Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Menopur 150 IU Powder and Solvent for Solution for Injection
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Menotrophin may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for MENOPUR is provided as a powder which must be mixed with liquid (solvent) before it is used. It is given as an injection into a muscle or under the skin. The active ingredient in MENOPUR is highly purified and is known as menotrophin. Menotrophin is extracted from the urine of postmenopausal women and contains three hormones: follicle stimulating hormone (FSH), human chorionic gonadotrophin (hCG) and luteinising hormone (LH). hCG, extracted from the urine of pregnant women may be added to contribute to the total LH bioactivity. FSH, hCG and LH are natural hormones produced in women. They help the reproductive organs to work normally.
In women, MENOPUR is used to treat infertility in the following two situations: •
To promote the release of eggs from the ovaries (ovulation) in women who are not ovulating including with polycystic ovarian disease and who have not responded to treatment with another medicine called clomiphene citrate.
For Internal Use – Internal
•
To help multiple follicles and therefore eggs to develop in women having in vitro fertilisation (IVF) treatment or other types of 'assisted conception'. The eggs are then harvested and fertilised outside the body.
In men, MENOPUR is used to treat infertility in the following situation: •
Low sperm count (oligospermia).
What you need to know before you take it
e MENOPUR Before starting treatment with MENOPUR, you and your partner should be evaluated by a doctor for the causes of your fertility problems. In particular you should be checked for the following conditions so that any other appropriate treatment can be given: • • • •
Underactive thyroid or adrenal glands High levels of a hormone called prolactin (hyperprolactinemia) Tumours of the pituitary gland (a gland located on the base of the brain which produces certain hormones, including growth hormones) Tumours of the hypothalamus (an area located under the part of the brain called the thalamus which controls the conditions within your body including body temperature and blood pressure)
If you know you have any of the conditions listed above, please tell your doctor before starting treatment with MENOPUR.
Do not use MENOPUR if: • • •
You are allergic (hypersensitive) to menotrophin or any of the other ingredients of MENOPUR (listed in Section 6). You have a tumour in your pituitary gland. You have a tumour in the hypothalamus.
Also, if you are a woman do not use MENOPUR if: • •
• • • • • •
You have tumours of the womb (uterus), ovaries or breasts. You have sacs of fluid known as cysts on your ovaries (ovarian cysts) or enlarged ovaries that are not due to polycystic ovarian disease (a condition that prevents eggs from being released from the ovaries). You have bleeding from your vagina for an unknown reason. You are having an early (premature) menopause. You have certain physical problems in your reproductive organs (womb, fallopian tubes, ovaries or cervix). Your womb has been removed (hysterectomy). You have fibroid tumours (tumours in your womb that are not cancer). You are pregnant or breast-feeding.
For Internal Use – Internal
Also, if you are a man do not use MENOPUR if: • •
You have cancer of your testicles. You have prostate cancer.
Do not use MENOPUR if any of the above applies to you. If you are not sure, talk to your doctor, nurse or pharmacist before you start using MENOPUR.
Warnings and precautions Talk to your doctor or nurse if: • • • • • •
You get pain or swelling in the stomach You get nausea or vomiting You get diarrhea You gain weight You have difficulty in breathing You get decreased urination (produce less urine)
Tell your doctor straight away, even if the symptoms develop some days after the last injection has been given. These can be signs of high levels of activity in the ovaries which might become severe. If these symptoms become severe, the infertility treatment should be stopped and you should receive treatment in hospital. Keeping to your recommended dose and careful monitoring of your treatment will reduce your chances of getting these symptoms.
If you stop using MENOPUR you might still experience these symptoms. Please contact your doctor immediately if any of these symptoms occur.
While you are being treated with this medicine, your doctor will normally arrange for you to have ultrasound scans and sometimes blood tests to monitor your response to treatment.
Being treated with hormones like MENOPUR can increase the risk of: • • • •
Ectopic pregnancy (pregnancy outside of the womb) if you have a history of fallopian tube disease. Miscarriage Multiple pregnancy (twins, triplets, etc) Congenital malformations (physical defects present in baby at birth).
For Internal Use – Internal
Some women who have been given infertility treatment with multiple medicines have developed tumours in the ovaries and other reproductive organs. It is not yet known if treatment with hormones like MENOPUR causes these problems.
