Lutropin Alfa

Pronunciation: LOO-troe-pin AL-fah
Class: Gonadotropin

Trade Names

Luveris
- Powder for injection, lyophilized 82.5 units/vial (to deliver 75 units)

Pharmacology

Increases estradiol secretion, thereby supporting follicle stimulating hormone (FSH)-induced follicular development.

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Pharmacokinetics

Absorption

Following subcutaneous administration, C max is reached after about 4 to 16 h. After subcutaneous administration of lutropin alfa 150 units, the C max is 1.1 units/L, the AUC is about 44 h•units/L, and T max is about 6 h.

Distribution

Steady state Vd is about 10 L.

Elimination

After subcutaneous administration of lutropin alfa 150 units, the t ½ is about 14 h. Mean terminal t ½ is about 18 h. Total body Cl is about 2 to 3 L/h with less than 5% excreted unchanged by the kidney.

Indications and Usage

Lutropin alfa is coadministered with follitropin alfa for stimulation of follicular development in infertile, hypogonadotropic, hypogonadal women with profound luteinizing hormone (LH) deficiency.

Contraindications

Women who exhibit prior hypersensitivity to human LH preparations or their excipients; primary ovarian failure; uncontrolled thyroid or adrenal dysfunction; uncontrolled organic intracranial lesion such as a pituitary tumor; abnormal uterine bleeding of undetermined origin; ovarian cyst or enlargement of undetermined origin; sex hormone dependent tumors of the reproductive tract and accessory organs; pregnancy.

Dosage and Administration

Adults

Subcutaneous 75 units coadministered with follitropin alfa as 2 separate injections, both given daily until adequate follicular development as indicated by ovary ultrasonography and serum estradiol. Duration usually should not exceed 14 days, unless signs of imminent follicular development are present. To complete follicular development and effect ovulation in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) is given 1 day after the last dose of lutropin alfa and follitropin alfa. Withhold treatment with hCG if ovaries are abnormally enlarged or if excessive estradiol production has occurred. Individualize doses for subsequent cycles.

General Advice

  • For subcutaneous administration only. Not for intradermal, IM, IV, or intra-arterial administration.
  • Reconstitute powder for injection by adding 1 mL sterile water for injection and mix gently until solution is clear. Do not shake vial during reconstitution. Reconstituted vial will deliver lutropin alfa 75 units.
  • Do not administer if solution is discolored or cloudy, or if particulate matter is noted.
  • Replace needle used for reconstituting powder for injection with new needle before administering dose.
  • Administer solution immediately after reconstitution.
  • If more than 1 vial is needed to provide prescribed dose, administer entire contents of each vial as separate subcutaneous injections.
  • Administer subcutaneous doses in either side of lower abdomen in alternating fashion. Vary the actual injection site a little with each injection. Do not administer subcutaneous into thigh unless the lower abdomen is not usable because of scaring, surgical deformity, or other medical conditions.
  • Discard any unused solution. Do not save unused solution for later administration.

Storage/Stability

Store lyophilized powder in refrigerator or at room temperature (36° to 77°F). Protect from light.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Headache, fatigue (at least 2%).

GI

Abdominal pain, constipation, diarrhea, flatulence, nausea (at least 2%).

Genitourinary

Breast pain, dysmenorrhea, ovarian cyst, ovarian disorder, ovarian hyperstimulation (at least 2%).

Local

Injection site reaction and pain (at least 2%).

Respiratory

Upper respiratory tract infection (at least 2%).

Precautions

Monitor

Ovarian response

To reduce risk of overstimulation of the ovary and to determine the number of follicles, ensure that ovarian response to therapy is closely monitored with serum estradiol levels and ultrasonography. If excessive estradiol production has occurred, the ovaries are abnormally enlarged, or if abdominal pain occurs, discontinue treatment with lutropin alfa and follitropin alfa, do not administer hCG, and caution patient to avoid intercourse.


Pregnancy

Category X .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Multiple births

Increased risk of multiple births.

Ovarian enlargement

Mild to moderate uncomplicated ovarian enlargement may occur.

Ovarian hyperstimulation

May occur within 24 h to several days after treatment and is characterized by an increase in vascular permeability that can result in rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially the pericardium. Monitor patient for signs and symptoms of ovarian hyperstimulation syndrome (eg, dyspnea, severe pelvic pain, nausea, vomiting, diarrhea, rapid weight gain, abdominal pain or distension, oliguria) during therapy and for 2 wk after hCG has been discontinued.

Pulmonary/vascular complications

Potential for occurrence of arterial thromboembolism exists. Monitor patient for signs and symptoms of thromboembolic events (eg, venous thrombophlebitis, pulmonary embolism, pulmonary infarction, stroke, arterial occlusion). Report to health care provider immediately if noted or suspected.

Overdosage

Symptoms

Ovarian hyperstimulation, multiple gestations.

Patient Information

  • Explain name, action, and potential side effects of the treatment regimen, including risk of multiple births and ovarian hyperstimulation syndrome. Review the treatment regimen, including duration of treatment and monitoring that will be required.
  • If patient will be self-administering at home, ensure the patient understands how to store, prepare, and administer the dose, and dispose of used equipment and supplies.
  • Caution patient not to change the dose or stop taking unless advised by health care provider.
  • Caution patient that if a dose is missed not to double the dose to catch up. Advise patient to contact health care provider for further instructions.
  • Remind patient that drug is administered to promote follicular growth and egg production, and that hCG will need to be administered to induce ovulation.
  • Encourage patient receiving drug for infertility to have intercourse daily, beginning on the day prior to administration of hCG, and until ovulation has become apparent.
  • Warn patient that close monitoring for overstimulation of the ovary is required and to report any of the following immediately to health care provider: difficulty breathing, severe pelvic pain, nausea, vomiting, diarrhea, rapid weight gain, stomach pain or bloating, or infrequent urination.
  • Advise patient to inform health care provider of any side effects, symptoms, or physical changes, or bothersome injection site reactions.

Copyright © 2009 Wolters Kluwer Health.

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