Pergoveris(150 IU+75 IU)/vial

Pergoveris is a recombinant gonadotropin combination indicated for the stimulation of follicular development in adult women with severe luteinizing hormone (LH) and follicle-stimulating hormone (FSH) deficiency (hypogonadotropic hypogonadism), as part of an assisted reproductive technology (ART) treatment protocol such as in vitro fertilization (IVF).

• Established/approved use: Stimulation of follicular development in women with profound endogenous LH deficiency, defined by a baseline serum LH level less than 1.2 IU/L, in combination with follicle-stimulating activity.
• Requires combination therapy: Pergoveris is used together with a controlled ovarian stimulation protocol under specialist supervision, and treatment cycles typically require monitoring by transvaginal ultrasound and serum estradiol measurement, followed by administration of human chorionic gonadotropin (hCG) to trigger final oocyte maturation.
• Not indicated for women with normal pituitary-gonadal function or with causes of infertility unrelated to gonadotropin deficiency.

Each formulation of Follitropin Alfa + Lutropin Alfa contains recombinant human follicle-stimulating hormone (follitropin alfa) combined with recombinant human luteinizing hormone (lutropin alfa) in a fixed ratio (commonly 2:1, e.g. 150 IU follitropin alfa with 75 IU lutropin alfa per vial/pen), supplied as a lyophilized powder with solvent for reconstitution or as a pre-filled solution for subcutaneous injection.

Pergoveris is a biotechnology-derived combination product of two recombinant human gonadotropins: follitropin alfa (recombinant FSH) and lutropin alfa (recombinant LH). It is produced using recombinant DNA technology in genetically engineered mammalian (Chinese hamster ovary) cell lines. The fixed-ratio combination is designed to replicate the physiological FSH and LH activity required for adequate follicular growth and estradiol production in women who lack sufficient endogenous LH.

Pergoveris belongs to the therapeutic class of gonadotropins, specifically recombinant fertility hormones used in ovulation induction and controlled ovarian stimulation.

Follitropin Alfa + Lutropin Alfa supplies both FSH and LH bioactivity. Follitropin alfa binds to FSH receptors on ovarian granulosa cells, stimulating follicular growth and maturation. Lutropin alfa binds to LH receptors on theca cells, stimulating androgen production that is subsequently aromatized to estradiol by granulosa cells (the 'two-cell, two-gonadotropin' mechanism). In women with severe LH deficiency, FSH alone is insufficient to achieve adequate estradiol synthesis and follicular development; the addition of LH activity via Follitropin Alfa + Lutropin Alfa restores this synergistic steroidogenic pathway, supporting follicular maturation in preparation for oocyte retrieval or ovulation triggering.

Pergoveris is administered by subcutaneous injection, typically self-administered by the patient or a caregiver after proper training. If supplied as a lyophilized powder, it must be reconstituted with the accompanying solvent immediately before use (see Reconstitution). Injection sites should be rotated to minimize local irritation. Doses should be given at approximately the same time each day.

No formal drug interaction studies have been conducted with Pergoveris. Concomitant use with other agents that stimulate ovulation (e.g. clomiphene citrate) may enhance follicular response and should only be undertaken under specialist supervision with appropriate dose adjustment. Use with other fertility medications should be coordinated by the treating physician to avoid excessive ovarian stimulation.

Common side effects of Pergoveris include headache, injection site reactions (pain, redness, bruising, swelling), abdominal pain, pelvic pain, nausea, and breast pain. A serious but less common risk is ovarian hyperstimulation syndrome (OHSS), which can present with abdominal distension, nausea, vomiting, and in severe cases ascites, pleural effusion, thromboembolism, and ovarian enlargement; this requires prompt medical evaluation. Multiple pregnancy (twins or higher-order) is a recognized risk of gonadotropin therapy, including with Pergoveris, due to the potential for multiple follicle development.

Pergoveris is contraindicated during pregnancy, as there is no indication for its use once pregnancy has occurred. It should be discontinued as soon as pregnancy is confirmed. There are no data on use during lactation; because gonadotropin therapy is used to achieve pregnancy prior to breastfeeding, use during established lactation is not a typical clinical scenario, and a physician should be consulted regarding any inadvertent exposure.

Treatment with Pergoveris should only be initiated after a thorough evaluation of infertility and exclusion of contraindications to pregnancy, and must be supervised by a physician experienced in fertility disorders.

• Ovarian hyperstimulation syndrome (OHSS): Close monitoring by ultrasound and estradiol measurement is required to reduce the risk of OHSS; if signs develop, treatment should be withheld and hCG should not be given.
• Multiple pregnancy: Risk of twin or higher-order multiple pregnancy is increased; monitoring of follicular development helps minimize this risk.
• Thromboembolism: Women with additional risk factors for thromboembolic events should be assessed carefully before treatment, as OHSS and pregnancy independently increase this risk.
• Ovarian torsion has been reported following gonadotropin therapy and ART procedures.
• Requires specialist monitoring throughout the treatment cycle; not for unsupervised or self-directed use.

The effects of overdosage with Pergoveris are not well characterized but may include an increased risk of ovarian hyperstimulation syndrome. In case of suspected overdose, seek immediate medical attention or contact a poison control center; do not attempt home treatment.

Store at room temperature (below 30°C) or as directed on the product label, away from light and moisture. Some formulations may require refrigeration (2-8°C) prior to first use — check the specific product packaging. Do not freeze. Keep out of reach of children.

Renal/hepatic impairment: Follitropin alfa and lutropin alfa have not been formally studied in renal or hepatic impairment; use with caution and under specialist supervision. Elderly: Not applicable, as Pergoveris is used only in women of reproductive age. Pediatric use: Not indicated; see Pediatric Uses.

Treatment duration with Pergoveris is individualized per cycle, typically ranging from about 7 to 14 days, continuing until ultrasound and hormonal monitoring confirm adequate follicular development, at which point hCG is administered to trigger ovulation or final oocyte maturation. Prolonged use beyond 3 weeks in a single cycle is generally not recommended without specialist reassessment.

If supplied as a lyophilized powder, Pergoveris must be reconstituted using only the diluent (solvent) provided with the product, immediately before injection. Gently swirl (do not shake vigorously) until the powder is fully dissolved, forming a clear, colorless to slightly yellow solution. Discard any reconstituted solution that is cloudy or contains particles. Use immediately after reconstitution unless the product labeling states otherwise.

Recombinant human gonadotropins (FSH and LH combination); fertility/ovulation-induction agents.

Follitropin Alfa + Lutropin Alfa acts by providing exogenous FSH and LH bioactivity that binds to their respective ovarian receptors, driving follicular granulosa cell proliferation (FSH effect) and theca cell androgen synthesis for aromatization to estradiol (LH effect), together supporting complete follicular maturation in women whose endogenous LH secretion is severely deficient.

Pergoveris is not indicated for use in children or pediatric populations. Its safety and efficacy have not been established in this age group, as the product is intended solely for adult women undergoing fertility treatment.