Follitropin Alfa + Lutropin Alfa

Introduction: Follitropin Alfa + Lutropin Alfa is a preparation of recombinant human follicle stimulating hormone (follitropin alfa, r-hFSH) and recombinant human luteinising hormone (lutropin alfa, r-hLH) produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.

How it works: This injection stimulates follicular development in women with severe LH and FSH deficiency. The primary effect resulting from administration of lutropin alfa is an increase in oestradiol secretion by the follicles, the growth of which is stimulated by FSH.

Important Information: In clinical trials, the ovulation rate per cycle was 70-75% in patients with severe FSH and LH deficiency. Treatment should be tailored to the individual patient's response.

• Stimulation of follicular development in adult women with severe LH and FSH deficiency - defined by an endogenous serum LH level < 1.2 IU/L in clinical trials.

Drugs for Infertility

Recombinant Gonadotropin

This injection is a preparation of recombinant human follicle stimulating hormone (follitropin alfa, r-hFSH) and recombinant human luteinising hormone (lutropin alfa, r-hLH) produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. In clinical trials the efficacy of the combination of follitropin alfa and lutropin alfa has been demonstrated in women with hypogonadotropic hypogonadism. In the stimulation of follicular development in anovulatory women deficient in LH and FSH, the primary effect resulting from administration of lutropin alfa is an increase in oestradiol secretion by the follicles, the growth of which is stimulated by FSH.

Follitropin alfa stimulates follicular growth and lutropin alfa increases oestradiol secretion, which helps in follicular maturation and ovulation.

Adult Dose (Women with LH and FSH deficiency):

• Start with one vial daily (subcutaneous injection).
• If needed, increase FSH dose by 37.5-75 IU after 7-14 day intervals.
• Stimulation in any one cycle may be extended up to 5 weeks.
• When optimal response is obtained, administer r-hCG (250 mcg) or hCG (5,000-10,000 IU) 24-48 hours after the last injection.
• If excessive response occurs, stop treatment and withhold hCG.

* Use as directed by the registered physician

Subcutaneous injection. The first injection should be performed under direct medical supervision. The powder should be reconstituted immediately prior to use with the solvent provided. Self-administration only for well motivated, adequately trained patients with access to expert advice.

If you miss a dose, consult your doctor. Do not double the dose.

Common Side Effects:

• Injection site reactions
• Ovarian hyperstimulation syndrome (OHSS) - mild to severe
• Abdominal pain
• GI disturbances
• Headache
• Ovarian cysts

Serious Side Effects: Severe OHSS, ovarian torsion, thromboembolism, anaphylaxis.

Precautions:

• This injection contains potent gonadotrophic substances capable of causing mild to severe adverse reactions - should only be used by physicians thoroughly familiar with infertility problems and their management.
• Regular ultrasound and oestradiol monitoring is required.
• Some patients may have a poor response to FSH/LH.
• The lowest effective dose should be used.

Contraindications:

• Hypersensitivity to active substances or excipients
• Tumours of the hypothalamus and pituitary gland
• Ovarian enlargement or cyst unrelated to polycystic ovarian disease of unknown origin
• Gynaecological haemorrhages of unknown origin
• Ovarian, uterine or mammary carcinoma
• Primary ovarian failure
• Malformations of sexual organs incompatible with pregnancy
• Fibroid tumours of the uterus incompatible with pregnancy

Drug Interactions:

• This injection should not be administered as a mixture with other medicinal products in the same injection (except follitropin alfa, where co-administration does not significantly alter activity, stability, pharmacokinetic nor pharmacodynamic properties).

Food Interactions: No interaction found/established.

Use in Pregnancy: No indication for use during pregnancy. Limited data show no adverse reactions, but insufficient data to exclude teratogenic effects.

Use in Lactation: Not indicated during breast-feeding.

Pediatric Use: No relevant use in the paediatric population.

Geriatric Use: No relevant indication for use in the elderly population. Safety and effectiveness have not been established.

Renal & Hepatic Impairment: Safety, efficacy, and pharmacokinetics in patients with renal or hepatic impairment have not been established.

Overdose: Too high a dosage may lead to ovarian hyperstimulation. No specific antidote. Give supportive care.

Storage: Do not store above 25°C. Store in the original package in order to protect from light.

Follitropin Alfa + Lutropin Alfa Injection