Puregon (Follitropin beta) Uses, Dosage, Side Effects and more

FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.

Used for the treatment of female infertility, urofollitropin or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of urofollitropin is the primary hormone responsible for follicular recruitment and development.

Trade Name	Puregon (Follitropin beta)
Availability	Prescription only
Generic	Urofollitropin
Urofollitropin Other Names	Follitropin human, Urofollitrophin, Urofollitropin
Related Drugs	progesterone, clomiphene, Clomid, chorionic gonadotropin (hcg), Pregnyl, Menopur, Gonal-f, Follistim, Follistim AQ
Type
Formula	C42H65N11O12S2
Weight	980.162 Da
Groups	Approved, Vet approved
Therapeutic Class	Trophic Hormones & Related Synthetic Drugs
Manufacturer
Available Country	Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia (Hrvatska), Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovakia, Slovenia, Spain, Sweden, United Kingdom, Vietnam
Last Updated:	January 7, 2025 at 1:49 am

Uses

Puregon (Follitropin beta) lyophilized powder for injection containing 82.5 International Units of FSH, to deliver 75 International Units FSH after reconstituting, supplied as lyophilized powder in sterile vials with diluent vials

Puregon (Follitropin beta) is a gonadotropin used for:

• Induction of ovulation in women who have previously received pituitary suppression: intramuscular and subcutaneous administration
• Development of multiple follicles as part of an Assisted Reproductive Technology (ART) cycle in ovulatory women who have previously received pituitary suppression

Puregon (Follitropin beta) is also used to associated treatment for these conditions: Infertility, Assisted Reproductive Technology therapy, Ovulation induction therapy

How Puregon (Follitropin beta) works

FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.

Dosage

Puregon (Follitropin beta) dosage

Ovulation Induction:

• Initial starting 150 International Units per day for 5 days, administered subcutaneously or intramuscularly
• Individualization of dosing after 5 days
• Dosage adjustments not to occur more frequently than once every 2 days and not to exceed 75 to 150. International Units per adjustment
• Do not administer greater than 450 International Units per day

Assisted Reproductive Technology (ART):

• Initial starting dose of the first cycle-225 International Units per day for 5 days, administered subcutaneously
• Individualization of dosing after 5 days
• Dosage adjustments not to occur more frequently than once every 2 days and not to exceed 75 to 150. International Units per adjustment
• Do not administer greater than 450 International Units per day

Side Effects

The most common adverse reactions (≥5% incidence) in ovulation induction include headache, hot flashes, OHSS, pain, and respiratory disorder.

The most common adverse reactions (≥2% incidence) in ART include: abdominal cramps, abdominal fullness/enlargement, headache, nausea, OHSS, pain, pelvic pain, and post retrieval pain

Precaution

• Abnormal Ovarian Enlargement
• Ovarian Hyperstimulation Syndrome
• Pulmonary and Vascular Complications
• Ovarian Torsion
• Multi-fetal Gestation and Birth
• Congenital Malformations
• Ectopic Pregnancy
• Spontaneous Abortion
• Ovarian Neoplasms

Interaction

No drug/drug interaction studies have been conducted for Puregon (Follitropin beta) in humans

Food Interaction

No interactions found.

Puregon (Follitropin beta) Disease Interaction

Major: adrenal dysfunction, thyroid dysfunction, tumors, thromboembolism, intracranial tumorsModerate: pulmonary conditions

Volume of Distribution

Time to peak in plasma: IM: 17 hours (single dose), 11 hours (multiple doses) SubQ: 21 hours (single dose), 10 hours (multiple doses)

Elimination Route

74%

Half Life

Circulation half life of 3-4 hours, elimination half life of 35-40 hours

Elimination Route

Via liver and kidneys

Pregnancy & Breastfeeding use

Pregnancy Category X. Do not use Puregon (Follitropin beta) in pregnant women. It is not known whether Puregon (Follitropin beta) is excreted in human milk

Contraindication

Puregon (Follitropin beta) is contraindicated in women who exhibit:

• Prior hypersensitivity to urofollitropins
• High levels of FSH indicating primary ovarian failure
• Pregnancy
• Presence of uncontrolled non-gonadal endocrinopathies
• Sex hormone dependent tumors of the reproductive tract and accessory organ
• Tumors of pituitary gland or hypothalamus
• Abnormal uterine bleeding of undetermined origin
• Ovarian cysts or enlargement of undetermined origin, not due to polycystic ovary syndrome

Special Warning

Pediatric Use: Safety and efficacy not established.

Renal and Hepatic Insufficiency: Safety, efficacy, and pharmacokinetics of Urofollitrophin in women with renal or hepatic insufficiency have not been established.

Storage Condition

Lyophilized powder may be stored refrigerated or at room temperature (3° to 25° C). Protect from light. Use immediately after reconstitution. Discard unused material.

Innovators Monograph