Menotrophin injection, all strengths
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of menotrophin (corresponding to follicle-stimulating hormone (FSH) and human luteinising hormone (LH) in a ratio of 1:1).
Drugs List
Therapeutic Indications
Uses
Anovulation unresponsive to clomifene citrate
Ovarian stimulation before in vitro fertilisation
Stimulation of spermatogenesis with concomitant hCG therapy in hypogonadism
Anovulation in amenorrhoeic women with a variety of menstrual cycle disturbances, who have been unresponsive to treatment with clomifene citrate, including women with polycystic ovary disease.
Ovarian stimulation in patients using assisted reproductive technologies such as in vitro fertilisation (IVF).
For the stimulation of spermatogenesis in men with hypogonadotrophic hypogonadism, when used in combination with human chorionic gonadotrophin. Patients with primary testicular failure are usually unresponsive to treatment.
Dosage
The lowest effective dose in relation to the treatment objective should be used in both men and women.
Adults
Anovulatory infertility
Menotrophin is administered to induce follicular maturation and is followed by treatment with chorionic gonadotrophin (hCG) to stimulate ovulation and corpus luteum formation.
The dosage and schedule of treatment must be determined according to the needs of each patient. Response is monitored by studying the patient's urinary oestrogen excretion or by ultrasound visualisation of follicles.
In menstruating patients, treatment should be started within the first 7 days of the menstrual cycle. In amenorrhoeic women (such as those with severe LH and FSH deficiency), treatment may commence at any time.
Menotrophin may be given daily to provide a dose of 75units to 150units of menotrophin, and gradually increased if necessary until an adequate response is achieved, followed after 1 or 2 days by hCG. The treatment course should be abandoned if no response is seen within 3 weeks.
An alternative treatment schedule is three equal doses of menotrophin, each providing 225units to 375units given on alternate days followed by hCG one week after the first dose.
In the daily therapy schedule, the dose is gradually increased until oestrogen levels start to rise. The effective dose is then maintained until adequate pre-ovulatory oestrogen levels are reached. If oestrogen levels rise too rapidly, the dose should be decreased. Treatment should commence in the next cycle at a lower dose than in the previous cycle.
As a measure of follicle maturity the following values can be taken:
- total urinary oestrogen: 75 to 150microgram (270 to 540nanomol)/24 hours
- plasma 17 beta-estradiol: 400 to 800picogram/ml (1500 to 3000picomol/L)
When adequate pre-ovulatory oestrogen levels have been reached, administration of menotrophin is stopped, and ovulation may then be induced by administering hCG at a dose of 5000-10000 i.u. 30 - 40 hours after the last injection of menotrophin(some manufacturers suggest 24 - 48 hours).
Women undergoing superovulation within a medically assisted fertilisation programme
In in-vitro fertilisation procedures or other assisted conception techniques, menotrophin is used in conjunction with hCG and sometimes also clomifene citrate or a gonadorelin agonist. Stimulation of follicular growth is produced by menotrophin in a dose providing 75units to 300units. Treatment is continued until an adequate response is obtained and the final injection of menotrophin is followed 1 or 2 days later with up to 10,000units of hCG to induce follicular maturation.
Follicle maturation is monitored by measurement of oestrogen levels, clinical evaluation of oestrogen levels and/or ultrasound. It is recommended that there should be at least 3 follicles greater than 17mm in diameter with 17 beta-estradiol levels of at least 3,500picomol/L (920picogram/ml). Egg maturation is achieved by administering 5000units to 10,000units of hCG 30 to 40 hours (some manufacturers suggest 24 to 48 hours) after the last injection of menotrophin. hCG should not be administered if these criteria have not been met. Egg retrieval is carried out 32 to 36 hours after the hCG injection.
Male infertility
Spermatogenesis is stimulated with hCG (1000units to 2000units two or three times a week) and then menotrophin is given in a dose of 75units or 150units two or three times weekly. Treatment should be continued for at least 3 or 4 months.
Administration
For intramuscular or subcutaneous injection after reconstitution.
Rotate subcutaneous injection sites to minimise the risk of lipoatrophy.
