Package leaflet: Information for the patient

REKOVELLE 12 micrograms/0.36 mL solution for injection in a pre-filled pen

follitropin delta
Please read all of this leaflet carefully before you start taking 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 give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What REKOVELLE is and what it is used for
What you need to know before using REKOVELLE
How to use REKOVELLE
Possible side effects
How to store REKOVELLE
Contents of the pack and other information

1. What REKOVELLE is and what it is used for

REKOVELLE contains follitropin delta, a follicle-stimulating hormone, which belongs to the family of
hormones called gonadotropins. Gonadotropins are involved in reproduction and fertility.
REKOVELLE is used for the treatment of female infertility and in women undergoing assisted reproductive
technologies such as in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI). REKOVELLE
stimulates the ovaries to mature and develop multiple fluid-filled sacs containing eggs (follicles), from which the eggs are retrieved and fertilized in the laboratory.

2. What you need to know before using REKOVELLE

Before starting treatment with this medicine, a doctor must evaluate you and your partner to identify possible causes of fertility problems.

Do not use REKOVELLE

if you are allergic to follicle-stimulating hormone or to any of the other ingredients of this medicine (listed in section 6)
if you have a tumour of the uterus, ovaries, breast, pituitary gland, or hypothalamus
if you have enlarged ovaries or ovarian cysts (unless caused by polycystic ovary syndrome)
if you have vaginal bleeding of unknown cause
if you have experienced premature menopause
if you have congenital abnormalities of the reproductive organs that make a normal pregnancy impossible
if you have uterine fibroids that make a normal pregnancy impossible.

Warnings and precautions
Talk to your doctor before using REKOVELLE

Ovarian hyperstimulation syndrome
Gonadotropins, the class of medicines to which this medicine belongs, may cause ovarian hyperstimulation syndrome. This occurs when follicles develop excessively and become large cysts.
Talk to your doctor if you experience:

abdominal pain, discomfort, or swelling
nausea
vomiting
diarrhoea
weight loss
difficulty breathing

Your doctor may ask you to stop using this medicine (see section 4). Ovarian hyperstimulation syndrome is less likely if the recommended dose is taken and the administration schedule is followed.

Blood clotting problems (thromboembolic events)
Blood clots in blood vessels (veins or arteries) are more common in pregnant women. Infertility treatment may increase the risk of this occurring, especially if you are overweight or if you or a family member (blood relative) have a known blood clotting disorder (thrombophilia). Inform your doctor if you think this may apply to you.

Ovarian torsion
Cases of ovarian torsion (twisting of the ovary) have been reported following assisted reproductive techniques. Ovarian torsion may interrupt blood flow to the ovary.

Multiple pregnancy and birth defects
When undergoing treatment with assisted reproductive techniques, the likelihood of a multiple pregnancy (e.g. twins) is primarily related to the number of embryos transferred into the uterus, embryo quality, and your age. A multiple pregnancy may lead to medical complications for you and your babies. In addition, the risk of birth defects, which is thought to be due to parental characteristics (such as age and partner's sperm characteristics) and multiple pregnancies, may be slightly higher following infertility treatment.

Pregnancy loss
When undergoing treatment with assisted reproductive techniques, you have a higher chance of miscarriage compared to natural conception.

Ectopic pregnancy (tubal pregnancy)
When undergoing treatment with assisted reproductive techniques, you have a higher chance of ectopic pregnancy compared to natural conception. If you have a history of tubal disorders, your risk of ectopic pregnancy is increased.

Ovarian and other reproductive system tumours
Ovarian and other reproductive system tumours have been reported in women who have undergone infertility treatment. It is not known whether fertility drug treatment increases the risk of these tumours in infertile women.

Other medical conditions
Before starting to use this medicine, inform your doctor if:

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

Children and adolescents (under 18 years of age)
This medicine is not intended for use in children and adolescents.

