Elonva
Active Substance: corifollitropin alfa
Common Name: Corifollitropin
alfa (rch)
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about
ELONVA.
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 ELONVA against the benefits they expect it
will have for you.
If you have any concerns about using this medicine,
tell your doctor or pharmacist.
Keep this leaflet with the medicine. You may want to read it again.
What ELONVA is used for
ELONVA contains corifollitropin alfa, a medicine
belonging to the group of gonadotrophic hormones. These hormones play an
important part in human fertility and reproduction. One of these gonadotrophic
hormones is follicle-stimulating hormone (FSH), which is needed in women for
the growth and development of follicles (small round sacs in your ovaries that
contain the eggs).
ELONVA is especially designed to work much longer
than FSH. One single injection of ELONVA can replace a whole week of daily FSH
injections in women participating in in vitro fertilisation (IVF).
ELONVA is used to help achieve pregnancy in women
having infertility treatment, such as IVF. ELONVA causes the growth and development
of several follicles at the same time by controlled stimulation of the ovaries.
The eggs are collected from the ovary, fertilised in the laboratory and the
embryos are transferred into the uterus a few days later.
ELONVA is not addictive.
Ask your doctor if you have any questions about why
this medicine has been prescribed for you.
Before you use ELONVA
When you must not use it
Do not use ELONVA if you:
are allergic (hypersensitive) to
corifollitropin alfa or to any of the ingredients in ELONVA listed at the
end of this leaflet.are pregnant or think you may be
pregnant.are breastfeeding.have cancer of the ovary, breast,
uterus, or brain (pituitary gland or hypothalamus).have recently had unexpected vaginal
bleeding (other than periods) where the cause is unknown.have ovaries that do not work
because of a condition called primary ovarian failure.have ovarian cysts or enlarged
ovaries.have polycystic ovarian syndrome (PCOS).have had ovarian hyperstimulation
syndrome (OHSS). OHSS is a serious medical problem that can happen when
the ovaries are overly stimulated. See below for further explanation.have previously had a treatment
cycle of controlled stimulation of the ovaries that resulted in the growth
of more than 30 follicles with a size of 11 mm or larger.have a basal antral follicle count
(the number of small follicles present in your ovaries at the beginning of
your menstrual cycle) higher than 20.have malformations of the sexual
organs which make a normal pregnancy impossible.have fibroid tumours in the uterus
which make a normal pregnancy impossible.
Do not use ELONVA:
if the syringe or needle is damagedif the solution is not clearif the packaging is torn or shows
signs of tamperingafter the expiry date printed on the
pack has passed
If it has expired or is damaged, return it to your
pharmacist or clinic.
If you are not sure whether you should start using
ELONVA, talk to your doctor.
Before you start to use it
Take special care with ELONVA
Before starting to use this medicine, tell your
doctor if you:
have ever had ovarian
hyperstimulation syndrome (OHSS)are pregnant or think you might be
pregnanthave ever had stomach (abdominal)
surgeryhave ever had a twisting of an ovary
(ovarian torsion). Twisting of an ovary could cause the blood flow to the
ovary to be cut off.have past or current cysts in you
ovary or ovarieshave kidney diseasehave uncontrolled pituitary gland or
hypothalamic problemshave an underactive thyroid
(hypothyroidism)have adrenal glands that are not
working properly (adrenocortical insufficiency)have high prolactin levels in the
blood (hyperprolactinemia)have any other medical conditions
(for example, diabetes, heart disease, or any other long-term disease)have been told by a doctor that
pregnancy would be dangerous for you
Ovarian Hyperstimulation Syndrome (OHSS)
Treatment with gonadotrophic hormones like ELONVA may cause ovarian
hyperstimulation syndrome (OHSS). This is a serious medical condition where the
ovaries are overly stimulated and the growing follicles become larger than
normal.
OHSS causes fluid to build up suddenly in your
stomach and chest areas and can cause blood clots to form.
Call you doctor right away if you have:
severe abdominal swelling and pain
in the stomach area (abdomen)feeling sick (nausea)vomitingsudden weight gain due to fluid
build updiarrhoeadecreased urine outputtrouble breathing
In rare cases, severe OHSS may be life-threatening.
