(300 IU + 150 IU) / 0.48 ml solution for injection in a pre-filled pen
follitropin alfa / lutropin alfa
What Pergoveris is and what it is used for
What Pergoveris is
Pergoveris solution for injection contains two different active substances called “follitropin alfa” and “lutropin alfa”. Both belong to a family of hormones called gonadotropins, which are involved in reproduction and fertility.
What Pergoveris is used for
This medicine is used to stimulate the development of the follicles (each containing an egg) in your ovaries (ovaries). This is to help you get pregnant. It should be used by adult women (18 years or older) who have low levels (severe deficiency) of “follicle-stimulating hormone” ( FSH ) and “luteinizing hormone” ( LH ). These women are usually infertile.
How Pergoveris works
The active substances in Pergoveris are copies of the natural hormones FSH and LH. In your body:
- stimulates FSH egg production
- LH stimulates the release of one of the eggs.
By replacing the missing hormones , Pergoveris enables women with low levels of FSH and LH to develop a follicle. This will then release an egg after injection of the hormone “human chorionic gonadotropin ( hCG )”. This helps the woman to get pregnant.
What you need to know before using Pergoveris
Before starting treatment, your and your partner’s fertility should be evaluated by a doctor who has experience in treating fertility disorders.
Do not use Pergoveris
- if you are allergic to follicle-stimulating hormone ( FSH ), luteinizing hormone ( LH ), or any of the other ingredients of this medicine (listed in section 6)
- if you have a brain tumor (in your hypothalamus or pituitary gland )
- if you have large ovaries or fluid-filled blisters 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 make a normal pregnancy impossible, such as menopause or malformed genitals, or benign tumors in your uterus.
Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist, or nurse before taking this medicine.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Pergoveris.
Talk to your doctor before starting treatment if you or someone in your family has porphyria (an inability to break down porphyrins that can be transmitted from parents to children).
Tell your doctor immediately if:
- Your skin becomes brittle and easily gets blisters, especially skin that has often been exposed to the sun
- if you get pain in the abdomen, arms, or legs.
In the above events, your doctor may recommend that you stop treatment.
Ovarian hyperstimulation syndrome (OHSS)
This drug stimulates the ovaries. This increases the risk of developing ovarian hyperstimulation syndrome (OHSS). This is when your follicles develop too much and become large cysts. If you experience pain in the lower abdomen, rapid weight gain, nausea or vomiting or if you have difficulty breathing, talk to a doctor immediately. Your doctor may ask you to stop using this medicine (see section 4, under “Most serious side effects”).
If you are not ovulating and if the recommended dose and administration schedules are followed, the occurrence of OHSS is less likely. Treatment with Pergoveris rarely causes severe OHSS. This becomes more likely if the medicine used for final follicular maturation (containing human chorionic gonadotropin, hCG ) is given (see section 3, under “How much to use” for information). If you develop OHSS, your doctor may not give you any hCG during this treatment cycle and you may be told not to have intercourse or to use barrier contraceptives for at least four days.
Your doctor will make sure that the ovarian response is carefully monitored using ultrasound and blood tests (estradiol measurements) before and during treatment.
When you use Pergoveris, there is a greater risk that you will become pregnant with more than one child at a time (“multiple births”, usually twins) than if you become pregnant naturally. Multiple pregnancies can cause medical complications for you and your children. You can reduce the risk of multiple pregnancies by using the right dose of Pergoveris at the right times.
To minimize the risk of multiple pregnancies, ultrasound examinations, as well as blood tests, are recommended.
When your ovaries are stimulated to produce eggs, you are at greater risk of miscarriage than the average woman.
For women who have or have had a blocked or damaged fallopian tube, there is a risk of pregnancy where the embryo attaches outside the uterus (ectopic pregnancy). This is regardless of whether the pregnancy came about through spontaneous conception or fertility treatment.
Problems with blood clots (thromboembolic events)
Talk to your doctor before using Pergoveris if you or a family member have ever had blood clots in your legs or lungs, or a heart attack or stroke. You may be at increased risk of having severe blood clots or worsening existing blood clots during treatment with Pergoveris.
The tumor is on the genitals
There have been reports of tumors, both benign and malignant, in the ovaries and other reproductive organs, in women who have undergone several courses of fertility treatments.
There have been isolated reports of non-severe allergic reactions to Pergoveris. Tell your doctor if you have had these types of reactions to a similar medicine before using Pergoveris.
Children and young people
Pergoveris should not be used in children or adolescents under 18 years of age.
Other medicines and Pergoveris
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pergoveris should not be used with other medicines in the same syringe. You can use Pergoveris at the same time as an approved preparation containing follitropin alfa as a separate injection if your doctor prescribes it.
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, cycle or use tools and machines.
Pergoveris contains sodium
Pergoveris contains less than 1 mmol (23 mg) sodium per dose, ie it is essentially ‘sodium-free’.
How to use Pergoveris
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Use of this medicine
- Pergoveris is intended to be given by injection just under the skin ( subcutaneously ). Choose a new injection site every day to minimize skin irritation.