Other medicines and REKOVELLE
Inform your doctor if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
Do not use this medicine if you are pregnant or breastfeeding.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

REKOVELLE contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially "sodium-free".

3. How to use REKOVELLE

Use this medicine exactly as instructed by your doctor and adhere strictly to the prescribed dose. If you have any doubts, consult your doctor.
The dose of REKOVELLE for the first treatment cycle will be calculated by your doctor using the level of anti-Müllerian hormone (AMH, an indicator of how the ovaries respond to gonadotropin stimulation) in your blood and your body weight. Therefore, the AMH result obtained from a blood sample (taken within the last 12 months) must be available before starting treatment. Your body weight will also be measured before treatment begins. The dose of REKOVELLE is indicated in micrograms.
The dose of REKOVELLE remains fixed throughout the entire treatment period, without adjustments intended to increase or decrease the daily dose. Your doctor will monitor the effect of treatment with REKOVELLE and will discontinue it when an adequate number of follicles containing oocytes is present. Generally, you will be given a single injection of a medicine containing a substance called human chorionic gonadotropin (hCG) at a dose of 250 micrograms or 5,000 IU to promote final follicular development.
If the response to treatment is too weak or too strong, your doctor may decide to stop treatment with REKOVELLE. In this case, for the next treatment cycle, your doctor will prescribe a higher or lower dose of REKOVELLE than the one previously used.

How the injections are administered
The instructions for using the pre-filled pen must be followed carefully. Do not use the pre-filled pen if the solution contains particles or does not appear clear.
The first injection of this medicine must be administered under the supervision of a doctor or nurse. Your doctor will decide whether you may self-administer further doses at home, but only after you have received adequate training.
This medicine must be administered by subcutaneous injection (just under the skin), usually in the abdomen. The pre-filled pen may be used for multiple injections.

If you use more REKOVELLE than you should
The effects of using an excessive amount of this medicine are not known. Ovarian hyperstimulation syndrome, described in section 4, may occur.

If you forget to take REKOVELLE
Do not take a double dose to make up for the forgotten dose. Please contact your doctor as soon as you realize you have missed a dose.

If you have any doubts about how to use this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Serious side effects:
Hormones used for the treatment of infertility, such as this medicine, may cause a high level of ovarian activity (ovarian hyperstimulation syndrome). Symptoms may include abdominal pain, discomfort or swelling, nausea, vomiting, diarrhoea, weight gain, or breathing difficulties. If you experience any of these symptoms, you must contact a doctor immediately.
The likelihood of experiencing a side effect is described using the following categories:
Common (may affect up to 1 in 10 people):

Headache
Nausea
Ovarian hyperstimulation syndrome (see above)
Pelvic pain and discomfort, including ovarian origin
Tiredness (fatigue)

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

Mood swings
Drowsiness
Dizziness
Diarrhoea
Vomiting
Constipation
Abdominal discomfort
Vaginal bleeding
Breast discomfort (including breast pain, breast swelling, breast tenderness and/or nipple pain)

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

5. How to store REKOVELLE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pre-filled pen label and on the
packaging after "Exp.". The expiry date refers to the last day of the month.
Store in the refrigerator (2 °C – 8 °C). Do not freeze.
Keep in the original packaging to protect the medicine from light.
REKOVELLE may be stored at a temperature not exceeding 25 °C for up to 3 months,
including the period after first use. The medicine must not be refrigerated again and must
be discarded if not used within 3 months.
After first use: 28 days when stored at a temperature not exceeding 25 °C.
At the end of treatment, any unused solution must be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What REKOVELLE contains

The active substance is follitropin delta. Each pre-filled multidose pen contains 12 micrograms of follitropin delta in 0.36 millilitres of solution. One millilitre of solution contains 33.3 micrograms of follitropin delta per millilitre of solution.
The other components are: phenol, polysorbate 20, L-methionine, sodium sulfate decahydrate, disodium phosphate dodecahydrate, concentrated phosphoric acid, sodium hydroxide and water for injections.

