corifollitropin alfa

Action and Spectrum

Actions and Spectrum: 

corifollitropin alfa is a synthetic hormone used in assisted reproductive technology (ART) treatments to stimulate the development of multiple ovarian follicles in women undergoing controlled ovarian stimulation. It is a long-acting gonadotropin with a specific action and spectrum of activity. 

Action:  

corifollitropin alfa has similar actions to the natural hormone follicle-stimulating hormone (FSH). It binds to FSH receptors on the ovaries, promoting the growth and development of multiple follicles, each containing an egg. This helps to increase the chances of successful ovulation and fertilization during ART procedures, such as in vitro fertilization (IVF). 

Spectrum:  

corifollitropin alfa has a prolonged action duration, distinguishing it from other traditional fertility medications like recombinant FSH (rFSH). A single injection of corifollitropin alfa can sustain FSH activity for up to one week. This extended activity reduces the need for daily FSH injections during controlled ovarian stimulation, making it more convenient and patient-friendly. 

Drug Interaction

Adverse Reaction

Frequency not defined 

OHSS  

Nausea  

Pelvic pain  

Pelvic discomfort  

Headache  

Fatigue  

Breast tenderness 

Black Box Warning

Black Box Warning: 

None 

Contraindication / Caution

Contraindication/Caution: 

Contraindication 

• Hypersensitivity: Individuals with known hypersensitivity or allergic reaction to corifollitropin alfa or its components should not use this medication. 
• Primary ovarian failure: corifollitropin alfa is unsuitable for women with primary ovarian failure, also known as premature ovarian insufficiency. This condition refers to the loss of ovarian function before age 40, resulting in a decreased or absent response to FSH stimulation. 
• Tumors of the hypothalamus or pituitary gland: Patients with tumors of the hypothalamus or pituitary gland should not use corifollitropin alfa. These tumors may interfere with the hormonal regulation of the menstrual cycle and ovarian function. 
• Ovarian cysts: The presence of large ovarian cysts or enlargement of the ovaries not caused by polycystic ovarian syndrome (PCOS) should be considered before starting corifollitropin alfa treatment. Using this medication in such cases may lead to complications or exacerbate the existing condition. 
• Uncontrolled thyroid or adrenal dysfunction: Patients with uncontrolled thyroid or adrenal gland disorders should not use corifollitropin alfa, as it may further disrupt hormonal balance. 
• Abnormal uterine bleeding: corifollitropin alfa is not recommended in women with abnormal uterine bleeding of undetermined origin, as it may exacerbate the condition. 
• Pregnancy and breastfeeding: corifollitropin alfa is intended explicitly for women undergoing fertility treatments and should not be used during pregnancy or while breastfeeding. 
• Genetic disorders: Certain genetic disorders may be incompatible with corifollitropin alfa treatment, and this medication should be carefully evaluated in such cases. 

Caution 

• Ovarian Hyperstimulation Syndrome (OHSS): corifollitropin alfa, like other fertility medications, may increase the risk of OHSS, a condition in which the ovaries become swollen and also painful due to the development of numerous ovarian follicles. Severe cases of OHSS can be life-threatening.  
• Multiple Pregnancy: Using corifollitropin alfa can lead to the development of multiple follicles, which increases the risk of multiple pregnancies (e.g., twins or more). Multiple pregnancies carry higher health risks for the mother and the babies, including preterm delivery and other complications. 
• Ectopic Pregnancy: As with any fertility treatment, there is a risk of ectopic pregnancy, where the fertilized egg implants outside the uterus in fallopian tubes. 
• Thromboembolic Events: There have been reports of thromboembolic events (blood clots) associated with the use of gonadotropins, including corifollitropin alfa. Patients with a history of thromboembolic disorders should be closely monitored during treatment. 
• Ovarian Torsion: Stimulating multiple ovarian follicles can increase the risk of ovarian torsion, in which the ovary twists on itself, potentially leading to reduced blood flow and ovarian damage. 
• Allergic Reactions: Although rare, allergic reactions to corifollitropin alfa may occur.  
• Pre-existing Medical Conditions: Patients with certain pre-existing medical conditions, such as asthma, epilepsy, migraines, or kidney or liver problems, should be cautious when using corifollitropin alfa. The medication may interact with their existing treatment or condition. 
• Contraindications: As mentioned earlier, patients with certain conditions, such as primary ovarian failure, tumors of the hypothalamus or pituitary gland, or uncontrolled thyroid or adrenal dysfunction, should not use corifollitropin alfa. 

Pregnancy / Lactation

Pregnancy consideration:  

US FDA pregnancy category: Not assigned. 

Lactation:   

Excreted into human milk: Not known. 

Pregnancy category: 

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

corifollitropin alfa is a synthetic, long-acting follicle-stimulating hormone (FSH) analog used in assisted reproductive technology (ART) treatments. It binds to the FSH receptors on the ovaries, promoting the growth and development of multiple ovarian follicles. Due to its extended half-life, a single injection of corifollitropin alfa can sustain FSH activity for up to one week, reducing the need for daily FSH injections during controlled ovarian stimulation.

This prolonged activity helps simplify the treatment protocol and enhances patient convenience and compliance. corifollitropin alfa’s pharmacology aims to increase the number of mature eggs available for retrieval during ART procedures like in vitro fertilization (IVF), thus improving the chances of successful fertilization and pregnancy. 

