Prospecto: information for the user

Ovitrelle 250micrograms injectable solution in pre-filled syringe

coriogonadotropin alpha

Read this prospectus carefully before starting to use this medication, as 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 prescribed only to you, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section4.

1.What is Ovitrelle and for what it is used

2.What you need to know before starting to use Ovitrelle

3.How to use Ovitrelle

4.Possible adverse effects

5.Storage of Ovitrelle

6.Contents of the package and additional information

What is Ovitrelle

Ovitrelle contains a medication called “coriogonadotropin alfa”, manufactured in a laboratory using a special recombinant DNA technique. Coriogonadotropin alfa is similar to a hormone that is naturally found in the body called “chorionic gonadotropin”, which is involved in reproduction and fertility.

What is Ovitrelle used for

Ovitrelle is used in conjunction with other medications:

• To help develop and mature several follicles (each containing an egg) in women undergoing assisted reproductive techniques (a procedure that may help you become pregnant), such as “in vitro fertilization”. Other medications will first be given to trigger the growth of several follicles.
• To help release an egg from the ovary (induction of ovulation) in women who cannot produce eggs (“anovulation”) or produce very few (“oligovulation”). Other medications will first be given to develop and mature the follicles.

Do not use Ovitrelle

• if you are allergic to coriogonadotropin alfa or any of the other components of this medication (listed in section6),
• if you have a tumor in thehypothalamus or pituitary gland (both are parts of the brain),
• if you have large ovaries or large fluid-filled sacs within the ovaries (ovarian cysts) of unknown origin,
• if you have unexplained vaginal bleeding,
• if you have ovarian, uterine, or breast cancer,
• if you have severe inflammation of the veins or blood clots in the veins (active thromboembolic problems),
• if you have any condition that generally prevents a normal pregnancy, such as menopause or premature menopause (ovarian insufficiency), or genital malformations.

Do not use Ovitrelle if any of the above conditions apply. If you are unsure, consult your doctor before taking this medication.

Warnings and precautions

Before starting treatment, your fertility and that of your partner must be evaluated by a doctor who specializes in fertility treatment.

Ovarian Hyperstimulation Syndrome (OHSS)

This medication may increase the risk of developing OHSS. This occurs when the follicles develop too much and become large cysts.

If you experience pain in the lower abdomen, rapid weight gain, nausea, vomiting, or difficulty breathing, do not administer the Ovitrelle injection and consult your doctor immediately (see section4). If you develop OHSS, you may be advised not to have sex or to use a barrier method of contraception for at least four days.

The risk of OHSS decreases if you use the usual dose of Ovitrelle and are closely monitored throughout the treatment cycle (e.g., through blood tests to measure estradiol levels and ultrasound scans).

Multiple pregnancy and/or congenital anomalies

During the use of Ovitrelle, you have a higher risk of becoming pregnant with more than one baby at the same time (“multiple pregnancy”, usually twins) than if you conceive naturally. Multiple pregnancy can lead to complications for you and your babies. During assisted reproduction techniques, the risk of multiple pregnancy is related to your age and the quality and number of eggs fertilized or embryos implanted in your body. Multiple pregnancies and certain characteristics of couples with fertility problems (e.g., age) may also be related to an increased risk of congenital anomalies.

The risk of multiple pregnancies decreases if you are closely monitored throughout the treatment cycle (e.g., through blood tests to measure estradiol levels and ultrasound scans).

Ectopic pregnancy

You may develop an ectopic pregnancy in women with damage to the fallopian tubes (the tubes that transport the egg from the ovary to the uterus). Therefore, your doctor should perform an early ultrasound scan to rule out the possibility of an ectopic pregnancy.

Abortion

During assisted reproduction or ovarian stimulation to produce eggs, you have a higher risk of abortion than the average woman.

Blood clotting problems (thromboembolic episodes)

Consult your doctor before using Ovitrelle if you or a family member have ever had blood clots in the leg or lung, or a heart attack or stroke. You may be at a higher risk of severe blood clots or worsening existing clots when receiving Ovitrelle treatment.

Sexual organ tumors

There have been reports of tumors in the ovaries and other sexual organs, both benign and malignant, in women who have received various pharmacological treatments for infertility.

Pregnancy tests

If you take a pregnancy test with serum or urine after using Ovitrelle, and up to ten days later, you may get a false-positive result. If you are unsure, consult your doctor.

Children and adolescents

Ovitrelle should not be used in children and adolescents.

Other medications and Ovitrelle

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

Pregnancy and breastfeeding

Do not use Ovitrelle if you are pregnant or breastfeeding.

If you are pregnant or breastfeeding, consult your doctor before using this medication.

Driving and operating machinery

Ovitrelle is not expected to affect your ability to drive or operate machinery.

Ovitrelle contains sodium

This medication contains less than 1mmol of sodium (23mg) per dose; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

How much to use

• The recommended dose of Ovitrelle is 1 preloaded pen (250 micrograms/0.5 ml) in a single injection.
• Your doctor will explain exactly when you should administer the injection.

Use of this medication

• If you are going to administer Ovitrelle yourself, read carefully and follow the “Instructions for use” provided in the packaging.
• Ovitrelle is administered by subcutaneous injection.
• Each preloaded pen is for single use.
• Your doctor or nurse will teach you how to use the preloaded pen of Ovitrelle to administer the medication.

• Administer Ovitrelle as instructed by your doctor or nurse.
• After the injection, dispose of the used needle safely and dispose of the pen.

If you use more Ovitrelle than you should

The effects of an overdose of Ovitrelle are unknown; however, there is a possibility of ovarian hyperstimulation syndrome (OHSS), which is described in more detail in section 4.

If you forgot to use Ovitrelle

If you forgot to use Ovitrelle, contact your doctor as soon as possible.