Description of the appearance of REKOVELLE and contents of the pack
REKOVELLE is a clear, colourless injectable solution supplied in a pre-filled pen (injectable preparation). It is available in packs containing 1 pre-filled pen and 3 injection needles for the pen.

Marketing Authorisation Holder
Ferring Pharmaceuticals A/S
Amager Strandvej 405
2770 Kastrup
Denmark

Manufacturer
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Ferring N.V. CentralPharma Communications UAB
Tel/Tél: +32 53 72 92 00 Tel: +370 5 243 0444
[email protected] [email protected]

България Luxembourg/Luxemburg
Фармонт ЕООД Ferring N.V.
Тел: +359 2 807 5022 Belgique/Belgien
[email protected] Tel/Tél: +32 53 72 92 00
[email protected]

Česká republika Magyarország
Ferring Pharmaceuticals CZ s.r.o. Ferring Magyarország Gyógyszerkereskedelmi Kft.
Tel: +420 234 701 333 Tel: +36 1 236 3800
[email protected] [email protected]

Danmark Malta
Ferring Lægemidler A/S E.J. Busuttil Ltd.
Tlf: +45 88 16 88 17 Tel: +356 21447184
[email protected]

Deutschland Nederland
Ferring Arzneimittel GmbH Ferring B.V.
Tel: +49 431 5852 0 Tel: +31 235680300
[email protected] [email protected]

Eesti Norge
CentralPharma Communications OÜ Ferring Legemidler AS
Tel: +372 601 5540 Tlf: +47 22 02 08 80
[email protected] [email protected]

Ελλάδα Österreich
Ferring Ελλάς ΜΕΠΕ Ferring Arzneimittel Ges.m.b.H
Τηλ: +30 210 68 43 449 Tel: +43 1 60 8080
[email protected]

España Polska
Ferring S.A.U. Ferring Pharmaceuticals Poland Sp. z o.o.
Tel: +34 91 387 70 00 Tel: +48 22 246 06 80
[email protected] [email protected]

France Portugal
Ferring S.A.S. Ferring Portuguesa – Produtos Farmacêuticos,
Tél: +33 1 49 08 67 60 Sociedade Unipessoal, Lda.
[email protected] Tel: +351 21 940 51 90

Hrvatska România
Clinres farmacija d.o.o. Ferring Pharmaceuticals Romania SRL
Tel: +385 1 2396 900 Tel: +40 356 113 270
[email protected]

Ireland Slovenija
Ferring Ireland Ltd. SALUS, Veletrgovina, d.o.o.
Tel: +353 1 4637355 Tel: +386 1 5899 100
[email protected] [email protected]

Ísland Slovenská republika
Vistor hf. Ferring Slovakia s.r.o.
Sími: +354 535 70 00 Tel: +421 2 54 416 010
[email protected]

Italia Suomi/Finland
Ferring S.p.A. Ferring Lääkkeet Oy
Tel: +39 02 640 00 11 Puh/Tel: +358 207 401 440
[email protected]

Κύπρος Sverige
A.Potamitis Medicare Ltd Ferring Läkemedel AB
Τηλ: +357 22583333 Tel: +46 40 691 69 00
[email protected] [email protected]

Latvija United Kingdom (Northern Ireland)
CentralPharma Communications SIA Ferring Ireland Ltd.
Tālr: +371 674 50497 Tel.: +353 1 4637355
[email protected] [email protected]

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

Instructions for use

REKOVELLE pre-filled pen

follitropin delta
A healthcare professional must show you how to correctly prepare and inject REKOVELLE before your first injection.
Do not attempt to perform the injection until your healthcare provider has shown you the correct way to administer it.
Read this entire leaflet carefully before using the REKOVELLE pre-filled pen and each time you receive a new pen. There may be new information. Follow the instructions carefully even if you have previously used a similar injection pen. Incorrect use of the pen may result in administering an incorrect dose of the medication.
Contact your healthcare provider (physician, nurse, or pharmacist) if you have any doubts about how to perform your REKOVELLE injection.