Contraindications
Children under 18 years
Elderly
Breast neoplasm
Breastfeeding
Fallopian tube occlusion - except in superovulation in-vitro fertilisation
Hypothalamic neoplasm
Non-polycystic ovarian cyst
Non-polycystic ovarian enlargement
Ovarian neoplasm
Pituitary neoplasm
Pregnancy
Premature menopause
Primary ovarian failure
Prostate cancer
Testicular malignancy
Undiagnosed gynaecological haemorrhage
Uterine neoplasm
Precautions and Warnings
Predisposition to venous thromboembolism
Adrenal insufficiency
Hyperprolactinaemia
Hypothyroidism
Polycystic ovarian syndrome
Porphyria
First dose should be given under medical supervision: Risk of anaphylaxis
Not all available brands are licensed for all indications
Treat other endocrine disorders and causes of infertility first
Treatment to be initiated and supervised by a specialist
Reconstitute only with the solvent supplied by the manufacturer
Exclude other causes of infertility before commencing treatment
Monitor ovarian response using ultrasound prior to and during treatment
Monitor urinary oestrogens, plasma estradiol + follicle diameter in women
Patients undergoing IVF therapy are at increased risk of ectopic pregnancy
Ovarian hyperstimulation syndrome can occur
Pregnancy: Increased risk of multiple pregnancies
Discontinue if unwanted ovarian hyperstimulation occurs
Prior to treatment patients should be evaluated for hyper thyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumours.
Patients should be advised that multiple pregnancy, particular high order pregnancy, carries a higher risk of adverse maternal and perinatal outcomes. In patients undergoing ovulation induction the majority of multiple conceptions are twins.
The incidence of pregnancy wastage by miscarriage or abortion is higher in patients undergoing stimulation of follicular growth for ovulation induction or assisted reproduction technologies than in the normal population.
The incidence of congenital malformations after ART may be slightly higher than in spontaneous conceptions, and is believed to be related to differences in parental characteristics (e.g. sperm characteristics, maternal age) and multiple pregnancy.
Ovarian hyperstimulation syndrome (OHSS)
Ultrasonographical assessment of follicular development and oestrogen levels can confirm diagnosis of OHSS. If urinary oestrogen levels rise above 150micrograms/24 hours, or if plasma 17 beta-estradiol levels rise above 3000picomol/L, or if there is a rapid and significant rise in these values, the patient is at an increased risk of developing OHSS and treatment should be discontinued immediately. In the event of hyperstimulation the patient should be advised to refrain from coitus or to use barrier methods of contraception for at least 4 days and hCG must be withheld.
If during ultrasound of patient (not currently receiving treatment for multiple follicular development before assisted reproductive technologies), several mature follicle are visualised, then hCG should not be given as there is risk of multiple ovulation and hyperstimulation syndrome.
Adherence to the recommended dosage schedule and careful monitoring during treatment will minimise the risk of developing OHSS and multiple pregnancy.
Pregnancy and Lactation
Pregnancy
Menotrophin is contraindicated during pregnancy.
Use of menotrophin during pregnancy is contraindicated by the manufacturer. At the time of writing there is limited published information regarding the use of menotrophin during pregnancy. Potential risks are unknown.
Lactation
Menotrophin is contraindicated during breastfeeding.
Use of menotrophin when breastfeeding is contraindicated by the manufacturer. Effects on exposed infants are unknown.
Side Effects
Abdominal cramps
Abdominal distension
Abdominal pain
Ascites
Back pain
Bruising at injection site
Deep vein thrombosis (DVT)
Dizziness
Enlarged abdomen
Fatigue
Fever
Haemorrhagic cystitis
Headache
Hot flushes
Hypersensitivity reactions
Increased risk of ectopic pregnancy
Joint pain
Local pain (injection site)
Local reaction at injection site
Multiple pregnancy
Nausea
Ovarian cysts
Ovarian hyperstimulation syndrome (OHSS)
Ovarian torsion
Pelvic pain
Pleural effusion
Shock
Swelling (injection site)
Thirst
Thromboembolic disorders
Vomiting
Weight gain
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: November 2019
Reference Sources
Summary of Product Characteristics: MERIOFERT 75 IU powder and solvent for solution for injection. Pharmasure Ltd. Revised April 2017.
Summary of Product Characteristics: MERIOFERT 150 IU powder and solvent for solution for injection. Pharmasure Ltd. Revised April 2017.
Summary of Product Characteristics: Menopur 75 IU. Ferring Pharmaceuticals. Revised September 2015.
Summary of Product Characteristics: Menopur 150 IU. Ferring Pharmaceuticals. Revised April 2017.
Summary of Product Characteristics: Menopur 600 IU. Ferring Pharmaceuticals. Revised May 2015.
Summary of Product Characteristics: Menopur 1200 IU. Ferring Pharmaceuticals. Revised May 2015.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 27 September 2019
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