AFOLIA follitropin alfa (rch) 300 IU/0.5 mL (22 microgram) solution for injection cartridge in a pre-filled pen

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Follitropin alfa, Quantity: 300 IU

Available from:

Gedeon Richter Australia Pty Ltd

INN (International Name):

Follitropin alfa

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: poloxamer; sucrose; dibasic sodium phosphate dihydrate; monobasic sodium phosphate dihydrate; methionine; phosphoric acid; thymidine; Trypsin

Administration route:

Subcutaneous

Units in package:

5, 10, 1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

In adult women:,- Afolia is indicated for the treatment of anovulatory infertility in women who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated,- Controlled ovarian hyperstimulation in women undergoing assisted reproductive technologies,- Afolia in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level <1.2 IU/L.,In adult men:,- Afolia is indicated with concomitant human chorionic gonadotrophin (hCG) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hCG alone is ineffective.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Cartridge; 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:

2015-11-27

Patient Information leaflet

Consumer Medicine Information
Afolia
Gedeon Richter
November 2022
1
AFOLIA®
_Recombinant human follicle stimulating hormone (follitropin alfa
[rch]) _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Afolia.
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 using
Afolia against the benefits it is
expected to have for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE, ASK
YOUR DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS INFORMATION WITH
YOUR MEDICINE.
You may need to read it again
later.
WHAT IS AFOLIA USED FOR
Afolia contains follitropin alfa,
which is similar to follicle
stimulating hormone (FSH)
found naturally in humans.
Afolia belongs to a class of
hormones called
gonadotrophins. FSH is
necessary for the growth and
development of egg cells
(follicles) in women, and sperm
production in men.
Afolia is an approved biosimilar
to the reference product
Gonal-f®.
Comparability in safety,
efficacy and quality between
Afolia and Gonal-f® have been
established.
IN WOMEN
Afolia can be used to bring
about the development of
follicles in women who are not
ovulating and who have not
responded to treatment with
clomiphene citrate.
Afolia is also used to stimulate
the development of several
follicles in women undergoing
assisted reproductive
technologies (ART) such as _in _
_vitro _fertilisation (IVF).
Afolia can be used together
with another hormone called
Luteinising Hormone (LH) to
stimulate development of
follicles in women who have
been shown to produce very
low levels of some of the
hormones involved in the
natural reproductive cycle.
IN MEN
Afolia is used in combination
with human chorionic
gonadotrophin (hCG) to
stimulate the production of
sperm.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
AFOLIA HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have
prescribed it for another
reason.
Afolia is availa

Summary of Product characteristics

GEDEON RICHTER
AUSTR 262645, AUSTR 262646, AUSTR 262647, AUSTR 262648, AUSTR 262649
Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION
AFOLIA (FOLLITROPIN ALFA (RCH)) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
follitropin alfa, (rch)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
AFOLIA is a biosimilar medicinal product, i.e. a medicine that has
been demonstrated to be similar in
quality, safety and efficacy to the reference medicinal product
GONAL-f®.
AFOLIA contains the active ingredient follitropin alfa (rch). This is
produced by a Chinese Hamster
Ovary cell line transfected with the human FSH subunit genes (i.e. by
recombinant DNA technology).
Clear glass cartridges containing AFOLIA solution for injection are
designed for subcutaneous
injection pre-assembled in a disposable pen. AFOLIA is available as
solution for injection, containing
follitropin alfa (rch) 75 IU/0.125 mL (5.5 micrograms/0.125 mL), 150
IU/0.25 mL (11
micrograms/0.25 mL), 225 IU/0.375 mL (16.5 micrograms/0.375 mL), 300
IU/0.5 mL (22
micrograms/0.5 mL) or 450 IU/0.75 mL (33 micrograms/0.75 mL) in
pre-filled pens.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
AFOLIA is a clear, colourless solution for injection for subcutaneous
injection pre-assembled in a
disposable pen.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In adult women:
•
AFOLIA is indicated for the treatment of anovulatory infertility in
women who have been
unresponsive to clomiphene citrate or where clomiphene citrate is
contraindicated.
•
Controlled ovarian hyperstimulation in women undergoing assisted
reproductive
Technologies
•
AFOLIA in association with a luteinising hormone (LH) preparation is
recommended for the
stimulation of follicular development in women with severe LH and FSH
deficiency. In clinical
trials these patients were defined by an endogenous serum LH level
<1.2 IU/l.
In adult men:
•
AFOLIA is indicated with concomitant human chorionic gonadotrophin
(hCG) therapy for the
stimulation of spermatogenesis in gonado