Blood clot formation inside the blood vessels (veins or arteries) are more likely to occur in women who are pregnant. Infertility treatment can increase the chances of this happening, especially if you are overweight or known with blood clotting disease (thrombophilia) or if you or someone in your family (blood relative) has had blood clots. Tell your doctor if you think this applies to you.
Children There is no relevent use of MENOPUR in children.
Other medicines and MENOPUR Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Clomiphene citrate is another medicine used in the treatment of infertility. If MENOPUR is used at the same time as clomiphene citrate the effect on the ovaries may be increased.
Pregnancy and breast-feeding MENOPUR should not be used during pregnancy or breastfeeding.
Driving and using machines MENOPUR is unlikely to affect your ability to drive and use machines.
Important information about some of the ingredients of MENOPUR MENOPUR contains less than 1 mmol sodium (23 mg) per dose, so it is essentially 'sodium-free'. MENOPUR also contains lactose (which is a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before using this medicine.
How to take it
MENOPUR Always use MENOPUR exactly as your doctor or nurse has told you. You should check with your doctor, nurse or pharmacist if you are not sure.
For Internal Use – Internal
Using MENOPUR • • • •
You will have MENOPUR as an injection into a muscle or under the skin. You will either be given MENOPUR by a doctor or nurse or you will be taught how to give it to yourself. MENOPUR comes as a dry powder in small bottles (vials). Once the dry powder has been mixed with the salt solution (solvent) it should be used straight away.
The dose and length of your treatment • • •
The dose, and how long your treatment lasts, depends on why you are using MENOPUR and how well it works. Your doctor or nurse will monitor how you respond to your treatment. This will help them to work out what dose you need and how long you need to use MENOPUR for.
In women: i.
Women who are not ovulating (not producing eggs):
Treatment should start within the first 7 days of the menstrual cycle (day 1 is the first day of your period). Treatment should be given every day for at least 7 days.
The starting dose is normally 75-150 IU daily but this may be adjusted depending on your response (up to a maximum of 225 IU). A particular dose should be given for at least 7 days before the dose is changed by your doctor. It is recommended that the dose should be increased by 37.5 IU per adjustment (and not more than 75 IU). The cycle of treatment should be abandoned if there is no response after 3 weeks.
When a good response is obtained a single injection of another hormone called human chorionic gonadotrophin (hCG), at a dose of 5,000 to 10,000 IU, should be given 1 day following the last MENOPUR injection. It is recommended to have sexual intercourse on the day of the hCG injection and the day after. Alternatively, artificial insemination (injection of sperm directly into the womb) may be performed. Your doctor will closely monitor your progress for at least 2 weeks after you have received the hCG injection.
Your doctor will monitor the effect of MENOPUR treatment. If an excessive response occurs, your doctor may decide to stop treatment with MENOPUR and not give you the hCG injection. In this case, you will be instructed to use a barrier method of contraception (e.g. condom) or not have sexual intercourse until your next period has started. For the following cycle your doctor will give you a lower dose of MENOPUR than before.
For Internal Use – Internal
ii.
Women in assisted reproductive technology programs:
If you are also receiving treatment with a GnRH agonist (a medicine which helps a hormone called Gonadotropin Releasing Hormone (GnRH) to work), MENOPUR should be started approximately 2 weeks after the start of the GnRH agonist therapy.
If you are also receiving treatment with a GnRH antagonist, MENOPUR treatment should be started on day 2 or 3 of the menstrual cycle (day 1 is the first day of your period).
MENOPUR should be given every day for at least 5 days. The initial dose of MENOPUR is normally 150-225 IU. This dose may be increased according to your response to the treatment up to a maximum of 450 IU per day. The dose should not be increased by more than 150 IU per adjustment. Normally treatment should not continue for more than 20 days.
If enough egg sacs are present, you will be given a single injection of a medicine called human chorionic gonadotrophin (hCG) at a dose of up to 10,000 IU to induce ovulation (release of an egg).
Your doctor will closely monitor your progress for at least 2 weeks after you have received the hCG injection.
Your doctor will monitor the effect of MENOPUR treatment. If an excessive response occurs, your doctor may decide to stop treatment with MENOPUR and not give you the hCG injection. In this case, you will be instructed to use a barrier method of contraception (e.g. condom) or not have sexual intercourse until your next period has started. For the following cycle your doctor will give you a lower dose of MENOPUR than before.
