Schering-Plough announces European submission of fertility medicine Corifollitropin Alfa

Schering-Plough Corp. has announced that the European Medicines Agency (EMEA) has validated (accepted for review) its Marketing Authorization Application (MAA) for corifollitropin alfa, the company's experimental, sustained follicle stimulant (SFS).

This application will follow the Centralized Procedure.

Corifollitropin alfa is being developed as a potential treatment in Controlled Ovarian Stimulation (COS) for the development of multiple follicles and pregnancy in women participating in an Assisted Reproductive Technology (ART) program. Corifollitropin alfa is designed as a sustained follicle stimulant with the same pharmacodynamic profile as (recombinant)Follicle Stimulating Hormone (FSH), but with a markedly prolonged duration of FSH activity. Due to its ability to initiate and sustain multiple follicular growth for an entire week, a single subcutaneous injection of the recommended dose of corifollitropin alfa may replace the first seven injections of (recombinant)FSH preparation in a COS treatment cycle.

If approved, corifollitropin alfa would extend Schering-Plough's leading fertility portfolio, which also includes PUREGON(R).

Corifollitropin alfa Important Safety Information

The most frequently reported adverse drug reactions during treatment with corifollitropin alfa in clinical trials are Ovarian Hyperstimulation Syndrome (OHSS), pelvic pain and discomfort, headache, nausea, fatigue and breast complaints (including tenderness). They are reported with an incidence between 1% and 6%.

PUREGON(R) Important Safety Information

Always use PUREGON exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Do not use PUREGON if you:

• are allergic (hypersensitive) to follitropin beta or any of the other ingredients of PUREGON
• have a tumour of the ovary, breast, uterus, testis, pituitary gland or hypothalamus
• are pregnant or breast-feeding
• have heavy or irregular vaginal bleeding where the cause is not known
• suffer from primary ovarian failure
• have ovarian cysts or enlarged ovaries not caused by polycystic ovarian disease (PCOD)
• have malformations of the sexual organs which make a normal pregnancy impossible
• have fibroids in the uterus which make a normal pregnancy impossible.  

Take special care with PUREGON  

Please inform your doctor if you have experienced an allergic reaction to neomycin and/or streptomycin (antibiotics) in the past.

Close supervision by your doctor is very important. Usually ultrasound scans of the ovaries are regularly made, and blood or urine samples are regularly taken. The results of these tests allow your doctor to choose the correct dose of PUREGON from day to day. This is very important since too high a dose of FSH may lead to rare but serious complications in which the ovaries become overstimulated. This may be noticed as pain in the abdomen. Regular monitoring of the response to FSH-treatment helps your doctor to prevent ovarian overstimulation. So contact your doctor without delay if you are experiencing significant abdominal pain, also if this occurs some days after the last injection has been given.

Treatment with PUREGON (like pregnancy itself) may increase the risk of thrombosis (the formation of a blood clot in a blood vessel, most often in the veins of the legs or the lungs).

Please discuss this with your doctor, before starting treatment, especially if:

• you already know you have an increased risk of thrombosis
• you, or anyone in your immediate family, have ever had a thrombosis
• you are severely overweight.  

Pregnancy and breast-feeding  

Ask your doctor or pharmacist for advice before taking any medicine. You should not use PUREGON if you are already pregnant, or suspect that you might be pregnant, or if you are breast-feeding.

After treatment with gonadotropin preparations, there is an increased risk of having multiple pregnancies. Multiple pregnancies carry an increased health risk for both the mother and her babies around the time of birth. Furthermore, multiple pregnancies and characteristics of the patients undergoing fertility treatment (e.g. age of the female, sperm characteristics) may be associated with an increased risk of congenital abnormalities. There is a slightly increased risk of extra-uterine pregnancy in women with damaged fallopian tubes.

In women undergoing fertility treatment there may be a slightly higher risk of miscarriage.

Possible side effects

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

Minor side effects include bruising, pain, redness, swelling and itching at the site of the injection. Occasionally, more widespread reactions like rash have been observed.

A complication with FSH treatment is unwanted overstimulation of the ovaries. This condition can become very serious, but the risk can be reduced by careful monitoring of follicle development during treatment. The first symptoms of ovarian overstimulation may be noticed as pain in the abdomen, feeling sick or diarrhoea. In more severe cases symptoms may include enlargement of the ovaries, accumulation of fluid in the abdomen and/or chest, weight gain and the occurrence of blood clots in the circulation. Contact your doctor without delay if you are experiencing any of these symptoms, also if they develop some days after the last injection has been given.

Rarely, blood clots may also occur in the absence of unwanted overstimulation of the ovaries (see also "Take special care with PUREGON").

Other side effects observed include headache and nausea.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Additional Important Product Information

Complete product information can be found at: http://www.emea.europa.eu/humandocs/PDFs/EPAR/Puregon/H-086-PI-en.pdf