Prospecto: information for the user

Elonva 100micrograms injectable solution

Elonva 150micrograms injectable solution

corifolitropina alfa

Read this prospectus carefully before starting to use this medication, because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribedonlyto you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

• Ifyouexperienceadverse effects, consult your doctor or pharmacist,even if they do not appear in this prospectus. See section4.

1.What is Elonva and for what it is used

2.What you need to knowbefore starting to use Elonva

3.How to use Elonva

4.Possible adverse effects

5.Storage of Elonva

6.Contents of the package andadditional information

Elonva contains the active ingredient corifolitropina 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 needed in women for the growth and development of follicles (small round sacs in their ovaries that contain the eggs) and in adolescent males (14years 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 fertility treatment, such as in vitro fertilization (IVF). IVF includes the extraction of eggs from the ovary, fertilization of the eggs in the laboratory, and the transfer of the embryos to the uterus a few days later. Elonva causes the growth and development of several follicles at the same time through controlled stimulation of the ovaries.

In adolescent males(14years and older)

Elonva is used to induce the development and function of the testicles and to induce the development of male sexual characteristics in adolescent males with delayed puberty due to HH.

No use Elonva:

• If you are allergic (hypersensitive) to corifolitropina alfa or any of the other components of this medication (listed in section 6)
• If you have ovarian, breast, uterine, or brain cancer (hypophysis or hypothalamus)
• If you have recently experienced unexpected vaginal bleeding, not menstrual bleeding, due to undiagnosed causes
• If your ovaries do not function due to a disease called primary ovarian insufficiency
• If you have ovarian cysts or an increase in the size of your 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 (elOHSS is a serious clinical condition that can occur when the ovaries are overstimulated. It is explained in detail later in this prospectus):

• If you have polycystic ovary syndrome (PCOS)
• If you have had ovarian hyperstimulation syndrome (OHSS)
• If you have previously received a cycle of controlled ovarian stimulation treatment with a result of more than 30follicles with a size of 11mm 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

Consult your doctor before starting to use Elonva.

Ovarian Hyperstimulation Syndrome (OHSS)

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

OHSS causes sudden fluid accumulation in your stomach and in areas of your chest, which can cause blood clots to form. Inform your doctor immediately if you have:

• Severe abdominal bloating and pain in the stomach area (abdomen)
• Dizziness (nausea)
• Vomiting
• Sudden weight gain due to fluid accumulation
• Diarrhea
• Decreased urine output
• Difficulty breathing

You should only use Elonva once during the same treatment cycle, as the risk of OHSS may increase.

Before starting treatment with this medication, inform your doctor if you have ever had ovarian hyperstimulation syndrome (OHSS).

Ovarian Torsion

Ovarian torsion is the twisting of an ovary. The twisting of the ovary could cause a blockage of blood flow to the ovary.

Before starting to use this medication, inform your doctor if:

• You have ever had ovarian hyperstimulation syndrome (OHSS).
• You are pregnant or think you may be pregnant.
• You have had abdominal surgery.
• You have ever had ovarian torsion.
• You have cysts or have had cysts in your ovary or ovaries.

Blood Clots (Thrombosis)

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

Blood clots can cause serious diseases, such as:

• Obstruction in your lungs (pulmonary embolism)
• Stroke
• Heart attack
• Problems with blood vessels (thrombophlebitis)
• Lack of blood flow (deep vein thrombosis), which can cause the loss of your 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 any of your direct relatives have ever had thrombosis
• You have significant obesity.

Multiple Births or Birth Defects

There is an increased risk of having twins or even more babies, even when a single embryo is transferred to the uterus. Multiple pregnancies increase the risk for the health of both the mother and her babies. Multiple pregnancies and specific characteristics of infertile couples (such as the woman's age, certain semen problems, genetic backgrounds of both parents) may be associated with an increased probability of birth defects.

Complications in Pregnancy

If treatment with Elonva results in pregnancy, there is a higher risk of ectopic pregnancy. Therefore, your doctor should make an ultrasound scan at the beginning to rule out the possibility of 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 followed fertility treatment. It is not known if fertility treatment with medications increases the risk of these tumors in infertile women.

Other Diseases

Before starting to use this medication, inform your doctor if:

• You have kidney disease.
• You do not have controlled pituitary gland function or have hypothalamic problems.
• You have underactive thyroid gland (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 (such as diabetes, heart disease, or any other long-term disease).
• Your doctor has informed you that pregnancy would be dangerous for you.

Use of Elonva with Other Medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

Pregnancy and Breastfeeding

You should not use Elonva if you are already pregnant, or think you may be pregnant, or if you are breastfeeding.

Consult your doctor or pharmacist before using this medication.

Driving and Operating Machines

Elonva may cause dizziness. If you feel dizzy, do not drive or operate machines.

Elonva Contains Sodium

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

Follow exactly the administration instructions for Elonva indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

In women

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

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

In adolescent males (14 years and older)

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

Dose

Women

The dose of Elonva for women in fertile age depends on weight and age.

• A single dose of 100 micrograms is recommended in women whose weight is less than or equal to 60 kilograms and whose age is up to 36 years inclusive.

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

• whose weight is greater than 60 kilograms, regardless of age.
• from 50 kilograms of weight and older than 36 years of age.

No studies have been conducted in women over 36 years of age whose weight is less than 50 kilograms.