In men: For low sperm count: • •
The usual dose is 75 or 150 IU two or three times a week. Treatment is normally continued for at least 3 or 4 months.
INSTRUCTIONS FOR USE If your doctor has asked you to inject MENOPUR yourself, you should follow the instructions provided below.
For Internal Use – Internal
The first injection of MENOPUR should be given under the supervision of a doctor or nurse. DISSOLVING MENOPUR: MENOPUR is provided as a powder and must be dissolved before it is injected. The liquid (solvent) which you should use to dissolve MENOPUR is provided with the powder. MENOPUR should only be dissolved immediately before use.
Please note: 1 drop of solvent can dissolve the powder immediately, leading to the impression that no powder was present in the vial. Check the vial for powder before mixing the solvent.
What to do:
1. Firmly attach the long, thick needle (drawing up/reconstitution needle) to the syringe. 2. Break the liquid (solvent) ampoule with the dot pointing towards yourself. 3. Insert the needle in the liquid ampoule.
4. Draw up all the liquid from the ampoule into the syringe. 5. Insert the needle through the rubber stopper of the powder vial and slowly inject all of the liquid. Aim at the side of the vial to avoid creating bubbles. 6. The powder should quickly dissolve (within 2 minutes) to form a clear solution.
7. To help the powder dissolve, swirl the solution. Do not shake as this will cause air bubble to form. If the solution is not clear or if it contains particles it SHOULD NOT be used.
For Internal Use – Internal
8. Draw up the solution back into the syringe. If you have been prescribed more than one vial of MENOPUR powder per injection, you can draw up the solution (the first MENOPUR dilution) back into the syringe and inject it into a second vial of powder. You can do this with up to three vials of powder in total – but only do as your doctor has told you.
INJECTING MENOPUR:
9. Once you have your prescribed dose drawn up into the syringe, change the needle to a short, thin needle (the injection needle). 10. Turn the syringe with the needle upwards and flick it gently so if any air bubbles, they are collected at the tip. Depress the plunger carefully until the first drop of fluid comes out. 11. Your doctor or nurse will tell you where to inject yourself e.g. front of thigh, stomach (abdomen) etc.. 12. Disinfect the injection site.
13. To inject, pinch the skin produce a fold and insert the needle in one swift motion at 90 degrees to the body. Press down on the plunger to inject the solution and then remove the needle. 14. After removing the syringe, apply pressure to the injection site to stop any bleeding. Gently massaging the injection site will help to disperse the solution under the skin. 15. Do not put used items into normal domestic waster; these should be disposed of appropriately.
If you use more MENOPUR than you should If you think you have used too much MENOPUR, tell your doctor, nurse or pharmacist.
If you forget to use MENOPUR Do not take a double dose to make up for a forgotten dose. Please tell your doctor, nurse or pharmacist.
For Internal Use – Internal
4. Possible side effects Like all medicines, MENOPUR can cause side effects, although not everybody gets them.
Side effects that can happen in women: If you notice any of the following signs, tell your doctor immediately. It may mean that your ovaries have been stimulated too much Ovarian Hyperstimulation Syndrome (OHSS), especially in women with polycystic ovaries and you may need urgent medical treatment.
Symptoms include: • • • • •
Nausea (feeling sick) Vomiting (being sick) Diarrhoea. Weight gain. Pain or swelling of the stomach
In cases of severe OHSS: • • • • •
Fluid build-up in the stomach, pelvis and/or chest Difficulty in breathing. Decreased urination (producing less urine when you go to the toilet or going to the toilet less often). Formation of blood clots in blood vessels (thromboembolism) Twisting of ovaries (ovarian torsion)
If you notice any of the above signs, tell your doctor immediately.
