Elonva

Package leaflet: Information for the user

Elonva 100 micrograms solution for injection, 150 micrograms solution for injection

corifollitropin alfa
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms seem identical to yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Elonva is and what it is used for
2. What you need to know before using Elonva
3. How to use Elonva
4. Possible side effects
5. How to store Elonva
6. Contents of the pack and other information

1. What Elonva is and what it is used for

Elonva contains the active substance corifollitropin alfa and belongs to a group of medicines called gonadotropin hormones. Gonadotropin hormones play an important role in human fertility and reproduction. One of these gonadotropin hormones is Follicle-Stimulating Hormone (FSH), which is necessary in women for the growth and development of follicles (small round sacs in the ovaries that contain eggs), and in male adolescents (from 14 years of age onwards) for the treatment of pubertal delay due to hypogonadotropic hypogonadism (HH), in combination with a medicine called human chorionic gonadotropin (hCG).

In women
Elonva is used to help achieve pregnancy in women undergoing infertility treatment, such as in vitro fertilization (IVF). IVF involves removing eggs from the ovary, fertilizing them in the laboratory, and transferring the embryos into the uterus after a few days.
Elonva induces the growth and development of multiple follicles at the same time through controlled ovarian stimulation.

In male adolescents (from 14 years of age onwards)
Elonva is used to stimulate the development and function of the testes and to induce the development of male sexual characteristics in male adolescents with pubertal delay due to HH.

2. What you need to know before using Elonva

Do not use Elonva if:

• you are allergic (hypersensitive) to corifollitropin alfa or to any of the other ingredients of this medicine (listed in section 6)
• you have an ovarian, breast, uterine, or brain tumor (pituitary gland or hypothalamus)
• you have recently had unexpected vaginal bleeding other than menstrual bleeding, without a diagnosed cause
• you have ovaries that do not function due to a condition called primary ovarian dysfunction
• you have ovarian cysts or enlarged ovaries
• you have malformations of the reproductive organs that make a normal pregnancy impossible
• you have fibroid tumors in the uterus that make a normal pregnancy impossible
• you have risk factors for OHSS (OHSS is a serious medical condition that may occur when the ovaries are overstimulated. See below for further explanation): or you have polycystic ovary syndrome (PCOS), or you have a history of ovarian hyperstimulation syndrome (Ovarian Hyperstimulation Syndrome - OHSS), or you have previously undergone an ovarian stimulation treatment cycle that resulted in the growth of more than 30 follicles measuring 11 mm or larger, or you have a baseline antral follicle count (the number of small follicles present in the ovaries at the beginning of the menstrual cycle) greater than 20.

Warnings and precautions
Talk to your doctor before using Elonva.
Ovarian hyperstimulation syndrome (OHSS)
Treatment with gonadotropin hormones such as Elonva can cause ovarian hyperstimulation syndrome (OHSS). This is a serious medical condition in which the ovaries are overstimulated and follicular growth becomes greater than normal. In rare cases, severe OHSS can be life-threatening. Therefore, careful medical supervision is very important. To monitor the effects of treatment, your doctor will perform ovarian ultrasounds. Your doctor may also check hormone levels in your blood (see also section 4).
OHSS causes sudden accumulation of fluid in the abdomen and chest areas and may lead to blood clot formation. Call your doctor immediately if you experience:

• severe abdominal swelling and pain in the stomach area (abdomen)
• feeling unwell (nausea)
• vomiting
• sudden weight gain due to fluid accumulation
• diarrhea
• decreased urine output
• breathing difficulties

You may use Elonva only once during the same treatment cycle; otherwise, the risk of developing OHSS increases.
Before starting to use this medicine, inform your doctor if you have ever had ovarian hyperstimulation syndrome (OHSS).
Ovarian torsion
Ovarian torsion is the twisting of an ovary. Twisting of the ovary may interrupt blood flow to the ovary.
Before starting to use this medicine, inform your doctor if:

• you have ever had ovarian hyperstimulation syndrome (OHSS).
• you are pregnant or suspect you may be pregnant.
• you have ever had abdominal surgery.
• you have ever had ovarian torsion.
• you have had or currently have cysts in one or both ovaries.

Blood clots (Thrombosis)
Treatment with gonadotropin hormones such as Elonva may (as in pregnancy) increase the risk of developing 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 the lungs (pulmonary embolism)
• stroke
• heart attack
• problems with blood vessels (thrombophlebitis)
• reduced blood flow (deep vein thrombosis), which may lead to loss of an arm or leg.

Talk to your doctor before starting treatment, especially if:

• you know you already have a high risk of developing thrombosis
• you or anyone in your family has ever had a blood clot
• you are severely overweight.

