Luveris (Lutropin Alfa)

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

The effects of an overdose of LUVERIS are unknown, nevertheless there is a possibility that ovarian hyperstimulation syndrome may occur. If you inject more medication at one time that you were prescribed, you should contact your doctor.

Missed dose:

If you forget to take LUVERIS, do not take a double dose. In the case of a forgotten dose, please contact your doctor.

As with any drug, you may experience side effects when taking LUVERIS. In clinical trials, the most common side effects (experienced by more than 2% of patients) were headache, pelvic and abdominal pain, nausea, OHSS, breast pain, ovarian cysts, flatulence, injection site reactions, general pain, constipation, fatigue, painful menstruation, ovarian disorder, diarrhea and upper respiratory tract infections.

When taking LUVERIS, there is a risk of developing ovarian hyperstimulation syndrome (OHSS). The early warning signs of development of OHSS are severe abdominal pain, nausea, vomiting and weight gain. Since OHSS develops rapidly, if you experience any of these symptoms, contact your doctor immediately.

It is important to regularly tell your health care professional how you are feeling and if you have developed any new symptoms while taking LUVERIS.

Serious Side Effects, How Often They Happen and What to Do About Them:

The most serious side effect associated with LUVERIS is ovarian hyperstimulation syndrome (OHSS). If you experience the early warning signs of OHSS, including severe abdominal pain, nausea, vomiting and weight gain, contact your doctor as soon as possible.

This is not a complete list of side effects. For any unexpected effects while taking LUVERIS, contact your doctor or pharmacist.

BEFORE you use LUVERIS talk to your doctor or pharmacist if:

• You have sex hormone-dependent tumours of the reproductive tract and accessory organs
• You have active, untreated tumours of the hypothalamus or pituitary gland
• You are pregnant or are breast-feeding your baby
• You have ovarian failure
• You have abnormal uterine bleeding of unknown origin
• You have hypersensitivity to gonadotropins or to any of the nonmedicinal ingredients

Compared with natural conception, the incidence of multiple pregnancies (mainly twins) and births is increased in patients undergoing this type of treatment. However, this can be minimized by using the recommended dose and schedule of administration.

Miscarriages are higher than in the normal population, but comparable with the rates found in women with fertility problems.

Women with a history of tubal disease are at a risk of ectopic pregnancy (pregnancy where the embryo is implanted outside the womb), whether the pregnancy is obtained by spontaneous conception or with fertility treatments.

There have been reports of tumours of the ovary and other reproductive organs, both benign and malignant, in women who have undergone multiple drug regimens for infertility treatment.

If you are at risk of thromboembolic events (formation of a blood clot in vein or artery), because of your personal or family history, treatment with gonadotropins, like pregnancy itself, may further increase the risk. If you think you may have such a risk, please ask your doctor.

Birth defects after ART (Assisted Reproduction Techniques) may be slightly higher than after spontaneous conceptions, although this is not confirmed. This could be due to differences in parental factors like maternal age, genetics, as well as the ART procedures and multiple pregnancies.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

LUVERIS has not been shown to affect the activity of co-administered GONAL-F.