RISTEMPA pegfilgrastim 6 mg/0.6 mL injection syringe with automatic needle guard

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Pegfilgrastim, Quantity: 6 mg

Available from:

Amgen Australia Pty Ltd

INN (International Name):

Pegfilgrastim

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium; polysorbate 20; acetate; sorbitol; water for injections

Administration route:

Subcutaneous

Units in package:

1 prefilled syringe with automatic needle guard

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infection, as manifested by febrile neutropenia.

Product summary:

Visual Identification: clear, colourless liquid; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 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:

2017-01-30

Patient Information leaflet

RISTEMPA®
1
RISTEMPA
®
_pegfilgrastim (rbe) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
WHAT RISTEMPA IS USED FOR ............ 1
How it works ............................. 1
BEFORE YOU USE IT ............................ 1
When you must not use it .......... 1
Before you start to use it ............ 2
Taking other medicines .............. 2
HOW TO USE IT................................... 2
HOW TO INJECT RISTEMPA USING A
PRE-FILLED SYRINGE WITH AN
AUTOMATIC NEEDLE GUARD ................. 2
Important ................................... 2
Before you use Ristempa pre-
filled syringe with automatic
needle guard, read this important
information: ............................... 2
Guide to parts ............................. 2
Things to do before you inject ... 2
Where to inject ........................... 3
How to inject ............................. 3
How to remove detachable label 4
Disposing ................................... 4
FURTHER INFORMATION ON USE .......... 4
How much to inject .................... 4
When to inject ............................ 4
If you forget your injection ........ 4
If you inject too much (overdose)
................................................... 4
WHILE YOU ARE USING IT ................... 4
Things you must do ................... 4
Things you must not do ............. 4
SIDE EFFECTS ...................................... 4
AFTER USING IT .................................. 5
Storage ....................................... 5
Disposal ..................................... 5
PRODUCT DESCRIPTION ....................... 5
What it looks like ...................... 5
Ingredients ................................. 5
Sponsor ...................................... 5
This leaflet answers some common
questions about Ristempa.
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 prescribed
Ristempa after considering its likely
benefit to you, as well as the
p

Summary of Product characteristics

RISTEMPA
® (PEGFILGRASTIM) - SOLUTION FOR INJECTION -
PRODUCT INFORMATION
PAGE 1 OF 17
AUSTRALIAN PI - RISTEMPA
® (PEGFILGRASTIM)
1
NAME OF THE MEDICINE
Ristempa
®
is the Amgen Inc. trademark for pegfilgrastim (rbe), a long-acting
form of
recombinant human granulocyte colony-stimulating factor (G-CSF).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ristempa is composed of filgrastim (recombinant methionyl human G-CSF,
tradename
NEUPOGEN) with a 20,000 dalton polyethylene glycol (PEG) molecule
covalently bound to
the N-terminal methionine residue.
Filgrastim is a 175 amino acid protein manufactured by recombinant DNA
technology.
Filgrastim is produced by _Escherichia coli_ (_E coli_) bacteria into
which has been inserted the
human G-CSF gene. Filgrastim is unglycosylated and contains an
N-terminal methionine
necessary for expression in _E coli_. Ristempa has a total molecular
weight of 39,000 daltons.
Each single-use pre-filled syringe with automatic needle guard of
Ristempa contains 6 mg of
pegfilgrastim (based on protein mass only).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Ristempa is a sterile, clear, colourless, preservative-free liquid for
subcutaneous (SC)
administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ristempa is indicated for the treatment of cancer patients following
chemotherapy, to
decrease the duration of severe neutropenia and so reduce the
incidence of infection, as
manifested by febrile neutropenia.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE (DOSE AND INTERVAL)
The recommended dosage of Ristempa is a single SC injection of 6 mg
administered once
per chemotherapy cycle. Ristempa should be administered approximately
24 hours after the
administration of cytotoxic chemotherapy. In clinical studies,
Ristempa has been safely
RISTEMPA
® (PEGFILGRASTIM) - SOLUTION FOR INJECTION -
PRODUCT INFORMATION
PAGE 2 OF 17
administered 14 days before chemotherapy (see Section 4.4 Special
warnings and
precautions for use).
METHOD OF ADMINISTRATION