Prospecto: information for the user

REKOVELLE 12micrograms/0.36ml

Injectable solution in preloaded pen

Follitropin delta

Read this prospectus carefully before starting to use the 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.
• Ifyouexperienceadverse effects,consult your doctor, or pharmacist,eveniftheydo not appearin this prospectus. See section4.

1. What isREKOVELLEand for what it is used

2. What you need to know beforeusingREKOVELLE

3. How to useREKOVELLE

4. Possible adverse effects

5. Storage ofREKOVELLE

6. Contents of the package and additional information

REKOVELLE contains follitropin delta, a follicle-stimulating hormone that belongs to the family of hormones called gonadotropins. Gonadotropins are involved in reproduction and fertility.

REKOVELLE is used in the treatment of female infertility and in women undergoing assisted reproductive techniques such as in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI). REKOVELLE stimulates the ovaries to grow and develop numerous sacs (‘follicles’), from which eggs are obtained that are fertilized in the laboratory.

Before starting treatment with this medication, a doctor must evaluate you and your partner to examine the possible causes of infertility.

Do not use REKOVELLE

• if you are allergic to follicle-stimulating hormone or any of the other components of this medication (listed in section 6)
• if you have a tumor in the uterus, ovaries, breasts, pituitary gland, or hypothalamus
• if you have ovarian enlargement or unexplained ovarian cysts not caused by polycystic ovary syndrome
• if you have unexplained vaginal bleeding
• if you have premature menopause
• if you have malformations in the reproductive organs that make a normal pregnancy impossible
• if you have uterine fibroids that make a normal pregnancy impossible

Warnings and precautions

Consult your doctor before using REKOVELLE

Ovarian hyperstimulation syndrome

Gonadotropins, such as this medication, can cause ovarian hyperstimulation syndrome. This occurs when your follicles develop excessively and become large cysts.

Consult your doctor if:

• you experience abdominal pain, discomfort, or swelling
• you experience nausea
• you experience vomiting
• you experience diarrhea
• you experience weight gain
• you have difficulty breathing

Your doctor may ask you to stop treatment with this medication (see section 4).

If you follow the recommended dose and administration schedule, it is less likely that ovarian hyperstimulation syndrome will occur.

Coagulation problems (thromboembolic events)

Blood clot formation within blood vessels (veins or arteries) is more likely in pregnant women. Fertility treatments may increase the risk of this occurring, especially if you are overweight or if you or a family member (blood relative) has a known coagulation disorder (thrombophilia). Consult your doctor if you think this applies to you.

Ovarian torsion (ovarian torsion)

Cases of ovarian torsion have been reported after assisted reproduction treatment. Ovarian torsion can cut off blood flow to the ovaries.

Multiple pregnancy and birth defects

When undergoing assisted reproduction treatment, the likelihood of having a multiple pregnancy (such as twins) is mainly related to the number of embryos deposited in your uterus, the quality of the embryos, and your age. Multiple pregnancy can lead to medical complications for you and your babies. Additionally, the risk of birth defects may be slightly higher when undergoing fertility treatments, which is thought to be due to the characteristics of the parents (such as their age, and the sperm quality of your partner) and multiple pregnancy.

Miscarriage

When following assisted reproduction treatment, it is more likely that a spontaneous abortion will occur than with natural conception.

Extrauterine pregnancy (ectopic pregnancy)

When following assisted reproduction treatment, it is more likely that you will have an extrauterine pregnancy (ectopic pregnancy) than with natural conception. If you have a history of tubal disease, your risk of ectopic pregnancy is increased in your case.

Ovarian tumors and other reproductive system tumors

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

Other medical conditions

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

• another doctor has told you that pregnancy could be dangerous for you
• you have liver or kidney disease

Children and adolescents (under 18 years of age)

This medication is not indicated for use in children and adolescents.

Other medications and REKOVELLE

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

Pregnancy and breastfeeding

Do not use this medication if you are pregnant or breastfeeding.

Driving and operating machinery

This medication does not affect your ability to drive and operate machinery.