Multiple births or congenital abnormalities
There is an increased chance of having twins or even more than two babies, even when only one embryo is transferred into the uterus. Multiple pregnancies carry higher risks for both mother and babies. Multiple pregnancies and specific characteristics of couples with fertility problems (e.g. woman's age, certain sperm issues, genetic history of both parents) may also be associated with an increased risk of birth defects.
Pregnancy complications
If treatment with Elonva results in pregnancy, there is an increased chance that the pregnancy will develop outside the uterus (ectopic pregnancy). Therefore, your doctor must perform an ultrasound examination first to rule out the possibility of an ectopic pregnancy.
Ovarian tumors and other reproductive system tumors
There have been reports of ovarian tumors and other reproductive system tumors in women who have undergone infertility treatment. It is not known whether fertility drug treatment increases the risk of these tumors in infertile women.
Other medical conditions
Additionally, before starting to use this medicine, inform your doctor if:

• you have kidney disease.
• you have uncontrolled pituitary gland or hypothalamic problems.
• you have an underactive thyroid gland (hypothyroidism).
• you have adrenal glands that do not function properly (adrenal insufficiency).
• you have high levels of prolactin in your blood (hyperprolactinemia).
• you have any other medical condition (e.g., diabetes, heart disease, or any other long-term illness).
• a doctor has told you that pregnancy could be dangerous for you.

Other medicines and Elonva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
If you perform a pregnancy test during infertility treatment with Elonva, the test may falsely indicate that you are pregnant. Your doctor will inform you about the appropriate time to take a pregnancy test. If you get a positive pregnancy test result, contact your doctor.
Pregnancy and breastfeeding
You must not use Elonva if you are pregnant, suspect you may be pregnant, or are breastfeeding with breast milk.
Ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
Elonva may cause dizziness. If you experience dizziness, you must not drive or operate machinery.
Elonva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per injection, i.e., essentially “sodium-free”.

3. How to use Elonva

Use Elonva exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

In women
Elonva is used in women undergoing infertility treatment, such as in vitro fertilization (IVF). During this treatment, Elonva is used in combination with a medicine called a GnRH antagonist to prevent the ovary from releasing an egg too early. Treatment with the GnRH antagonist usually starts 5 to 6 days after the Elonva injection.

The use of Elonva in combination with a GnRH agonist (another medicine used to prevent the ovary from releasing an egg too early) is not recommended.

In adolescent males (from 14 years of age onwards)
Elonva, in combination with a medicine called hCG, is used to treat delayed puberty due to HH. Elonva should be administered once every two weeks, on the morning of the same day of the week.

Dosage

Women
In the treatment of women of reproductive age, the dose of Elonva is based on body weight and age.

• A single dose of 100 micrograms is recommended for women with a body weight less than or equal to 60 kilograms and age less than or equal to 36 years.
• A single dose of 150 micrograms is recommended for women:
  • with body weight greater than 60 kilograms, regardless of age.
  • with body weight equal to or greater than 50 kilograms and age greater than 36 years.

Women over 36 years of age with body weight less than 50 kilograms have not been studied.

During the first seven days after injection with Elonva, you must not use follicle-stimulating hormone (recombinant) ((rec)FSH). Seven days after the Elonva injection, your doctor may decide to continue the stimulation cycle with another gonadotropic hormone, such as (rec)FSH. This may continue for several days until a sufficient number of follicles of the appropriate size are present, as monitored by ultrasound examination. Treatment with (rec)FSH is then stopped, and the eggs are matured by administering hCG (human chorionic gonadotropin). The eggs are retrieved from the ovary 34–36 hours later.

In male adolescents (from 14 years of age onwards)

The dose of Elonva is based on body weight:

For male adolescents weighing less than or equal to 60 kg:

• 100 micrograms of Elonva once every two weeks for 12 weeks, followed by administration of Elonva (once every two weeks) together with hCG. If body weight increases to more than 60 kg during treatment, the doctor may increase the dose of Elonva to 150 micrograms.

For male adolescents weighing more than 60 kg:

• 150 micrograms of Elonva once every two weeks for 12 weeks, followed by administration of Elonva (once every two weeks) together with hCG.

Combined therapy with hCG twice weekly (500–5,000 IU) may be required for 52 weeks or longer to achieve adult gonadal development.

How Elonva is administered

Treatment with Elonva must be supervised by a doctor experienced in treating fertility problems. Elonva must be injected under the skin (subcutaneously) into a skin fold (pinched between thumb and index finger), preferably just below the navel.

The injection may be administered by a healthcare professional (e.g., a nurse), by your partner, or by yourself, provided you carefully follow your doctor's instructions. Always use Elonva exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist. Step-by-step "instructions for use" are provided at the end of this leaflet.

