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Follitropin

Generic Name
Follitropin
Brand Names
Bemfola, Follistim, Gonal F, Gonal-F, Menopur, Ovaleap, Pergoveris, Puregon, GONAL-f, Rekovelle
Drug Type
Biotech
CAS Number
146479-72-3
Unique Ingredient Identifier
2M2GGL7HUP

Overview

Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.

Background

Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.

Indication

In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).

Associated Conditions

No associated conditions information available.

FDA Approved Products

Follistim AQ
Manufacturer:Organon LLC
Route:SUBCUTANEOUS
Strength:300 [iU] in 0.36 mL
Approved: 2023/07/24
NDC:78206-129
Gonal-f RFF Redi-ject
Manufacturer:EMD Serono, Inc.
Route:SUBCUTANEOUS
Strength:900 [iU] in 1.5 mL
Approved: 2020/02/19
NDC:44087-1117
Follistim AQ
Manufacturer:Merck Sharp & Dohme LLC
Route:SUBCUTANEOUS
Strength:650 [iU] in 0.78 mL
Approved: 2023/11/17
NDC:0052-0316
Follistim AQ
Manufacturer:Merck Sharp & Dohme LLC
Route:SUBCUTANEOUS
Strength:350 [iU] in 0.42 mL
Approved: 2023/11/17
NDC:0052-0313
Follistim AQ
Manufacturer:Organon LLC
Route:SUBCUTANEOUS
Strength:900 [iU] in 1.08 mL
Approved: 2023/07/24
NDC:78206-131

Singapore Approved Products

REKOVELLE SOLUTION FOR INJECTION IN A PRE-FILLED PEN 72MCG/2.16ML
Manufacturer:Vetter Pharma-Fertigung GmbH & Co. KG (Bulk Production and Primary Packager)
Form:INJECTION, SOLUTION
Strength:72.0 mcg
Online:Yes
Approved: 2019/03/25
Approval:SIN15651P
REKOVELLE SOLUTION FOR INJECTION IN A PRE-FILLED PEN 36MCG/1.08ML
Manufacturer:Vetter Pharma-Fertigung GmbH & Co. KG (Bulk Production and Primary Packager)
Form:INJECTION, SOLUTION
Strength:36.0 mcg
Online:Yes
Approved: 2019/03/25
Approval:SIN15652P
Puregon solution for injection 900IU/1.08ml
Manufacturer:VETTER PHARMA-FERTIGUNG GMBH & CO KG, Vetter Pharma-Fertigung GmbH & Co. KG
Form:INJECTION
Strength:833 IU/ml
Online:Yes
Approved: 2013/12/30
Approval:SIN14474P
PUREGON SOLUTION FOR INJECTION 300 iu/0.36 ml
Manufacturer:VETTER PHARMA-FERTIGUNG GMBH & CO KG, Vetter Pharma-Fertigung GmbH & Co. KG
Form:INJECTION
Strength:833IU/ml
Online:Yes
Approved: 2003/02/06
Approval:SIN12185P
Gonal-f 900 iu/1.5 ml (66 mcg/1.5 ml) Solution for Injection in a pre-filled pen
Manufacturer:Merck Serono S.p.A., Bari (Italy)
Form:INJECTION, SOLUTION
Strength:66.69 mcg
Online:Yes
Approved: 2004/08/18
Approval:SIN13024P

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