Luveris (Lutropin alfa) is a recombinant Luteinizing hormone derived from Chinese hamster cells. It is used in female patients with infertility due to the reduced production of luteinizing hormone from the pituitary.

Lutropin alfa Uses:

Note: Not approved in the US

• Infertility:

  • It is recommended in females with hypogonadotropic hypogonadism who want to conceive. It is used to stimulate the development of follicles and production of estradiol in females with marked deficiency of luteinizing hormone (<1.2 units/L).
  • It is used in combination with follitropin alfa.

Luveris (Lutropin alfa) Dose in Adults:

Luveris (Lutropin alfa) Dose in the treatment of Infertility:

• Females (≥16 years to ≤60 years):

  • 75 units administered subQ daily until adequate follicular development is noted.
  • The maximum dose is 75 units daily.
  • The maximum duration of treatment is 14 days unless the clinical signs of follicular development are present.
  • The duration of ovarian stimulation may be extended in any one cycle for up to 5 weeks. However, the treatment should be individualized based on response to the previous cycle.
  • It should be administered concomitantly with follitropin alfa. hCG should be administered one day after the last dose of lutropin alfa and follitropin alfa.
  • Couples should be encouraged to have daily intercourse beginning one day before hCG administration and until ovulation is apparent.
  • If the patient feels abdominal pain or the ovaries are abnormally enlarged, hCG should be withheld, lutropin alfa and follitropin alfa should be discontinued, and the patients should be advised to avoid intercourse.

Dose in Children:

Not indicated.

Pregnancy Risk Category: X

• It is not recommended for women who are pregnant or have been confirmed.
• It can cause ectopic pregnancy, spontaneous abortion, miscarriage and multiple pregnancies if administered to women.
• Congenital abnormalities can be more likely in a female who has had assisted reproduction techniques than if she is able to conceive naturally.

Lutropin alfa use during breastfeeding:

• It is recommended that you avoid breastfeeding while taking the drug. However, it is not known if the drug will be excreted into breastmilk.

Dose in Kidney Disease:

There are no dosage adjustments provided in the manufacturer's labeling. It has not been studied in patients with kidney disease.

Dose in Liver disease:

There are no dosage adjustments provided in the manufacturer's labeling. It has not been studied in patients with liver disease.

Common Side Effects of Luveris (Lutropin alfa):

• Central nervous system:

  • Headache
  • Pain

• Endocrine & metabolic:

  • Ovarian cyst

• Gastrointestinal:

  • Flatulence
  • Abdominal pain

• Genitourinary:

  • Dysmenorrhea
  • Mastalgia

Less Common Side Effects of Luveris (Lutropin alfa):

• Central nervous system:

  • Fatigue

• Endocrine & metabolic:

  • Ovarian hyperstimulation
  • Ovarian disease
  • Increased serum cholesterol

• Gastrointestinal:

  • Nausea
  • Constipation
  • Diarrhea

• Hepatic:

  • Increased serum ALT
  • Increased serum AST

• Local:

  • Injection site reaction

• Respiratory:

  • Upper respiratory tract infection

Contraindication to Luveris (Lutropin alfa):

• Allergy reactions to any component of the drug or the drug itself
• Primary ovarian failure
• Patients suffering from uncontrolled thyroid or adrenal dysfunction
• Patients with hypothalamic or pituitary tumors
• Breast, uterine or ovarian cancer
• Patients suffering from abnormal uterine bleeding due to undetermined causes.
• Ovarian cysts or ovarian enlargement that isn't due to polycystic renal disease, and not caused by undetermined causes.
• Incompatible with pregnancy: Malformed sexual organs
• Uterine fibroids not compatible with pregnancy
• Pregnancy
• Breastfeeding

Warnings and precautions

• Neoplasm

  • Patients who have received infertility treatments are more likely to develop benign and malignant neoplasms. 
  • It has not been proven that gonadotropin therapy is directly linked to an increased chance of malignancy.

• Ovarian enlargement:

  • Ovarian enlargement can cause abdominal distension and pain. 
  • Most patients experience improvement within two to three weeks of receiving no treatment.
  • Patients with polycystic-ovarian disease are more likely to experience ovarian enlargement. 
  • To reduce the risk of developing ovarian hyperstimulation syndrome, hCG must not be administered to patients whose ovarian enlargement is detected on the last day.

