lutropin alfa

Action and Spectrum

Actions and Spectrum: 

The action of lutropin alfa:  

lutropin alfa acts on the ovaries in females and the testes in males to stimulate the production of sex hormones. In females, it works with follicle-stimulating hormone (FSH) to induce the growth and maturation of ovarian follicles during the menstrual cycle. This process helps in the release of a mature egg (ovulation). 

In males, lutropin alfa stimulates the Leydig cells in the testes to process testosterone, which is crucial for the development and maintenance of male reproductive tissues and sexual characteristics. 

The spectrum of use:  

lutropin alfa is primarily used in assisted reproductive techniques, like in vitro fertilization (IVF) and intrauterine insemination (IUI). It can be used in men and women with fertility issues related to a deficiency of LH or LH-like activity. 

For women, it is used to trigger ovulation and stimulate the release of mature eggs during infertility treatment. It is usually combined with FSH in fertility treatments to achieve better results. 

For men, lutropin alfa treats hypogonadotropic hypogonadism. In this condition, the testes typically do not produce enough testosterone due to insufficient LH and FSH secretion from the pituitary gland. Testosterone production can be stimulated by administering lutropin alfa, leading to improved fertility and reproductive function. 

Drug Interaction

Adverse Reaction

Frequency defined 

1-10% 

Ovarian cyst 

Ovarian hyper-stimulation syndrome  

Pelvic pain  

Breast pain 

Frequency not defined 

Uterine spasm 

Premenstrual tension 

Vaginitis 

Hemorrhage in pregnancy 

Pelvic pain 

Endometrial disorder 

Abortion 

Vaginal candidiasis 

Ectopic pregnancy 

Genital edema 

Vaginal hemorrhage 

Breast enlargement 

Pelvic congestion 

Leucorrhoea 

Black Box Warning

Black Box Warning: 

None 

Contraindication / Caution

Contraindication/Caution: 

Contraindication 

• Hypersensitivity: Individuals with known hypersensitivity or allergy to lutropin alfa or its components should not use this medication. 
• Primary Ovarian Failure: lutropin alfa is not effective in individuals with primary ovarian failure, which is the inability of the ovaries to produce eggs, as it acts by stimulating the ovaries to produce and release mature eggs. 
• Primary Testicular Failure: For men with primary testicular failure (the inability of the testes to produce sperm and testosterone), lutropin alfa may not be effective as it primarily stimulates the Leydig cells in the testes to produce testosterone. 
• Tumors of the Reproductive System: lutropin alfa is not recommended for individuals with tumors of the reproductive system, such as ovarian, uterine, or testicular tumors, as it could exacerbate tumor growth. 
• Pregnancy: lutropin alfa should not be used during pregnancy. It is intended for use in individuals undergoing fertility treatments, and it should be discontinued if pregnancy is achieved. 
• Breastfeeding: It is unclear whether lutropin alfa passes into breast milk. Therefore, it is generally not recommended during breastfeeding. If it is deemed necessary, breastfeeding should be stopped during treatment. 
• Thyroid or Adrenal Dysfunction: lutropin alfa may interact with thyroid or adrenal disorders, and caution should be exercised in individuals with these conditions. 

Caution 

• Multiple Births: lutropin alfa treatment, mainly when used in conjunction with follicle-stimulating hormone (FSH) in assisted reproductive techniques like in vitro fertilization (IVF), may increase the risk of multiple births (e.g., twins, triplets). Multiple pregnancies can carry higher health risks for both the mother and the babies and require careful monitoring throughout pregnancy. 
• Ovarian Hyperstimulation Syndrome (OHSS): lutropin alfa treatment can lead to ovarian hyperstimulation syndrome, characterized by enlarged ovaries and fluid accumulation in the abdominal cavity. OHSS can be mild to severe and may require medical intervention. Healthcare providers monitor patients closely during fertility treatments to minimize the risk of OHSS. 
• Testicular Enlargement: The treatment may cause testicular enlargement in men receiving lutropin alfa. This side effect is usually reversible after the medication is discontinued. 
• Respiratory Disorders: Individuals with a history of or pre-existing respiratory disorders, such as asthma or chronic obstructive pulmonary disease (COPD), should be closely monitored while using lutropin alfa, as there have been reports of exacerbation of respiratory symptoms. 
• Cardiovascular Disorders: Patients with a history of cardiovascular diseases, such as heart disease or hypertension, should use lutropin alfa cautiously, as hormonal treatments may impact cardiovascular health. 
• Adrenal Disorders: lutropin alfa can interact with adrenal function, so individuals with adrenal insufficiency or other adrenal disorders should be closely monitored during treatment. 
• Thromboembolic Events: There have been reports of thromboembolic events (blood clots) associated with fertility treatments, including lutropin alfa. Patients with a prior history of blood clotting disorders or those at an increased risk of blood clot formation should be monitored cautiously. 
• Use in Geriatric or Pediatric Populations: The safety and efficacy of lutropin alfa in elderly individuals and children have not been well-established, and caution should be exercised when considering its use in these populations. 

Pregnancy / Lactation

Pregnancy consideration:  

AU TGA pregnancy category: B3
US FDA pregnancy category: X 

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. 
• 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: 

lutropin alfa, or recombinant luteinizing hormone (rLH), is a synthetic form of human luteinizing hormone (LH) produced through genetic engineering. Pharmacologically, lutropin alfa mimics the action of endogenous LH in the body, binding to specific receptors on the ovaries in females and testes in males. In women, it stimulates the final maturation of ovarian follicles and triggers ovulation.