Therefore close supervision by your doctor is very important. To check the
effects of treatment, your doctor will do ultrasound scans of your ovaries.
Your doctor may also check blood hormone levels (see also Side Effects).
Use ELONVA only once during the same treatment
cycle otherwise the chance of having OHSS may increase.
Thrombosis (blood clot)
Treatment with gonadotrophic hormones like ELONVA may (as in pregnancy)
increase the risk of having a blood clot (thrombosis). Thrombosis is the
formation of a blood clot in a blood vessel.
Blood clots can cause serious medical conditions,
such as:
blockage in your lungs (pulmonary
embolus)strokeheart attackblood vessel problems
(thrombophlebitis)a lack of blood flow (deep venous
thrombosis) that may result in a loss of your arm or leg
Please discuss this with your doctor, before
starting treatment, especially if:
you know you already have an
increased chance of having a thrombosisyou, or anyone in your immediate
family, have ever had a thrombosisyou are severely overweight
Multiple pregnancies
In women having fertility treatment, the risk of multiple pregnancies (having
twins or even more than two babies) is mainly related to the number of embryos
transferred into the uterus.
Multiple pregnancies carry an increased health risk
for both the mother and her babies. Multiple pregnancies and specific
characteristics of couples with fertility problems (e.g. a woman's age, certain
sperm problems, genetic background of both parents) may also be associated with
an increased chance of birth defects.
Pregnancy complications
If treatment with ELONVA results in pregnancy, there is a higher chance of
pregnancy outside the uterus (an ectopic pregnancy). Therefore your doctor
should perform an early ultrasound examination to exclude the possibility of
pregnancy outside the uterus.
Ovarian and other reproductive system tumours
There have been reports of ovarian and other reproductive system tumours in
women who have had infertility treatment. It is not known if treatment with
fertility medicines increases the risk of these tumours in infertile women.
Taking other medicines
Tell your doctor if you are taking or have recently
taken any other medicines, including any that you get without a prescription
from your pharmacy, supermarket or health food shop.
How to use ELONVA
Follow all directions given to you by your doctor,
nurse or pharmacist carefully. You should check with your doctor or pharmacist
if you are not sure.
Treatment with ELONVA should be started under the
supervision of a specialist doctor experienced in fertility treatment.
How much to inject
In the treatment of women of reproductive age, the
dose of ELONVA is based on weight and age.
A single 100 - microgram dose is recommended in
women who weigh less than or equal to 60 kilograms and who are 36 years of age
or younger.
A single 150 - microgram dose is recommended in
women:
who weigh more than 60 kilograms,
regardless of age.who weigh 50 kilograms or more and
who are older than 36 years of age.
Women older than 36 years of age who weighed less
than 50 kilograms were not studied.
Your doctor will explain exactly when to give the
injection.
Your doctor may also give you other medication
(such as a GnRH antagonist) to prevent early release of eggs from your ovary.
Seven days after the injection of ELONVA, your
doctor may decide to continue your treatment cycle with another gonadotrophic
hormone, like follicle-stimulating hormone (FSH) medicine. This may be
continued for a few days until enough follicles of adequate size are present.
This can be checked by ultrasound examination. FSH treatment is then stopped and
the eggs are matured by giving hCG (human Chorionic Gonadotrophin). The eggs
are collected from the ovary 34-36 hours later.
How to inject
ELONVA must be injected under the skin
(subcutaneous) into a skin fold (that you pinch between your thumb and index
finger), preferably just below the navel.
Do not inject ELONVA into a muscle. The doctor or nurse may give you the
injection.
ELONVA can also be injected by yourself or by your
partner.
If the doctor decides you can give the injection
yourself, the doctor or nurse will teach you the injection technique.
A step-by-step "instructions for use" is
given at the end of this leaflet.
Do not attempt self-injection until you are sure of
how to do it. Your partner may be
trained to give the injection at home.
ELONVA is supplied in pre-filled syringes that have
an automatic safety system to help prevent needle stick injuries after use.
If you forget to inject ELONVA
Contact your doctor immediately if you forget to
inject ELONVA on the day you should have. Do not inject ELONVA without talking
to your doctor.
