Pergoveris 150 IU/75 IU powder and solvent for solution for injection
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Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Pergoveris 150 IU/75 IU powder and solvent for solution for injection
folitropin alfa/lutropin alfa
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
- What Pergoveris is and what it is used for
- What you need to know before using Pergoveris
- How to use Pergoveris
- Possible side effects
- How to store Pergoveris
- Contents of the pack and other information
1. What Pergoveris is and what it is used for
What Pergoveris is
Pergoveris contains two different active substances called “folitropin alfa” and “lutropin alfa”. Both belong to a family of hormones known as “gonadotropins”, which are involved in reproduction and fertility.
What Pergoveris is used for
This medicine is used to stimulate the development of follicles (each containing an egg) in the ovaries in order to help you become pregnant. It is intended for use in adult women (18 years of age or older) who have low levels (severe deficiency) of “follicle-stimulating hormone” (FSH) and “luteinizing hormone” (LH). Typically, these women are infertile.
How Pergoveris works
The active substances in 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 replacing the missing hormones, Pergoveris enables women with low levels of FSH and LH to develop a follicle, from which an egg will be released following an injection of the hormone “human chorionic gonadotropin (hCG)”. This helps women to become pregnant.
2. What you need to know before starting Pergoveris
Before starting treatment, your fertility and that of your partner should be evaluated by a physician experienced in the management of fertility disorders.
Do not use Pergoveris:
- if you are allergic to follicle-stimulating hormone (FSH), luteinizing hormone (LH), or any of the other components of this medicine (listed in section 6).
- if you have a brain tumor (in the hypothalamus or pituitary gland).
- if you have enlarged ovaries or fluid-filled sacs in the ovaries (ovarian cysts) of unknown origin.
- if you have unexplained vaginal bleeding.
- if you have cancer of the ovary, uterus, or breast.
- if you have a condition that would prevent a normal pregnancy, such as premature menopause, malformations of the reproductive organs, or benign tumors in the uterus.
Do not use this medicine if any of the above conditions apply to you. If you are unsure, consult your doctor, pharmacist, or nurse before starting to use this medicine.
Warnings and precautions
Talk to 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 disorder affecting the breakdown of porphyrins that may be inherited).
Immediately inform your doctor if:
- your skin becomes fragile and blisters easily, especially in areas frequently exposed to sunlight.
- you experience stomach, arm, or leg pain.
In such cases, your doctor may advise you to discontinue treatment.
Ovarian hyperstimulation syndrome (OHSS)
This medicine stimulates your ovaries, increasing the risk of developing ovarian hyperstimulation syndrome (OHSS). This occurs when your follicles develop excessively and become large cysts. If you experience pelvic pain, rapid weight gain, nausea or vomiting, or difficulty breathing, contact your doctor immediately, as they may instruct you to stop treatment (see section 4, “More serious side effects”).
If ovulation does not occur and the recommended dosage and regimen are followed, severe OHSS is less likely. Treatment with Pergoveris rarely causes severe OHSS. The risk increases if the medication used to trigger final follicular maturation (containing human chorionic gonadotropin, hCG) is administered (see details in section 3, “What dose should be used”). If OHSS develops, your doctor may withhold hCG in this treatment cycle and advise you to abstain from sexual intercourse or use a barrier contraceptive method for at least 4 days.
Your doctor will carefully monitor your ovarian response through ultrasound scans and blood tests (estradiol measurements) before and during treatment.
Multiple pregnancy
If you use Pergoveris, you have a higher chance of becoming pregnant with more than one baby at a time (“multiple pregnancy,” usually twins) compared to natural conception. Multiple pregnancy may lead to 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, ultrasound scans and blood tests are recommended.
Miscarriage
If you undergo ovarian stimulation to produce eggs, the likelihood of miscarriage is higher than in the average woman.