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

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

If you notice any of the following serious side effects, stop using Ovitrelle and consult a doctor immediately, you may need urgent medical treatment:

• Allergic reactions such as rash, rapid or irregular heartbeat, swelling of the tongue or throat, sneezing, wheezing or severe breathing difficulty are very rare (may affect up to 1 in 10,000 people).
• Abdominal pain in the lower abdomen, abdominal distension or abdominal discomfort accompanied by nausea (feeling like vomiting) or vomiting may be symptoms of ovarian hyperstimulation syndrome (OHSS). This may indicate that the ovaries overreacted to the treatment and large ovarian cysts developed (see also in section 2 under “Ovarian hyperstimulation syndrome”). These episodes are frequent (may affect up to 1 in 10 people).
• OHSS can become severe with clearly enlarged ovaries, decreased urine production, weight gain, breathing difficulty and possible accumulation of fluid in the stomach or chest. These episodes are infrequent (may affect up to 1 in 100 people).
• Severe blood clotting complications (thromboembolic episodes), sometimes independent of OHSS, are very rare. These may cause chest pain, shortness of breath, stroke or heart attack (see also in section 2 under “Blood clotting problems”).

Other side effects

Frequent (may affect up to 1 in 10 people)

• Headache.
• Local reactions at the injection site, such as pain, redness or swelling.

Infrequent (may affect up to 1 in 100 people)

• Diarrhea.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label and on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Do not use Ovitrelle if you observe visible signs of deterioration, if the liquid contains particles or is not transparent.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Ovitrelle

• The active ingredient is recombinant DNA technology-produced coriogonadotropin alfa.
• Each preloaded pen contains 250 micrograms of coriogonadotropin alfa in 0.5 ml (equivalent to approximately 6,500 International Units, UI).
• The other components are mannitol, methionine, disodium dihydrogen phosphate dihydrate, sodium dihydrogen phosphate monohydrate, poloxamer 188, phosphoric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injectable preparations.

Appearance of the product and contents of the package

• Ovitrelle is presented as a transparent, colorless, or slightly yellowish liquid for injection in a preloaded pen.
• Each pen contains 0.5 ml of solution.
• It is supplied in packages of 1 preloaded pen and 2 injection needles (one spare).

Marketing Authorization Holder

Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, Netherlands

Manufacturer

Merck Serono S.p.A., Via delle Magnolie 15, 70026 Modugno (Bari), Italy.

Last revision date of this leaflet: 10/2021

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

INSTRUCTIONS FOR USE

Ovitrelle 250micrograms

Injectable solution in preloaded pen

Coriogonadotropin alfa

Index

Important information about the Ovitrelle preloaded pen

• Read the instructions for use and the leaflet before using the Ovitrelle preloaded pen.
• Always follow all the instructions in these instructions for use and the training provided by the healthcare professional, as they may be different from those received previously. This information will help avoid errors in treatment or infections from needlestick or glass breakage.
• The Ovitrelle preloaded pen is only for subcutaneous injection.
• The Ovitrelle preloaded pen is for single use only.
• Each package of the Ovitrelle preloaded pen contains one injection needle and one spare needle.
• Only use the Ovitrelle preloaded pen if the healthcare professional teaches you how to use it correctly.
• Store in the refrigerator.

Do not freeze.

Do not share the pen or needles with anyone else.

Do not use the Ovitrelle preloaded pen if it has fallen, or if the pen is cracked or damaged, as this may cause injury.

Familiarize yourself with the Ovitrelle preloaded pen

Step1 Assemble the materials

Step2 Prepare for injection

Step3 Attach the needle

Do not use the needle if it is damaged or expired or if the outer needle cap or needle cap is damaged or loose.

3.6Twist the outer needle cap onto the threaded connector of the needle on the Ovitrelle preloaded pen until you feel a slight resistance (Figure8).

Do not twist the needle too tightly, as it may be difficult to remove it after injection.

3.7Remove the outer needle cap by pulling it gently (Figure9).

3.8Leave it aside to use later (Figure10).

Do not dispose of the outer needle cap, as it will prevent needlestick injuries and infections when separating the needle from the pen.

3.9Hold the Ovitrelle preloaded pen with the needle pointing upwards (Figure11).

3.10Remove and dispose of the green protective cap from the needle (Figure12).

Do not re-cap the needle with the green protective cap, as this may cause needlestick injuries and infections.

3.11Examine the needle tip carefully for any droplets of liquid.

If you do not observe any droplet of liquid on the needle tip or nearby when using a new pen:

1.Twist the dose adjustment button gently forward until you see a point (?) in the dose information window (Figure14).

• You can twist the dose adjustment button backward if you have moved it beyond the point (?).

2.Hold the pen with the needle pointing upwards.

3.Gently tap the reservoir support (Figure15).

4.Pull the dose adjustment button all the way down. A droplet of liquid will appear on the needle tip (Figure16)*.

5.Check that thedose information windowindicates “0” (Figure17).

*Note: If you do not observe any liquid, you can start again from step 1 (in this section) only once. If no droplet of liquid appears the second time, contact the healthcare professional.

Step4 Select the 250 microgram dose

Step5 Inject the dose

Important:inject the dose as instructed by the healthcare professional.

Do not release the dose adjustment button until the needle is removed from the skin.

Step6 Remove the needle after injection

Step7 After injection

1. Check that the injection was complete:

If the dose information window indicates “0”, you have completed the dose.

If thedose information windowdoes notindicate “0”, contact the healthcare professional.

Do not attempt to administer the injection again.

Step8 Dispose of the Ovitrelle preloaded pen

Contact the healthcare professional if you have any questions.

Last revision date of these instructions for use: 11/2022