Pharmacodynamics: 

Mechanism of action: corifollitropin alfa’s mechanism of action is similar to the natural hormone follicle-stimulating hormone (FSH). It is a synthetic, long-acting FSH analog used in assisted reproductive technology (ART) treatments to stimulate ovarian follicle development in women undergoing controlled ovarian stimulation.  

• FSH Receptor Binding: corifollitropin alfa binds to the FSH receptors located on the granulosa cells of the ovarian follicles. These receptors are specialized proteins on the cell surface activated upon binding with FSH or FSH analogs like corifollitropin alfa. 
• Follicular Growth and Development: Once corifollitropin alfa binds to the FSH receptors, it initiates a series of intracellular signaling events within the granulosa cells. These signals promote the growth and development of multiple ovarian follicles, each containing an immature egg (oocyte). 
• Oocyte Maturation: As the ovarian follicles develop, the oocytes mature. corifollitropin alfa’s action helps facilitate the final maturation of the oocytes, making them ready for ovulation and potential fertilization. 
• Hormonal Support: corifollitropin alfa’s stimulation of multiple ovarian follicles increases the ovaries’ secretion of estrogen and other hormones. These hormonal changes are crucial in preparing the uterine lining for potential embryo implantation. 

Pharmacokinetics: 

Absorption 

corifollitropin alfa is administered via subcutaneous injection. After injection, it is expected to be absorbed into the bloodstream over time. The absorption rate and extent can be influenced by factors such as injection site, formulation, and individual patient characteristics. 

Distribution 

Once in the bloodstream, corifollitropin alfa is expected to distribute throughout the body. The distribution may be limited to specific tissues or organs, with a preference for the ovaries, where it exerts its follicle-stimulating hormone (FSH)-like effects. 

Metabolism 

As a protein-based medication, corifollitropin alfa is expected to undergo enzymatic degradation or proteolysis. The metabolic breakdown of corifollitropin alfa may occur in various tissues, primarily in the liver and kidneys. 

Elimination and Excretion 

The metabolized corifollitropin alfa and its breakdown products are eliminated from the body through urine and feces. The rate and extent of excretion may vary among people and can be influenced by factors like renal and hepatic function. 

Adminstartion

Administration: 

corifollitropin alfa is a long-acting gonadotropin used for controlled ovarian stimulation in assisted reproductive technology (ART) treatments. It is typically administered through a subcutaneous injection.  

Preparation: Before administering the injection, the following steps are essential: 

• Wash your hands thoroughly with soap and water. 
• Gather all the necessary supplies, including the corifollitropin alfa pen or vial, alcohol swabs, and a sharps container for safe disposal of the used needles. 

Inspect the Medication: Check the corifollitropin alfa pen or vial for any signs of damage or defects. Do not use the medication if the packaging is compromised or the solution appears discolored or contains particles. 

Prepare the Injection Site: Choose an injection site on your abdomen, approximately two inches from your belly button. Avoid areas with scars, bruises, or tenderness. Rotate injection sites to prevent irritation. 

Reconstitute (If using a vial): If you have a vial, you may need to reconstitute the medication before injecting it.  

Administer the Injection: For a pen injection: 

• Remove the cap from the corifollitropin alfa pen. 
• Hold the pen with the needle pointing the upwards and tap the cartridge gently to remove any air bubbles. 
• Select the dose as prescribed by your healthcare provider. 
• Pinch the skin at the chosen injection site and also insert the needle into the skin at a 90-degree angle. 
• Press the injection button to deliver the medication. 
• Keep the button pressed for a few seconds to ensure the total dose is delivered. 
• Withdraw the needle from skin and release the injection button. 

For a vial injection: 

• Draw up the prescribed dose of reconstituted corifollitropin alfa into an insulin syringe with the appropriate needle. 
• Pinch the skin at the chosen injection site and also insert the needle into the skin at a 90-degree angle. 
• Inject the medication slowly and steadily. 
• Withdraw the needle from the skin. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: corifollitropin alfa 

Why do we use corifollitropin alfa? 

corifollitropin alfa is a medication used in assisted reproductive technology (ART) treatments to stimulate ovarian follicle development in women undergoing controlled ovarian stimulation.  

• In Vitro Fertilization (IVF): IVF is a commonly used ART procedure where eggs and sperm are fertilized outside the body in a laboratory. corifollitropin alfa is used in IVF to stimulate the ovaries to produce multiple mature eggs, increasing the chances of successful fertilization and pregnancy. 
• Intracytoplasmic Sperm Injection (ICSI): ICSI is an advanced form of IVF in which one sperm is directly injected into an egg. corifollitropin alfa may be used in ICSI cycles to induce the development of multiple mature eggs. 
• Frozen Embryo Transfer (FET): In some cases, embryos obtained from a previous IVF cycle are cryopreserved and stored for future use. corifollitropin alfa may be used in FET cycles to prepare the endometrial lining for embryo transfer. 
• Oocyte Cryopreservation (Egg Freezing): Egg freezing is a fertility preservation process that allows women to store their eggs for later use. corifollitropin alfa can be used to collect multiple eggs before they are cryopreserved. 
• Ovulation Induction: In some ovulatory disorders, corifollitropin alfa may induce ovulation, increasing the chances of natural conception. 
• Preimplantation Genetic Testing (PGT): In cases where genetic testing of embryos is required before transfer, corifollitropin alfa may be used in the IVF cycle to obtain multiple embryos for testing.