Ectopic pregnancy
Women who have previously had blocked or damaged fallopian tubes (tubal disease) are at risk of ectopic pregnancy (pregnancy with embryo implantation outside the uterus), whether conception occurs spontaneously or through fertility treatments.
Blood clotting problems (thromboembolic events)
Consult your doctor before starting Pergoveris if you or any family member has ever had blood clots in the leg or lung, heart attack, or stroke. You may have an increased risk of developing serious blood clots or worsening of existing clots during treatment with Pergoveris.
Tumors of the reproductive organs
Benign and malignant tumors of the ovaries and other reproductive organs have been reported in women who have undergone multiple cycles of infertility treatment.
Allergic reactions
Isolated cases of non-serious allergic reactions to Pergoveris have been reported. If you have previously experienced such a reaction to a similar medicine, consult your doctor before starting Pergoveris.
Children and adolescents
Pergoveris must not be used in children and adolescents under 18 years of age.
Other medicines and Pergoveris
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Do not mix Pergoveris with other medicines in the same injection, except with follitropin alfa, if prescribed by your doctor.
Pregnancy and breastfeeding
Do not use Pergoveris if you are pregnant or breastfeeding.
Driving and using machines
This medicine is not expected to affect your ability to drive or operate machinery.
Pergoveris contains sodium
Pergoveris contains less than 1 mmol of sodium (23 mg) per dose; hence, it is essentially “sodium-free”.
3. How to use Pergoveris
Follow exactly the instructions given by your doctor or pharmacist for administering this medicine. If in doubt, consult your doctor or pharmacist again.
Use of this medicine
- Pergoveris is intended to be injected just under the skin (subcutaneously). To minimize skin irritation, select a different injection site each day.
- It is supplied as a powder and liquid that must be mixed and used immediately.
- Your doctor or nurse will show you how to prepare and inject this medicine. They will supervise your first injection.
- Once they are satisfied that you can safely administer Pergoveris, you may then prepare and inject the medicine yourself at home. When doing so, carefully read and follow the instructions below in the section "How to prepare and use the powder and solvent of Pergoveris".
What dose to use
The usual starting dose is 1 vial of Pergoveris daily.
- Depending on your response, your doctor may decide to add daily a licensed preparation of follitropin alfa to the Pergoveris injection. In this case, the dose of follitropin alfa is usually increased every 7 or 14 days by 37.5–75 IU.
- Treatment continues until the desired response is achieved. This occurs when you have developed a suitable follicle, assessed by ultrasound and blood tests.
- Up to five weeks may be needed.
When the desired response is achieved, you will receive a single injection of human chorionic gonadotropin (hCG) 24 to 48 hours after your last Pergoveris injection. The best time for sexual intercourse is on the day of the hCG injection and the following day. Alternatively, intrauterine insemination or another medically assisted reproductive procedure may be performed, at your doctor's discretion.
If you have an excessive response, your treatment will be stopped and you will not receive hCG (see section 2, "Ovarian Hyperstimulation Syndrome (OHSS)"). In this case, your doctor will prescribe a lower dose of follitropin alfa in the next cycle.
How to prepare and use the powder and solvent of Pergoveris
Before starting preparation, first read these instructions in full:
Inject your dose at the same time each day.
- Wash your hands and find a clean place
- It is important that your hands and materials used are as clean as possible.
- A suitable place is a clean table or kitchen surface.
- Gather and lay out all the items you will need
- 1 vial containing Pergoveris powder
- 1 vial containing water for injections (solvent)
Not supplied in the pack:
- 2 alcohol swabs
- 1 empty syringe for injection
- 1 needle for preparation
- 1 fine needle for subcutaneous injection
- a sharps container for the safe disposal of glass vials and needles
- Preparation of the solution
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- Preparing the injection syringe
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- Injection of the dose
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- After injection
Dispose of all materials: After completing the injection, immediately dispose of all needles and empty vials into a sharps container. Any unused portion of the solution must also be discarded.
