Elonva 150 micrograms solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Elonva 100 micrograms solution for injection

Elonva 150 micrograms solution for injection

corifollitropin alfa

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the 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 gonadotrophic hormones. Gonadotrophic hormones play an important role in fertility and human reproduction. One of these gonadotrophic hormones is Follicle-Stimulating Hormone (FSH), which is required in women for the growth and development of follicles (small, round sacs in their ovaries that contain the eggs) and in adolescent males (14 years of age and older) for the treatment of delayed puberty 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 the eggs in the laboratory, and transferring the embryos into the uterus a few days later. Elonva stimulates the growth and development of multiple follicles simultaneously through controlled ovarian stimulation.

In adolescent males (14 years of age and older)

Elonva is used to stimulate the development and function of the testes and to induce the development of male sexual characteristics in adolescent males with delayed puberty 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 any of the other ingredients of this medicine (listed in section 6)

• if you have cancer of the ovary, breast, uterus, or brain (pituitary or hypothalamus)

• if you have recently had unexpected vaginal bleeding not related to menstruation, due to causes that have not been diagnosed

• if your ovaries do not function due to a condition called primary ovarian insufficiency

• if you have ovarian cysts or enlarged ovaries

• if you have malformations of the reproductive organs that make normal pregnancy impossible

• if you have uterine fibroids that make normal pregnancy impossible

• if you have risk factors for OHSS (OHSS is a serious clinical condition that may occur when the ovaries are overstimulated. It is explained in detail later in this leaflet):

• if you have polycystic ovary syndrome (PCOS)

• if you have previously had ovarian hyperstimulation syndrome (OHSS)

• if you have previously undergone a controlled ovarian stimulation treatment cycle resulting in the growth of more than 30 follicles measuring 11 mm or larger

• if your baseline antral follicle count (number of small follicles present in your ovaries at the beginning of the menstrual cycle) is greater than 20

Warnings and precautions

Talk to your doctor before starting to use Elonva.

Ovarian hyperstimulation syndrome (OHSS)

Treatment with gonadotropin hormones such as Elonva may cause ovarian hyperstimulation syndrome (OHSS). This is a serious condition in which the ovaries become overstimulated and the growing follicles become larger than normal. In rare cases, severe OHSS can be potentially life-threatening. Therefore, close medical monitoring is very important. To monitor the effects of treatment, your doctor will perform ultrasound scans of your ovaries. Your doctor may also check hormone levels in your blood. (See also section 4.)

OHSS may cause sudden accumulation of fluid in your abdomen and chest areas, which can lead to blood clot formation. Inform your doctor immediately if you experience:

• severe abdominal swelling and pain in the stomach area (abdomen)
• dizziness (nausea)
• vomiting
• sudden weight gain due to fluid accumulation
• diarrhea
• reduced volume of urine
• difficulty breathing

Elonva should only be used once during the same treatment cycle, as otherwise the risk of developing OHSS may increase.

Before starting treatment with 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 cut off the blood supply 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 think you might be pregnant.
• you have ever had surgery in the abdominal area (abdominal surgery).
• you have ever had torsion of an ovary.
• you have cysts or have previously had cysts in your ovary or ovaries.

Blood clots (Thrombosis)

Treatment with gonadotropin hormones such as Elonva may (as in pregnancy) increase the risk of blood clots (thrombosis). Thrombosis is the formation of a blood clot in a blood vessel.

Blood clots can lead to serious conditions such as:

• blockage in your lungs (pulmonary embolism)
• stroke
• heart attack
• blood vessel problems (thrombophlebitis)
• lack of blood flow (deep vein thrombosis), which may result in loss of an arm or leg.

Discuss this with your doctor before starting treatment, especially if:

• you already know you have an increased risk of thrombosis
• you or a close family member has ever had thrombosis
• you have significant overweight.

Multiple births or birth defects

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 increase the health risks for both mother and babies. Multiple pregnancies and specific characteristics of infertile couples (e.g., the woman's age, certain semen problems, genetic history of both parents) may be associated with an increased likelihood of birth defects.

Pregnancy complications

If treatment with Elonva results in pregnancy, there is a higher chance of ectopic pregnancy (pregnancy outside the uterus). Therefore, your doctor should perform an ultrasound early in pregnancy to rule out ectopic pregnancy.

Ovarian tumors and other reproductive system tumors

Cases of ovarian tumors and other reproductive system tumors have been reported in women who have undergone infertility treatment. It is not known whether fertility medication treatment increases the risk of these tumors in infertile women.

Other diseases

Additionally, before starting to use this medicine, inform your doctor if:

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

Using Elonva with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

If you take a pregnancy test during your infertility treatment with Elonva, the test may incorrectly indicate that you are pregnant. Your doctor will advise you on when to start taking pregnancy tests. If you have a positive pregnancy test, inform your doctor.

Pregnancy and breastfeeding

You must not use Elonva if you are already pregnant, think you might be pregnant, or are breastfeeding.

Consult your doctor or pharmacist before using this medicine.

Driving and using machines

Elonva may cause dizziness. If you feel dizzy, you should not drive or operate machinery.

Elonva contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per injection; essentially, it is "sodium-free".

3. How to use Elonva

Follow exactly the administration instructions for Elonva provided by your doctor. If in doubt, consult your doctor or pharmacist again.

In women

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

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

In adolescent males (14 years and older)

Elonva, in combination with a medication called hCG, is used to treat delayed puberty due to HH. Elonva should be administered once every two weeks, in the morning, on the same day of the week.

Dosage

Women

In the treatment of women of reproductive age, the dose of Elonva depends on body weight and age.

