75 IU powder and solvent for injection, solution
lutropin alfa
What Luveris is and what it is used for
Luveris is recommended for the treatment of adult women who have very low levels of certain hormones involved in the normal reproductive cycle. The drug is used together with another hormone called follicle-stimulating hormone ( FSH ) to cause follicle development. It is accompanied by a single dose of human chorionic gonadotropin ( hCG ) which results in the release of the egg from the follicle (ovulation).
Luveris is a medicine that contains lutropin alfa, a recombinant luteinizing hormone ( LH ), which is almost identical to the hormone found naturally in the body, but lutropin alfa is made using biotechnology. It belongs to the hormone group gonadotropins, which are involved in the normal regulation of reproduction.
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 any of the other ingredients of this medicine (listed in section 6).
- if you have ovarian, uterine or breast cancer.
- if you have had a brain tumor.
- if you have enlarged ovaries or bladder fluid in the ovaries ( cysts in the ovaries) of unknown origin.
- if you have unexplained vaginal bleeding.
Do not use Luveris if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Luveris. You and your partner’s fertility should be evaluated before starting treatment.
The use of Luveris is not recommended if you have a condition that usually makes a normal pregnancy impossible, e.g. that the ovaries are not functioning due to a condition called a primary ovarian failure or genital malformations.
Porphyry
If you or anyone in your family has porphyria (an inability to break down porphyrins that may have been transmitted from parents to children), tell your doctor before starting treatment.
Ovarian overstimulation syndrome (OHSS)
This medicine stimulates your ovaries. This increases the risk of developing a condition called ovarian hyperstimulation syndrome or OHSS. In ovarian overstimulation syndrome, the follicles develop too much and become large cysts. If you have lower abdominal pain, start to gain weight quickly, feel unwell or vomit or if you have difficulty breathing, talk to your doctor immediately who may ask you to stop using this medicine (see section 4 under “Serious side effects ”).
If you are not ovulating and following the recommended dose and schedule of administration, you are less likely to have OHSS. Treatment with Luveris rarely gives rise to severe OHSS. This is more likely if the drug used to induce definitive follicular maturation (containing human chorionic gonadotropin, hCG ) is administered (see section 3 under “How much to take” for more information). If you develop OHSS, it is possible that your doctor will not give you hCG during this treatment cycle and ask you to refrain from intercourse or to use barrier prevention methods for at least four days.
Your doctor will make sure that the ovarian response is carefully monitored using ultrasound and blood tests before and during treatment.
Multiple pregnancies
When you use Luveris, you are more likely to become pregnant with more than one child at a time (“multiple pregnancies”, usually twins) than with natural conception. Multiple pregnancies can lead to medical complications for you and the children you are expecting. You can reduce the risk of multiple pregnancies by using the right dose of Luveris at the right time. With assisted reproduction technology, the risk of multiple pregnancies is related to your age, the quality, and number of fertile eggs or embryos that have been introduced into you.
Miscarriage
With assisted reproduction technology or stimulation of the ovaries to produce eggs, there is a risk of miscarriage that is above average.
Ectopic pregnancy
Women who have had fallopian tube disease are at risk for ectopic pregnancy (pregnancy where the embryo attaches outside the uterus), regardless of whether the pregnancy arose through spontaneous conception or with fertility treatment.
Blood clot ( thromboembolism )
Talk to your doctor before using Luveris if you or a family member have ever had a blood clot in your leg or lung, or a heart attack or stroke. You may be at greater risk of getting severe blood clots or existing blood clots may worsen with Luveris treatment.
A tumor is in the genitals
There have been reports of tumors in the ovaries and other genitals, both benign and malignant, in women who have undergone several treatments for infertility.
Malformations
Malformations after assisted reproductive technology may be slightly higher than after spontaneous conception. It can be due to various factors in the parents, such as the mother’s age, genes, as well as assisted reproductive technology procedures, and multiple births.
Children and young people
Luveris should not be used by children and young people under 18 years of age.
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 mixed with other medicines in the same injection, with the exception of follitropin alfa, unless your doctor prescribes it.
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 has no or negligible effect on the ability to drive and use machines.
Luveris contains sodium
Luveris contains less than 1 mmol (23 mg) sodium per dose, ie it is essentially ‘sodium-free’.
How to use Luveris
Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
How to use this medicine
Your doctor will decide which dose is most suitable for you and how often you should take the medicine during treatment.
How much to take
Luveris is usually used every day for up to three weeks, at the same time as the injection of FSH.
- The usual starting dose is 75 IU (1 vial ) of Luveris together with 75 IU or 150 IU FSH .
- Depending on your response , your doctor may increase the dose of the FSH in steps of 37.5-75 IU at 7 to 14 days apart.
Your doctor may extend your treatment for up to 5 weeks.