In men, lutropin alfa stimulates the Leydig cells in the testes to process testosterone, which is crucial for spermatogenesis and the maintenance of male reproductive tissues. Its therapeutic uses include ovulation induction in women with fertility issues, supporting assisted reproductive techniques like in vitro fertilization (IVF), and treating male hypogonadism. Proper administration and monitoring are essential to ensure the safety and efficacy of lutropin alfa in reproductive medicine. 

Pharmacodynamics: 

Mechanism of action: The action of lutropin alfa involves interacting with specific receptors in the ovaries to induce the final maturation and release of eggs (oocytes) from ovarian follicles. This is important in cases of infertility, where the normal process of ovulation might not occur or might be insufficient. 

• Stimulation of Ovarian Follicles: lutropin alfa stimulates the growth and development of ovarian follicles, each containing an immature egg. These follicles are present in the ovaries and are essential for ovulation. 
• Triggering Ovulation: As the follicles mature, they produce increasing estrogen. When the follicles reach a certain level of maturity, a surge in LH hormone production occurs naturally during a woman’s menstrual cycle. lutropin alfa mimics this LH surge and triggers the follicles’ final stages of oocyte maturation. 
• Egg Release: Once the oocytes reach full maturity, lutropin alfa promotes the release (ovulation) of one or more eggs from the ovaries. The mature eggs are then available for fertilization by sperm during sexual intercourse or specific ART procedures such as in vitro fertilization or intrauterine insemination (IUI). 

By facilitating the ovulation process, lutropin alfa increases the chances of successful conception in women who experience ovulation difficulties or undergo specific fertility treatments. It is typically prescribed under the supervision of a fertility specialist and administered through subcutaneous injection. 

Pharmacokinetics: 

Absorption 

lutropin alfa is administered through subcutaneous injections. Once injected, the drug is absorbed slowly and steadily through the subcutaneous tissues into the bloodstream. 

Distribution 

lutropin alfa is a protein-based hormone that circulates in the bloodstream after absorption. It has specific receptors on target tissues, such as the ovaries in women and the testes in men, where it exerts its effects. 

Metabolism 

Protein-based drugs like lutropin alfa are typically metabolized in the same way as endogenous proteins. They are broken down into smaller amino acids by various enzymes in the body. lutropin alfa’s metabolism primarily occurs in the liver and other tissues. 

Elimination and Excretion 

As a protein-based drug, lutropin alfa is mainly eliminated through renal (kidney) clearance. Once metabolized into smaller amino acids, these breakdown products are filtered by the kidneys and excreted in the urine. 

Adminstartion

Administration: 

Subcutaneously administration 

lutropin alfa, also known as recombinant luteinizing hormone (rLH), is a medication used in assisted reproductive techniques to stimulate ovulation in women and testosterone production in men.  

• Prescription and Preparation: lutropin alfa is a prescription medication, so you’ll need a doctor’s prescription to obtain it. The medication is usually supplied in a vial or cartridge containing a powder that needs to be reconstituted with a suitable solvent before administration. 
• Reconstitution: To prepare the medication for injection, follow the instructions provided by the healthcare professional or pharmacist. Typically, a sterile liquid (diluent) is provided with the vial or cartridge of lutropin alfa. The diluent must be mixed with the powder to create a solution for injection. 
• Injection Technique: lutropin alfa is administered through subcutaneous (under the skin) injections. Your doctor or healthcare provider will guide you on the proper injection technique. They may teach you how to self-administer the injections if you must take them home. 
• Injection Site: The recommended injection sites for lutropin alfa are typically the lower abdomen or the upper thigh. Rotate the injection sites to minimize injection site reactions and discomfort. 
• Dosage and Schedule: Your healthcare provider will determine the dosage and schedule of lutropin alfa injections based on the specific medical condition and response to the treatment. Follow their instructions carefully, and do not change the dosage or schedule without consulting them. 
• Combined Treatment: In some cases, lutropin alfa is used with other medications, such as follicle-stimulating hormone (FSH), to optimize fertility treatments like in vitro fertilization (IVF). If you are on a combined treatment regimen, understand the administration instructions for all medications. 
• Monitoring: During lutropin alfa treatment, your healthcare provider will monitor your response to the medication through regular check-ups, ultrasounds, and hormone level measurements. This monitoring helps ensure the treatment is progressing as expected and helps detect any adverse effects or complications. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: lutropin alfa 

Why do we use lutropin alfa? 

lutropin alfa, also known as recombinant luteinizing hormone (rLH), is used in reproductive medicine for various purposes. Its main therapeutic uses are related to fertility treatments in both men and women.  

• Inducing Ovulation in Women: lutropin alfa is used with follicle-stimulating hormone (FSH) to induce ovulation in women undergoing fertility treatments. During a woman’s menstrual cycle, lutropin alfa stimulates the final maturation and the release of a mature egg (ovulation) from the ovaries. This is particularly helpful for women who have difficulty ovulating independently or undergoing assisted reproductive techniques like in vitro fertilization (IVF). 
• Assisted Reproductive Techniques (ART): In assisted reproductive techniques, such as IVF, lutropin alfa supports ovarian stimulation and FSH. The combined use of these hormones helps increase the number of mature eggs available for fertilization, improving the chances of successful embryo development and implantation. 
• Male Hypogonadism: lutropin alfa is used in men with hypogonadotropic hypogonadism, a condition characterized by low levels of LH and follicle-stimulating hormone (FSH) due to a dysfunction in the pituitary gland or hypothalamus. By administering lutropin alfa, testosterone production is stimulated, which helps improve fertility and the development of male reproductive tissues and sexual characteristics. 
• Stimulation of Testicular Function: In some cases, lutropin alfa may be used in men to stimulate the function of the testes and improve sperm production in combination with other medications.