Possible side effects
that can happen in both women and men: STOP USING MENOPUR if you experience allergic (hypersensitivity) reactions including; skin rashes, itching, swelling of the face, lips or throat and difficulty in breathing. If you experience any of these rare side effects, you should contact your doctor or go to the nearest hospital immediately. Common (may affect up to 1 in 10 people): • • • • • •
Pain or swelling of the stomach Headache Nausea Pelvic pain Overstimulation of the ovaries resulting into high levels of activity (OHSS) Pain or inflammation at the injection site (redness, bruising, swelling and/or itching)
For Internal Use – Internal
Uncommon (may affect up to 1 in 100 people): • • • • • • • •
Vomiting Discomfort in stomach Diarrhoea Fatigue Dizziness Sacs of fluid within ovaries (ovarian cysts) Breast complaints (include breast pain, breast tenderness, breast discomfort, nipple pain and breast swelling) Hot flush
Rare (may affect up to 1 in 1,000 people) • •
Acne Rash
Unknown (the frequency of these reported side effects is not known) • • • • • •
Eyesight disturbances Allergic reactions Pain in muscle and joint (e.g. back pain, neck pain and pain in arms and legs) Twisting of ovary (ovarian torsion) as a complication of OHSS Itching Hives
Reporting of side effects If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: https://yellowcard.mhra.gov.uk/. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
MENOPUR • • • • • •
Keep out of the sight and reach of children. Do not use MENOPUR after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month. For immediate and single use following reconstitution. Do not store above 25°C. Do not freeze. Store in the original package in order to protect from light. 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.
For Internal Use – Internal
6. Content of the pack and other information What MENOPUR contains •
• •
MENOPUR is a sterile freeze dried powder for injection. The active substance is highly purified menotrophin. Each vial contains 150 IU of the active substance, corresponding to 150 IU of FSH bioactivity and 150 IU of LH bioactivity. The other ingredients for powder are Lactose monohydrate, Polysorbate 20, Sodium hydroxide and Hydrochloric acid. The solvent (Sodium Chloride Solution for Injections 0.9% w/v) contains, Sodium chloride, Hydrochloric acid and Water for injection.
What MENOPUR looks like and contents of the pack MENOPUR is powder and solvent for solution for injection. Supplied in cartons of 5 or 10 clear glass vials which contain a white to off-white lyophilised powder. The carton also contains an equal number of clear glass ampoules containing a colourless solvent (Sodium Chloride Solution for Injection 0.9%w/v). The solvent is used to dissolve the powder before it is injected. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer. Marketing Authorisation Holder: Ferring Pharmaceuticals Ltd. Drayton Hall, Church Road, West Drayton, UB7 7PS, UK
Manufacturer: Ferring GmbH Wittland 11, D-24109 Kiel, Germany
This leaflet was last revised in February 2026.
MENOPUR, Ferring and the Ferring Pharmaceuticals logo are trademarks of Ferring
For Internal Use – Internal
Frequently asked questions about Menopur 150 IU Powder and Solvent for Solution for Injection
How do I take Menopur 150 IU Powder and Solvent for Solution for Injection?
Menopur 150 IU Powder and Solvent for Solution for Injection comes as injection containing 150iu. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Menopur 150 IU Powder and Solvent for Solution for Injection?
The active substance in Menopur 150 IU Powder and Solvent for Solution for Injection is menotrophin.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Menopur 150 IU Powder and Solvent for Solution for Injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Menopur 150 IU Powder and Solvent for Solution for Injection without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: menotrophin
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Treatment of female and male infertility in the following groups of patients:
Anovulation, including polycystic ovarian disease (PCOD) in women who have been unresponsive to treatment with clomiphene citrate:
- Women undergoing controlled ovarian hyperstimulation: MENOPUR can induce the development of multiple follicles for assisted reproductive technologies (ART) (e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)).
- Hypogonadotrophic hypogonadism in men: MENOPUR may be given in combination with human chorionic gonadotrophin (e.g. Choragon) for the stimulation of spermatogenesis. Patients with primary testicular failure are usually unresponsive.
4.2. Posology and method of administration
Treatment with MENOPUR should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Posology
For intramuscular or subcutaneous use. The dosage regimens described below are identical for both forms of administration.
There are great inter-individual variations in the response of the ovaries to exogenous gonadotrophins. This makes it impossible to set a uniform dosage scheme. The dosage should, therefore, be adjusted individually depending on the ovarian response. Recommendations about dosage and duration of treatment may change depending on the actual treatment protocol.
Anovulatory infertility:
Menotrophin is administered to induce follicular maturation and is followed by treatment with chorionic gonadotrophin to stimulate ovulation and corpus luteum formation.