The REKOVELLE pre-filled pen is a disposable dose pen that can be used to administer more than one dose of REKOVELLE. The pen is available in three different strengths:

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

REKOVELLE pre-filled pen and its components

Diagram of the parts of a Rekovelle pen with labels indicating cap, needle, cartridge, selector, dosage scale, and injection button

Instructions for use – REKOVELLE pre-filled pen (follitropin delta)
Important information

The REKOVELLE pre-filled pen and needles are designed for single-person use only and must not be shared with others.
Use the pen only for the medical condition for which it was prescribed and as directed by your doctor.
If you are blind or have low vision and cannot read the dose scale on the pen, do not use this pen without assistance. Ask for help from someone with normal vision who has been trained to use the pen.
If you have any questions, contact your healthcare provider or a local representative of the marketing authorization holder (please refer to the package leaflet for contact details) before administering your REKOVELLE injection.

Information about the REKOVELLE pre-filled pen
The pen can be set to deliver doses ranging from 0.33 micrograms to 20 micrograms of REKOVELLE in increments of 0.33 micrograms. See "Examples of how to set a dose" on pages 20 and 21.

The pen's dose scale is numbered from 0 to 20 micrograms.
Each number is separated by two lines, each representing an increment of 0.33 micrograms.
As you turn the dose selector, you will feel a click and resistance for each increment to help you set the correct dose.

Cleaning

If necessary, the outside of the pen may be cleaned with a cloth moistened with water.
Do not immerse the pen in water or any other liquid.

Storage

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

Before use:

Store the pen in the refrigerator at 2 °C to 8 °C. Do not freeze.
If stored outside the refrigerator (at temperatures below 25 °C), the pen may be used for up to a maximum of 3 months, including the period of use. Discard the pen if not used within 3 months.

After first use (period of use):

The pen may be stored for up to 28 days at temperatures below 25 °C. Do not freeze.

Accessories required for REKOVELLE injection

Before use – (Step 1)
Step 1:

Wash your hands.
Check that the pen is not damaged. Do not use the pen if it is damaged.
Check that the solution in the pen (cartridge) is clear and free of particles. Do not use the pen if the cartridge contains a solution with particles or that is not clear.
Make sure you have the correct pen with the correct strength.
Check the expiry date on the label of the

Schematic of the Rekovelle drug package insert showing dosage in mcg and mL, subcutaneous administration instructions, and expiration date

pen.
Attaching the needle – (Steps 2 to 6)
Important:

Always use a new needle for each injection.
Use only the single-use “click-on” needles supplied with the pen.

Step 2:

Remove the pen cap.

Two hands inserting a graduated syringe into a

Step 3:

Remove the protective tab from the needle.

Two hands gripping and forcefully separating a white medical device composed of two connected parts

Step 4:

Attach the needle.
You may hear or feel a click when the needle is correctly attached.
You may also screw the needle on. When you feel slight resistance, the needle is correctly attached.

Two hands holding a graduated syringe with a blue arrow indicating clockwise rotation movement and the number 4 in an orange circle

Step 5:

Remove the outer needle cap.
Do not discard the outer needle cap. You will need it to dispose of the needle after the injection.

Hands removing the protective cap from a syringe needle with a blue arrow and a symbol prohibiting disposal in household waste

Step 6:

Remove the inner needle cap and discard it.

Hands removing the protective cap from a graduated syringe needle with a green checkmark on a sharps disposal bin

Priming – (Steps 7 to 9)

Before using the pen for the first time, air bubbles must be removed from the cartridge (priming) to ensure you receive the correct dose of medication.
Prime the pen only the first time it is used.
Perform steps 7 to 9 even if you do not see air bubbles.
If the pen has already been used, proceed directly to step 10.