REKOVELLE contains sodium

This medication contains less than 1 mmol of sodium chloride (23 mg) per dose, which is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again.

The dose of REKOVELLE for the first treatment cycle will be calculated by your doctor using the level of anti-Müllerian hormone (AMH) - a marker of how your ovaries will respond to stimulation with gonadotropins - in your blood and body weight. Therefore, before the start of treatment, you must have the result of the AMH from a blood sample (taken in the last 12 months). Your body weight will also be measured before the start of treatment. The dose of REKOVELLE is expressed in micrograms.

The dose of REKOVELLE is set throughout the treatment period, without adjustments to increase or decrease the daily dose. Your doctor will monitor the effect of treatment with REKOVELLE, and treatment will be suspended when a sufficient number of follicles is produced. In general, you will be administered a single injection of a medication called human chorionic gonadotropin (hCG) with a dose of 250micrograms or 5,000UI for the final development of the follicles.

If your body's response to treatment is very weak or very strong, your doctor may decide to suspend treatment with REKOVELLE. For the next treatment cycle, your doctor may give you a higher or lower daily dose of REKOVELLE than the previous one.

How to administer injections

The instructions for use of the pre-filled pen must be followed carefully. Do not use the pre-filled pen if the solution contains particles or does not appear transparent.

The first injection of this medication must be administered under the supervision of a doctor or nurse. Your doctor will decide if you can self-administer this medication at home, but only after receiving proper training.

This medication is indicated for subcutaneous injection, usually in the abdomen. The pre-filled pen can be used for multiple injections.

If you use more REKOVELLE than you should

The effects of using too much medication are unknown. It is possible that you may experience ovarian hyperstimulation syndrome (OHSS), which is described in section4.

If you forgot to use REKOVELLE

Do not administer a double dose to compensate for missed doses. Please contact your doctor or pharmacist as soon as you realize you have missed a dose.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Severe Adverse Effects:

The hormones used in the treatment of infertility, such as this medication, may causehigh levels of activity in the ovaries (Ovarian Hyperstimulation Syndrome).The symptoms may include pain, discomfort, and swelling in the abdomen, nausea, vomiting, diarrhea, weight gain, or difficulty breathing. If you experience any of these symptoms, please contact your doctor immediately.

The risk of adverse reactions is classified into the following categories:

Frequent (may affect up to 1 in 10people):

• Headache
• Nausea
• Ovarian Hyperstimulation Syndrome (see above)
• Lower abdominal pain and discomfort, including that originating from the ovaries
• Fatigue

Rare (may affect up to 1 in 100people):

• Mood changes
• Drowsiness / Drowsiness
• Dizziness
• Diarrhea
• Vomiting
• Constipation
• Abdominal discomfort
• Vaginal bleeding
• Mastalgia (including breast pain, breast swelling, breast tenderness, and/or nipple pain)

Reporting Adverse Effects.

If you experience any type of adverse effect, consult your doctoror pharmacistor nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the preloaded pen label and the packaging after “CAD”. The expiration date is the last day of the month indicated.

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

Store in the original packaging to protect it from light.

REKOVELLE can be stored at or below 25°C for up to 3 months, including the period after the first use. It should not be refrigerated again and should be discarded if not used after 3 months.

After the first use: 28 days when stored at or below 25°C.

At the end of treatment, the unused product should be discarded.

Medicines should not be thrown away through drains or in the trash. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

Composition of REKOVELLE

• The active substance is follitropin delta.

Cada pen prefilled with a multidose cartridge contains 12micrograms of follitropin delta in 0.36milliliters of solution. One milliliter of solution contains 33.3micrograms of follitropin delta in each milliliter of solution.

• The rest of the components are phenol, polysorbate20, L-methionine, sodium decahydrate sulfate, dodecahydrate disodium phosphate, concentrated phosphoric acid, sodium hydroxide, and water for injection.

Appearance of the product and contents of the pack.

REKOVELLE is a transparent and colorless injection solution in a prefilled pen. It is available in packs of 1pen prefilled and 3needles.

