Package Insert: Information for the User

Pergoveris (900 IU + 450 IU)/1.44 ml pre-filled syringe injectable solution

Follitropin alfa/lutropin alfa

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

What is Pergoveris

Pergoveris contains two different active principles called “folitropin alfa” and “lutropin alfa”. Both belong to the family of hormones called “gonadotropins”, which are involved in reproduction and fertility.

What is Pergoveris used for

This medication is used to stimulate the development of follicles (each containing an egg) in the ovaries in order to help a woman become pregnant. It is intended for use in adult women (18 years of age or older) with low (severe deficiency) levels of “follicle-stimulating hormone” (FSH) and “luteinizing hormone” (LH). Normally, these women are infertile.

How Pergoveris works

The active principles of Pergoveris are copies of the natural hormones FSH and LH. In the body:

• FSH stimulates the production of eggs

• LH stimulates the release of eggs.

By substituting the missing hormones, Pergoveris allows women with low levels of FSH and LH to develop a follicle, from which an egg will be released, after an injection of the hormone “human chorionic gonadotropin (hCG)”. This helps women to become pregnant.

Before starting treatment, your fertility and that of your partner should be evaluated by an experienced doctor in the treatment of fertility disorders.

Do not use Pergoveris:

• if you are allergic to the follicle-stimulating hormone (FSH), luteinizing hormone (LH), or any of the other components of this medication (listed in section 6).
• if you have a brain tumor (in the hypothalamus or pituitary gland).

• if you have large ovaries or fluid-filled sacs in the ovaries (ovarian cysts) of unknown origin.
• if you have unexplained vaginal bleeding.
• if you have ovarian, uterine, or breast cancer.
• if you have a condition that would prevent a normal pregnancy, such as premature menopause, genital malformations, or benign tumors in the uterus.

Do not use this medication if any of the above conditions apply to you. If you are unsure, consult your doctor, pharmacist, or nurse before starting to use this medication.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Pergoveris.

Porphyria

Consult your doctor before starting treatment if you or any family member has porphyria (a condition that prevents the breakdown of porphyrins that can be passed down from parents to children).

Inform your doctor immediately if:

• your skin becomes fragile and you develop blisters easily, especially in areas exposed to the sun frequently.
• you have stomach, arm, or leg pain.

Your doctor may recommend stopping treatment in these cases.

Hyperstimulation syndrome (HSS)

This medication stimulates your ovaries, increasing the risk of developing hyperstimulation syndrome (HSS). This occurs when your follicles develop too much and become large cysts. If you experience pelvic pain, rapid weight gain, nausea, vomiting, or difficulty breathing, consult your doctor immediately, who may order you to stop treatment (see section 4, "Serious side effects").

In cases where you do not ovulate and the recommended dose and regimen are followed, severe HSS is less likely to occur. Pergoveris treatment rarely causes severe HSS. This is more likely if the medication used for final follicular maturation (containing human chorionic gonadotropin, hCG) is administered (see details in section 3, "How much to use"). If you develop HSS, your doctor may not prescribe hCG for this treatment cycle and advise you to avoid intercourse or use a barrier method of contraception for at least 4 days.

Your doctor will ensure careful monitoring of your ovarian response, using ultrasound and blood tests (estradiol determinations), before and during treatment.

Multiple pregnancy

If you use Pergoveris, you have a higher risk of becoming pregnant with more than one baby at a time ("multiple pregnancy," usually twins) than if you become pregnant naturally. Multiple pregnancy can cause medical complications for you and your babies. You can reduce the risk of multiple pregnancy by using the correct dose of Pergoveris at the correct times.

To minimize the risk of multiple pregnancy, it is recommended to perform ultrasound and blood tests.

Abortion

If you undergo ovarian stimulation to produce eggs, the likelihood of having an abortion is higher than the average for women.

Ectopic pregnancy

Women who have had a blockage or damage to the fallopian tubes (tubal disease) have a higher risk of pregnancy with implantation of the embryo outside the uterus (ectopic pregnancy). This is the case whether the pregnancy is spontaneous or achieved through fertility treatments.

Blood clotting disorders (thromboembolic episodes)

Consult your doctor before starting to use Pergoveris if you or any family member has ever had blood clots in the leg or lung, heart attack, or stroke. You may have a higher risk of developing severe blood clots or worsening existing clots with Pergoveris treatment.

Sex organ tumors

Tumors in the ovaries and other sex organs, both benign and malignant, have been reported in women who have undergone multiple treatment cycles for infertility.

Allergic reactions

Isolated cases of non-severe allergic reactions to Pergoveris have been reported. If you have ever had this type of reaction with a similar medication, consult your doctor before starting to use Pergoveris.

Children and adolescents

Pergoveris should not be used in children and adolescents under 18 years of age.

Other medications and Pergoveris

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

Do not use Pergoveris with other medications in the same injection. You can use Pergoveris with a folitropin alfa preparation authorized in separate injections if prescribed by your doctor.

Pregnancy and breastfeeding

Do not use Pergoveris if you are pregnant or breastfeeding.

