Menopur ® 75 Iu/600 Iu/1200 Iu Solution

MENOPUR ® is a highly purified, sterile freeze dried powder for injection. It contains the active ingredient menotrophin with follicle stimulating hormone activity (FSH) and luteinising hormone activity (LH) MENOPUR ® is used for infertility treatment.

In females:

• Women who cannot become pregnant because their ovaries do not produce eggs (including polycystic ovarian disease).
• Women in assisted reproductive technology programs (ART) (including in vitro fertilisation/embryo transfer [IVF/ET], gamete intra-fallopian transfer [GIFT] and intracytoplasmic sperm injection [ICSI]. MENOPUR ® helps the ovaries to develop many egg sacs (follicles) where an egg might develop (multiple follicular development).

In males:

• To treat low sperm count (oligospermia).

MENOPUR ® should not be administered to you:

• if you are hypersensitive (allergic) to menotrophin or any of the other ingredients of MENOPUR ® (listed in section 6)
• if you have tumours of the uterus (womb), ovaries, breasts, testicles, prostate, pituitary gland or hypothalamus
• if you have cysts on your ovaries or enlarged ovaries (unless caused by polycystic ovarian disease).
• if you have any physical defects of the uterus (womb) or other sexual organs
• if you suffer from bleeding from the vagina where the cause is not known
• if you have fibroids of the uterus (womb)
• if you are pregnant or breastfeeding
• if you have experienced an early menopause.

Warnings and precautions

Tell your doctor or health care provider before being given the injection:

• if you experience pain in the abdomen
• if you experience swelling in the abdomen
• if you experience nausea
• if you are vomiting
• if diarrhoea occurs
• if you gain weight
• if you experience difficulty in breathing
• if a decrease in urination occurs.

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 (see section 3, ‘If you stop using MENOPUR ® ’).

While you are being treated with MENOPUR ®, 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 have developed tumours in the ovaries and other reproductive organs. It is not yet known if treatment with hormones like MENOPUR ® causes these problems. Infertility treatment can increase the chances of blood clots in the veins especially if you are overweight or if you or someone in your family (blood relative) has had blood clots. Tell your doctor if you think this applies to you.

Special populations

MENOPUR ® is not recommended for elderly patients.

MENOPUR ® is not recommended for children.

Other medicines and MENOPUR ®

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines).

Pregnancy, breastfeeding and fertility

You should not use MENOPUR ® if you are pregnant or breastfeeding your baby. MENOPUR ® is indicated for use in infertility (see section 1). If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking MENOPUR ®.

Driving and using machines

MENOPUR ® may make you feel dizzy which may influence your ability to drive and use machinery. It is not always possible to predict to what extent MENOPUR ® may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which MENOPUR ® affects them.

MENOPUR ® contains sodium MENOPUR ® contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

Do not share medicines prescribed for you with any other person. Always use MENOPUR ® exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. MENOPUR ® should only be used under the supervision of a medical practitioner suitably qualified in the treatment of infertility. There are many different dosage schemes and your doctor will decide which one is appropriate for you.

In females:

To induce follicular maturation:

In menstruating patients, treatment will be started within the first 7 days of the menstrual cycle. A daily dose of 75 to 150 IU of MENOPUR ® will be given for at least 7 days. The dose may then be adjusted by your doctor, according to your body’s response, up to a maximum daily dose of 225 IU of MENOPUR ®.

To induce multiple follicular development:

Stimulation of follicular growth is produced by MENOPUR ® in daily doses of 150 to 225 IU. Treatment will be maintained for at least 5 days. A maximum daily dose of 450 IU may be given and treatment beyond 20 days is not recommended.

In males:

Treatment of oligospermia:

MENOPUR ® will be given in a dose of 75 IU every other day. A maintenance of 75 to 150 IU every week is recommended. Treatment will normally continue for at least 90 to 120 days. Your doctor will tell you how long your treatment with MENOPUR ® will last. If you have the impression that the effect of MENOPUR ® is too strong or too weak, tell your doctor or pharmacist.

