Luveris
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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.
Uses
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:
- Patients should have baseline serum hormone levels of LH < 1.2 IU/L and FSH < 5 IU/L.
- 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.
- Patients should have a negative progestin challenge test.
- 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.
- Evaluation of the partner’s fertility potential should be included in the initial evaluation.
History
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
Sources
Luveris Manufacturers
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Emd Serono, Inc.
![Luveris (Lutropin Alfa) Kit [Emd Serono, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Luveris | Emd Serono, Inc.
For Subcutaneous Use Only
Dosage
It is recommended that 75 IU Luveris® be concomitantly administered subcutaneously with 75 IU to 150 IU Gonal-f® as two separate injections in the initial treatment cycle. Concomitant administration of Luveris® with Gonal-f® was studied in the clinical trials for Luveris®. The safety and effectiveness of concomitant administration of Luveris® with any other preparation of recombinant human FSH or urinary human FSH is unknown. Luveris® and Gonal-f® should be administered daily until adequate follicular development is indicated by ovary ultrasonography and serum estradiol. Treatment duration should not normally 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) should be given one day after the last dose of Luveris® and Gonal-f®. Treatment with hCG should be withheld if the ovaries are abnormally enlarged or if excessive estradiol production has occurred. If the ovaries are abnormally enlarged or abdominal pain occurs, treatment with Luveris® and Gonal-f® should be discontinued and hCG should not be administered, and the patient should be advised not to have intercourse; this may reduce the chances of developing Ovarian Hyperstimulation Syndrome and, should spontaneous ovulation occur, reduce the chances of multiple gestation. A follow-up visit should be conducted in the luteal phase.
Doses administered in subsequent cycles should be individualized for each patient based on her response in the preceding cycle. Doses of Gonal-f® greater than 225 IU per day are not routinely recommended. As in the initial cycle, hCG must be given to complete follicular development and induce ovulation. The precautions described above should be followed to minimize the chance of developing Ovarian Hyperstimulation Syndrome.
The couple should be encouraged to have intercourse daily, beginning on the day prior to hCG administration until ovulation becomes apparent in the indices used for the determination of progestational activity.
In light of the indices and parameters mentioned, it should become obvious that, unless a physician is willing to devote considerable time to these patients and be familiar with and conduct the necessary laboratory studies, he/she should not prescribe Luveris®.
Administration:
Dissolve the contents of one vial of Luveris® in 1 mL Sterile Water for Injection, USP. Gonal-f® should be reconstituted and administered as directed in the prescriber labeling for this product. Administer entire contents of each vial SUBCUTANEOUSLY as separate injections. For single use. Use immediately after reconstitution. Any unused reconstituted material should be discarded. Mix gently. Do not shake.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Directions for Administration of Luveris®:
Luveris® and Gonal-f® may be self-administered by the patient. Follow the directions below for reconstituting and injecting as separate injections of Luveris® and Gonal-f®. Gonal-f® should be reconstituted and administered as directed in the prescriber labeling for this product. Any unused reconstituted material should be discarded.
Step 1: Prepare the vials
Wash your hands thoroughly with soap and water.
Begin by opening the carton of Luveris®. Remove the plastic flip-tops from the vial of Luveris® powder and the vial of diluent provided with Luveris®. After removing the plastic flip-tops with your thumb, wipe the rubber stoppers with alcohol. The rubber stoppers should not be touched after they are wiped.
Step 2: Withdraw the Water into the Syringe
Carefully remove the needle cover. Do not touch the needle or allow the needle to touch any surface. After removing the needle cover, draw air into the syringe by slowly pulling back the plunger to the 1 cc mark. Place the vial of diluent on a hard, flat surface. Carefully insert the needle through the rubber stopper into the vial with the sterile water (diluent).
Gently inject the air into the vial (the injected air creates pressure, which makes withdrawing the solution easier). Without removing the needle, turn the vial upside down and withdraw all of the water into the syringe, making sure the tip of the needle remains in the water. Remove the needle from the vial.
Step 3: Inject the Water into the Luveris® Vial
Place the vial containing the Luveris® powder on a hard, fl at surface. Insert the needle through the rubber stopper into the vial. Keep the syringe in a straight, upright position as you insert it through the center of the rubber stopper, or it may be difficult to depress the plunger. After inserting the needle, slowly inject the sterile water (diluent) by depressing the plunger on the syringe into the vial of Luveris® powder.
Step 4: Gently Dissolve the Luveris® Powder
Leaving the needle in the vial, gently rotate the vial between your fingers until all of the powder is dissolved. Do not shake. Check that the solution is clear and colorless. Do not use if the solution is cloudy, discolored, or contains particles.
Step 5: Withdraw the Luveris® solution from the Vial
Without removing the needle, turn the vial upside down and withdraw all of the Luveris® solution into the syringe. Make sure the tip of the needle remains in the solution by slowly backing the needle out of the vial to withdraw as much of the solution as possible. Next, remove the needle from the vial.
Step 6: Replace needle and remove air bubbles in the syringe
Recap the syringe needle and twist the cap and needle off of syringe. Twist a new needle onto the end of the syringe and carefully remove the cap of the needle. To remove any air bubbles in the syringe, point the needle up and gently tap the syringe. When all the bubbles float to the top, slightly push the plunger until a small drop or two of solution begins to appear from the tip of the needle.
Step 7: Recap the syringe needle
Recap the syringe needle. Do not touch the needle or allow the needle to touch any surface. Carefully lay the syringe down on a flat, clean surface.
Step 8: Carefully clean the injection site
Suitable injection sites on the stomach (a few inches above or below the navel) will be advised by your fertility specialist. Occasionally your fertility specialist may suggest an alternative site. Make yourself comfortable by sitting or lying down. Carefully clean the injection site with an alcohol wipe and allow it to air-dry.
Step 9: Administer your injection
Remove the needle cap from the syringe needle. Hold the syringe like a pencil. With your other hand, pinch the skin together. Using a dart-like motion, insert the needle at a 45° to 90° angle (just under the skin) into the pad of tissue as shown or as directed by your doctor, nurse, or pharmacist. Do not inject into a vein.
Release the hand pinching the skin and depress the plunger in a slow, steady motion until all the medication is injected.
Step 10: Gently withdraw the needle
Withdraw the needle.
Step 11: Storage and clean up
Discard the used needle and syringe into your safety container. Place gauze over the injection site. If any bleeding occurs, apply gentle pressure. If bleeding does not stop within a few minutes, place a clean piece of gauze over the injection site and cover it with an adhesive bandage. Remember that your injection materials must be kept sterile and cannot be reused.
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