Do not inject Elonva into a muscle.

Elonva is supplied in pre-filled syringes that have an automatic safety system designed to help prevent needle-stick injuries after use.

If you use more Elonva or (rec)FSH than you should

If you think you have used more Elonva or (rec)FSH than you should have, contact your doctor immediately.

If you forget to use Elonva

If you forget to inject Elonva on the day you were supposed to, contact your doctor immediately. Do not inject Elonva without first talking to your doctor.

If you have any doubts about using this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Serious side effects
A possible complication of treatment with gonadotropin hormones such as Elonva is unwanted overstimulation of the ovaries. The risk of this complication can be reduced by careful monitoring of the number of maturing follicles. Your doctor will perform ovarian ultrasounds to closely monitor the number of maturing follicles and may also check hormone levels in your blood. Early symptoms of ovarian overstimulation may include abdominal pain, feeling unwell, or diarrhoea. Ovarian overstimulation may progress to a medical condition called ovarian hyperstimulation syndrome (OHSS), which can be a serious medical problem. In severe cases, OHSS may lead to enlarged ovaries, accumulation of fluid in the abdomen and/or chest (which may cause weight gain due to fluid retention), or blood clots in blood vessels.
Contact your doctor immediately if you experience abdominal pain or any other symptoms of ovarian overstimulation, even if they occur several days after receiving the injection.
The likelihood of experiencing side effects is described according to the following categories:
Common (may affect up to 1 in 10 women)

• Ovarian hyperstimulation syndrome (OHSS)
• Pelvic pain
• Feeling unwell (nausea)
• Headache
• Pelvic discomfort
• Breast tenderness
• Tiredness (fatigue)

Uncommon (may affect up to 1 in 100 women)

• Twisting of an ovary (ovarian torsion)
• Increased liver enzymes
• Abortion
• Pain after egg retrieval
• Procedure-related pain
• Premature release of an egg (premature ovulation)
• Abdominal distension
• Vomiting
• Diarrhoea
• Constipation
• Back pain
• Breast pain
• Burning or pain at the injection site
• Irritability
• Mood swings
• Dizziness
• Hot flushes

Not known (frequency cannot be estimated from the available data)

• Allergic reactions (hypersensitivity reactions, both local and generalized, including rash).

Ectopic pregnancy (pregnancy outside the uterus) and multiple pregnancies have been reported.
These side effects are not considered related to the use of Elonva, but rather to Assisted Reproductive Techniques (ART) or to the subsequent pregnancy.
In rare cases, as with other gonadotropins, blood clots (thrombosis) forming within a blood vessel, detaching and travelling through the bloodstream to block another blood vessel (thromboembolism), have been associated with treatment using Elonva.
If you are a male adolescent
Side effects reported in male adolescents:
Common (may affect up to 1 in 10 male subjects)

• Vomiting
• Injection site pain
• Hot flushes

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Elonva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the carton after
"Exp." (expiry date). The expiry date refers to the last day of that month.
Storage by the pharmacist
Store in a refrigerator (2°C-8°C). Do not freeze.
Storage by the patient
There are two options:

1. Store in a refrigerator (2°C-8°C). Do not freeze.
2. Store at a temperature not exceeding 25°C for a period of no longer than one month. Note the date when you start storing the medicine outside the refrigerator and use it within one month from that date.

Keep the syringe in the carton to protect the medicine from light.
Do not use Elonva

• if it has been stored outside the refrigerator for more than one month.
• if it has been stored outside the refrigerator at a temperature above 25°C.
• if you notice that the solution is not clear.
• if you notice that the syringe or needle is damaged.

Do not dispose of an empty or unused syringe via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Elonva contains

• The active substance is corifollitropin alfa. Each pre-filled syringe of Elonva 100 microgram injectable solution contains 100 micrograms in 0.5 millilitres (mL) of injectable solution. Each pre-filled syringe of Elonva 150 microgram injectable solution contains 150 micrograms in 0.5 millilitres (mL) of injectable solution.
• The other components are: sodium citrate, sucrose, polysorbate 20, methionine and water for injections. The pH may have been adjusted with sodium hydroxide and/or hydrochloric acid.

Description of the appearance of Elonva and contents of the pack
Elonva is a clear, colourless aqueous injectable solution (injectable preparation) in a pre-filled syringe equipped with an automatic safety system that prevents needle-stick injuries after use.
The syringe is packaged together with a sterile injection needle. Each syringe contains 0.5 mL of solution.
Each single pack contains one pre-filled syringe.
Elonva is available in two strengths: 100 micrograms and 150 micrograms injectable solution.

