follitropin delta

Action and Spectrum

Actions and Spectrum: 

follitropin delta is a recombinant follicle-stimulating hormone (FSH) used to treat infertility. It is structurally and functionally like the pituitary gland’s natural FSH. The mechanism of action of follitropin delta involves binding to specific receptors on the surface of ovarian granulosa cells, stimulating follicular growth and maturation. 

When administered, follitropin delta stimulates the development of ovarian follicles, which contain eggs. It acts directly on the granulosa cells within the follicles and promotes their growth and maturation. follitropin delta helps to initiate the recruitment and selection of follicles, stimulates granulosa cell proliferation, and enhances estrogen production by these cells. 

The spectrum of activity of follitropin delta primarily targets the ovaries in women. It is used for controlled ovarian stimulation (COS) in assisted reproductive technologies (ART) such as in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI). follitropin delta is indicated for treating women with severe follicle deficiency or insufficient ovarian response. 

Drug Interaction

Adverse Reaction

Frequency defined 

1-10% 

Headache 

Nipple pain 

Fatigue 

Nausea 

Pelvic pain 

Pelvic cramps  

Uterine pain 

Antibody development 

<1% 

Constipation 

Breast tenderness 

Diarrhea 

Black Box Warning

Black box warning: 

None 

Contraindication / Caution

Contraindications/caution: 

Contraindications: 

• Hypersensitivity: follitropin delta should not be used in individuals with known hypersensitivity or allergy to follitropin delta or its components. Hypersensitivity reactions can range from mild skin reactions to severe allergic reactions and anaphylaxis. 
• Primary Ovarian Failure: follitropin delta is unsuitable for individuals with primary ovarian failure, also known as premature ovarian insufficiency or menopause. In these cases, the ovaries do not produce enough follicles or eggs, making FSH stimulation ineffective. 
• Tumors of the Hypothalamus or Pituitary Gland: follitropin delta should be avoided in individuals with hypothalamus or pituitary gland tumors. These tumors can interfere with the hormonal regulation of the menstrual cycle and may increase the risk of complications. 
• Ovarian Cysts: follitropin delta should not be used when there are large ovarian cysts or enlarged ovaries of unknown origin. Ovarian cysts can be stimulated and worsened using FSH, potentially leading to complications. 

Caution: 

• Ovarian Hyperstimulation Syndrome (OHSS): follitropin delta treatment can potentially lead to OHSS, characterized by enlarged ovaries and fluid accumulation in the abdomen or chest. OHSS can range from mild to severe and, in rare cases, can be life-threatening.  
• Multiple pregnancy: follitropin delta treatment may increase the risk of multiple pregnancies (e.g., twins, triplets). Multiple pregnancies carry a higher risk of complications for both the mother and the unborn babies.  
• Ectopic pregnancy: follitropin delta treatment does not eliminate the risk of ectopic pregnancy, which occurs when the fertilized egg implants outside the uterus, typically in the fallopian tubes.  
• Ovarian Torsion: Using follitropin delta may increase the risk of ovarian torsion, a condition in which the ovary twists on its blood supply. Ovarian torsion can cause severe abdominal pain and may require immediate medical intervention. 

Pregnancy / Lactation

Pregnancy consideration: It is used to induce ovulation; and is not recommended for pregnant women. 

Lactation: Excretion of the drug in human breast milk is unknown. It is not recommended to use follitropin delta when nursing. 

Pregnancy category: 

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: 

• Stimulation of Follicular Development: follitropin delta promotes the recruitment and development of ovarian follicles. It initiates the growth of small, dormant follicles and helps select dominant follicles that have the potential to release a mature egg during the menstrual cycle.  
• FSH-Dependent Actions: follitropin delta primarily exerts its effects through FSH receptors in the ovaries. These receptors are expressed on granulosa cells, surrounding and nurturing the developing egg within the follicles. follitropin delta stimulates the proliferation and differentiation of granulosa cells, leading to increased production of estradiol, a form of estrogen. 
• Estrogen Production: follitropin delta treatment results in estrogen production by the granulosa cells. Estrogen is essential for developing and maturing the uterine lining (endometrium) for embryo implantation. It also helps regulate the menstrual cycle and maintains the proper hormonal environment for successful fertility and assisted reproductive technologies. 
• Controlled Ovarian Stimulation (COS): follitropin delta is commonly used in assisted reproductive technologies, such as in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI). It is administered to stimulate the growth and development of multiple ovarian follicles, aiming to increase the chances of obtaining multiple eggs for fertilization. 

Pharmacokinetics: 

Absorption 

follitropin delta is administered via subcutaneous injection, typically into the fatty tissue beneath the skin. Upon injection, the protein is absorbed into the bloodstream, allowing it to reach its target organs, primarily the ovaries. 

Distribution 

follitropin delta is distributed throughout the body via the bloodstream. However, due to its large molecular size and protein nature, it is predominantly distributed within the extravascular space and may have limited distribution into tissues.  

Metabolism 

follitropin delta is a recombinant protein that closely resembles the natural follicle-stimulating hormone (FSH) produced by the pituitary gland. As a protein, it is not typically subjected to extensive metabolism in the body.   

Elimination and Excretion 

The primary route of excretion for Follitropin delta is likely through renal elimination. After the protein is degraded into smaller peptides or amino acids, these components can be filtered by the kidneys and eliminated through urine.

Adminstartion

Administration: 

• follitropin delta is typically administered via subcutaneous injection. Here is a summary of the administration process: 
• Gather the necessary supplies, including the follitropin delta vial, a syringe, and a clean needle. 
• Reconstitute the lyophilized powder with the provided diluent or sterile water for injection according to the manufacturer’s instructions. 
• Ensure the solution is clear and free of particles after reconstitution. 
• Choose an injection site, such as the lower abdomen or thigh area, and cleanse it with an alcohol swab. 
• Pinch a fold of skin at the injection site and insert the needle at a 45 to 90-degree angle, depending on the needle length and instructions. 
• Inject the solution slowly and steadily. 
• Remove the needle from the skin and dispose of it safely in a designated sharps container. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: follitropin delta 

Why do we use follitropin delta? 

follitropin delta, a recombinant human follicle-stimulating hormone (r-hFSH), is primarily used for the following purposes: 

• Controlled Ovarian Stimulation (COS) in Assisted Reproductive Technologies (ART): follitropin delta is commonly used in fertility treatments, particularly in assisted reproductive technologies like in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI).  
• Ovulation Induction: follitropin delta can induce ovulation in women with inadequate endogenous follicle-stimulating hormone (FSH) secretion. Promoting the maturation of the dominant follicle helps facilitate the release of a mature egg for fertilization. 
• Treatment of Severe Follicle Deficiency or Insufficient Ovarian Response: follitropin delta is indicated for use in women with severe follicle deficiency or insufficient ovarian response, where the ovaries do not adequately respond to natural or conventional stimulation.