MENOPUR therapy should start within the initial 7 days of the menstrual cycle. The recommended initial dose of MENOPUR is 75-150 IU daily, which should be maintained for at least 7 days. Based on clinical monitoring (including ovarian ultrasound alone or in combination with measurement of oestradiol levels) subsequent dosing should be adjusted according to individual patient response. Adjustments in dose should not be made more frequently than every 7 days. The recommended dose increment is 37.5 IU per adjustment and should not exceed 75 IU. The maximum daily dose should not be higher than 225 IU. If a patient fails to respond adequately after 3 weeks of treatment, that cycle should be abandoned, and the patient should recommence treatment at a higher starting dose than in the abandoned cycle.
When an optimal response is obtained, administration of MENOPUR is stopped. A single injection of 5,000 IU to 10,000 IU of hCG should be given 1 day after the last MENOPUR injection. The patient is recommended to have coitus on the day of and the day following hCG administration. Alternatively, intrauterine insemination (IUI) may be performed. If an excessive response to MENOPUR is obtained, treatment should be stopped and hCG withheld (see section 4.4), and the patient should use a barrier method of contraception or refrain from having coitus until the next menstrual bleeding has started. Treatment should recommence in the next treatment cycle at a dose lower than in the previous cycle.
Women undergoing controlled ovarian hyperstimulation for multiple follicular development for assisted reproductive technologies (ART):
In a protocol using down-regulation with a GnRH agonist, MENOPUR therapy should start approximately 2 weeks after the start of agonist treatment. In a protocol using down-regulation with a GnRH antagonist, MENOPUR therapy should start on day 2 or 3 of the menstrual cycle. The recommended initial dose of MENOPUR is 150-225 IU daily for at least the first 5 days of treatment. Based on clinical monitoring (including ovarian ultrasound alone or in combination with measurement of oestradiol levels) subsequent dosing should be adjusted according to individual patient response and should not exceed more than 150 IU per adjustment. The maximum daily dose given should not be higher than 450 IU daily and, in most cases, dosing beyond 20 days is not recommended.
When a suitable number of follicles have reached an appropriate size a single injection of 5,000 IU up to 10,000 IU hCG should be administered to induce final follicular maturation in preparation for oocyte retrieval. Patients should be followed closely for at least 2 weeks after hCG administration. If an excessive response to MENOPUR is obtained treatment should be stopped and hCG withheld (see section 4.4) and the patient should use a barrier method of contraception or refrain from having coitus until the next menstrual bleeding has started.
Male infertility:
Spermatogenesis is stimulated with chorionic gonadotrophin (1000 – 2000 IU two to three times a week) and then menotrophin is given in a dose of 75 or 150 IU units of FSH with 75 or 150 IU units of LH two or three times weekly. Treatment should be continued for at least 3 or 4 months.
Paediatric population:
There is no relevant use of MENOPUR in the paediatric population.
Elderly:
There is no relevant use of MENOPUR in the elderly population.
Method of Administration:
By intramuscular or subcutaneous use.
The powder must be reconstituted immediately with the solvent provided prior to use (see section 6.6). In order to avoid the injection of large volumes up to 3 vials of the powder may be dissolved in 1 ml of the solvent provided.
Shaking should be avoided. The solution should not be used if it contains particles or if it is not clear.
4.3. Contraindications
Women and Men
MENOPUR is contraindicated in women and men with:
- Tumours of the pituitary gland or hypothalamus
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Women
- Ovarian, uterine or mammary carcinoma
- Pregnancy and lactation
- Gynaecological haemorrhage of unknown aetiology
- Ovarian cysts or enlarged ovaries not due to polycystic ovarian disease.
In the following situations treatment outcome is unlikely to be favourable, and therefore MENOPUR should not be administered:
- Primary ovarian failure
- Malformation of sexual organs incompatible with pregnancy
- Fibroid tumours of the uterus incompatible with pregnancy
- Structural abnormalities in which a satisfactory outcome cannot be expected, for example, tubal occlusion (unless superovulation is to be induced for IVF), ovarian dysgenesis, absent uterus or premature menopause.
Men
- Tumours in the testes
- Prostate carcinoma
4.4. Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
MENOPUR is a potent gonadotropic substance capable of causing mild to severe adverse reactions and should only be used by physicians who are thoroughly familiar with infertility problems and their management.
