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Questions & Answers

Side Effects & Adverse Reactions

Gonadotropins, including Luveris® (lutropin alfa for injection), should only be used by physicians who are thoroughly familiar with infertility problems and their management. Like other gonadotropin products, Luveris® is a potent gonadotropic substance capable of contributing to the development of Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. The risks of gonadotropin treatment should be considered for women with risk factors of thromboembolic events such as prior medical or family history.  Gonadotropin therapy requires a certain time commitment by physicians and supportive health professionals, and requires the availability of appropriate monitoring facilities (see “PRECAUTIONS/ Laboratory Tests”). Safe and effective use of Luveris® requires monitoring of ovarian response with serum estradiol and ovary ultrasound on a regular basis.

Overstimulation of the Ovary Following Gonadotropin Therapy:

Ovarian Enlargement:

Mild to moderate uncomplicated ovarian enlargement which may be accompanied by abdominal distension and/or abdominal pain may occur in patients treated with gonadotropins (such as Luveris®). These conditions generally regress without treatment within two or three weeks.  Careful monitoring of ovarian response can further minimize the risk of overstimulation.

If the ovaries are abnormally enlarged on the last day of therapy with Luveris® and Gonal-f®, hCG should not be administered in this course of therapy. This will reduce the risk of development of Ovarian Hyperstimulation Syndrome.

Ovarian Hyperstimulation Syndrome (OHSS):

OHSS is a medical event distinct from uncomplicated ovarian enlargement. Severe OHSS may progress rapidly (within 24 hours to several days) to become a serious medical event. It is characterized by an apparent dramatic increase in vascular permeability which can result in a rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially, the pericardium. The early warning signs of development of OHSS are severe pelvic pain, nausea, vomiting, and weight gain. The following symptomatology has been seen with cases of OHSS: abdominal pain, abdominal distension, gastrointestinal symptoms including nausea, vomiting and diarrhea, severe ovarian enlargement, weight gain, dyspnea, and oliguria. Clinical evaluation may reveal hypovolemia, hemoconcentration, electrolyte imbalances, ascites, hemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events (see “Pulmonary and Vascular Complications”). Transient liver function test abnormalities that are suggestive of hepatic dysfunction have been reported in association with Ovarian Hyperstimulation Syndrome (OHSS).  These liver function test abnormalities may be accompanied by morphological changes on liver biopsy.

In hypogonadotropic hypogonadal women with profound LH and FSH deficiency from five clinical trials, four cases of OHSS were reported in 4 of 70 (5.7%) patients treated with 75 IU Luveris® and Gonal-f® and one case was reported in 1 of 31 (3.2%) patients treated with Gonal-f® alone.  Among women treated with any dose of Luveris® in these studies, five of 96 (5.2%) patients reported 6 cases of OHSS after treatment with Luveris® and Gonal-f®.

OHSS may be more severe and more protracted if pregnancy occurs. OHSS develops rapidly; therefore, patients should be followed for at least two weeks after hCG administration. Most often, OHSS occurs after treatment has been discontinued and reaches its maximum severity at seven to ten days following treatment. Usually, OHSS resolves spontaneously with the onset of menses. If there is evidence that OHSS may be developing prior to hCG administration (see “PRECAUTIONS/Laboratory Tests”), hCG must be withheld.

If severe OHSS occurs, treatment with gonadotropins must be stopped and the patient should be hospitalized.

A physician experienced in the management of this syndrome, or who is experienced in the management of fluid and electrolyte imbalances should be consulted.

Multiple Births: Patients should be advised of the potential risk of multiple births before starting treatment.

Pulmonary and Vascular Complications: As with other gonadotropin products, a potential for the occurrence of arterial thromboembolism exists.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


Luveris® (lutropin alfa for injection), concomitantly administered with Gonal-f® (follitropin alfa for injection), is indicated for stimulation of follicular development in infertile hypogonadotropic hypogonadal women with profound LH deficiency (LH < 1.2 IU/L). A definitive effect on pregnancy in this population has not been demonstrated. The safety and effectiveness of concomitant administration of Luveris® with any other preparation of recombinant human FSH or urinary human FSH is unknown.

Selection of Patients:

  1. Patients should have baseline serum hormone levels of LH < 1.2 IU/L and FSH < 5 IU/L.
  2. Before treatment with gonadotropins is instituted, a thorough gynecologic and endocrinologic evaluation must be performed.  This should include an assessment of pelvic anatomy and exclusion of pregnancy.
  3. Patients should have a negative progestin challenge test.
  4. Patients in later reproductive life have a greater predisposition to endometrial carcinoma as well as a higher incidence of anovulatory disorders. A thorough diagnostic evaluation should always be performed in patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities before starting Luveris® and follitropin alfa therapy.
  5. Evaluation of the partner’s fertility potential should be included in the initial evaluation.


There is currently no drug history available for this drug.

Other Information

Luveris® (lutropin alfa for injection) is a sterile lyophilized powder composed of recombinant human luteinizing hormone, r-hLH. r-hLH is a heterodimeric glycoprotein consisting of two non-covalently linked subunits (designated α and β) of 92 and 121 amino acids, respectively.  The carbohydrate chain attachment to the r-hLH protein core occurs via N- but not O-linkage. The N-glycosylation sites are Asn-52 and Asn-78 for the α–subunit and Asn-30 for the β–subunit. The β-chain has an N-glycosylation site and its structure and glycosylation pattern are very similar to that of pituitary-derived hLH.

The production process involves expansion of genetically modified Chinese Hamster Ovary (CHO) cells from an extensively characterized cell bank into large scale cell culture processing. Lutropin alfa is secreted by the CHO cells directly into the cell culture medium that is then purified using a series of chromatographic steps. The biological activity of lutropin alfa is determined using the Van Hell Bioassay described in the British Pharmacopoeia.  The in vivo biological activity is determined using a house standard properly calibrated against the relevant international standard.

Luveris® is a sterile, lyophilized powder, which after reconstitution with Sterile Water for Injection, USP, is intended for subcutaneous (sc) administration.  Each vial of Luveris® contains 82.5 IU lutropin alfa, 48 mg sucrose, 0.83 mg dibasic sodium phosphate dihydrate, 0.052 mg monobasic sodium phosphate monohydrate, 0.05 mg polysorbate 20, and 0.1 mg L-methionine. Phosphoric acid and/or sodium hydroxide are used to adjust the pH. After reconstitution with 1 mL of enclosed diluent, the product will deliver 75 IU of recombinant human lutropin alfa. The pH of the reconstituted solution is 7.5 to 8.5.

Therapeutic Class: Infertility

Luveris Manufacturers

  • Emd Serono, Inc.
    Luveris (Lutropin Alfa) Kit [Emd Serono, Inc.]

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