Method of administration

MENOPUR ® will be administered as an injection under the skin or in the muscle:

• MENOPUR ® 75 IU is intended for injection under the skin [subcutaneous (S.C.)] or into the muscle [intramuscular (I.M.)], after reconstitution with the solvent provided
• MENOPUR ® 600 IU and 1200 IU are intended for S.C injection as the syringe provided is for S.C. administration only. If your clinic has asked you to inject MENOPUR ® yourself, you should follow the instructions provided below (see section 6). The first injection of MENOPUR ® should be given under the supervision of a doctor.

MENOPUR ® is provided as a powder in small bottles (vials) and must be dissolved before it is injected. The liquid (solvent) which you should use to dissolve MENOPUR ® is provided with the powder.

• MENOPUR ® 75 IU: Once MENOPUR ® 75 IU dry powder has been mixed with the solvent it should be used straight away.
• MENOPUR ® 600 IU and 1200 IU: The reconstituted solution is intended for multiple uses over a period of 28 days and can be stored below 30°C.

If you use more MENOPUR ® than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to use MENOPUR ®

Do not give a double dose to make up for forgotten individual doses. Please tell your doctor, nurse or pharmacist.

If you stop using MENOPUR ®

If you stop using MENOPUR ® you might experience some symptoms (see section 2, ‘Warnings and precautions’). Please contact your doctor immediately if any of these symptoms occur.

MENOPUR ® can have side effects. Not all side effects reported for MENOPUR ® are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using MENOPUR ®, please consult your health care provider for advice. If any of the following happens, stop using MENOPUR ® and tell your doctor immediately or go to the casualty department at your nearest hospital:

• rash or itching,
• swelling of the throat,
• difficulty in breathing.

These are all very serious side effects. If you have them, you may have had a serious reaction to MENOPUR ®. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following symptoms, even if they develop some days after the last injection has been given. Treatment with MENOPUR ® may cause high levels of activity in the ovaries leading to a disease called Ovarian Hyperstimulation Syndrome (OHSS), especially in women with polycystic ovaries. Symptoms include:

• pain and swelling in the abdomen
• nausea
• vomiting
• diarrhoea
• weight gain.

In cases of severe OHSS:

• fluid in abdomen, pelvis and/or chest cavity
• difficulty in breathing
• decreased urination
• formation of blood clots in blood vessels (thromboembolism)
• twisted ovaries (ovarian torsion).

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

Common side effects:

• overstimulation of the ovaries resulting in high levels of activity (ovarian hyperstimulation syndrome)
• pain in the abdomen
• swelling in the abdomen
• pelvic pain
• injection site pain and reactions (such as redness, bruising, swelling and/or itching)
• headache
• nausea.

Uncommon side effects:

• vomiting
• discomfort in abdomen

Rare side effects:

• acne
• rash.

Unknown side effects:

(the frequency of these side effects reported during post-marketing experience is not known)

• twisted ovaries (ovarian torsion)
• fever
• blood clots in your legs (venous thrombosis, pulmonary embolism)
• eyesight disturbances
• feeling sick
• increase in weight
• pains in muscle and joint e.g. back pain, neck pain and pain in arms and legs
• itching
• hives.

In men, the following side effects were observed since MENOPUR ® has been marketed and frequency of these side effects is unknown:

• enlargement of the male breast tissue known as gynaecomastia
• acne
• weight gain
• administration site reactions and hypersensitivity may occur.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/documents/adverse-drug-reactions-and-quality-problem-reporting-form. By reporting side effects, you can help provide more information on the safety of MENOPUR ®.

MENOPUR ® 75 IU and MENOPUR ® SOLVENT:

• Store all medicines out of reach of children.
• Do not store above 30 ºC.
• Do not freeze.
• Store in the original container.
• Protect from light.
• For immediate and single use following reconstitution.
• Discard any unused portion.
• Do not use this medicine after the expiry date stated on the container.

MENOPUR ® 600 IU and 1200 IU:

• Store all medicines out of reach of children.
• Prior to reconstitution: Store in a refrigerator (2 °C to 8 ºC). Do not freeze.
• Store in the original container, within the outer carton until required for use.
• After reconstitution: The solution can be stored for a maximum of 28 days below 30 ºC. Do not freeze.
• The reconstituted solution should not be administered if it contains particles or is not clear.
• Do not use MENOPUR ® after the expiry date which is stated on the carton.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).