Once the desired response is obtained, an injection of hCG is given 24 to 48 hours after the last injections of Luveris and FSH. You are advised to have intercourse on the day of injection one of hCG, and the day after. Alternatively, intrauterine insemination (IUI) can be performed.
If the response is too strong, treatment should be discontinued and hCG not given (see section 4 under “Ovarian overstimulation syndrome.”) In the next treatment cycle, your doctor will prescribe a lower dose of FSH than with the previous treatment.
Method of administration
Luveris is intended for subcutaneous use, ie it is given as an injection under the skin. The vials are for single use only.
If you are giving yourself Luveris, read the instructions below carefully:
- Wash your hands. It is important that the hands and tools you use are as clean as possible.
- Gather everything you need, find a clean surface and lay out everything:
- a vial of Luveris
- a vial of liquid
- two alcohol wipes
- a syringe
- a needle for reconstitution , dissolving the powder in the liquid
- a fine needle for subcutaneous injection
- a waste container for glass and needles
Once the powder is dissolved (which usually happens immediately), check that the solution is clear and does not contain any particles. Turn the vial upside down and gently pull the solution back into the syringe.
You can also mix Luveris with follitropin alfa instead of injecting each medicine separately. After the Luveris powder has dissolved, withdraw the solution into the syringe and inject it into the follitropin alfa powder container. When the powder is dissolved, withdraw the solution into the syringe. Inspect the solution for particles in the same way as before, do not use the solution if it is not ready.
Up to 3 containers of powder can be dissolved in 1 ml of liquid.
- Dispose of all used items: Once you have finished injecting one, immediately dispose of all needles and empty glass containers in the waste container you received. Any excess solution must be discarded.
If you use more Luveris than you should
The effects of an overdose of Luveris are unknown but ovarian hyperstimulation syndrome may occur (see section 4).
This can only occur if hCG has been administered (see section 2 under “Warnings and precautions”).
If you forget to use Luveris
Do not take a double dose to make up for a forgotten dose. Contact your doctor.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Contact a doctor immediately if you notice any of the following side effects. Your doctor may ask you to stop using Luveris.
Allergic reaction
Allergic reactions, such as rash, redness, hives, swelling of the face, or difficulty breathing can sometimes be serious. This side effect is very rare (may affect up to 1 in 10,000 people).
Ovarian overstimulation syndrome
- Lower abdominal pain along with nausea or vomiting may be symptoms of ovarian hyperstimulation syndrome (OHSS). Your ovaries may have overreacted to the treatment and formed large fluid bubbles or cysts (see section 2 under “Ovarian overstimulation syndrome”). This side effect is common (may affect up to 1 in 10 people). If this happens, your doctor will need to examine you as soon as possible.
- Serious complications with blood clots ( thromboembolism ) usually accompanied by severe OHSS are very rare. This can cause chest pain, shortness of breath, stroke or heart attack (see section 2 under “Blood clots”).
Other common side effects are
- Headache
- Nausea, vomiting, diarrhea, pain or discomfort in the abdomen
- Ovarian cysts (ovarian cysts), chest pain and pelvic pain
- Local reactions at the injection site, such as pain, itching , bruising, swelling or irritation.
Twisted ovaries and bleeding in the abdominal cavity have not been reported for Luveris, but it has been reported rarely in treatment with human menopausal gonadotropin (hMG), a drug extracted from urine, which also contains LH.
Ectopic pregnancy (ectopic pregnancy) can occur, especially in women with a previous disease of the fallopian tubes.
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 carton and vial after EXP. or EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Store in the original package. Sensitive to light.
Do not use this medicine for visible signs of deterioration, such as discoloration of the powder or if the container is damaged.
The medicine should be used immediately after dissolving the powder.
The reconstituted solution should not be injected if it contains particles or is not ready.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is lutropin alfa. One vial of powder contains 75 IU (International Units).
- Lutropin alfa is a recombinant human luteinizing hormone (r-hLH), produced by recombinant DNA technology.
- The other ingredients in the powder are polysorbate 20, sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, concentrated phosphoric acid , sodium hydroxide, L-methionine and nitrogen.
- The liquid is water for injections.
What the medicine looks like and contents of the pack
- Luveris comes as a powder and solvent for solution for injection .
- Each vial of powder contains 75 IU lutropin alfa and each vial of liquid contains 1 ml of water for injections.
- Luveris is available in packs of 1, 3 or 10 vials of powder together with the same number of vials of liquid.
Marketing Authorization Holder and Manufacturer
Merck Europe BV
Gustav Mahlerplein 102
1082 MA Amsterdam
Netherlands
Manufacturer
Merck Serono SpA
Via Delle Magnolia 15
70026 Modugno (Bari)
Italy
Further information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.