Step 7:

Rotate the dose selector clockwise until a droplet symbol aligns with the dose indicator.
If you select the wrong injection dose, the dose can be corrected, either increased or decreased, without loss of medication by rotating the dose selector in either direction until the droplet symbol aligns with the dose indicator.

Diagram showing a medical device with a dose indicator and a droplet symbol held by two hands with a blue arrow pointing toward the

Step 8:

Hold the pen with the needle pointing upward.
Gently tap the cartridge holder to allow air bubbles to rise to the top of the cartridge.

Two hands holding an injection pen vertically with purple markings and numerical scale while a finger presses the top part

Step 9:

With the needle still pointing upward (away from your face), press the injection button fully until you see the number '0' aligned with the dose indicator.
Check that a drop of liquid appears at the tip of the needle.
If no drop appears, repeat steps 7 to 9 (priming) until a small drop is visible.
If no drop appears after five attempts, remove the needle (see Step 13), attach a new needle (see Steps 3 to 6), and repeat priming (see Steps 7 to 9). If no drop appears even after using a new needle, replace the pen.

Medical diagram showing hands holding an injection pen with close-ups of a liquid droplet at the tip and a digital display showing zero

Setting the dose – (Step 10)
See “Examples of how to set a dose” on pages 20 and 21.
Step 10:

Rotate the dose selector clockwise until the prescribed dose aligns with the dose indicator in the viewing window.
The dose can be corrected, either increased or decreased, without loss of medication by rotating the dose selector in either direction until the correct dose aligns with the dose indicator.
Do not press the injection button while selecting the dose to avoid loss of medication.

Two hands holding a white medical device with a curved blue arrow indicating a clockwise rotational movement

Split dosing:

You may need to use more than one pen to complete the prescribed dose.
If you are unable to set the full dose, this means there is not enough medication left in the pen. You will need to administer an injection with a split dose or discard the current pen and use a new one for the injection.

See "Administering a split dose of REKOVELLE" on pages 22 to 23 for an example of how to calculate and record a split dose.
Injecting the dose – (Steps 11 to 12)
Important:

Do not use the pen if the solution contains particles or is not clear.
Read Steps 11 and 12 on pages 14 to 15 before administering your injection.
This medicine must be administered by subcutaneous injection under the skin in the abdominal area (abdomen).
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 painful (tender), bruised, red, hard, injured, or has stretch marks.

Steps 11 and 12:

Clean 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 injection.
Pinch the skin and insert the needle perpendicularly into the skin as demonstrated by your healthcare provider. Do not press the injection button yet.
After inserting the needle, place your thumb on the injection button.
Press the injection button fully and hold it down. Continue pressing the injection button until you see the number '0' aligned with the dose indicator, then wait 5 seconds (count slowly to 5). This ensures the full dose is delivered.

A hand holding an injection pen ready to apply to the skin with a blue arrow and a gray circle indicating the

Medical illustration showing a hand holding an injection pen on the thigh with a timer indicating 5 seconds and a blue arrow

Notes:

Do not tilt the pen during injection or removal from the skin.
Tilting the pen may cause the needle to bend or break.
If a broken needle remains in the body or under the skin, seek immediate medical assistance.

Disposing of the needle – (Step 13)
Step 13:

Carefully reattach the outer needle cap by pressing firmly (A).
Unscrew the needle counterclockwise to remove it from the pen (B + C).
Dispose of the used needle carefully (D).
See "Disposal" on page 18.

Medical diagram showing proper disposal of the outer cap of the

Note:

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

Replacing the pen cap – (Step 14)
Step 14:

Firmly replace the pen cap to store the pen between injections.

A hand holding a white and purple cylindrical container being inserted into a

Note:

The pen cap does not fit onto the needle.
If administering a split dose, discard (dispose of) the pen only when it is empty.
If using a new pen to administer the full prescribed dose instead of a split dose, discard (dispose of) the pen when there is not enough medication left for a full dose.
Keep the cap on the pen when not in use.

