benefit to you, as well as the
potential risks.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS BOOKLET WITH YOUR
MEDICINE.
You may need to read this
information again.
WHAT IS LONQUEX USED
FOR
Lonquex is used following
chemotherapy to help fight infection.
Some chemotherapy will reduce the
number of neutrophils in your body.
Although Lonquex is not a treatment
for cancer, it does help the body to
make new neutrophils and this may
reduce your chance of developing
infections that might require
antibiotics and/or hospital stays. It
may even increase your chance of
receiving your chemotherapy on time
and at the right dose.
_HOW IT WORKS_
Lonquex contains the active
substance lipegfilgrastim.
Lipegfilgrastim is a long-acting
modified protein produced by
biotechnology in bacteria called
Escherichia coli. It belongs to a
group of proteins called cytokines
and is similar to a natural protein
(granulocyte-colony stimulating
factor [G-CSF]) produced by your
own body.
Lipegfilgrastim stimulates the bone
narrow (the tissue where new blood
cells are made) to produce more
white blood cells. White blood cells
are important as they help your body
fight infection. These cells are very
sensitive to the effects of
chemotherapy which can cause the
number of these cells in your body to
decrease. If white blood cells fall to a
low level, there may not be enough
left in the body to fight bacteria and
you may have an increased risk of
infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only wi

Summary of Product characteristics

Teva Pharma Australia Pty Limited Version 5.0 1
AUSTRALIAN PI – LONQUEX
® (LIPEGFILGRASTIM) SOLUTION FOR
INJECTION
1
NAME OF THE MEDICINE
Lipegfilgrastim.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lonquex® is the Teva Pharmaceuticals Ltd. trademark for
lipegfilgrastim (rbe), a long-acting form of
recombinant human granulocyte colony-stimulating factor (G-CSF).
Lonquex® contains the active substance lipegfilgrastim (rbe).
Lipegfilgrastim is a covalent conjugate
of a 19,000 dalton E.Coli produced r-metHuG-CSF and a 20,000 dalton
polyethylene glycol (PEG)
moiety. The theoretical molecular mass of r-metHuG-CSF is 18,798.9 Da.
The molecular mass of the
final glycoPEGylated human N-methionyl granulocyte-colony stimulating
factor is approximately
39,000 Da. The PEG moiety is attached enzymatically through a
glycolinker (glycyl-sialyl-GalNac) to
the amino acid Thr134 (which corresponds to the glycosylation site
Thr133 in endogenous G-CSF).
Lipegfilgrastim is a covalent conjugate of filgrastim with a single
methoxy polyethylene glycol (PEG)
molecule via a carbohydrate linker consisting of L-Glycine,
N-acetylneuraminic acid (Sialic Acid) and a
N-acetylgalactosamine (GalNAc) moiety to Threonine134. The average
molecular mass is
approximately 39,000 dalton of which the protein moiety constitutes
approximately 48%.
The potency of this medicinal product should not be compared to the
potency of another pegylated
or non-pegylated protein of the same therapeutic class. For more
information, see SECTION 5,
PHARMACOLOGICAL PROPERTIES.
Each single-use pre-filled syringe of Lonquex® contains 6 mg of
lipegfilgrastim in 0.6 mL solution.
Each mL of solution for injection contains 10 mg of lipegfilgrastim.
This medicinal product contains 30 mg sorbitol per pre-filled syringe.
Patients with rare hereditary
problems of fructose intolerance should not use this medicinal
product.
This medicinal product contains less than 1 mmol sodium (0.14 mg) per
pre-filled syringe, i.e.
essentially ‘sodium-free’.
For the full list of excipients