Marketing Authorization Holder

Ferring Pharmaceuticals A/S

Amager Strandvej 405

2770 Kastrup

Denmark

Responsible for manufacturing

Ferring GmbH

Wittland 11

D-24109 Kiel

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last update of this leaflet.

The detailed and up-to-date information about this medicine is available on the website of the European Medicines Agency (EMA):http://www.ema.europa.eu.

Instructions for use

REKOVELLE prefilled pen

follitropin delta

Your healthcare professional should teach you how to prepare and inject REKOVELLE correctly before you inject it for the first time.

Do not attempt to inject it yourself until you have been trained by your healthcare professional in the correct way to administer injections.

Read this manual in full before using the REKOVELLE prefilled pen and each time you acquire a new pen. There may be new information. Follow these instructions carefully even if you have used a similar injectable pen before. The incorrect use of the pen could result in an incorrect dose of the medicine.

Contact your healthcare professional (doctor, nurse, or pharmacist) if you have any doubts about how to administer your REKOVELLE injection.

The REKOVELLE prefilled pen is a disposable, dose-setting pen that can be used for the administration of more than one dose of REKOVELLE. The pen is available in 3 different concentrations:

• 12 micrograms/0.36 mL
• 36 micrograms/1.08 mL
• 72 micrograms/2.16 mL

REKOVELLE prefilled pen and its parts

Instructions for use – REKOVELLE prefilled pen (follitropin delta)

Important information

• The REKOVELLE prefilled pen and needles are for use by one person only and should not be shared with others.
• Use the pen only for the medical condition that you have been prescribed and as your healthcare professional has instructed.
• If you are blind or have poor vision and cannot read the dose scale on the pen, do not use this pen without assistance. Ask someone with good vision and who has been trained in how to use the pen to help you.
• If you have any questions, contact your healthcare professional or the local representative of the marketing authorization holder (see the leaflet for contact information) before administering your REKOVELLE injection.

Information about your REKOVELLE pen

The pen can be graduated for the administration of doses from 0.33 micrograms to 20 micrograms of REKOVELLE in marked increments of 0.33 micrograms. See “Examples of how to mark a dose” on pages 20 to 211.

• The dose scale on the pen is numbered from 0 to 20 micrograms.
• Each number is separated by two lines, each line representing an increment of 0.33 micrograms.
• When you turn the dose marker to your dose, you will hear a click sound and feel resistance in the marker to help you mark the correct dose.

Cleaning

• The exterior of your pen can be wiped clean with a damp cloth, if necessary.
• Do not insert the pen into water or any other liquid.

Storage

• Always store the pen with the cap on and without a needle attached.
• Do not use the pen after the expiry date (EXP) printed on the pen label.
• Do not store the pen at extreme temperatures, direct sunlight, or very cold conditions, such as a car or a freezer.
• Store the pen out of reach of children and anyone who has not been trained in the use of the pen.

Before use:

• Store the pen in the refrigerator between 2°C and 8°C. Do not freeze.
• If stored outside the refrigerator (at a temperature equal to or below 25°C), the pen can last up to 3 months, including the period of use. Dispose of the pen if it has not been used after 3 months.

After the first use (period of use):

• The pen can be stored for up to 28 days at a temperature equal to or below 25°C. Do not freeze.

Items you will need to administer your REKOVELLE injection

Before use – (Step 1)

Step 1:

• Wash your hands.
• Check the pen to see if it is damaged. Do not use the pen if it is damaged.
• Check the pen (cartridge) to see if the medicine is transparent and does not contain particles. Do not use a pen that contains particles or cloudy medicine in the cartridge.
• Make sure you have the correct pen with the correct concentration.
• Check the expiry date on the pen label.

Attaching the needle – (Steps 2 to 6)

Important:

• Always use a new needle for each injection.
• Only use the single-use click-on needles that come with the pen.

Step 2:

• Remove the cap from the pen.

Step 3:

• Remove the protective cover from the needle.

Step 4:

• Insert the needle.
• You will hear or feel a “click” when the needle is securely attached.
• You will also feel a slight resistance when the needle is securely attached.

Step 5:

• Remove the outer protective cover from the needle.
• Do not dispose of the outer protective cover. You will need it to dispose of the needle after the injection.