• A single dose of 100 micrograms is recommended for women whose weight is less than or equal to 60 kilograms and who are aged up to and including 36 years.

• A single dose of 150 micrograms is recommended for women:

• whose weight is greater than 60 kilograms, regardless of age.

• who weigh 50 kilograms or more and are older than 36 years of age.

Studies have not been conducted in women over 36 years of age who weigh less than 50 kilograms.

During the first seven days after the injection of Elonva, you must not use recombinant Follicle Stimulating Hormone (FSH(rec)). Seven days after the Elonva injection, your doctor may decide to continue the stimulation cycle with another gonadotrophin hormone, such as FSH(rec). This may continue for several days until there are enough follicles of an appropriate size, which can be checked by ultrasound. Then, treatment with FSH(rec) is stopped, and the eggs mature following administration of hCG (human Chorionic Gonadotropin). The eggs are retrieved from the ovary 34–36 hours later.

In adolescent males (14 years of age and older)

The dose of Elonva depends on body weight:

For adolescent males with body weight 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 2 weeks) together with hCG. If during treatment your body weight increases to more than 60 kg, your doctor may increase your dose of Elonva to 150 micrograms.

For adolescent males with body weight greater than 60 kg

• 150 micrograms of Elonva once every two weeks for 12 weeks, followed by administration of Elonva (once every 2 weeks) together with hCG.

Combined therapy with hCG (500–5000 IU) twice weekly 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 physician experienced in the treatment of fertility disorders. Elonva must be injected under the skin (subcutaneously) into a skin fold (pinched with your thumb and index finger), preferably just below the navel. The injection may be administered by a healthcare professional (e.g., a nurse), your partner, or by yourself, provided your doctor has carefully instructed you. Always use Elonva exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. Step-by-step “instructions for use” are provided at the end of this leaflet.

Do not inject Elonva into the muscle.

Elonva is supplied in prefilled syringes that have an automatic safety system designed to help prevent needlestick injuries after use.

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

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

If you forget to use Elonva

If you forget to inject Elonva on the day you were supposed to, inform your doctor immediately. Do not inject Elonva without consulting your doctor.

If you have any further questions about the use of this medicine, ask your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

A potential complication of treatment with gonadotrophic hormones such as Elonva is unwanted overstimulation of the ovaries. The likelihood of this complication can be reduced by careful monitoring of the number of mature follicles. Your doctor will perform ultrasounds of your ovaries to closely monitor the number of mature follicles. Your doctor may also check hormone levels in your blood. Early symptoms of ovarian overstimulation may include abdominal pain, dizziness, or diarrhea. Ovarian overstimulation may trigger a condition called ovarian hyperstimulation syndrome (OHSS), which can be a serious clinical condition. In more severe cases, it may lead to enlarged ovaries, accumulation of fluid in the abdomen and/or chest (which may cause sudden 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 hyperstimulation, even if they occur several days after receiving the injection.

The likelihood of experiencing an adverse effect is classified into the following categories:

Frequent (may affect up to 1 in 10 women)

• Ovarian hyperstimulation syndrome (OHSS)
• Pelvic pain
• Dizziness (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
• Spontaneous abortion
• Pain after oocyte retrieval
• Procedure-related pain
• Premature release of the egg (premature ovulation)
• Abdominal distension
• Vomiting
• Diarrhea
• Constipation
• Back pain
• Breast pain
• Bruising or pain at the injection site
• Irritability
• Mood changes
• Dizziness
• Hot flushes

Frequency not known (cannot be estimated from available data)

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

Ectopic pregnancies (pregnancies outside the uterus) and multiple pregnancies have also been reported. These adverse 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, blood clots (thrombosis) forming within a blood vessel have been associated with Elonva therapy, as well as with other gonadotropins. These clots may break loose and travel through the bloodstream, blocking another blood vessel (thromboembolism).

If you are an adolescent male

Adverse effects reported in adolescent males:

Frequent (may affect up to 1 in 10 males)

• Vomiting
• Pain at the injection site
• Hot flushes

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Elonva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after "CAD" or "EXP" (expiry date). The expiry date refers to the last day of the month indicated.

Storage by the pharmacist

Store in the refrigerator (between 2°C and 8°C). Do not freeze.

Storage by the patient

There are two options:

1. Store in the refrigerator (between 2°C and 8°C). Do not freeze.
2. Store at a temperature not exceeding 25°C for a maximum period of one month. Record the date on which you started storing the medicine outside the refrigerator, and use it within one month from that date.

Keep the syringe in the outer packaging to protect it 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.

Empty or unused syringes must not be disposed of down drains or in household waste. Ask your pharmacist how to dispose of any packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Elonva

• The active substance is corifollitropin alfa. Each pre-filled syringe of Elonva 100 micrograms solution for injection contains 100 micrograms in 0.5 millilitres (ml) of solution for injection. Each pre-filled syringe of Elonva 150 micrograms solution for injection contains 150 micrograms in 0.5 ml of solution for injection.
• 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.

Nature of the product and contents of the pack

Elonva is a clear, colourless, aqueous injectable solution in a pre-filled syringe with an automatic safety system that prevents needlestick injuries after use. The syringe is supplied with a sterile injection needle. Each syringe contains 0.5 ml of solution.

The pre-filled syringe is presented in an individual pack.

Elonva is available in two strengths: 100 micrograms and 150 micrograms solution for injection.

Marketing Authorization 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 Authorization Holder:

Date of the most recent review of this leaflet: MM/YYYY

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Instructions for use

Components of the Elonva syringe and needle