REKOVELLE follitropin delta (rhu) 12 microgram/0.36 mL solution for injection pre-filled multidose pen

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

follitropin delta, Quantity: 12 microgram

Available from:

Ferring Pharmaceuticals Pty Ltd

INN (International Name):

follitropin delta

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: phenol; methionine; sodium sulfate decahydrate; dibasic sodium phosphate dodecahydrate; polysorbate 20; phosphoric acid; sodium hydroxide; water for injections

Administration route:

Subcutaneous

Units in package:

Pack of 1 pre-filled multidose pen and 3 needles

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.

Product summary:

Visual Identification: REKOVELLE solution for injection is a sterile aqueous solution supplied in colourless cartridges. It is intended to be used for subcutaneous administration with the REKOVELLE pre-filled pen.; 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:

2017-09-21

Patient Information leaflet

REKOVELLE
®
_SOLUTION FOR INJECTION IN A PRE-FILLED PEN_
_follitropin delta (rhu)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about REKOVELLE. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using REKOVELLE
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 WITH THE MEDICINE.
You may need to read it again.
WHAT REKOVELLE IS
USED FOR
REKOVELLE contains follitropin
delta, which is a recombinant human
follicle-stimulating hormone (FSH)
produced in a human cell line
(PER.C6
®
) by recombinant DNA
technology.
REKOVELLE belongs to a class of
hormones called gonadotropins. FSH
is necessary for the growth and
development of egg sacs (follicles) in
women.
This medicine is used for controlled
ovarian stimulation for the
development of multiple follicles in
women undergoing assisted
reproductive technologies (ART)
such as an in vitro fertilisation (IVF)
or intracytoplasmic sperm injection
(ICSI) cycle.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
It is available only with a doctor's
prescription.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
BEFORE YOU USE
REKOVELLE
_WHEN YOU MUST NOT USE IT_
DO NOT USE REKOVELLE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing the
active substance
•
any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty
breathing
•
swelling of the face, lips,
tongue or other parts of the
body
•
rash, itching or hives on the
skin.
DO NOT USE REKOVELLE IF ANY OF
THE FOLLOWING APPLY TO YOU:
•
tumours

Summary of Product characteristics

#45403-v3G
AUSTRALIAN PI - REKOVELLE
® (FOLLITROPIN DELTA*) SOLUTION FOR
INJECTION PRE-FILLED MULTIDOSE PEN
1 NAME OF THE MEDICINE
Follitropin delta*
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
*Follitropin delta (rhu) is a recombinant human follicle-stimulating
hormone (FSH)
produced in a human cell line (PER.C6
®
) by recombinant DNA technology
REKOVELLE 12 micrograms: contains 12 micrograms follitropin delta
(rhu) in 0.36
mL. One pre-filled multidose pen contains 12 micrograms follitropin
delta (rhu)* in
0.36 mL solution
REKOVELLE 36 micrograms: contains 36 micrograms follitropin delta
(rhu) in 1.08
mL. One pre-filled multidose pen contains 36 micrograms follitropin
delta (rhu)* in
1.08 mL solution
REKOVELLE 72 micrograms: contains 72 micrograms follitropin delta
(rhu) in 2.16
mL. One pre-filled multidose pen contains 72 micrograms follitropin
delta (rhu)* in
2.16 mL solution
Each mL of the solution contains 33.3 micrograms of follitropin delta
(rhu).
This medicinal product contains less than 1 mmol (23 mg) sodium per
dose.
REKOVELLE (follitropin delta) solution for injection includes the
following excipients:
phenol, polysorbate 20, methionine, sodium sulfate, dibasic sodium
phosphate
dodecahydrate, phosphoric acid (for pH adjustment), sodium hydroxide
(for pH
adjustment) and water for injections.
3 PHARMACEUTICAL FORM
Follitropin delta is a recombinant human follicle-stimulating hormone
(FSH) produced
in a human cell line (PER.C6
®
) by recombinant DNA technology.
The average molecular weights of the glycosylated α and β subunits
are
approximately 15,200 and 18,500 Daltons (Da), respectively. Thus,
approximately
40% of the total molecular weight of the molecule is due to
glycosylation. No animal-
derived materials are used in the REKOVELLE manufacturing processes.
Solution for injection in a pre-filled multidose pen with injection
needles.
Clear and colourless solution. The pH of the solution is 6.0–7.0.
#45403-v3G
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Controlled ovarian stimulation for th