Step 6:

• Remove the inner protective cover from the needle and dispose of it.

Preparation – (Steps 7 to 9)

• Before using the pen for the first time, you must remove any air bubbles from the cartridge (priming) to receive the correct dose of medicine.
• You should only prepare the pen the first time you use it.
• Perform steps 7 to 9 even if you do not see any air bubbles.
• If the pen has already been used, go directly to step 10.

Step 7:

• Turn the dose button clockwise until the drop symbol aligns with the dose indicator.
• If you mark the incorrect dose for priming, it can be corrected both upwards and downwards without losing medicine, by turning the dose button in either direction until the drop symbol aligns with the dose indicator.

Step 8:

• Hold the pen with the needle pointing upwards.
• Tap the cartridge support with your finger to get any air bubbles present in the cartridge to rise to the top of the cartridge.

Step 9:

• With the needle still pointing upwards (away from your face), press the injection button until you see the number ‘0’ align with the dose indicator.
• Check that a drop of liquid appears at the needle tip.
• If no drop appears, repeat steps 7 to 9 (Preparation) until a drop appears.
• If no drop appears after 5 attempts, remove the needle (see step 13), and attach a new needle (see steps 3 to 6), and repeat the preparation (see steps 7 to 9).

(See step 13 for needle removal.)

Marking the dose – (Step 10)

See “Examples of how to mark a dose” on pages 20 to 211.

Step 10:

• Turn the dose button clockwise until the prescribed dose aligns with the dose indicator in the dose window.
• The dose can be corrected both upwards and downwards without losing medicine, by turning the dose button in either direction until the correct dose aligns with the dose indicator.
• Do not press the injection button when marking a dose to avoid losing medicine.

Dose division:

• You may need more than one pen to complete the dose that has been prescribed.
• If you cannot mark your complete dose, this means that there is not enough medicine left in the pen to administer the complete dose. You will need to administer part of your prescribed dose using the pen you are using, and the rest of the dose using a new pen (dose division) or you will need to dispose of the pen you are using and use a new pen to administer the complete dose that has been prescribed.

See “Administering a divided dose of REKOVELLE” on pages 22 to 231for examples of how to calculate and record your divided dose.

Injecting the dose – (Steps 11 and 12)

Important:

• Do not use the pen if the medicine contains particles or is cloudy.
• Read steps 11 and 12 on pages 14 to 151before administering your injection.
• This medicine must be administered by injection just below the skin (subcutaneously) in the abdominal area.
• Use a new injection site for each injection to reduce the risk of skin reactions such as redness and irritation.
• Do not inject into an area that is irritated (sensitive), bruised, red, hard, scarred, or has stretch marks.

Steps 11 and 12:

• Clean the skin at the injection site with an alcohol swab. Do not touch this area again before administering the injection.

• Hold the pen so that the dose window is visible during the injection.
• Pinch your skin and insert the needle directly as your healthcare professional has shown you. Do not touch the injection button yet.
• After inserting the needle, place your thumb on the injection button.
• Press the injection button until it reaches the end and keep it pressed.
• Continue pressing the injection button and when you see the number ‘0’ align with the dose indicator, wait 5 seconds (counting slowly to 5). This will ensure that you receive your complete dose.

• After pressing the injection button for 5 seconds, release it. Then, remove the needle slowly from the injection site, pulling it straight out of the skin.
• If blood appears at the injection site, press gently on the site with a cotton ball or gauze.

Note:

• Do not tilt the pen or during the injection or during the removal of the needle from the skin.
• Tilting the pen can cause the needle to bend or break.
• If a broken needle becomes stuck in the body or under the skin, seek medical help immediately.

Disposing of the needle – (Step 13)

Step 13:

• Put the used needle back on the pen carefully with a firm push (A).
• Unwind the needle in the opposite direction to the clock hands to remove it from the pen (B+C).
• Dispose of the used needle carefully (D).
• See “Disposal” on page 181.

Note:

• Remove the needle after each use. Needles are for single use only.
• Do not store the pen with the needle attached.

