LUVERIS 75 IU/ML Порошок и раствор для инъекционного раствора

Содержание инструкции

1. Luveris 75 IU powder and solvent for injectable solution
   1. What is Luveris and what is it used for
   2. What you need to know before using Luveris
   3. How to use Luveris
   4. Possible side effects
   5. How to store Luveris
   6. Contents of the pack and other information

Solvent in vials

Luveris 75 IU powder and solvent for injectable solution

lutropin alfa

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Luveris is and what it is used for
• 2. What you need to know before you use Luveris
• 3. How to use Luveris
• 4. Possible side effects
• 5. How to store Luveris
• 6. Contents of the pack and other information

1. What is Luveris and what is it used for

What is Luveris
Luveris is a medicine containing lutropin alfa, the recombinant luteinizing hormone (LH)
essentially similar to the hormone naturally present in the human body, but prepared in the laboratory
using biotechnological methods. It belongs to the family of hormones called gonadotropins, which are
involved in the normal control of reproduction.

What is Luveris used for
The use of Luveris is indicated in the treatment of adult women who show a low level of
production of some hormones involved in the natural reproductive cycle. The medicine is used in
association with another hormone called follicle stimulating hormone (FSH) to induce the development
of follicles which are the structures that allow the maturation of eggs (oocytes) in the ovary.
Taking Luveris is followed by the administration of a single dose of human chorionic gonadotropin (hCG) to allow the release of an egg from the follicle (ovulation).

2. What you need to know before using Luveris

Do not use Luveris

• if you are allergic to gonadotropins (such as luteinizing hormone, follicle-stimulating hormone or human chorionic gonadotropin) or to any of the other ingredients of this medicine (listed in section 6).
• if you have a tumor of the ovary, uterus or breast.
• if you have been diagnosed with a brain tumor.
• if you have enlarged ovaries or fluid-filled sacs in the ovaries (ovarian cysts) of unknown origin.
• if you have vaginal bleeding of unknown cause.

Do not use Luveris if you have any of the above conditions. If you have doubts, consult your doctor or pharmacist before using this medicine.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Luveris.
Before starting treatment, your fertility and that of your partner must be assessed.
It is not recommended to use Luveris if you have any condition that usually makes a normal pregnancy impossible, for example ovaries that are not functioning due to a condition called primary ovarian insufficiency, or malformations of the reproductive organs.
Porphyria
Before starting treatment, tell your doctor if you or a family member suffers from porphyria (inability to break down porphyrins, which can be passed on from parents to children).
Ovarian hyperstimulation syndrome (Ovarian hyperstimulation syndrome, OHSS)
This medicine stimulates the ovaries, increasing the risk of developing ovarian hyperstimulation syndrome or OHSS. This occurs when the follicles develop too much and become large cysts. If you experience lower abdominal pain, rapid weight gain, nausea or vomiting, or difficulty breathing, consult your doctor immediately, who may ask you to stop taking this medicine (see “Serious side effects” in section 4).
In the absence of ovulation and if the recommended dosages and timing of administration are respected, the onset of OHSS is less likely. The use of Luveris rarely causes the occurrence of severe OHSS. This possibility becomes more likely if the medicine used for the final maturation of the follicle, containing human chorionic gonadotropin, hCG, is administered (see “Recommended dosage” in section 3). If you are developing OHSS, your doctor may avoid the administration of hCG in this treatment cycle and you may need to abstain from sexual intercourse or use barrier contraceptive methods for at least four days.
The doctor will schedule careful monitoring of the ovarian response by ultrasound and blood tests, before and during treatment.
Multiple pregnancy
While using Luveris, you have a higher risk of establishing a multiple pregnancy, mostly twins, compared to natural conception. Multiple pregnancy can cause medical complications for you and your babies. It is possible to reduce the risk of multiple pregnancy by taking the right dose of Luveris at the established times. If you are undergoing assisted reproductive techniques, the risk of multiple pregnancy is related to age, quality and number of eggs fertilized or embryos implanted.
Miscarriage
If you are undergoing assisted reproductive techniques or ovarian stimulation for the production of eggs, the probability of miscarriage is higher than the average for women.
Ectopic pregnancies
Women with a history of tubal disorders are at risk of ectopic pregnancies (pregnancies in which the embryo implants outside the uterus), whether the pregnancy is obtained by spontaneous conception or by infertility treatments.
Blood clotting problems (thromboembolic events)
Talk to your doctor before using Luveris if you or a family member has suffered from blood clots in the legs or lungs, or if you have had a heart attack or stroke. With the use of Luveris, you may be at a higher risk of developing serious blood clots or worsening of existing ones.
Tumors of the reproductive organs
Cases of tumors of the ovaries and other reproductive organs, both benign and malignant, have been reported in women undergoing repeated cycles of pharmacological therapy for the treatment of infertility.
Birth defects
Birth defects following assisted reproductive techniques may be slightly higher compared to natural conceptions. This is thought to be due to different characteristics of the parents, such as maternal age, genetic factors, as well as the assisted reproduction procedures and multiple pregnancy.