If you use more Pergoveris than you should
The effects of an overdose of Pergoveris are unknown; however, OHSS may be expected. Nevertheless, this will only occur if hCG is administered (see section 2, “Ovarian hyperstimulation syndrome (OHSS)”).
If you forget to use Pergoveris
Do not use a double dose to make up for a missed dose. Contact your doctor.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
More serious adverse effects
Contact your doctor immediately if you notice any of the adverse effects listed below. Your doctor may tell you to stop using Pergoveris.
Allergic reactions
Allergic reactions, such as skin rash, redness of the skin, blisters, swelling of the face with difficulty breathing, can sometimes be severe. This adverse effect is very rare.
Ovarian hyperstimulation syndrome (OHSS)
- Pelvic pain, accompanied by nausea or vomiting. These may be symptoms of ovarian hyperstimulation syndrome (OHSS). Your ovaries may have overreacted to treatment, resulting in the development of ovarian cysts or large fluid-filled sacs (see section 2 under “Ovarian hyperstimulation syndrome (OHSS)”). This adverse effect is common. If this occurs, your doctor will need to examine you as soon as possible.
- OHSS may worsen with clearly enlarged ovaries, decreased urine production, weight gain, difficulty breathing, and/or possible accumulation of fluid in the abdomen or chest. This adverse effect is uncommon (may affect up to 1 in 100 people).
- Complications of OHSS, such as ovarian torsion or blood clotting, occur rarely (may affect up to 1 in 1,000 people).
- Serious blood clotting problems (thromboembolic events), usually associated with severe OHSS, occur very rarely. These could cause chest pain, shortness of breath, stroke, or myocardial infarction. In rare cases, this could also occur independently of OHSS (see section 2 under “Blood clotting problems (thromboembolic events)”).
Other adverse effects
Very common (may affect more than 1 in 10 people)
- fluid-filled sacs within the ovaries (ovarian cysts)
- headache
- local reactions at the injection site such as pain, itching, bruising, swelling, or irritation.
Common (may affect up to 1 in 10 people)
- diarrhoea
- chest pain
- nausea or vomiting
- abdominal or pelvic pain
- abdominal cramps or bloating
Very rare (may affect up to 1 in 10,000 people)
- asthma may worsen.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Pergoveris
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vials and the outer carton after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 25 °C. Store in the original packaging to protect from light.
The medicine should be administered immediately after reconstitution.
Do not use Pergoveris if you notice any visible signs of deterioration.
The reconstituted solution must not be administered if it contains particles or is not clear.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Pergoveris
The active substances are follitropin alfa and lutropin alfa.
- One vial contains 150 IU of follitropin alfa (equivalent to 11 micrograms) and 75 IU of lutropin alfa (equivalent to 3 micrograms).
- After reconstitution, each ml of solution contains 150 IU of follitropin alfa and 75 IU of lutropin alfa per millilitre.
The other components are:
- Sucrose, disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate monohydrate, methionine and polysorbate 20, as well as concentrated phosphoric acid and sodium hydroxide for pH adjustment.
Nature of the product and contents of the pack
- Pergoveris is presented as a powder and solvent for injectable solution.
- The powder is a white to off-white lyophilised cake in a glass vial with a bromobutyl rubber stopper, containing 150 IU (equivalent to 11 micrograms) of follitropin alfa and 75 IU (equivalent to 3 micrograms) of lutropin alfa.
- The solvent is a clear, colourless liquid in a glass vial containing 1 ml of water for injections.
- Pergoveris is available in packs containing 1, 3 or 10 vials of powder with the same number of solvent vials (1, 3 and 10 vials). Not all pack sizes may be marketed.
Marketing Authorisation Holder
Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands
Manufacturer
Merck Serono S.p.A, Via delle Magnolie 15 (Zona industriale), 70026 Modugno (Bari), Italy
Date of the most recent revision of this leaflet: {MM/YYYY}.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.