Driving and operating machinery

No adverse effects on your ability to drive or operate machinery are expected from this medication.

Pergoveris contains sodium

Pergoveris contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free."

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Use of this medication

• Pergoveris is designed to be injected just below the skin (subcutaneously). To minimize skin irritation, select a different injection site each day.
• Your doctor or nurse will teach you how to use the pre-filled Pergoveris pen to inject the medication.
• If you are confident that you can administer Pergoveris safely, you will be able to prepare and inject the medication yourself at home in the future.
• If you administer Pergoveris yourself, read and follow the “Instructions for use” carefully.

What amount should be used

A treatment cycle begins with the recommended dose of Pergoveris containing 150 international units (UI) of follitropin alfa and 75 UI of lutropin alfa, administered daily.

• Based on the response, your doctor may decide to add a daily dose of an authorized follitropin alfa preparation to the Pergoveris injection. In this case, the follitropin alfa dose is usually increased every 7 or 14 days by 37.5-75 UI.

• Treatment continues until the desired response is achieved. This occurs when you have developed an adequate follicle, evaluated through ultrasound and blood analysis.
• It may take up to five weeks.

When the desired response is achieved, you will be administered a single injection of human chorionic gonadotropin (hCG) 24 to 48 hours after your last Pergoveris injection. The best time for sexual intercourse is the same day as the hCG injection and the following day. Alternatively, intrauterine insemination or other medically assisted reproduction procedures may be performed at your doctor's discretion.

If an excessive response is obtained, treatment will be discontinued, and hCG will not be administered (see section 2, “Ovarian Hyperstimulation Syndrome (OHSS)”). In this case, your doctor will prescribe a lower dose of follitropin alfa for the next cycle.

If you use more Pergoveris than you should

The effects of an overdose of Pergoveris are unknown; however, it is expected that OHSS will occur. Nevertheless, this will only happen if hCG is administered (see section 2, “Ovarian Hyperstimulation Syndrome (OHSS)”).

If you forgot to use Pergoveris

Do not use a double dose to compensate for the missed doses. Contact your doctor.

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

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

More serious side effects

Consult your doctor immediately if you notice any of the following side effects. Your doctor may tell you to stop using Pergoveris.

Allergic reactions

Allergic reactions, such as skin rash, skin redness, blisters, facial swelling with difficulty breathing, can sometimes be severe. This side effect is very rare.

Ovarian hyperstimulation syndrome (OHSS)

• Lower abdominal pain, accompanied by nausea or vomiting. These symptoms may be signs of ovarian hyperstimulation syndrome (OHSS). It is possible that your ovaries have reacted excessively to treatment and have developed ovarian cysts or large fluid-filled sacs (see section 2 in “Ovarian hyperstimulation syndrome (OHSS)”). This side effect is common. If this happens, your doctor will have to examine you as soon as possible.

• OHSS can worsen with clearly enlarged ovaries, decreased urine production, weight gain, difficulty breathing, and/or possible fluid accumulation in the abdomen or chest. This side effect is uncommon (can affect up to 1 in 100 people).

• OHSS complications such as ovarian torsion or blood clotting occur rarely (can affect up to 1 in 1,000 people).

• Severe blood clotting problems (thromboembolic episodes), usually with severe OHSS, occur very rarely. This could cause chest pain, shortness of breath, stroke, or myocardial infarction. In rare cases, this can also occur independently of OHSS (see section 2 in “Blood clotting problems (thromboembolic episodes)”).

Other side effects

Very common(can affect more than 1 in 10 people)

• fluid-filled sacs inside the ovaries (ovarian cysts)
• headache
• local reactions at the injection site such as pain, itching, bruising, swelling, or irritation.

Common(can affect up to 1 in 10 people)

• diarrhea
• chest pain
• nausea or vomiting
• abdominal or pelvic pain
• cramping or abdominal distension

Very rare(can affect up to 1 in 10,000 people)

• asthma can worsen.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish 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 in the box after CAD. The expiration date is the last day of the month indicated.

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

Store in the original packaging to protect it from light.

Once opened, the preloaded pen can be stored for a maximum of 28 days outside the refrigerator (at 25 °C). Do not use any remaining portion of the medication in the preloaded pen after 28days.

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

After injection, dispose of the used needle safely.

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

Composition of Pergoveris

The active principles are follitropin alfa and lutropin alfa.

• Each pre-filled Pergoveris pen (900 UI + 450 UI)/1.44 ml contains 900 UI (International Units) of follitropin alfa and 450 UI of lutropin alfa in 1.44 ml and can administer six doses of Pergoveris 150 UI/75 UI.

The other components are:

• Sucrose, arginine hydrochloride, poloxamer 188, methionine, phenol, disodium dihydrogen phosphate dihydrate, sodium dihydrogen phosphate monohydrate and water for injection. Small amounts of concentrated phosphoric acid and sodium hydroxide are added to maintain normal pH levels.

Appearance of the product and contents of the pack

Pergoveris is presented as a transparent, colourless to slightly yellowish solution in a pre-filled multidose pen:

• Pergoveris (900 UI + 450 UI)/1.44 ml is presented in packs containing 1 pre-filled multidose pen and 14 disposable injection needles.