If you use too much (overdose)
Contact your doctor immediately if you think you
have used more ELONVA or additional medicines (for example,
follicle-stimulating hormone) that make your ovaries continue to grow mature
eggs.
While you are using ELONVA
Your doctor will carefully monitor your response
using ultrasound scans of your ovaries during treatment with ELONVA. Your
doctor may also check blood hormone levels.
Things you must do
See your doctor regularly so you can be monitored
closely throughout your treatment.
If you are about to be started on any new medicine,
tell your doctor and pharmacist that you are taking ELONVA.
If you plan to have surgery, tell your doctor or
dentist that you are using ELONVA.
Tell all doctors and dentists who are treating you
that you are using ELONVA.
Things you must not do
Be careful driving or operating machinery until you
know how ELONVA affects you. ELONVA
may cause dizziness. If you feel dizzy, you should not drive a car, operate
machinery or do anything else that could be dangerous.
Do not give your medicine to anyone else, even if
they have the same condition as you.
Side effects
Tell your doctor as soon as possible if you do not
feel well while you are taking ELONVA.
All medicines can have side effects. Sometimes they
are serious, most of the time they are not. You may need medical treatment if
you get some of the side effects.
Common (affects 1 to 10 users in 100):
Ovarian hyperstimulation syndrome
(OHSS)Pelvic painFeeling sick (nausea)HeadacheTiredness (fatigue)Pelvic discomfortBreast tenderness
Uncommon (affects 1 to 10 users in 1,000):
Ovarian torsion (twisting of the
ovary resulting in extreme lower stomach pain)Liver enzyme increasesMiscarriagePain after oocyte retrievalProcedural painReleasing an egg too early
(premature ovulation)Abdominal distensionVomitingDiarrhoeaConstipationBack painBreast painBruising or pain at the injection
siteIrritabilityMood swingsDizzinessHot flush
A possible complication of treatment with
gonadotrophic hormones like ELONVA is unwanted overstimulation of the ovaries.
The chance of having this complication can be
reduced by carefully monitoring the number of maturing follicles. Your doctor
will do ultrasound scans of your ovaries to carefully monitor the number of
maturing follicles. Your doctor may also check blood hormone levels.
The first symptoms of ovarian overstimulation may
be noticed as: pain in the stomach (abdomen), feeling sick or diarrhoea.
Ovarian overstimulation may develop into a serious
medical condition called ovarian hyperstimulation syndrome (OHSS). Signs and
symptoms of severe OHSS may include:
acute stomach pain, weight gain,
shortness of breath and passing less urine.in rare cases blood clots. Signs of
a blood clot include pain, warmth, redness, numbness or tingling in your
arm or leg.
Tell your doctor immediately or go to the accident
and emergency at your nearest hospital if you have stomach pains or any of the
other symptoms of ovarian hyperstimulation, even if they happen some days after
the injection has been given.
In general use there have been reports of allergic
reactions (hypersensitivity reactions, both local and generalised, including
rash).
The following side effects are considered to be
related to Assisted Reproductive Technology (ART) or subsequent pregnancy.
ectopic pregnancy (pregnancy that
occurs outside the uterus)multiple pregnancies
The incidence of congenital malformations (a
physical defect present in a baby at birth) after ART may be slightly higher
than after spontaneous conceptions. The slightly higher incidence is thought to
be due to differences in patients undergoing fertility treatment (e.g. age of
the female, sperm characteristics) and to the higher incidence of multiple
pregnancies after ART.
Tell your doctor if you notice anything that is
making you feel unwell.
Other side effects not listed above may occur in
some patients.
After using it
Storage
Store ELONVA in the refrigerator (2°C to 8°C) until
the expiry date. Do not freeze.
Do not use after the expiry date on the carton.
OR
Store at or below 25°C for a total period of not
more than one month. Make a note of when you start storing the product out of
the refrigerator, and use it within one month of that date.
Keep the syringe in the outer carton in order to
protect from light until you are ready to use it.
Keep ELONVA in a safe place away from the sight and
reach of children.