Marketing Authorisation Holder and Manufacturer
N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Organon Belgium Organon Pharma B.V. Lithuania atstovybė
Tél/Tel: 0080066550123 (+32 2 2418100) Tel.: +370 52041693
[email protected] [email protected]

България Luxembourg/Luxemburg
Органон (И.А.) Б.В. - клон България Organon Belgium
Тел.: +359 2 806 3030 Tél/Tel: 0080066550123 (+32 2 2418100)
[email protected] [email protected]

Česká republika Magyarország
Organon Czech Republic s.r.o. Organon Hungary Kft.
Tel: +420 233 010 300 Tel.: +36 1 766 1963
[email protected] [email protected]

Danmark Malta
Organon Denmark ApS Organon Pharma B.V., Cyprus branch
Tlf: +45 4484 6800 Tel: +356 2277 8116
[email protected] [email protected]

Deutschland Nederland
Organon Healthcare GmbH N.V. Organon
Tel.: 0800 3384 726 (+49 (0) 89 2040022 10) Tel: 00800 66550123
[email protected] (+32 2 2418100)
[email protected]

Eesti Norge
Organon Pharma B.V. Estonian RO Organon Norway AS
Tel: +372 66 61 300 Tlf: +47 24 14 56 60
[email protected] [email protected]

Ελλάδα Österreich
BIANEΞ Α.Ε. Organon Austria GmbH
Τηλ: +30 210 80091 11 Tel: +43 (0) 1 263 28 65
[email protected] [email protected]

España Polska
Organon Salud, S.L. Organon Polska Sp. z o.o.
Tel: +34 91 591 12 79 Tel.: +48 22 105 50 01
[email protected] [email protected]

France Portugal
Organon France Organon Portugal, Sociedade Unipessoal Lda.
Tél: +33 (0) 1 57 77 32 00 Tel: +351 218705500
[email protected]

Hrvatska România
Organon Pharma d.o.o. Organon Biosciences S.R.L.
Tel: +385 1 638 4530 Tel: +40 21 527 29 90
[email protected] [email protected]

Ireland Slovenija
Organon Pharma (Ireland) Limited Organon Pharma B.V., Oss, podružnica
Tel: +353 15828260 Ljubljana
[email protected] Tel: +386 1 300 10 80
[email protected]

Ísland Slovenská republika
Vistor hf. Organon Slovakia s. r. o.
Sími: +354 535 7000 Tel: +421 2 44 88 98 88
[email protected]

Italia Suomi/Finland
Organon Italia S.r.l. Organon Finland Oy
Tel: +39 06 3336407 Puh/Tel: +358 (0) 29 170 3520
[email protected] [email protected]

Κύπρος Sverige
Organon Pharma B.V., Cyprus branch Organon Sweden AB
Τηλ : +357 22866730 Tel: +46 8 502 597 00
[email protected] [email protected]

Latvija United Kingdom (Northern Ireland)
Ārvalsts komersanta “Organon Pharma B.V.” Organon Pharma (Ireland) Limited
pārstāvniecība Tel: +353 15828260
Tel: +371 66968876 [email protected]
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu .

Instructions for use

Components of the Elonva syringe with needle

Preparation for injection

• Wash your hands with soap and water and dry them before using Elonva.
• Clean the injection site (the area just below the navel) with a disinfectant (for example, alcohol) to remove any bacteria from the surface.
• Clean an area of about 5 cm around the point where the needle will be inserted and allow the disinfectant to dry for at least one minute before proceeding.

• While waiting for the disinfectant to dry, break the label along the perforation and pull off the needle cap.
• Leave the protective needle cap on the needle itself.
• Place the protective cap (containing the needle) on a clean, dry surface while preparing the syringe.

• Hold the syringe with the grey cap facing upwards.
• Gently tap the syringe with your finger to allow any air bubbles to rise to the top.

• Keep the syringe facing upwards.
• Unscrew the syringe cap by turning it counterclockwise.

• Keep the syringe facing upwards.
  • Screw the protective needle cap (containing the needle) onto the syringe clockwise.

• Keep the syringe facing upwards.
• Remove the protective needle cap by pulling it straight upward and discard it.
• BE CAREFUL of the needle.

Injection

• Now hold the syringe between your index and middle fingers, keeping it facing upwards.
• Place your thumb on the plunger.
• Carefully press the plunger upward until you see a small drop of liquid at the tip of the needle.

• Pinch a fold of skin between your thumb and index finger.
• Insert the entire needle into the pinched skin at a 90-degree angle.
• Press the plunger GENTLY until it stops and keep it pressed.
• COUNT TO FIVE to ensure that all the solution is injected.

• Release your thumb from the plunger.
• The needle will automatically retract into the syringe and be permanently locked in place.