- Your doctor or nurse will show you how to use the Pergoveris pre-filled pen to inject the medicine.
- If they think you can safely administer Pergoveris, you can then prepare and inject the medicine yourself at home.
- If you are injecting Pergoveris yourself, read it carefully and follow the “Instructions for Use”.
How much to use
Treatment is initiated at the recommended dose of one of Pergoveris containing 150 International Units (IU) follitropin alfa and 75 IU lutropin alfa daily.
- Depending on how you respond to treatment, your doctor may decide to add a dose of an approved preparation containing follitropin alfa to your Pergoveris injection every day. In this case, one dose of follitropin alfa is usually increased every 7 or 14 days by 37.5 to 75 IU.
- The treatment continues until you get the desired answer. This is when you have developed a suitable follicle as assessed by ultrasound scan and blood tests.
- This can take up to 5 weeks.
Once you have received the desired response, you will receive an injection of human chorionic gonadotropin ( hCG ) 24 to 48 hours after your last Pergoveris injection. The best time to have intercourse is the same day as the hCG injection one and the day after. Alternatively, intrauterine insemination or any other medically assisted reproductive technology may be performed based on the physician’s judgment.
If your body responds too strongly, your treatment will be stopped and you will not receive any hCG (see section 2, under “Ovarian hyperstimulation syndrome (OHSS)”). In that case, your doctor will give you a lower dose of follitropin alfa during the following cycle.
If you use more Pergoveris than you should
The effects of an overdose of Pergoveris are unknown, but OHSS may occur. However, this only occurs if hCG has been administered (see section 2, under “Ovarian hyperstimulation syndrome (OHSS)”).
If you forget to use Pergoveris
Do not use a double dose to make up for a forgotten dose. Contact your doctor.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious side effects
Contact your doctor immediately if you get any of the side effects listed below. Your doctor may ask you to stop using Pergoveris.
Allergic reactions such as skin rash, reddening of the skin, hives, and swelling of the face with difficulty breathing can sometimes be serious. This side effect is very rare.
Ovarian hyperstimulation syndrome (OHSS)
- Pain in the lower abdomen along with nausea or vomiting. These are symptoms of ovarian hyperstimulation syndrome (OHSS). This may indicate that the ovaries are overreacting to the treatment and that large ovarian cysts have developed (see section 2, under “Ovarian hyperstimulation syndrome (OHSS)”). This side effect is common. If this happens, your doctor will need to examine you as soon as possible.
- OHSS can become difficult with clearly enlarged ovaries, decreased urine production, weight gain, difficulty breathing, and/or possible fluid accumulation in the abdominal cavity or chest. This side effect is less common (may affect up to 1 in 100 people).
- Complications of OHSS, such as ovarian torsion or blood clots, can occur in rare cases (may affect up to 1 in 1,000 people).
- Severe thrombotic complications (thromboembolic events) with severe OHSS can occur in very rare cases. This can cause chest pain, shortness of breath, stroke, or heart attack. In rare cases, this can also occur independently of OHSS (see section 2, under “Problems with blood clots (thromboembolic events)”).
Other side effects include
Very common (may affect more than 1 user in 10)
- fluid-filled blisters in the ovaries (ovarian cysts)
- local reactions at the injection site such as pain, itching, bruising, swelling, or irritation.
Common (may affect up to 1 in 10 people)
- chest pain
- nausea or vomiting
- abdominal and pelvic pain
- abdominal cramps and flatulence
Very rare (may affect up to 1 in 10,000 people)
- Your asthma can get worse.
How to store Pergoveris
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP or EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C ‑ 8 ° C). Do not freeze.
Store in the original package. Sensitive to light.
Once the package has been opened, the pre-filled pen can be stored for a maximum of 28 days outside the refrigerator (at 25 ° C). Do not use medicines left in the pre-filled pen after 28 days.
Do not use Pergoveris if you notice signs of the deteriorating product if the liquid contains particles or is not clear.
Dispose of the used needle safely after injection.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
The active substances are follitropin alfa and lutropin alfa.
- 1 Pergoveris (300 IU + 150 IU) / 0.48 ml pre-filled pen contains 300 IU (international units) follitropin alfa and 150 IU lutropin alfa in 0.48 ml and can deliver two doses of Pergoveris 150 IU / 75 IU.
Other ingredients are:
- Sucrose, arginine monohydrochloride, poloxamer 188, methionine, phenol, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, and water for injections. Very small amounts of concentrated phosphoric acid and sodium hydroxide are added to keep the acidity ( pH value) normal.
What the medicine looks like and the contents of the pack
Pergoveris is supplied as a clear, colorless to pale yellow solution for injection in a pre-filled multi-dose pen:
- Pergoveris (300 IU + 150 IU) / 0.48 ml is supplied in packs of 1 pre-filled multi-dose pen and 5 disposable injection needles.
Marketing Authorisation Holder
Merck Europe BV, Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands
Merck Serono SpA, Via delle Magnolie 15 (Industrial Zone), I-70026 Modugno (Bari), Italy