Do not use ELONVA:
If it has been stored out of the
refrigerator for more than one month.If it has been stored out of the
refrigerator at a temperature of more than 25°C.
Disposal
Do not dispose of an empty or unused syringe in
household waste.
Ask your pharmacist or doctor how to dispose of
medicines no longer required. These measures will help protect the environment.
Product description
What it looks like
ELONVA is a clear and colourless solution in a
pre-filled syringe for single use.
The syringe has an automatic safety system, which
prevents needle stick injuries after use.
One pre-filled syringe contains 100 micrograms or
150 micrograms of corifollitropin alfa in 0.5 mL.
ELONVA is available in packs containing 1
pre-filled syringe and a sterile injection needle.
Ingredients
Active ingredient
corifollitropin alfa (rch)
Inactive ingredients
sodium citratesucrosepolysorbate 20methioninewater for injectionssodium hydroxide and/or hydrochloric
acid for adjustment of pH.
ELONVA contains less than 1 mmol sodium (23 mg) per
injection, i.e. essentially "sodium-free".
Supplier
Merck Sharp & Dohme (Australia)
Pty Limited
Level 1, Building A
26TalaveraRoad
MacquarieParkNSW 2113
Australia
Merck Sharp & Dohme (New
Zealand) Limited
P O Box99851
Newmarket
Auckland1149
New Zealand
Australian Registration Numbers:
AUST R 160646 (100 mcg/0.5 mL)
AUST R 160645 (150 mcg/0.5 mL)
Date of preparation: 14 June 2017
Instructions for use
Components of the ELONVA syringe with needle
Preparing the injection
Wash your hands with soap and water
and dry them before you use ELONVA.
Swab the injection site (the area just below your belly button) with a
disinfectant (for example, alcohol) to remove any surface bacteria.
Clean about 5 cm around the point where the needle will go in and let the
disinfectant dry for at least one minute before proceeding.
While waiting for the disinfectant
to dry, break the label perforation and pull off the needle-cap.
Leave the needle shield on the needle.
Place the needle shield (containing the needle) on a clean dry surface,
while preparing the syringe.
Hold the syringe with the grey cap
pointing upwards.
Tap the syringe gently with your finger to help air bubbles rise to the
top.
Keep the syringe pointing upwards.
Unscrew the syringe cap counter-clockwise.
Keep the syringe pointing upwards.
Screw the needle shield (containing the needle) clockwise onto the
syringe.
Keep the syringe pointing upwards.
Remove the needle shield straight up and discard it.
BE CAREFUL with the needle.
Injecting
Now take the syringe between index
and middle finger in the upward position.
Place your thumb on the plunger.
Carefully push the plunger upwards until a tiny droplet appears at the tip
of the needle.
Pinch a fold of the skin between
thumb and index finger.
Insert the entire needle at an angle of 90 degrees into the fold of the
skin.
CAREFULLY press the plunger until it can not go further and hold the
plunger down
COUNT TO FIVE to ensure that all of the solution is injected.
Release your thumb from the plunger.
The needle will withdraw automatically into the syringe where it will be
locked permanently.
Published by MIMS October 2017
Consumers should be aware that the information
provided by the Consumer Medicines Information (CMI) search (CMI Search) is for
information purposes only and consumers should continue to obtain professional
advice from a qualified healthcare professional regarding any condition for
which they have searched for CMI. CMIs are provided by MIMS Australia. CMI is
supplied by the relevant pharmaceutical company for each consumer medical
product. All copyright and responsibility for CMI is that of the relevant pharmaceutical
company. MIMS Australia uses its best endeavours to ensure that at the time of
publishing, as indicated on the publishing date for each resource (e.g.
Published by MIMS/myDr January 2007), the CMI provided was complete to the best
of MIMS Australia's knowledge. The CMI and the CMI Search are not intended to
be used by consumers to diagnose, treat, cure or prevent any disease or for any
therapeutic purpose. Dr Me Pty Limited, its servants and agents shall not be
responsible for the continued currency of the CMI, or for any errors, omissions
or inaccuracies in the CMI and/or the CMI Search whether arising from
negligence or otherwise or from any other consequence arising there from.
