Usage
- Medical Conditions: Recombinant human luteinizing hormone (r-hLH) is prescribed for the stimulation of follicular development in infertile women with hypogonadotropic hypogonadism and profound LH deficiency (LH < 1.2 IU/L) in conjunction with recombinant follicle stimulating hormone (r-hFSH). It plays a crucial role in inducing final follicular maturation and ovulation in in vitro fertilization (IVF) procedures.
- Pharmacological Classification: Gonadotropin.
- Mechanism of Action: r-hLH mimics the action of endogenous luteinizing hormone, binding to LH receptors in the ovaries. This stimulates the theca cells to produce androgens, which are then converted to estrogens in the granulosa cells by the action of FSH. r-hLH also triggers ovulation and the development of the corpus luteum.
Alternate Names
- Lutropin alfa
- Brand Names: Luveris
How It Works
- Pharmacodynamics: The primary effect of r-hLH is a dose-dependent increase in estradiol secretion. This potentiates the effect of FSH on follicular growth and development. r-hLH also promotes the final maturation of ovarian follicles and triggers ovulation after the administration of human chorionic gonadotropin (hCG).
- Pharmacokinetics: r-hLH is administered subcutaneously. Its pharmacokinetic profile is similar to that of endogenous LH. Studies have shown that after administration, lutropin alfa reaches peak concentration and is metabolized similar to endogenous LH.
- Mode of Action: r-hLH binds to luteinizing hormone/choriogonadotropin receptor (LHCGR) on the surface of ovarian cells, specifically theca cells and granulosa cells. This receptor activation initiates a signaling cascade that results in increased steroidogenesis (production of androgens and estrogens).
- Elimination Pathways: Metabolized similar to endogenous LH.
Dosage
Standard Dosage
Adults:
- r-hLH is typically administered concomitantly with follitropin alfa (r-hFSH). A recommended starting regimen is 75 IU of lutropin alfa daily with 75 to 150 IU of FSH.
- The dosage should be adjusted based on the patient’s individual response, assessed by monitoring follicle size via ultrasound and estrogen levels. Dose adjustments, if necessary, should be made at 7-14 day intervals, preferably in increments of 37.5 IU to 75 IU. The duration of stimulation in one cycle can be extended up to 5 weeks.
Children:
- There is no relevant use of r-hLH in the pediatric population.
Special Cases:
- Elderly Patients: There is no relevant use of r-hLH in elderly patients.
- Patients with Renal Impairment: No specific dose adjustments are available for patients with renal impairment. Close monitoring is recommended.
- Patients with Hepatic Dysfunction: No specific dose adjustments are available for patients with hepatic dysfunction. Close monitoring is recommended.
- Patients with Comorbid Conditions: Dose adjustments may be necessary for patients with certain comorbid conditions. Careful consideration should be given to each individual case.
Clinical Use Cases
- r-hLH is not typically used in clinical settings such as intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations. Its primary use is in assisted reproduction technology (ART).
Dosage Adjustments
- Dosage adjustments are based on the patient’s ovarian response, as assessed by ultrasound monitoring of follicular development and serum estradiol levels.
Side Effects
Common Side Effects
- Ovarian hyperstimulation syndrome (OHSS)
- Abdominal pain
- Headache
- Nausea
Rare but Serious Side Effects
- Severe OHSS
- Thromboembolism
Long-Term Effects
- No long-term adverse effects have been specifically reported with r-hLH use.
Adverse Drug Reactions (ADR)
- Severe OHSS requiring hospitalization.
Contraindications
- Hypersensitivity to lutropin alfa or any of its components.
- Ovarian enlargement or ovarian cysts not due to polycystic ovarian syndrome.
- Gynecological bleeding of unknown origin.
- Ovarian, uterine, or breast cancer.
- Pregnancy.
Drug Interactions
- No clinically significant drug interactions have been reported with r-hLH.
Pregnancy and Breastfeeding
- r-hLH is contraindicated in pregnancy.
- It is unknown whether r-hLH is excreted in human milk.
Drug Profile Summary
- Mechanism of Action: Binds to LH receptors in the ovaries, stimulating steroidogenesis and ovulation.
- Side Effects: OHSS, abdominal pain, headache, nausea.
- Contraindications: Hypersensitivity, ovarian enlargement, gynecological bleeding, ovarian/uterine/breast cancer, pregnancy.
- Drug Interactions: None reported.
- Pregnancy & Breastfeeding: Contraindicated in pregnancy; unknown if excreted in breast milk.
- Dosage: 75 IU daily with 75-150 IU FSH, adjusted based on individual response.
- Monitoring Parameters: Follicle size (ultrasound), serum estradiol levels.
Popular Combinations
- r-hLH is commonly used in combination with r-hFSH (follitropin alfa) for ovarian stimulation in IVF procedures.
Precautions
- General Precautions: Assess for contraindications before initiating therapy.
- Specific Populations: Contraindicated in pregnant women. Use with caution in women with risk factors for thromboembolism.
- Lifestyle Considerations: No specific lifestyle considerations have been identified.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Recombinant Human Luteinizing hormone?
A: The starting dose is 75 IU daily in conjunction with 75-150 IU of r-hFSH, with adjustments based on individual ovarian response.
Q2: What is the primary use of r-hLH?
A: Stimulation of follicular development in infertile women with hypogonadotropic hypogonadism with profound LH deficiency, used in conjunction with r-hFSH for controlled ovarian stimulation.
Q3: What is the mechanism of action of r-hLH?
A: It mimics endogenous LH, binding to LH receptors in the ovaries, which stimulates steroidogenesis (estrogen production) and triggers ovulation.
Q4: What are the common side effects?
A: Ovarian hyperstimulation syndrome (OHSS), abdominal pain, headache, nausea.
Q5: What are the contraindications for using r-hLH?
A: Hypersensitivity, ovarian enlargement or cysts (not due to PCOS), unexplained vaginal bleeding, ovarian/uterine/breast cancer, and pregnancy.
Q6: How is r-hLH administered?
A: Subcutaneously.
Q7: What monitoring is required during r-hLH therapy?
A: Follicle size monitoring via ultrasound and serum estradiol levels.
Q8: How is r-hLH dosage adjusted?
A: Based on the individual patient’s ovarian response, as determined by follicular development and estradiol levels. Adjustments are typically made in increments of 37.5-75 IU at 7-14 day intervals.
Q9: Can r-hLH be used in patients with renal or hepatic impairment?
A: No specific dose adjustments are available, so caution and close monitoring are advised.
Q10: What is the difference between r-hLH and hCG?
A: Both stimulate the ovaries, but r-hLH is used for follicular development while hCG is typically used to trigger final follicular maturation and ovulation.