Children and adolescents
Luveris is not indicated for children and adolescents under the age of 18 years.

Other medicines and Luveris
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not use Luveris by mixing it with other medicines in a single injection, except follitropin alfa, if prescribed by your doctor.

Pregnancy and breastfeeding
Do not use Luveris if you are pregnant or breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Luveris does not alter or alters negligibly the ability to drive vehicles and use machines.

Luveris contains sodium
Luveris contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially “sodium-free”.

3. How to use Luveris

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor.

Use of the medicine
The doctor will decide the dose and the administration schedule most appropriate during the course
of treatment.

Recommended dosage
Luveris is generally taken daily, for a maximum of 3 weeks, together with an injection of FSH.

• The most common starting dose is75 IU (1 vial) of Luveris associated with 75 or 150 IU of FSH.
• Depending on your response,the doctor may increase the dose of FSH, preferably by 37.5-75 IU at intervals of 7-14 days.

The doctor may decide to extend the treatment up to 5 weeks.
Once the desired response is obtained, a single dose of hCG should be administered, 24-48 hours after
the last injection of Luveris and FSH. It is advisable to have intercourse on the day of
hCG administration and the following day. Alternatively, intrauterine insemination or another medically assisted reproductive procedure may be performed, at the doctor's discretion.
If an excessive response is obtained, treatment should be discontinued and hCG administration should be avoided (see “Ovarian hyperstimulation syndrome (OHSS)” in section 4). In the next
cycle, the doctor will prescribe a lower dose of FSH than in the previous cycle.

Method of administration
Luveris is to be used subcutaneously, i.e. with an injection under the skin. Each vial is a
single-dose preparation.

If you administer Luveris to yourself, read the following instructions carefully:

• Wash your hands. It is important to ensure that your hands and the accessories you use are thoroughly clean.
• Gather everything you need. Arrange it on a clean area:
• a vial of Luveris,
• a vial of solvent,
• two cotton balls soaked in alcohol,
• a syringe,
• a reconstitution needle to dissolve the powder with the solvent,
• a fine needle for subcutaneous injections,
• a special container for the disposal of glass and needles.
• Remove the protective cap from the solvent vial.Attach the reconstitution needleto the syringe and draw a little air into the syringe by pulling the plunger up to the mark indicating 1 mL. Then, insert the needle into the vial, press the plunger to expel the air, turn the vial upside down, and slowly draw up all the solvent.

Carefully place the syringe on the work surface,
being careful not to touch the needle.

• Prepare the solution for injection: remove the protective cap from the vial containing theLuveris powder, take the syringe and slowly inject the solvent into the Luveris vial. Gently rotate without removing the syringe. Do not shake.
• After the powder has dissolved (which should happen immediately), check that the

solution obtained is clear and free of particles.
Turn the vial over and slowly draw the
solution back into the syringe.
You can also reconstitute Luveris and follitropin alfa together, rather than inject each product
separately. After dissolving the Luveris powder, draw the solution back into the syringe
and re-inject it into the follitropin alfa powder container. Once the powder has dissolved,
draw the solution back into the syringe. Check for any particles as above, and if the
solution is not clear, do not use it.
Up to 3 containers of powder can be dissolved in 1 mL of solvent.

