Molecular Formula: C437H682N122O134S13
CAS Number: 152923-57-4
Gonad-stimulating hormone; a biosynthetic (recombinant DNA origin) form of naturally occurring human LH.1
Uses for Lutropin Alfa
Used in conjunction with recombinant FSH (follitropin alfa) to stimulate follicular development in anovulatory, infertile women with hypothalamic or pituitary insufficiency (hypogonadotropic hypogonadism)1 2 3 and profound LH deficiency (LH <1.2 international units [IU]/L).1 7
Lutropin Alfa Dosage and Administration
Should be prescribed by clinicians experienced in infertility treatment.1
Prior to initiating therapy with lutropin alfa, perform a thorough gynecologic and endocrinologic evaluation; assess pelvic anatomy and rule out early pregnancy.1 Determine that serum LH concentrations are <1.2 IU/L, FSH concentrations <5 IU/L, and a negative progestin challenge test (i.e., a lack of withdrawal bleeding with progesterone administration).1 2 3 5 8 Perform a thorough diagnostic evaluation in patients who demonstrate abnormal uterine bleeding and other signs of endometrial abnormalities.1 8 Evaluate partner’s infertility.1 8
Administer lutropin alfa in conjunction with recombinant follitropin alfa daily until follicular maturation (as determined by serum estradiol concentrations and ovary ultrasound examinations) occurs.1
When ultrasound assessment and serum estradiol concentrations show sufficient follicular maturation, discontinue lutropin alfa and follitropin alfa; administer hCG 1 day after the last dose of lutropin alfa and follitropin alfa to complete final follicular maturation and induce ovulation.1
Do not administer hCG if the ovaries show an excessive response to treatment with gonadotropins because of an increased risk of ovarian hyperstimulation syndrome.1 (See Ovarian Hyperstimulation Syndrome under Cautions.)
Encourage couple to have daily sexual intercourse beginning the day prior to administration of hCG, until ovulation occurs (as determined by a rise in basal body temperature, an increase in serum progesterone, and menstruation following a shift in basal body temperature).1 (See Adequate Patient Evaluation and Monitoring under Cautions.)
Administer lutropin alfa and follitropin alfa as separate injections.1
Reconstitute vial containing 82.5 units of lutropin alfa sterile lyophilized powder with 1 mL of sterile water for injection (provided by manufacturer).1
Dosage of lutropin alfa is expressed in terms of international units (IU, units) of LH activity.1
75 units daily in conjunction with follitropin alfa (75–150 units daily) until follicular maturation occurs.1 (See General under Dosage and Administration.)
Cautions for Lutropin Alfa
Risk of mild to moderate uncomplicated ovarian enlargement; may be accompanied by abdominal distension and/or pain but generally regresses without treatment within 2–3 weeks.1 Careful monitoring of ovarian response recommended.1
If ovaries are abnormally enlarged (i.e., development of ≥3 follicles with a mean diameter of ≥15 mm) and/or if excessive estradiol production (>1100 pg/mL) occurs following the last dose of lutropin alfa and follitropin alfa, withhold hCG administration during the current course of therapy to minimize the risk of development of ovarian hyperstimulation syndrome (OHSS).1 (See Ovarian Hyperstimulation Syndrome under Cautions.)
Ovarian Hyperstimulation Syndrome (OHSS)
Risk of potentially severe OHSS, characterized by an apparent dramatic increase in vascular permeability that may result in rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially, the pericardium.1
OHSS may progress rapidly (within 24 hours to several days) and is initially manifested by severe pelvic pain, nausea, vomiting, and weight gain.1 Other symptoms include abdominal pain/distension, diarrhea, dyspnea, and oliguria.1 Hypovolemia, hemoconcentration, electrolyte imbalances, ascites, hemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events may occur.1
Transient liver function test abnormalities, which may be accompanied by morphologic changes (as detected by liver biopsy) have been reported.1
OHSS occurs most often after completion of gonadotropin therapy; develops rapidly, reaching maximum severity after 7–10 days; and usually resolves spontaneously with the onset of menses.1 OHSS may be more severe and protracted if pregnancy occurs.1
Discontinue therapy with lutropin alfa and follitropin alfa if ovaries are abnormally enlarged or abdominal pain occurs; withhold hCG administration and advise patient to avoid sexual intercourse.1
If severe OHSS occurs, discontinue therapy, hospitalize patient, and consult a clinician experienced in the management of OHSS or fluid and electrolyte imbalances.1
Pulmonary and Vascular Complications
Potential for arterial thromboembolism exists.1
Adequate Patient Evaluation and Monitoring
Administer only under the supervision of qualified clinicians experienced in fertility disorders and in interpretation of indices of ovulation.1
Monitor follicular development (e.g., using ovarian ultrasound, serum estradiol concentrations) in order to correctly identify follicular maturation, determine timing of hCG administration, detect ovarian enlargement, and minimize risks of OHSS and multiple gestation.1
Obtain clinical confirmation of ovulation from direct and indirect indices of progesterone production, including a rise in basal body temperature, increase in serum progesterone, and menstruation following a shift in basal body temperature.1 Sonographic evidence of ovulation includes findings of fluid in the cul-de-sac, ovarian stigmata, collapsed follicle, and a secretory endometrium.1
Category X.1 (See Contraindications under Cautions.)