During the first seven days after the Elonva injection, do 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 gonadotropin hormone, such as FSH(rec). This can be continued for a few days until there are enough follicles of suitable size. This can be checked by ultrasound. Then the treatment with FSH(rec) is interrupted and the eggs mature by administering hCG (human chorionic gonadotropin). The eggs are extracted from the ovary 34-36 hours later.

In adolescent males (14 years and older)

The dose of Elonva depends on body weight:

For adolescent males with a body weight of 60 kg or less

• 100 micrograms of Elonva once every two weeks for 12 weeks, followed by the administration of Elonva (once every 2 weeks) with hCG. If during treatment your body weight increases to more than 60 kg, your doctor may increase your Elonva dose to 150 micrograms.

For adolescent males with a body weight of more than 60 kg

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

Combined therapy with hCG twice a week (500 – 5000 UI) may be necessary for 52 weeks or more to achieve adult gonadal development.

How to administer Elonva

Elonva treatment should be supervised by a doctor with experience in treating fertility problems. Elonva should be injected under the skin (subcutaneously) in a skin fold (pinching with your thumb and index finger), preferably just below the navel. You may administer the injection yourself, your partner, or a healthcare professional (such as a nurse), as long as your doctor has taught you carefully.

Always use Elonva as your doctor has instructed. Consult your doctor or pharmacist if you are unsure. At the end of this leaflet, there are "instructions for use" step-by-step.

Do not inject Elonva into the muscle.

Elonva is presented in pre-filled syringes with an automatic safety system that helps to 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 forgot to use Elonva

If you forgot to inject Elonva on the day you should have, inform your doctor immediately. Do not inject Elonva without consulting your doctor.

If you have any other questions about the use of this medication, ask your doctor.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Severe side effects

A possible complication of treatment with gonadotropin hormones such as Elonva is unwanted ovarian overstimulation. The likelihood of experiencing this complication can be reduced by a meticulous control of the number of mature follicles. Your doctor will perform ultrasound of your ovaries to meticulously control the number of mature follicles. Your doctor may also check hormone levels in your blood. The first symptoms of ovarian overstimulation may be noted as stomach pain (abdomen), dizziness, or diarrhea. Ovarian overstimulation may trigger a condition called ovarian hyperstimulation syndrome (OHSS), which can be a serious clinical problem. In more severe cases, it may cause an increase in the size of the ovaries, accumulation of fluid in the abdomen and/or chest (which may cause a sudden increase in weight due to fluid accumulation) or blood clots in the blood vessels.

Inform your doctor immediately if you experience stomach pain (abdomen) or any other symptoms of ovarian hyperstimulation, even if they occur a few days after the injection.

The likelihood of experiencing a side effect is classified in the following categories:

Frequent (may affect up to1in every10women)

-Ovarian hyperstimulation syndrome (OHSS)

-Pelvic pain

-Dizziness (nausea)

-Headache

-Pelvic discomfort

-Breast tenderness

-Fatigue (tiredness)

Less frequent (may affect up to1 in every100women)

-Ovarian torsion (twisting of an ovary)

-Increased liver enzymes

-Spontaneous abortion

-Pain after recovery of the oocytes

-Procedure-related pain

-Premature ovulation (ovulation too soon)

-Abdominal distension

-Vomiting

-Diarrhea

-Constipation

-Back pain

-Breast pain

-Swelling or pain at the injection site

-Irritability

-Mood changes

-Dizziness

-Hot flashes

Unknown frequency (cannot be estimated from available data)

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

Also, ectopic pregnancies (pregnancies outside the uterus) and multiple pregnancies have been reported. These side effects are not considered related to the use of Elonva, but to Assisted Reproductive Techniques (ART) or a subsequent pregnancy.

In rare cases, blood clots (thrombosis) have been associated with Elonva therapy, as well as with other gonadotropins, which form inside a blood vessel and may break and travel through the bloodstream to block another blood vessel (thromboembolism).

If you are a male adolescent

Side effects reported in male adolescents:

Frequent (may affect up to1in every10men)

• Vomiting
• Pain at the injection site
• Hot flashes

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after “CAD” or “EXP” (expiration date). The expiration date is the last day of the month indicated.

Conservation by the pharmacist

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

Conservation 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 equal to or less than 25°C for a period not exceeding one month. Note the date on which you started storing the medication outside of the refrigerator, and use it within one month from that date.

Store the syringe in the outer packaging to protect it from light.

Do not use Elonva

• If it has been stored outside of the refrigerator for more than one month.
• If it has been stored outside of the refrigerator at a temperature greater than 25°C.
• If you observe that the solution is not transparent.
• If you notice that the syringe or needle are damaged.

Used or unused syringes should not be thrown away through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Elonva

• The active principle is corifolitropina alfa. Each pre-filled syringe of Elonva 100micrograms injectable solution contains 100micrograms in 0.5milliliters (ml) of injectable solution. Each pre-filled syringe of Elonva 150micrograms injectable solution contains 150micrograms in 0.5milliliters (ml) of injectable solution.
• The other components are: sodium citrate, sucrose, polisorbate 20, methionine, and water for injectable preparations. The pH may have been adjusted with sodium hydroxide and/or hydrochloric acid.

Appearance of the product and contents of the package

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

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

Elonva is available in two doses: 100micrograms and 150micrograms injectable solution.

Marketing authorization holder and manufacturer

N.V. Organon

Kloosterstraat 6

5349AB Oss

Netherlands

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:MM/AAAA

Other sources of information

The detailed information about 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