Corifollitropin Alpha

Table of contents

  • Brand Names
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Genes that may be involved
  • Drug Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names

Europe

Austria: Elonva; Czech Republic: Elonva; Denmark: Elonva; Estonia: Elonva; Finland: Elonva; Germany: Elonva; Greece: Elonva; Hungary: Elonva; Ireland: Elonva; Latvia: Elonva; Lithuania: Elonva; Luxembourg: Elonva; Malta: Elonva; Netherlands: Elonva; Poland: Elonva; Portugal: Elonva; Romania: Elonva; Slovakia: Elonva; Slovenia: Elonva; Sweden: Elonva; UK: Elonva.

Drug combinations

Chemistry

Corifollitropin Alpha: Glycoprotein produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology, consists of recombinant human FSH (rec)FSH, in which the alpha subunit is identical with that of human FSH but with a C-terminal extension on the beta subunit.

Pharmacologic Category

Hormones and Synthetic Substitutes; Gonadotropins. Analog of Follicle-Stimulating Hormone (FSH); Recombinant Glycoprotein. (ATC-Code: G03GA09).

Mechanism of action

Corifollitropin alpha is designed as a sustained follicle stimulant with the same pharmacodynamic profile as (rec)FSH, but with a markedly prolonged duration of FSH activity. Due to its ability to initiate and sustain multiple follicular growth for an entire week, a single subcutaneous injection of the recommended dose may replace the first seven injections of any daily (rec)FSH preparation in a COS treatment cycle. The long duration of FSH activity was achieved by adding the carboxy-terminal peptide of the β-subunit of human chorionic gonadotropin (hCG) to the β-chain of human FSH. Corifollitropin alpha does not display any intrinsic LH/hCG activity.

Therapeutic use

Controlled Ovarian Stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) program.

Pregnancy and lactiation implications

The use of corifollitropin alpha during pregnancy and lactation is not indicated.

Unlabeled use

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Tumors of the ovary, breast, uterus, pituitary or hypothalamus. Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause. Primary ovarian failure. Ovarian cysts or enlarged ovaries. History of Ovarian Hyperstimulation Syndrome (OHSS). A previous COS cycle that resulted in more than 30 follicles ≥11 mm measured by ultrasound examination. A basal antral follicle count >20. Fibroid tumors of the uterus incompatible with pregnancy. Malformations of the reproductive organs incompatible with pregnancy.

Warnings and precautions

Before starting treatment the couple’s infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated. Women should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumors, and appropriate specific treatment given. For single subcutaneous injection only. In the first seven days after administration of corifollitropin alpha, no (rec)FSH should be administered. Not recommended in combination with a GnRH agonist. Use not recommended in women with polycystic ovarian syndrome (PCOS). Signs and symptoms of OHSS are stimulated by administration of human Chorionic Gonadotropin (hCG) and by pregnancy (endogenous hCG)(adherence to the recommended dose and treatment regimen; careful monitoring of ovarian response is important to minimize the risk of OHSS). Ovarian response was shown to be higher after treatment with corifollitropin alpha than after treatment with daily (rec)FSH. Multiple pregnancies and births have been reported for all gonadotropin treatments. Since infertile women undergoing ART, and particularly IVF, often have tubal abnormalities, the incidence of ectopic pregnancies might be increased (early ultrasound confirmation that a pregnancy is intrauterine is important). The incidence of congenital malformations after ART may be slightly higher than after spontaneous conceptions. Ovarian and other reproductive system neoplasms, both benign and malignant, have been reported in women who have undergone multiple treatment regimens for infertility treatment. In women with generally recognized risk factors for thromboembolic events, such as a personal or family history, severe obesity (Body Mass Index >30 kg/m^2^) or thrombophilia, treatment with gonadotropins may further increase this risk.

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