Prospect: information for the user

Pergoveris (450 UI + 225 UI)/0.72 ml injectable solution in preloaded pen

folitropin alfa/lutropin alfa

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed only to you, and you must 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, pharmacist or nurse, even if they are not listed in this prospect. 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 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 hyperstimulation syndrome (HSS). This occurs when your follicles develop too much and become large cysts. If you have 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, "Dosage"). 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 right 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 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 severe blood clots or worsening of 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 treatments 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 for 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 for this medication as indicated by your doctor or pharmacist. If in 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 satisfied that Pergoveris can be administered safely, you will be able to prepare and inject the medication yourself at home in the future.
• If you administer Pergoveris yourself, read and carefully follow the "Instructions for use".

How much to use

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 tests.
• 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.

Using more Pergoveris than you should

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

Missing a dose of Pergoveris

Do not use a double dose to compensate for 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 may 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 may be symptoms 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 accumulation of fluid in the abdomen or chest. This side effect is infrequent (can affect up to 1 in 100 people).

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

• Severe blood coagulation 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 coagulation 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 the 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 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 thrown away 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 syringe (450 UI + 225 UI)/0.72 ml contains 450 UI (International Units) of follitropin alfa and 225 UI of lutropin alfa in 0.72 ml and can administer three doses of Pergoveris 150 UI/75 UI,

The other components are:

• Sucrose, arginine hydrochloride monohydrate, 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 syringe:

• Pergoveris (450 UI + 225 UI)/0.72 ml is presented in packs containing 1 pre-filled multidose syringe and 7 disposable injection needles.

Marketing Authorisation Holder

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

Responsible Person

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 pre-filled syringe

Follitropin alfa/Lutropin alfa

Index

Important information about the Pergoveris pre-filled syringe

How to use the Pergoveris pre-filled syringe treatment diary

Get familiar with the Pergoveris pre-filled syringe

Step 11Get 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 pre-filled syringe

Treatment diary of the Pergoveris pre-filled syringe

Important information about the Pergoveris pre-filled syringe

• Read the instructions for use and the leaflet before using the Pergoveris pre-filled syringe.
• 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 pre-filled syringe is only for subcutaneous injection.
• Only use the Pergoveris pre-filled syringe if the healthcare professional teaches you how to use it correctly.
• The healthcare professional will tell you how many Pergoveris pre-filled syringes you need to complete your treatment.
• Administer the injection at the same time every day.

• The syringe 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 should be injected each day.
• The numbers shown on thedose information windowhelp you to:

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

Do not re-use the needles.

Do not share the syringe or needles with anyone else.

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

How to use the Pergoveris pre-filled syringe treatment diary

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 syringe volume (column 4).
• Record the doseprescribedby your healthcare professional (column 5).
• Check that you have selected the correct dose beforeinjecting(column 6).
• After the injection, read the numberindicatedon thedose information window.
• Confirm that you have received a complete injection (columna7) or record the numberindicatedon thedose information windowif it is different from “0” (columna8).
• When necessary, perform another injection with a second syringe, selecting the remaining dose that appearswrittenin the section “Dose to adjust for a second injection” (column 8).
• Record thisremainingdosein the section“Dose adjusted forthe injection”in the next row (column 6).

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

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

Get familiar with the Pergoveris pre-filled syringe

* Only for illustrative purposes.

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

Step 11 Get the materials

Step 22 Prepare for the injection

Step 33 Attach the needle

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

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

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

2.Hold the syringe with the needle pointing upwards.

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

4.Press the dose adjustment buttoncompletely. A droplet of liquid will appear on 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 44 Select the dose

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

• Example: 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 66 Remove the needle after each injection

Step 77 After the injection

7.1Check that the injection has been completed: Check that thedose information windowshows “0” (Figure 32).
If thedose information windowshows “0”, you have completed the dose. If thedose information windowshows a numbergreater than “0”, the Pergoveris pre-filled syringe is empty. You have not received the prescribed complete dose and you must perform the7.2 step described below.
7.2 Страна регистрации Іспанія Активное вещество Folitropina alfaLutropina alfa Требуется рецепт Да Производитель Merck Europe B.V. Состав 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) Информация носит справочный характер и не является медицинской рекомендацией. Перед приёмом любых препаратов проконсультируйтесь с врачом. Oladoctor не несёт ответственности за медицинские решения, принятые на основе этого контента. Общайтесь с врачом онлайн Есть вопросы по этому лекарству или вашим симптомам? Свяжитесь с лицензированным врачом для получения помощи и персонализированного ухода. 5.01 отзыв Анна Морет Дерматологія18 лет опыта Анна Морет — лікарка-дерматолог і дерматовенеролог із міжнародною сертифікацією. Спеціалізується на дерматології дорослих і дітей, венерології, естетичному догляді за шкірою та загальній медицині. 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Працює з такими станами, як: • хронічний біль будь-якого походження • мігрень і повторювані головні болі • біль у шиї, спині, попереку та суглобах • посттравматичний біль після травм, розтягнень або операцій • невропатичний біль, фіброміалгія, невралгії Окрім знеболення, Андрій Попов допомагає пацієнтам у веденні загальних медичних станів, зокрема: • респіраторні інфекції (застуда, бронхіт, пневмонія) • артеріальна гіпертензія, порушення обміну речовин, цукровий діабет • профілактичні огляди та контроль загального стану здоров’я Онлайн-консультація триває до 30 хвилин і включає детальний аналіз симптомів, рекомендації щодо обстежень, формування індивідуального плану лікування та подальший супровід за потреби. Андрій Попов дотримується принципів доказової медицини, поєднуючи клінічний досвід із уважним і персоналізованим підходом до кожного пацієнта. Записаться на онлайн-консультацию Больше времени 5.01 отзыв Євген Яковенко Загальна хірургія11 лет опыта Євген Яковенко — ліцензований лікар-хірург і терапевт в Іспанії. Спеціалізується на загальній і дитячій хірургії, внутрішній медицині та лікуванні болю. Проводить онлайн-консультації для дорослих і дітей, поєднуючи хірургічну практику з терапевтичним супроводом. Сфера медичної допомоги охоплює: • діагностику та лікування гострого й хронічного болю • перед- і післяопераційний супровід, оцінку ризиків, контроль стану • хірургічні захворювання: грижі, жовчнокам’яна хвороба, апендицит • консультації з дитячої хірургії: вроджені стани, дрібні втручання • травми: переломи, ушкодження м’яких тканин, обробка ран • онкохірургія: консультації, планування, супровід після лікування • внутрішні захворювання: патології серцево-судинної та дихальної систем • ортопедичні стани, реабілітація після травм • інтерпретація результатів візуалізації для хірургічного планування Євген Яковенко активно займається науковою діяльністю та міжнародною співпрацею. Член Асоціації хірургів Німеччини (BDC), співпрацює з Асоціацією сімейних лікарів Лас-Пальмаса та Німецьким консульством на Канарських островах. Регулярно бере участь у міжнародних медичних конференціях і публікує наукові статті. Поєднуючи багатопрофільний досвід із доказовою медициною, він надає точну та індивідуалізовану допомогу для пацієнтів із різними медичними запитами. Записаться на онлайн-консультацию Больше времени Смотреть всех врачей Следите за новостями и экономьте на услугах Советы врачей, обновления платформы и скидки для подписчиков. Подписаться Следите за нами в соцсетях УслугиВрачиПомощь Поиск