MENOPUR 1200 IU SOLUTION FOR INJECTION IN PRE-FILLED PEN - patient leaflet, side effects, dosage

MENOPUR® 600 IU solution for injection in pre-filled pen

Highly purified menotrophin

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet.

See section 4.

What is in this leaflet

• 1. What MENOPUR is and what it is used for

• 2. What you need to know before you use MENOPUR

• 3. How to use MENOPUR

• 4. Possible side effects

• 5. How to store MENOPUR

• 6. Contents of the pack and other information

1. What MENOPUR is and what it is used for

MENOPUR comes as a solution for injection in a pre-filled pen. The injection is given under your skin (‘subcutaneous’ injection), usually in the tummy.

What MENOPUR is

MENOPUR contains the active substance, ‘menotrophin’, which belongs to a group of medicines called gonadotrophins. Menotrophin is a highly purified mixture of two natural hormones called:

• Follicle Stimulating Hormone (FSH) and
• Luteinizing Hormone (LH).

These hormones help reproductive organs to work normally in both men and women. The FSH and LH hormones in menotrophin are obtained from the urine of women who have passed the menopause.

What MENOPUR is used for

In women , MENOPUR is used to treat infertility (women who cannot become pregnant), 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.
• 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).

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)

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

MENOPUR is not used 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

Do not use MENOPUR if you are pregnant or breast-feeding.

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’.

2. what you need to know before you use menopur

Checks before you use 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.
• 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.
• 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 of the stomach (abdomen)
• You get nausea or vomiting
• You get diarrhoea
• 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.

3. how to use menopur

Always use MENOPUR exactly as your doctor or nurse has told you. You should check with your doctor or nurse if you are not sure.

Using MENOPUR

Follow the ‘Instructions for Use (IFU)’ for the pre-filled pen very carefully. IFU provided separately inside the carton.

Do not use the pre-filled pen if:

• the solution contains particles or
• the solution does not look clear

A doctor or nurse will be there for your first injection of MENOPUR. Your doctor will decide if you can give yourself the following injections at home, after you have been fully trained.

You will be given MENOPUR as an injection under the skin (‘subcutaneous’ injection). This is usually in the tummy. Each pre-filled pen may be used for several injections.

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.

I. Women who are not ovulating (not producing eggs):

Your treatment will start within the first 7 days of your menstrual cycle.

• Day 1 is the first day of your period.
• You will have injections every day for at least 7 days.

How much MENOPUR?

• The normal starting dose is between 75 and 150 IU every day.
• The dose may be adjusted depending on your response (up to a maximum of 225 IU).
• You will have the chosen dose for at least 7 days before the doctor changes it.
• The dose will normally be increased by 37.5 IU at a time. It will not be increased by more than 75 IU each time.

Your doctor will monitor the effect of MENOPUR treatment. The treatment cycle will stop if you do not respond to the treatment after 3 weeks.

If you have a good response to MENOPUR:

• You will get a single injection of a hormone called ‘human chorionic gonadotrophin’ (hCG).
• The dose will be between 5,000 and 10,000 IU.
• You will get the hCG injection one day after your last MENOPUR injection.
• It is recommended to have sexual intercourse on the day of the hCG injection and the day after. Alternatively, sperm may be injected directly into your womb, known as ‘artificial insemination’.
• Your doctor will then monitor you closely for at least two weeks.

If you do not respond to MENOPUR:

• Your doctor will monitor the effect of MENOPUR treatment.
• Depending on your progress, 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 (for example a condom).
• Otherwise you should 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.

• II. Women in assisted reproduction programmes:

If you are in an assisted reproduction programme, you will also have a medicine which helps a hormone called ‘Gonadotropin Releasing Hormone’ (GnRH) to work. This other medicine is called a ‘GnRH agonist’. MENOPUR should be started around 2 weeks after the start of the GnRH agonist therapy.

You may also be having a medicine called 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).

How much MENOPUR?

