LUVERIS®

Description:
Luveris (lutropin alfa for injection) is a recombinant human luteinizing hormone (rhLH). Each package of Luveris is comprised of a vial of powdered medication containing 82.5 IU (International Units) and a 1cc vial of Sterile Water for injection, USP (diluent). After mixing the powdered Luveris with the 1cc of diluent, the product will deliver 75 IU of rhLH. It is formulated for subcutaneous injection.

How It Works:
Luveris is indicated for use in combination with gonadotropins to help stimulate follicular development in the ovaries of hypogonadotropic hypogonadal women with profound LH and FSH deficiency. It works by stimulating the theca cells (outer cell wall of the follicle) to secrete androgens, which will be used by the granulosa cells (part of the theca cells) to produce estradiol which will support the FSH induced follicular development..

Potential Side Effects:
Side effects that may occur include: nausea, vomiting, diarrhea, fever, breast tenderness, spotting or menstrual changes, ovarian enlargement, and injection site reaction (pain, swelling or irritation). Treatment with Luveris may increase the likelihood of multiple births. The risk of ovarian hyperstimulation syndrome (OHSS) should be discussed with your physician prior to treatment. Early warning signs include severe pelvic pain, nausea, vomiting and weight gain.

If you experience an allergic reaction: difficulty breathing; closing of throat; swelling of lips, tongue or face; or hives; seek emergency attention immediately. And if at any time you experience pain, warmth, redness, numbness, or tingling in an arm or leg; confusion, severe dizziness or severe headache, seek medical attention immediately.
PLEASE NOTE: If these or any other side effects occur, contact your physician.

Storage: Store Luveris at room temperature or refrigerate. Protect from light. Luveris cannot be mixed in advance. Once it is mixed, it must be used immediately.

LUVERIS

Mixing:

Pop off the plastic top of powdered medication and diluent (liquid)
Swab the top of each vial with an alcohol pad to prevent contamination.
Select a 3cc syringe with a 1 1/2 ” needle for mixing. Twist to secure needle.
Using your syringe, draw back 1cc of air into the syringe. Firmly insert the needle through the rubber stopper into the vial of diluent.
Firmly insert the needle through the rubber stopper into the vial of diluent. Invert, or turn upside down, the vial and syringe as one complete unit and depress the air into the vial in order to equalize the pressure, which will make withdrawal of the diluent easier. Once you depress the plunger of the air-filled syringe into the vial, make sure the tip of the needle is BELOW the liquid level and pull the plunger to withdraw 1cc of the diluent.
Slowly and cautiously deposit the diluent into the vial of powdered medication.
Rotate the vial between your thumb and index finger until the solution is clear.
Withdraw the newly mixed medication back into the syringe. Remove the syringe from the vial.
Invert the syringe so the needle is pointing upwards and tap the syringe to force any air bubbles to the top. Depress the plunger to expel the air.

If you are mixing a single vial, you are now ready for your injection. Withdraw the needle from the vial and carefully recap and replace the mixing needle with the smaller subcutaneous injection needle (usually 1/2” needle) and prepare for your injection.
Invert the syringe so the needle is pointing upwards and tap the syringe to force any air bubbles to the top. Depress the plunger to expel the air.
PROCEED TO SUBCUTANEOUS INJECTION INSTRUCTIONS

If Mixing More Than One Vial Of LUVERIS

Inject the contents of the syringe (powdered medication mixed with diluent) directly into the next vial of powdered medication, slowly and cautiously. Do not use more diluent for additional vials of LUVERIS. This will increase the dosage without increasing the liquid volume. Rotate the vial between your thumb and index finger until the solution is clear.
Withdraw the newly mixed Luveris from the second vial back into the syringe.
Invert the syringe so the needle is pointing upwards and tap the syringe to force any air bubbles to the top. Depress the plunger to expel the air. Repeat until you have reached your prescribed vial dosage. Withdraw the medication mixture from the final vial into the syringe and prepare for your injection.

When you are ready for your injection, recap and remove the mixing needle and replace it with a smaller subcutaneous injection needle (usually 1/2″ needle).

PROCEED TO SUBCUTANEOUS INJECTION INSTRUCTIONS

Subcutaneous Injection Instructions

Cleanse your selected SUBCUTANEOUS injection site with an alcohol wipe and allow to dry.

While holding the syringe with your dominant hand between your thumb and finger
(as you would a pencil), pinch the skin (with your other hand) at the site you have selected.

With a quick, dart-like motion, insert the entire needle (up to the hub of the syringe) at a 90° or a 45° angle and depress theplunger slowly and carefully.

After the injection is complete, quickly pull out the needle. If bleeding, apply pressure to the injection site with a sterile gauze pad. If stinging occurs after your injection, you maygently massage the injection site to alleviate your discomfort.

After injecting the medication dispose of the syringe into theSharps waste container. It is unnecessary to recap the needle as this could cause injury.