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Pergonal (Human Menopausal Gonadotrophin (HMG).)

Dizpharm Nigeria Limited
8, Akanbi-Onitiri Crescent, Off Eric Moore Road, Surulere, Lagos. Lagos.
Email: dizpharm@hyperia.com
Tel: 234-1-5875179, 5874082, 5877689; 90405798
Fax: 234-1-5875437

Brand Name

Pergonal (Human Menopausal Gonadotrophin (HMG).)

Manufacturer

Laboratories Serono SA., 1170, Aubonne, Switzerland.

Therapeutic Class

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Injections (NRN: 04-2006): Each ampoule of Pergonal contains Human Follicle-stimulating hormone (FSH) 75 IU, Human Luteinizing hormone (LH) 75 IU. Lactose (excipient) 10 mg.

 

How to identify the Product: White, freeze-dried, sterile and pyrogen-free powder.

 

Pack Size: Ampoules of Pergonal are packed singly and in boxes of ten. Each ampoule is accompanied by an ampoule of 1 mL of physiologic Sodium Chloride injection as solvent.

Pharmacology

Description:

Menotrophin Injection for IM use only. Ampoules of Pergonal contain Human menopausal gonadotrophin (HMG; Approved Name: Menotrophin) as a white freeze dried sterile and pyrogen free powder. Two strengths are available: 75 and 150 IU. 

One IU of human urinary FSH and one IU of human urinary LH are defined as the activities contained in 0.11388 mg and 0.13369 mg of the 1st International Standard, respectively.

Each ampoule of Pergonal is accompanied by a solvent ampoule containing 1 mL of isotonic, sterile and pyrogen-free Sodium Chloride Injection solution. Human menopausal gonadotrophin (HMG) is a hormonal substance containing FSH and LH in a ratio of about 1:1.

In the female, Pergonal stimulates both the growth and the maturation of follicles, it induces an increase of the oestrogen levels and a proliferation of the endometrium.

In the male, Pergonal stimulates spermatogenesis by acting on the production of the androgen-binding protein in the seminiferous tubules of the Sertoli cells.

Indications

Women:
Pergonal and subsequently chorionic gonadotrophin (hCG, Profasi) are indicated for the induction of ovulation in the amenorrhoeic patient or anovulatory woman with regular or irregular cycles.

Men:
Pergonal with concomitant Profasi therapy is indicated for the stimulation of spermatogenesis in men who have primary or secondary hypogonadotrophic hypogonadism.

Contra-indications

Women:
Pergonal therapy is precluded when an effective response cannot be obtained e.g. Ovarian dysgenesis; Absent uterus; Premature menopause; Tubal occlusion.

Men:
Elevated androgenous FSH levels indicative of primary testicular failure. Such patients are usually unresponsive to Pergonal/Profasi therapy.

Precautions/Warnings

Women:

Appropriate treatment should first be given for hypothyroidism, adrenocortical deficiency, hyperprolactinaemia or pituitary tumour. An acceptable semen analysis should be available before Pergonal treatment.

Adherence to the recommended dosage and monitoring schedules will minimize the possibility of ovarian hyperstimulation. Excessive oestrogenic responses to Pergonal do not generally give rise to significant side effects unless Profasi is given to induce ovulation.

Hormone assays will detect an excessive oestrogen response to Pergonal, and Profasi administration should be withheld. The incidence of multiple births following Pergonal/Profasi therapy has been variously reported between 10% and 40%.

However, the majority of multiple conceptions are twins. Pregnancy wastage by abortion is higher than in a normal population but comparable with the rates in women with other fertility problems. The risks of congenital abnormalities are not increased by Pergonal.

Interactions

Adverse Effects

In the female, a local reaction at the injection site, fever and arthralgia have been observed in rare cases. 

In the male, a combined treatment with Pergonal and HCG may cause gynaecomastia.

Dosage & Administration

Pergonal is given by IM injection only. The injection solution should be reconstituted with the solvent provided immediately prior to use. Up to 5 ampoules of Pergonal may be dissolved in 1 mL solvent.

Women:

The object is to develop a single mature Graafian follicle with individually tailored doses of Pergonal over several days and then give Profasi to release the ovum. Follicular development is judged by the concentration of oestrogen, measured in blood or urine. Clinical assessment of the response including pelvic examination and cervical mucus studies should be performed. Pergonal administration should continue until an adequate oestrogen level is achieved.

If the oestrogen values are less than either 180 nmol/24 h (50 mcg/24 h) for total urinary oestrogens or 1100 pmol/L (300 pg/ml) for plasma 17 beta-oestradiol, follicular development may be inadequate. Conversely, if the levels are higher than either 514 nmol/24 h (140 mcg/24 h) for total urinary oestrogens or 3000 pmol/L (800 pg/mL) for plasma 17 beta-oestradiol, there is an increased risk of ovarian hyperstimulation and Profasi should be withheld.

The optimal time for Profasi administration is the day of the urinary oestrogen peak or the day after the plasma 17 beta-oestradiol peak. In the anovulatory patient the stimulated follicles will not liberate ova spontaneously. Follicle rupture has to be achieved by injecting Profasi, which stimulates the normal surge of LH at ovulation.

If the patient wishes to conceive, she is recommended to have coitus on the day when Profasi is given and on the following day. The dose of Pergonal required to evoke the desired response is critical and varies both from patient to patient and in the same patient at different times. Monitoring by hormone assay is therefore essential. Two dosage schedules may be employed. 

Schedule 1:
Alternate day therapy - Three equal doses of Pergonal are given on alternate days. In a menstruating woman the initial injection of Pergonal should be given on day 7, 8 or 9 of the cycle.

A single dose of 10,000 IU Profasi is given one week after the first injection of Pergonal, provided the clinical and biochemical responses are adequate and not excessive. 

Schedule 2:
Daily therapy - Daily injections of Pergonal are given until an adequate response is achieved. This is judged on the basis of daily oestrogen determination. In the absence of a response, the dose of Pergonal may be increased or the course abandoned. 

A single injection of 10,000 IU Profasi is administered 24-48 hours after the last dose of Pergonal. Further details concerning Pergonal dosage and monitoring are available on request. Schedule 2 is most commonly used. 

Men:

Treatment should begin with Profasi 2000 IU 2-3 times a week to produce evidence of adequate masculinisation. If the only response to Profasi is androgenic in nature, Pergonal (1 ampoule 3 times a week) and Profasi 2000 IU (twice a week) should be given for a minimum period of four months. If the patient has not responded with evidence of increased spermatogenesis at the end of four months, therapy may be continued with Pergonal (1 or 2 ampoules 3 times a week) and Profasi 2000 IU (twice a week).

Storage/Handling Recommendations

Ampoules of Pergonal should be stored below 25oC and should not be used after the expiry date stated on the package. Solutions of Pergonal reconstituted in physiological sodium chloride should be used immediately after preparation.

Review Date

2016-11-01 04:57:17