Pharmacokinetics not evaluated.1
Pharmacokinetics not evaluated.1
Common Adverse Effects
Interactions for Lutropin Alfa
No formal drug interaction studies to date.1
Lutropin Alfa Pharmacokinetics
Mean absolute bioavailability is 56%.1
Following sub-Q administration, maximum serum concentrations reached after 4–16 hours.1
<5% of dose excreted renally as unchanged drug.1
Biphasic; terminal half-life is approximately 18 hours.1
Store refrigerated or at room temperature (2–25°C); protect from light.1
Use immediately after reconstitution; discard unused portion.1
Stimulates (in combination with FSH) the development of a potentially competent follicle to indirectly prepare the reproductive tract for implantation and pregnancy.1
Substitutes for the endogenous LH surge responsible for ovulation and stimulates late maturation of the ovarian follicle, resumption of oocytic meiosis, initiation of rupture of the preovulatory ovarian follicle, and oocyte expulsion. 1 4
Induces and maintains the corpus luteum.4
Advice to Patients
Importance of providing patient a copy of manufacturer’s patient information.1
Importance of patient understanding and following instructions regarding reconstitution of lutropin alfa, duration of treatment, and required monitoring procedures.1
Importance of informing patient of potential adverse effects (e.g., ovarian hyperstimulation syndrome, multiple gestation).1
Importance of patients informing a clinician if severe pain or bloating in the stomach or pelvic area, severe upset stomach, vomiting, or weight gain occurs.8
Importance of patients contacting a clinician immediately if a dose of lutropin alfa is missed.8
Importance of women informing their clinician if they plan to breast-feed.1
Importance of informing patient of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
For injection, for subcutaneous use only
82.5 units (delivers 75 units)
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2013, Selected Revisions September 1, 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
1. Serono. Luveris (lutropin alfa) for injection prescribing information. Rockland, MA; 2005 May.
2. European Recombinant Human LH Study Group. Recombinant human luteinizing hormone (LH) to support recombinant human follicle-stimulating hormone (FSH)-induced follicular development in LH- and FSH-deficient anovulatory women: a dose-finding study. J Clin Endorinol Metab. 1998; 83:1507-14.
3. Burgues S and the Spanish Collaborative Group on Female Hypogonadotrophic Hypogonadism. The effectiveness and safety of recombinant human LH to support follicular development induced by recombinant human FSH in WHO group I anovulation: evidence from a multicentre study in Spain. Hum Reprod. 2001; 16:2525-32. [PubMed 11726569]
4. le Contonnec JY, Porchet HC, Beltrami V et al. Clinical pharmacology of recombinant human luteinizing hormone: part I. Pharmacokinetics after intravenous administration to healthy female volunteers and comparison with urinary human luteinizing hormone. Fertil Steril. 1998; 69:189-94. [PubMed 9496327]
5. Kingingham RB, Apgar BS, Schwenk TL et al. Evaluation of amenorrhea. Am Fam Physician. 1996;53:1185-94.
6. Campo S, Campo V, Lanzone A. Twin pregnancy using recombinant gonadotropins in a woman with hypogondotropic hypogonadism. Gynecol Endocrinol. 2002; 16:27-32. [PubMed 11915578]
7. Serono, Rockland, MA: Personal communication.
8. Serono. Luveris (lutropin alfa) injection FAQ’s. Rockland, MA. Undated. Available at . Accessed 2006 Dec 1.