follitropin beta

Action and Spectrum

Actions and Spectrum 

follitropin beta binds to follicle-stimulating hormone (FSH) receptors on the surface of granulosa cells in the ovaries. This binding activates specific signalling pathways within the cells, leading to the development and maturation of ovarian follicles.  

The primary use of follitropin beta is in the treatment of female infertility caused by ovulatory dysfunction or inadequate ovarian follicle development.  

Drug Interaction

Adverse Reaction

Frequency defined  

1-10% 

For ovulation induction 

Abdominal discomfort (2.9%) 

Ovarian cyst (2.9%) 

Abdominal pain (1.9%)  

Miscarriage (9.5%) 

Ovarian Hyperstimulation Syndrome (7.6%) 

For ART 

Vaginal hemorrhage (1.5%) 

Ovarian Hyperstimulation Syndrome (5.2%) 

Injection site pain (1.7%) 

Abdominal pain (2.5%) 

Ectopic pregnancy (3%) 

For Spermatogenesis 

Rash (3.3%) 

Injection site reaction (6.7%) 

Gynecomastia (3.3%) 

Injection site pain (6.7%) 

Dermoid cyst (3.3%) 

Headache (6.7%) 

Acne (6.7%) 

Frequency Not Defined 

Hemoperitoneum 

Hair loss 

Breast tenderness 

Body rash 

Flu-like symptoms 

Tachycardia 

Hives 

Dry skin 

Erythema 

Dyspnea 

Tachypnea 

Dizziness 

Febrile reactions 

Post marketing reports 

Ovarian neoplasms  

Black Box Warning

Black Box Warning 

None

Contraindication / Caution

Contraindication/Caution: 

Contraindication: 

• follitropin beta should not be used in individuals who have a known hypersensitivity or allergic reaction to the active substance or any other components of these drug.  
• follitropin beta should not be used in patients with tumors of the hypothalamus or pituitary gland.  

Caution: 

• Patients should be carefully monitored during treatment to minimize the risk of Ovarian Hyperstimulation Syndrome (OHSS). due to its characterization of enlarged ovaries and the accumulation of fluid in the abdominal cavity.  
• Patients with a history of asthma, epilepsy, or heart disease, should use follitropin beta with caution. 
• It should be used cautiously in males with tumors of the hypothalamus or pituitary gland.  

Pregnancy / Lactation

Pregnancy consideration: 

Pregnancy category: N/A 

Lactation: Excretion into human milk is unknown  

Pregnancy Categories:         

Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.  

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women. 

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits. 

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women. 

Category N: There is no data available for the drug under this category. 

Pharmacology

Pharmacology  

In males, follitropin beta stimulates the Sertoli cells in the testes to support spermatogenesis, the process of sperm cell production. 

While in females, follitropin beta stimulates the growth and development of ovarian follicles. These follicles are fluid-filled sacs that contain the developing oocyte (egg).  

Pharmacodynamics 

follitropin beta binds and activates FSH receptors located on the surface of target cells in the gonads such as ovaries in females and testes in males.  

These receptors are G-protein-coupled receptors, and upon binding they start initiating to change the intracellular signaling pathways. 

Pharmacokinetics 

Absorption   

follitropin beta is absorbed from the injection site into the bloodstream. 

Distribution 

follitropin beta distributes throughout the body. but its distribution in the extracellular fluid and has a relatively limited distribution into tissues.  

Metabolism 

follitropin beta undergoes enzymatic metabolism in the body.  

Elimination and excretion 

follitropin beta is excreted primarily through the kidneys.  

Adminstartion

Administration 

follitropin beta is administered through subcutaneous (just beneath the skin) and intramuscular injection at the selected injection site. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: follitropin beta 

Why do we use follitropin beta? 

follitropin beta is widely used to stimulate multiple follicles growth and development in the ovaries during fertility treatments such as In-vitro fertilization (IVF).   

In females, who do not ovulate regularly or have irregular menstrual cycles in such cases follitropin beta may be used to induce ovulation and improve the chances of conception. In males it may use to stimulate spermatogenesis, the process of sperm cell production in the testes.