Disposal
Needles:
Place used needles immediately after use into a puncture-resistant container, such as a sharps disposal container. Do not dispose of used sharps containers in household waste.
If you do not have a sharps disposal container, you may use a household container that:

is made of heavy-duty plastic,
has a tight-fitting, puncture-resistant lid that prevents leakage and keeps needles inside,
remains upright and stable during use,
is leak-proof, and
is clearly labeled on the outside to indicate hazardous waste is inside.

REKOVELLE pre-filled pens:

Dispose of your used pens according to applicable waste regulations.

Examples of how to set a dose
Examples of how to set a dose using the REKOVELLE pre-filled pen.
The table below shows how to set prescribed doses and how the dose display window appears for prescribed doses.

Examples of prescribed doses (in micrograms)	Dose to be set on the pen	Dose display window for examples of prescribed doses
0.33	0 and 1 line (set 0 plus 1 click)
0.66 (loading dose)	0 and 2 lines (set 0 plus 2 clicks)
2.33	2 and 1 line (set 2 plus 1 click)
11.00	11 (set 11)
12.33	12 and 1 line (set 12 plus 1 click)
18.66	18 and 2 lines (set 18 plus 2 clicks)
20.00	20 (set 20)

Administer a split dose of REKOVELLE
If you are unable to set the full prescribed dose on the pen, this means there is not enough
medication left in the pen to administer the complete dose. You will need to administer part of the prescribed
dose using the pen you are currently using, and the remainder of the dose using a new pen (split-dose injection),
or you may discard (dispose of) the pen you are currently using and use a new pen to administer the full prescribed
dose in a single injection. If you choose to administer a split dose, follow
these instructions and record how much medication to administer in the split-dose diary found on
page 23.

Column A shows an example of the prescribed dose. Write the prescribed dose in column A.
Column B shows an example of the dose remaining in the pen (corresponding to what you are able to set).
Write the remaining dose in the pen in column B. Administer the injection using the remaining medication in the pen.
Prepare and prime a new pen (Steps 1 to 9).
Calculate and record the remaining dose to be injected in column C by subtracting the number in column B from the number in column A. If necessary, use a calculator to verify the result.
See "Examples of how to set a dose" on pages 20–21 if needed.
Doses must 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 the remaining dose down to 5.33. If the number in column C is 9.67, round the remaining dose down to 9.66.
Contact your doctor if you have any doubts about how to calculate the split dose.
Inject the remaining dose of medication (number in column C) using the new pen to complete the prescribed dose.

Split-dose diary

Medical table with three columns: A Prescribed Dose, B Dose Remaining in Pen, and C Dose to Inject, with calculation examples and instructions for clicks

Frequently Asked Questions (FAQ)

Is the priming step required before each injection?
- No. Priming should only be performed the first time you use a new pen.
How do I know the injection is complete?
- The injection button has been firmly pressed all the way down until it stops.
- The number '0' is aligned with the dose indicator.
- While keeping the injection button pressed, you have slowly counted to 5 and the needle is still in situ.
Why do I need to count to 5 while holding down the injection button?
- Pressing the injection button for 5 seconds ensures the full dose is delivered and absorbed into the skin.
What should I do if the dose selector cannot be turned to the required dose?
- The cartridge in the pen may not contain enough medication to deliver the prescribed dose.
- The pen will not allow you to set a dose higher than the amount remaining in the cartridge.
- You may inject the remaining medication in the pen and complete the prescribed dose using a new pen (split dosing), or use a new pen to administer the full prescribed dose.

Warnings

Do not use a pen if it has been dropped or has hit a hard surface.
If the injection button is difficult to press, do not force it. Change the needle. If, after changing the needle, the injection button is still difficult to press, use a new pen.
Do not attempt to repair a damaged pen. If the pen is damaged, contact your healthcare provider or the local representative of the marketing authorization holder (see the package leaflet for contact details).