• MENOPUR should be given every day for at least 5 days.
• The initial dose of MENOPUR is normally 150–225IU.
• 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 each time.
• Normally, treatment should not continue for more than 20 days.

If enough egg sacs (or follicles) 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 been given the hCG injection.

Your doctor will monitor the effect of MENOPUR treatment.

• Depending on your progress, your doctor may decide to stop treatment with MENOPUR and not give you the hCG injection.
• In this case, you will be told to use a barrier method of contraception (for example a condom).

Otherwise you should 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.

If you take more MENOPUR than you should

If you think you have used too much MENOPUR, tell your doctor or nurse. The effects of taking too much of this medicine are unknown. Ovarian hyperstimulation syndrome may possibly occur, which is described in section 4 below.

If you forget to take MENOPUR

Do not take a double dose to make up for a forgotten dose. Please tell your doctor or nurse.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. possible side effects

Like all medicines, MENOPUR can cause side effects, although not everybody gets them.

Side effects that can occur 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.

Side effects that can occur in both women and men:

STOP USING MENOPUR if you experience allergic (hypersensitivity) reactions including; itching, skin rashes, swelling of the face, lips or throat, 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 (feeling sick)
• 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)

Uncommon (may affect up to 1 in 100 people):

• Vomiting (being sick)
• Discomfort in the stomach
• Diarrhoea
• Fatigue (feeling tired)
• Dizziness
• Sacs of fluid within ovaries (ovarian cysts)
• Breast complaints (include breast pain, tenderness, discomfort, swelling and nipple pain)
• Hot flushes

Rare (may affect up to 1 in 1,000 people)

• Acne (spots)
• Rash

Unknown (the frequency of these reported side effects is not known)

• Problems with eyesight
• Allergic reactions
• Muscle and joint pains (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 or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store menopur

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 pre-filled pen label and carton after ‘EXP’. The expiry date refers to the last day of that month.

Before use: Store in a refrigerator, between 2 °C and 8 °C. Do not freeze.

After first use (in-use period): Use each pre-filled pen within 28 days of opening. After opening, store below 25 °C for a maximum of 28 days.

Always store the pen with the pen cap on, in order to protect from light.

At the end of the treatment, any unused solution must be discarded.

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.

6. contents of the pack and other information

What MENOPUR contains

The active substance is highly purified menotrophin (human menopausal gonadotrophin, HMG).

MENOPUR 600 IU solution for injection in pre-filled pen:

One pre-filled multidose pen delivers menotrophin corresponding to follicle stimulating hormone activity FSH 600 IU and luteinizing hormone activity LH 600 IU.

MENOPUR 1200 IU mL solution for injection in pre-filled pen:

One pre-filled multidose pen delivers menotrophin corresponding to follicle stimulating hormone activity FSH 1200 IU and luteinizing hormone activity LH 1200 IU.

The other ingredients are:

• Phenol
• Methionine
• Arginine hydrochloride
• Polysorbate 20
• Sodium hydroxide
• Hydrochloric acid, dilute
• Water for injections

What MENOPUR looks like and contents of the pack

MENOPUR is a clear and colourless solution for injection in a pre-filled pen.

MENOPUR 600 IU mL solution for injection in pre-filled pen is available in packs of 1 pre-filled pen and 12 pen injection needles.

MENOPUR 1200 IU solution for injection in pre-filled pen is available in packs of 1 pre-filled pen and 21 pen injection needles.

Marketing Authorisation Holder and Manufacturer

Ferring Pharmaceuticals Ltd.,

Drayton Hall, Church Road, West Drayton, UB7 7PS, (UK).

MENOPUR 600 IU solution for injection in pre-filled pen – PL 03194/0138

MENOPUR 600 IU solution for injection in pre-filled pen – PL 03194/0139

Manufacturer

Ferring GmbH

Wittland 11, D-24109 Kiel, Germany

This leaflet was last revised in November 2020.

FERRING

PHARMACEUTICALS