• Ovarian hyperstimulation syndrome:

  • Ovarian hyperstimulation syndrome is a serious side effect of hormone stimulation. This is a heightened response to ovulation-induction therapy.
  • This condition can develop within 24 hours of treatment initiation but may become severe after seven to ten days.
  • Mild to moderate OHSS symptoms include:
    • Abdominal discomfort or distention
    • diarrhea,
    • Nausea and/or vomiting
    • vomiting.
  • Symptoms of severe OHSS could include:
    • Extreme abdominal pain
    • Anuria or Oliguria
    • ascites,
    • severe dyspnea,
    • Hypotension, or
    • Intractable vomiting and nausea
  • Laboratory abnormalities in OHSS include:
    • Reduce creatinine clearance,
    • hemoconcentration,
    • hypoproteinemia,
    • Elevated liver enzymes
    • Leukocytosis is a form of leukocytosis.
    • electrolyte imbalances.
  • Symptomatic treatment of OHSS should be discontinued. 
  • Stop taking gonadotropin medication. 
  • Symptomatic therapy is the treatment of pain and fluid abnormalities.
  • It also prevents thromboembolic complications.

• Thromboembolism

  • Thromboembolic episodes may be seen in patients with ovarian hyperstimulation disorder, but they have also been reported in patients without OHSS.

• Porphyria

  • Patients with porphyria and those who have a family history are more likely to develop acute porphyric attacks after receiving lutropin alfa therapy.
  • Patients with an acute porphyric attack must stop receiving treatment.

Monitoring parameters:

• Before initiating treatment, check LH and FSH levels.
• It is usually given to patients who have a baseline LH <1.2 units/L and FSH <5 units/L.
• Follicular development should be monitored via sonographic visualization of the ovaries and endometrial lining.
• Concomitant estradiol levels may or may not be measured.
• Combined estradiol levels and sonographic visualization of follicular development for monitoring the growth and development of follicles and the timing of HCG administration is more useful.
• Indirect evaluation of estrogenic activity may also be measured via assessing changes in the appearance and volume of cervical mucous and changes in vaginal cytology.
• It should only be used as an adjunct to the more direct estimation of follicular development such as serum estradiol levels and ultrasonographic evaluation of follicular development.
• The direct and indirect indices of progesterone production may be used as clinical markers of ovulation.

These indices include:

• a rise in basal body temperature,
• an increase in serum progesterone, and
• menstruation following the shift in basal body temperature.

Ultrasound findings of ovulation include:

• collapsed follicle,
• fluid in the cul-de-sac,
• ovarian stigmata, and
• secretory endometrium.

Patients should be monitored for the clinical features of ovarian hyperstimulation syndrome at least 2 weeks following HCG administration.

Monitoring parameters of OHSS that should be checked daily include:

• abdominal circumference,
• albumin,
• cardiorespiratory status,
• electrolytes,
• fluid balance,
• hematocrit,
• hemoglobin,
• serum creatinine,
• urine output,
• urine specific gravity,
• vital signs,
• weight (all daily or as necessary) and

Liver enzymes should be checked weekly.

How to administer Luveris (Lutropin alfa)?

• It is administered as a subQ injection in the anterior abdomen or the thighs.
• The site of injections should be rotated.
• Before administering the drug, do not shake it and allow any bubbles to settle before its administration.
• It may also be mixed in the same syringe with follitropin alfa.

Mechanism of action of Luveris (Lutropin alfa):

• Lutropin alfa comes from Chinese hamster cells ovaries. 
• It is a recombinant hormone that stimulates the production of estradiol in the ovarian follicles and promotes follicular growth.

Bioavailability:

• 56%

Half-life elimination:

• Terminal: 21 hours

Time to peak, serum:

• 9 hours

Excretion:

• Urine (<5% unchanged)

International Brands of Lutropin alfa:

• Luveris
• Luver-I.S.

Lutropin alfa Brands Names in Pakistan:

No Brands Available in Pakistan.