Gonadotrophin therapy requires a certain time commitment by physicians and supportive health professionals, and calls for monitoring of ovarian response with ultrasound, alone or in combination with measurement of serum oestradiol levels, on a regular basis. There is considerable inter-patient variability in response to menotrophin administration, with a poor response to menotrophin in some patients. The lowest effective dose in relation to the treatment objective should be used.
The first injection of MENOPUR should be performed under direct medical supervision.
Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated. In particular, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given.
Patients undergoing stimulation of follicular growth, whether in the frame of a treatment for anovulatory infertility or ART procedures may experience ovarian enlargement or develop hyperstimulation. Adherence to recommended MENOPUR dosage and regimen of administration, and careful monitoring of therapy will minimise the incidence of such events. Acute interpretation of the indices of follicle development and maturation requires a physician who is experienced in the interpretation of the relevant tests.
Ovarian Hyperstimulation Syndrome (OHSS)
OHSS is a medical event distinct from uncomplicated ovarian enlargement. OHSS is a syndrome that can manifest itself with increasing degrees of severity. It comprises marked ovarian enlargement, high serum sex steroids, and an increase in vascular permeability which can result in an accumulation of fluid in the peritoneal, pleural and rarely, in the pericardial cavities.
The following symptoms may be observed in cases of OHSS: abdominal pain, abdominal distension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptoms including nausea, vomiting and diarrhoea. Clinical evaluation may reveal hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, haemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events.
If urinary oestrogen levels exceed 540 nmol (150 micrograms)/24 hours, or if plasma 17 beta-oestradiol levels exceed 3000 pmol/L (800 picograms/ml), or if there is any steep rise in values, there is an increased risk of hyperstimulation and MENOPUR treatment should be immediately discontinued and human chorionic gonadotrophin withheld. Ultrasound will reveal any excessive follicular development and unintentional hyperstimulation.
The severe form OHSS may be life-threatening and is characterised by large ovarian cysts (prone to rupture), acute abdominal pain, ascites, very often hydrothorax and occasionally thromboembolic phenomena. Other symptoms that may be observed include: abdominal distension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptoms including nausea, vomiting and diarrhoea. Clinical evaluation may reveal hypovolaemia, haemoconcentration, electrolyte imbalances, haemoperitoneum, pleural effusions and acute pulmonary distress.
Excessive ovarian response to gonadotrophin treatment seldom gives rise to OHSS unless hCG is administered to trigger ovulation. Therefore, in cases of ovarian hyperstimulation it is prudent to withhold hCG and advise the patient to refrain from coitus or to use barrier methods for at least 4 days. OHSS may progress rapidly (within 24 hours to several days) to become a serious medical event, therefore patients should be followed for at least two weeks after the hCG administration.
Adherence to recommended MENOPUR dosage, regimen of administration and careful monitoring of therapy will minimise the incidence of ovarian hyperstimulation and multiple pregnancy (see sections 4.2 and 4.8). Patients undergoing controlled ovarian hyperstimulation may be at an increased risk of developing hyperstimulation in view of the excessive oestrogen response and multiple follicular development. In ART, aspiration of all follicles prior to ovulation may reduce the occurrence of hyperstimulation.
OHSS may be more severe and more protracted if pregnancy occurs. Most often, OHSS occurs after hormonal treatment has been discontinued and reaches its maximum severity at about seven to ten days following treatment. Usually, OHSS resolves spontaneously with the onset of menses.
If severe OHSS occurs, gonadotrophin treatment should be stopped if still ongoing, the patient hospitalised and specific therapy for OHSS started.
This syndrome occurs with higher incidence in patients with polycystic ovarian disease.
Multiple pregnancy
Multiple pregnancy, especially high order, carries an increased risk of adverse maternal and perinatal outcomes.
In patients undergoing ovulation induction with gonadotrophins, the incidence of multiple pregnancies is increased compared with natural conception. The majority of multiple conceptions are twins. To minimise the risk of multiple pregnancy, careful monitoring of ovarian response is recommended.
In patients undergoing ART procedures the risk of multiple pregnancy is related mainly to the number of embryos replaced, their quality and the age of the patient.
The patient should be advised of the potential risk of multiple births before starting treatment.
Pregnancy wastage
The incidence of pregnancy wastage by miscarriage or abortion is higher in patients undergoing stimulation of follicular growth for ART procedures than in the normal population.
