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 utilised to encourage the growth of follicles and the production of estradiol in females who have a severe luteinizing hormone deficit (1.2 units/L).
  • Follitropin alfa is used in conjunction with it.

Luveris (Lutropin alfa) Dose in Adults:

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

• Females (≥16 years to ≤60 years):

  • 75 units are given subQ every day until sufficient follicular growth is seen.
  • The daily dose cap is 75 units.
  • Unless there are clinical symptoms of follicular development, the maximum treatment time is 14 days.
  • Ovarian stimulation can be prolonged for up to 5 weeks in a single cycle. However, the course of treatment needs to be tailored based on how the prior cycle went.
  • It needs to be taken alongside follitropin alfa. One day following the final dose of lutropin alfa and follitropin alfa, hCG should be given.
  • 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:

The manufacturer's labelling does not mention dosage modifications. Patients with kidney problems have not been studied with it.

Dose in Liver disease:

The manufacturer's labelling does not mention dosage modifications. Patients with kidney problems have not been studied with it.

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 who experience irregular uterine bleeding for unknown reasons.
• Ovarian cysts or ovarian enlargement that isn't due to polycystic renal disease, and are 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 the polycystic-ovarian disease are more likely to experience ovarian enlargement. 
  • In order to lower the chance of developing ovarian hyperstimulation syndrome, patients whose ovarian enlargement is discovered on the final day should not receive hCG injections.

• Ovarian hyperstimulation syndrome:

  • Ovarian hyperstimulation syndrome is a serious side effect of hormone stimulation. This is a heightened response to ovulation-induction therapy.
  • After starting medication, this illness may worsen within 24 hours, but it may also get worse 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
    • 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.
• The endometrial lining and ovaries should be seen sonographically to track follicular development.
• Estradiol levels that are concurrent may or may not be measured.
• For monitoring the size and development of follicles and the timing of HCG injection, combined estradiol levels and sonographic observation of follicular development are more useful.
• The volume and appearance of cervical mucus as well as changes in vaginal cytology can both be used as indirect indicators of estrogenic activity.
• 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.
• As clinical indicators of ovulation, the direct and indirect indices of progesterone production may be employed.

These indices include:

• Increased basal body temperature
• Increased serum progesterone
• Menstruation with a shift in basal body temperature.

Ultrasound findings of ovulation include:

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

At least two weeks after receiving HCG, patients should be checked for the clinical signs of ovarian hyperstimulation syndrome.

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 

Liver enzymes should be checked weekly.

How to administer Luveris (Lutropin alfa)?

• It is given as a subQ injection in the thighs or anterior abdomen.
• Rotate the injection site frequently.
• Don't shake the medication before taking it, and let any bubbles settle before taking it.
• 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.