Generic name: LUTROPIN ALFA 82.5[iU] in 1mL;
Dosage form: injection
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For Subcutaneous Use Only
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®.
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.