Reattaching the cap to the pen – (Step 14)

Step 14:

• Put the cap back on the pen firmly to protect it between injections.

Note:

• The cap of the pen will not fit if there is a needle attached.
• Do not dispose of the pen until it is empty if you are going to administer a divided dose in two injections.
• Do not dispose of the pen until there is not enough medicine left to administer a complete dose if you are going to use a new pen to administer the complete dose that has been prescribed.
• Keep the cap of the pen on when not in use.

Disposal

Needles:

Put the used needles in a sharps container, such as a container for sharp objects, immediately after use. Do not dispose of the used container in your household waste.

If you do not have a sharps container, you can use a household container that has the following characteristics:

• It is made of solid plastic and is resistant.
• It can be closed with a tight-fitting lid and is resistant to sharp objects, without the sharp object being able to escape to the outside.
• It can remain upright and stable during use.
• It is leak-proof, and
• It is correctly labeled to warn that it contains hazardous waste.

REKOVELLE prefilled pens:

• Dispose of used pens according to local regulations for waste disposal.

Examples of how to mark a dose

Examples of how to mark a dose using your REKOVELLE prefilled pen

The following table shows examples of prescribed doses, how to mark the examples of prescribed doses, and what the dose window will look like for the prescribed doses.

Administering a divided dose of REKOVELLE

If you cannot mark the complete dose that has been prescribed on your pen, this means that there is not enough medicine left in the pen to administer the complete dose. You will need to administer part of your prescribed dose using the pen you are using, and the rest of the dose using a new pen (dose division) or you will need to dispose of the pen you are using and use a new pen to administer the complete dose that has been prescribed.

• The column A shows an example of a prescribed dose. Write the dose that has been prescribed in column A.
• The column B shows an example of the dose that is left in the pen (this is equal to the dose that you can mark).
• Write the dose that is left in your pen in column B. Administer the injection using the remaining dose of medicine left in your pen.
• Prepare a new pen (steps 1 to 9).
• Calculate and write the remaining dose that needs to be injected in column C, by subtracting the number in column B from the number in column A. Use a calculator to check that you have done it correctly, if necessary.
• See “Examples of how to mark a dose” on pages 20 to 211if necessary.
• The doses should be rounded to the nearest increment, X.00, X.33, or X.66 micrograms. For example, if the number in column C is 5.34, round your dose to 5.33. If the number in column C is 9.67, round your dose to 9.66.
• Contact your healthcare professional if you have any doubts about how to calculate your divided dose.
• Inject the remaining dose of medicine (the number in column C) using a new pen to complete the prescribed dose.

Divided dose diary

Frequently Asked Questions

1. Do I need to perform the priming step before each injection?

• No. The priming step should only be performed before the administration of the first injection with a new pen.

1. How can I know if the injection is complete?

• The injection button has been pressed firmly until it stops.
• The number ‘0’ is aligned with the dose indicator.
• You have counted slowly to 5 while holding the injection button and the needle is still in the skin.

1. Why should I count to 5 while holding the injection button?

• Holding the injection button for 5 seconds allows the complete dose to be injected and absorbed under your skin.

1. What happens if the dose button cannot be turned to the prescribed dose?

• It is possible that the cartridge of the pen does not have enough medicine to release the prescribed dose.
• The pen will not allow you to mark a dose greater than what is left in the cartridge.
• You can inject the amount of medicine that is left in the pen and complete the prescribed dose with a new pen (dose division) or use a new pen to administer the complete dose that has been prescribed.

Precautions

• Do not use a pen that has fallen or been hit against hard surfaces.
• If it is difficult to press the injection button, do not use force. Change the needle. If the injection button continues to be difficult to press after changing the needle, use a new pen.
• Do not attempt to repair a damaged pen. If a pen is damaged, contact your healthcare professional or the local representative of the marketing authorization holder (see the leaflet for contact information).

Additional information

Needles

Needles are provided with the pen. If you need additional needles, contact your healthcare professional. Only use the needles that come with the REKOVELLE prefilled pen or the needles that your healthcare professional has prescribed.

Contact

If you