Ectopic pregnancy
Women with a history of tubal disease are at risk of ectopic pregnancy, whether the pregnancy is obtained by spontaneous conception or with fertility treatment. The prevalence of ectopic pregnancy after IVF has been reported to be 2 to 5%, as compared to 1 to 1.5% in the general population.
Reproductive system neoplasms
There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for infertility treatment. It is not yet established if treatment with gonadotrophins increases the baseline risk of these tumours in infertile women.
Congenital malformation
The prevalence of congenital malformations after ART may be slightly higher than after spontaneous conceptions. This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and multiple pregnancies.
Thromboembolic events
Women with generally recognised risk factors for thromboembolic events, such as personal or family history, severe obesity (Body Mass Index > 30kg/m2) or thrombophilia may have an increased risk of venous or arterial thromboembolic events, during or following treatment with gonadotrophins. In these women, the benefits of gonadotrophin administration need to be weighed against the risks. It should be noted however, that pregnancy itself also carries an increased risk of thromboembolic events.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed with MENOPUR in humans.
Although there is no controlled clinical experience, it is expected that the concomitant use of MENOPUR and clomiphene citrate may enhance the follicular response. When using GnRH agonist for pituitary desensitization, a higher dose of MENOPUR may be necessary to achieve adequate follicular response.
4.6. Fertility, pregnancy and lactation
Fertility
MENOPUR is indicated for use in infertility (see section 4.1).
Pregnancy
MENOPUR is contraindicated in women who are pregnant (see section 4.3).
There are no or limited amount of data from the use of menotrophins in pregnant women. No animal studies have been carried out to evaluate the effects of MENOPUR during pregnancy (see section 5.3).
Breast-feeding
MENOPUR is contraindicated in women who are breast-feeding (see section 4.3).
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, MENOPUR is unlikely to have influence on the patient's ability to drive and use machines.
4.8. Undesirable effects
The most frequently reported adverse drug reactions (ADR) during treatment with MENOPUR in clinical trials are Ovarian Hyperstimulation Syndrome OHSS, abdominal pain, headache, abdominal distension, and injection site pain. None of these ADRs have been reported with an incidence rate of more than 5%.
The table below displays the main ADR in women treated with MENOPUR in clinical trials distributed by system organ classes (SOCs) and frequency. ADRs seen during post-marketing experience are mentioned with unknown frequency.
System Organ Class
Common
(> 1/100 to < 1/10)
Uncommon
(> 1/1,000 to < 1/100)
Rare
(> 1/10,000 to < 1/1,000)
Unknown
Eye disorders
Visual disorders
Gastrointestinal disorders
Abdominal pain,
Abdominal distension,
Nausea
Vomiting,
Abdominal discomfort,
Diarrhoea
General disorders and administration site condition
Injection site reactions a
Fatigue
Immune system disorders
Hypersensitivity reactions b
Investigations
Musculoskeletal & connective tissue disorders
Musculoskeletal pain c
Nervous system disorders
Headache
Dizziness
Reproductive system disorders
OHSS d,
Pelvic paine
Ovarian cyst,
Breast complaints f
Ovarian torsion d
Skin and subcutaneous tissue disorders
Acne, Rash
Pruritus,
Urticaria
Vascular Disorders
Hot flush
a Most frequently reported injection site reaction was injection site pain.
b Cases of localised or generalised allergic reactions , including anaphylactic reaction, along with associated symptomatology have been reported rarely.
c Musculoskeletal pain includes arthralgia, back pain, neck pain and pain in extremities.
d Gastrointestinal symptoms associated with OHSS such as abdominal distension and discomfort, nausea, vomiting, diarrhoea have been reported with MENOPUR in clinical trials. In cases of severe OHSS ascites and pelvic fluid collection, pleural effusion, dyspnoea, oliguria, thromboembolic events and ovarian torsion have been reported as rare complications.
e Pelvic pain includes ovarian pain and adnexa uteri pain.
f Breast complaints include breast pain, breast tenderness, breast discomfort, nipple pain and breast swelling.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, website: https://yellowcard.mhra.gov.uk/
4.9. Overdose
The effects of an overdose is unknown, nevertheless one could expect ovarian hyperstimulation syndrome to occur (see section 4.4).
💬 Ask about this leaflet
Ask anything about Menopur 150 IU Powder and Solvent for Solution for Injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.