PLEGRIDY peginterferon beta-1a (rch) 63 microgram/0.5 mL and 94 microgram/0.5 mL solution for injection pre-filled pen TITRATION PACK
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
06-08-2021
Summary of Product characteristics
(SPC)
02-10-2021
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
peginterferon beta-1a, Quantity: 94 microgram
Available from:
Biogen Australia Pty Ltd
INN (International Name):
peginterferon beta-1a
Pharmaceutical form:
Injection, solution
Composition:
Excipient Ingredients: arginine hydrochloride; water for injections; sodium acetate trihydrate; polysorbate 20; glacial acetic acid
Administration route:
Subcutaneous
Units in package:
1 x peginterferon beta 1-a 63 microgram/0.5 mL pre-filled pen, 1 x peginterferon beta 1-a 94 microgram/0.5 mL pre-filled pen
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
PLEGRIDY is indicated for the treatment of relapsing forms of Multiple Sclerosis (MS) (see CLINICAL TRIALS).
Product summary:
Visual Identification: A clear, colorless liquid, essentially free of visible particles; Container Type: Syringe; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2014-11-10
Patient Information leaflet
PLEGRIDY
®
(PLEGG-RIH-DEE)
_peginterferon beta-1a (rch)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Plegridy.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
This leaflet was last updated on the
date at the end of this leaflet.
SPEAK TO YOUR PHARMACIST OR
DOCTOR TO OBTAIN THE MOST UP TO
DATE INFORMATION ON THIS MEDICINE.
You can also download the most up
to date leaflet from:
www.biogen.com.au/products/
plegridy-CMI.pdf
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Plegridy
against the benefits it is expected to
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 PLEGRIDY IS USED
FOR
Plegridy is a prescription medicine
used to treat people with relapsing
forms of Multiple Sclerosis (MS). It
is not known if Plegridy is safe and
effective in people under 18 or over
65 years of age.
The cause of MS is not yet known.
MS affects the brain and spinal cord.
In MS, the body's immune system
reacts against its own myelin (the
'insulation' surrounding nerve fibres).
In relapsing forms of MS, people
have 'exacerbations' from time to
time (e.g. blurred vision, weakness in
the legs or arms, or loss of control of
bowel or bladder function). They are
followed by periods of recovery.
Recovery may be complete or
incomplete. If it is incomplete there
is 'progression of disability'.
Plegridy belongs to a group of
medicines called interferons. The
active substance in Plegridy is
peginterferon beta-1a. Peginterferon
beta-1a is a long-acting form of
interferon. Interferons exist naturally
in the body to help fight viral
infections and regulate the body's
immunity.
Although the exact mechanism of
action of interferons in MS is
unknown, it is thought that Plegridy
works by decreasing the unwanted
immune reaction against myelin.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS
Read the complete document
Summary of Product characteristics
PLEGRIDY PI 210930 (bdpplgr11021)
1
AUSTRALIAN PRODUCT INFORMATION
PLEGRIDY (PEGINTERFERON BETA 1-A (RCH)) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Peginterferon beta-1a (rch)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled pen
A single pre-filled syringe contains 0.5 mL of solution of PLEGRIDY
containing 63 micrograms,
94 micrograms, or 125 micrograms of peginterferon beta-1a. The glass
syringe is contained
within a single-use, disposable, injection device (pre-filled pen).
Pre-filled syringe
A single pre-filled syringe contains 0.5 mL of solution of PLEGRIDY
containing 63 micrograms,
94 micrograms or 125 micrograms of peginterferon beta-1a.
PLEGRIDY
also
contains
sodium
acetate
trihydrate,
glacial
acetic
acid,
L-arginine
hydrochloride, and polysorbate 20 in water for injections.
3
PHARMACEUTICAL FORM
Solution for injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
PLEGRIDY is indicated for the treatment of relapsing forms of Multiple
Sclerosis (MS) (see
Section 5.1).
4.2
D
OSE AND METHOD OF ADMINISTRATION
PLEGRIDY is administered subcutaneously using a single-use pre-filled
pen or single-use pre-
filled syringe.
The recommended dosage of PLEGRIDY is 125 micrograms injected
subcutaneously every
2 weeks.
Treatment initiation
It is generally recommended that patients start treatment with 63
micrograms at dose 1
(day 0), increasing to 94 micrograms at dose 2 (day 14), reaching the
full dose of 125
micrograms by dose 3 (day 28) and continuing with the full dose (125
micrograms) every 14
days (2 weeks) thereafter (see Table 1).
PLEGRIDY PI 210930 (bdpplgr11021)
2
TABLE 1: TITRATION SCHEDULE AT INITIATION
DOSE
TIME*
AMOUNT (MICROGRAMS)
PEN/SYRINGE LABEL
Dose 1
Day 0
63
Orange
Dose 2
Day 14
94
Blue
Dose 3
Day 28
125 (full dose)
Grey
*Dosed every 14 days (2 weeks)
A Titration Pack is available containing the 63 micrograms (dose 1,
orange label) and 94
micrograms (dose 2, blue label) syringes/pens.
It is recommended that a health care professional trains patients in
the proper technique for
self-adm
Read the complete document