• Replace the needle with the fine needlefor injectionand remove any air bubbles: if you see air bubbles in the syringe, hold it with the needle facing up, and gently tap the syringe until all the air collects at the top. Gently push the syringe plunger until the air bubbles are expelled.
• Inject the solution immediately: the doctor or nurse should have already informed you

about the injection site (e.g. abdomen, front of the
thigh). Clean the chosen injection area with a
cotton ball soaked in alcohol. Firmly hold the
skin between your fingers and insert the needle at an angle between 45° and 90°
with a dart-like movement. Inject the solution
subcutaneously as you have been taught. Do not inject
directly into a vein. Inject the solution by slowly pressing the syringe plunger. Take all the
time necessary to inject all the solution.
Immediately remove the needle and clean the injection area with a
cotton ball soaked in alcohol, using a circular motion.

• Disposal of used items: once the injection is finished, immediately dispose of all used needles and empty containers in the special container provided. Any unused solution must be disposed of.

If you use more Luveris than you should
The effects of an overdose of Luveris are unknown, however ovarian hyperstimulation syndrome may occur (see section 4). However, this can only occur if hCG is also administered (see “Warnings and precautions” in section 2).

If you forget to use Luveris
Do not use a double dose to make up for a missed dose. Contact your doctor.
If you have any doubts about using this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Contact your doctor immediately if you notice any of the following side effects occurring
below. Your doctor may ask you to stop using Luveris.
Allergic reaction
Allergic reactions such as skin rash, reddened skin, hives or swelling of the face
accompanied by difficulty breathing can sometimes be serious. This side effect is
very rare (may affect up to 1 in 10,000 people).

Ovarian hyperstimulation syndrome (OHSS)

• Lower abdominal pain with nausea or vomiting may be symptoms of ovarian hyperstimulation syndrome (OHSS). The ovaries may have responded excessively to treatment and formed large fluid-filled sacs or cysts (see “Ovarian hyperstimulation syndrome (OHSS)” in section 2). This side effect is common (may affect up to 1 in 10 people). If this occurs, your doctor will need to see you as soon as possible.
• Serious complications related to blood clots (thromboembolic events), usually accompanied by severe OHSS, occur very rarely. This may cause chest pain, difficulty breathing, stroke or heart attack (see “Problems with blood clotting” in section 2).

Other common side effects

• Headache
• Nausea, vomiting, diarrhea, discomfort or abdominal pain
• Fluid-filled sacs inside the ovaries (ovarian cysts), breast pain and pelvic pain
• Local reactions at the injection site, such as pain, itching, bruising, swelling or irritation

Ovarian torsion and abdominal bleeding have not been reported during the use of Luveris, however
rare cases have been reported after treatment with human menopausal gonadotropin (hMG), a
product of urinary origin also containing LH.
Ectopic pregnancies (embryo implanted outside the uterus) may occur, especially in
women with a previous history of tubal disorders.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system listed in Appendix V. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Luveris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and vial after
Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C. Store in the original package to
protect the medicine from light.
Do not use this medicine if you notice visible signs of deterioration, such as a change in the colour of the
powder or damage to the container.
The medicine must be administered immediately after dissolving the powder.
The solution must not be administered if it contains particles or is not clear.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Luveris contains

• The active substance is lutropin alfa. 1 vial of powder for solution for injection contains 75 IU (International Units).
• Lutropin alfa is a recombinant human luteinizing hormone (r-hLH), produced using recombinant DNA technology.
• The other components of the powder are polysorbate 20, sucrose, monobasic sodium phosphate monohydrate, disodium phosphate dihydrate, concentrated phosphoric acid, sodium hydroxide, L-methionine and nitrogen.
• The solvent is water for injections.

Description of the appearance of Luveris and contents of the pack

• Luveris is supplied as powder and solvent for solution for injection.
• Each vial of powder contains 75 IU of lutropin alfa and each vial of solvent contains 1 mL of water for injections.
• Luveris is available in packs containing 1, 3 or 10 vials of powder with the same number of vials of solvent.

Marketing Authorisation Holder
Merck Europe B.V.
Gustav Mahlerplein 102
1082 MA Amsterdam
Netherlands

Manufacturer
Merck Serono S.p.A.
Via delle Magnolie 15
70026 Modugno (Bari)
Italy
More detailed information on this medicine is available on the European
Medicines Agency website: http://www.ema.europa.eu .