Marketing authorisation holder

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

Manufacturer

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

Last update of this leaflet: 10/2021

Other sources of information

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

Instructions for use

Pergoveris

(300 UI + 150 UI)/0.48 ml (450 UI + 225 UI)/0.72 ml (900 UI + 450 UI)/1.44 ml

Solution for injection in a pre-filled pen

Follitropin alfa/Lutropin alfa

Index

Important information about the Pergoveris pen

How to use the treatment diary of the Pergoveris pen

Get familiar with the Pergoveris pen

Step 11Collect the materials

Step 22Prepare for the injection

Step 33Attach the needle

Step 44Select the dose

Step 55Inject the dose

Step 66Remove the needle after each injection

Step 77After the injection

Step 88Storage of the Pergoveris pen

Treatment diary of the Pergoveris pen

Important information about the Pergoveris pen

• Read the instructions for use and the leaflet before using the Pergoveris 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 to avoid errors in treatment or needlestick injuries or glass breakage.
• The Pergoveris pen is only for subcutaneous injection.
• Only use the Pergoveris pen if the healthcare professional teaches you how to use it correctly.
• The healthcare professional will tell you how many Pergoveris pens you need to complete your treatment.
• Administer the injection at the same time every day.

• The pen is available in three different multidose presentations:

Note:

• The maximum dose that can be selected is 300 UI for the (300 UI + 150 UI)/0.48 ml presentation.
• The maximum dose that can be selected is 450 UI for the (450 UI + 225 UI)/0.72 ml and (900 UI + 450 UI)/1.44 ml presentations.
• The dose adjustment button turns in increments of 12.5 UI to reach the desired dose.

See the leaflet for more information on the recommended dosage regimen and always follow the dose recommended by your healthcare professional.

• The numbers on thedose information windowrepresent the number of International Units (UI) and show the dose of follitropin alfa. Your healthcare professional will tell you how many UI of follitropin alfa to inject each day.
• The numbers shown on thedose information windowwill help you:

• Remove the needle from the pen immediately after each injection.

Do not re-use the needles.

Do not share the pen or needles with anyone else.

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

How to use the treatment diary of the Pergoveris pen

Use the treatment diary to record the amount injected.

Injecting the wrong amount of medicine may affect the treatment.

• Record the day of treatment number (column 1), date (column 2), injection time (column 3) and pen volume (column 4).
• Record the dose prescribed (column 5).
• Check that you have selected the correct dose before making the injection (column 6).
• After the injection, read the number indicated on thedose information window.
• Confirm that you have received a complete injection (column 7) or record the number indicated on thedose information windowif it is different from “0” (column 8).
• When necessary, perform another injection with a second pen, selecting the remaining dose that appears written in the “Dose to adjust for a second injection” section (column 8).
• Record this remaining dose in the “Dose adjusted for the injection” section in the next row (column 6).

The use of the treatment diary to record the daily injections will allow you to check that you have received the complete prescribed dose each day.

Example of a treatment diary using a pen of (450 UI + 225 UI)/0.72 ml:

Get familiar with the Pergoveris pen

* Only for illustrative purposes.

** The numbers on thedose information windowand the pen support represent the number of International Units (UI) of the medicine.

Step 11Collect the materials

Step 22Prepare for the injection

Step 33Attach the needle

If you do not see any droplet of liquid at the needle tip or in its vicinity the first time you use a new pen:

1.Turn the dose adjustment button clockwise until “25” appears in thedose information window(Figure 18).

• You can turn the dose adjustment button counterclockwise if you have turned it past “25”.

2.Hold the pen with the needle pointing upwards.

3.Gently tap the pen support (Figure 19).

4.Press the dose adjustment button completely. A droplet of liquid will appear at the needle tip (Figure 20).

5.Check that thedose information windowindicates “0” (Figure 21).

6.Proceed with theStep 4 Select the dose..

If no droplet of liquid appears, contact your healthcare professional.

Step 44Select the dose

4.1.Gently turn the dose adjustment button until the desired dose appears in thedose information window.

• E.g. if the desired dose is “150”UI, check that thedose information windowshows “150” (Figure 22). Injecting the wrong amount of medicine may affect the treatment.

Step 66Remove the needle after each injection

Step 77After the injection

Step 88Storage of the Pergoveris pen

8.1Replace the pen cap to prevent infections (Figure 34).

8.2Store the pen in its original packaging in a safe place and as indicated Country of registration Spain Active substance Folitropina alfaLutropina alfa Prescription required Yes Manufacturer Merck Europe B.V. Composition Sacarosa (38,5 mg mg), Hidrogenofosfato disodico dihidratado (1,13 mg mg), Dihidrogenofosfato de sodio monohidrato (0,46 mg mg), Hidroxido de sodio (e 524) (C.S.P. pH 7,0+-0,2 mg mg) This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content. Talk to a doctor online Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care. 5.01 review Anna Moret Dermatology18 years of experience Dr. Anna Moret is a board-certified dermatologist and dermatovenereologist. 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