Additional Information
Needles
Needles are supplied with the pen. If you require additional needles, contact your healthcare provider.
Use only needles supplied with the REKOVELLE pre-filled pen or those prescribed by your doctor.
Contacts
If you have any questions or problems regarding the use of the pen, contact your healthcare provider or the
local representative of the marketing authorization holder (see the package leaflet for contact details).

Patient information leaflet

REKOVELLE 36 micrograms/1.08 mL solution for injection in a pre-filled pen

follitropin delta
Please read all of this leaflet carefully before 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 are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

What REKOVELLE is and what it is used for
What you need to know before using REKOVELLE
How to use REKOVELLE
Possible side effects
How to store REKOVELLE
Contents of the pack and other information

1. What REKOVELLE is and what it is used for

REKOVELLE contains follitropin delta, a follicle-stimulating hormone, which belongs to a family of
hormones called gonadotropins. Gonadotropins are involved in reproduction and fertility.
REKOVELLE is used for the treatment of female infertility and in women undergoing assisted
reproductive technologies such as in vitro fertilization (IVF) and intracytoplasmic sperm injection
(ICSI). REKOVELLE stimulates the ovaries to mature and develop multiple follicles containing oocytes
(follicles), from which oocytes are retrieved and fertilized in the laboratory.

2. What you should know before using REKOVELLE

Before starting treatment with this medicine, a doctor must evaluate you and your partner to identify possible causes of fertility problems.

Do not use REKOVELLE

if you are allergic to follicle-stimulating hormone or to any of the other ingredients of this medicine (listed in section 6)
if you have a tumour of the uterus, ovaries, breast, pituitary gland, or hypothalamus
if you have enlarged ovaries or ovarian cysts (unless caused by polycystic ovary syndrome)
if you have vaginal bleeding of unknown cause
if you have experienced premature menopause
if you have congenital abnormalities of the reproductive organs that make normal pregnancy impossible
if you have uterine fibroids that make normal pregnancy impossible.

Warnings and precautions
Talk to your doctor before using REKOVELLE

abdominal pain, discomfort, or swelling
nausea
vomiting
diarrhoea
weight loss
difficulty breathing

Your doctor may ask you to stop using this medicine (see section 4). The risk of ovarian hyperstimulation syndrome is lower if the recommended dose is used and administration schedule is followed.

Blood clotting problems (thromboembolic events)
Blood clots in blood vessels (veins or arteries) are more common in pregnant women. Infertility treatment may increase this risk, especially if you are overweight or if you or a family member (blood relative) have a known blood clotting disorder (thrombophilia). Inform your doctor if you think this may apply to you.

Ovarian torsion
Cases of ovarian torsion have been reported following assisted reproductive techniques. Ovarian torsion may interrupt blood flow to the ovary.

Multiple pregnancy and birth defects
When undergoing assisted reproductive techniques, the likelihood of multiple pregnancy (e.g. twins) is primarily related to the number of embryos transferred into the uterus, embryo quality, and your age. A multiple pregnancy may lead to medical complications for you and your babies. In addition, the risk of birth defects, which is thought to be due to parental characteristics (such as age and partner's sperm characteristics) and multiple pregnancies, may be slightly higher following infertility treatment.

Pregnancy loss
When undergoing assisted reproductive techniques, you have a higher chance of miscarriage compared to natural conception.

Ectopic pregnancy
When undergoing assisted reproductive techniques, you have a higher chance of ectopic pregnancy compared to natural conception. If you have a history of tubal disorders, your risk of ectopic pregnancy is increased.

Ovarian and other reproductive system tumours
Ovarian and other reproductive system tumours have been reported in women undergoing infertility treatment. It is not known whether fertility medicines increase the risk of these tumours in infertile women.

Other medical conditions
Before starting to use this medicine, inform your doctor if:

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

Children and adolescents (under 18 years of age)
This medicine is not indicated for use in children and adolescents.

Other medicines and REKOVELLE
Inform your doctor if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
Do not use this medicine during pregnancy or while breastfeeding.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

REKOVELLE contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially "sodium-free".