OVITRELLE

Ovitrelle Information

Ovitrelle is a medical preparation based on Choriogonadotropin alpha, in a concentration of 250 micrograms / 0.5 ml (approx. 6500 IU). This medicine also contains 0.1 mg L-methionine, 0.05 mg Poloxamer and 27.3 mg Mannitol. It is a colorless clear solution for injection, available in pre-filled syringes for subcutaneous administration.

Ovitrelle Indications

Ovitrelle is administered to female patients undergoing superovulation before the application of assisted reproductive techniques (for example in vitro fertilization). In this situation, Ovitrelle is administered after stimulation of the follicular growth, in order to start final follicular luteinisation and maturation.

Ovitrelle is also employed to trigger luteinisation and ovulation in oligo-ovulatory and anovulatory patients as well, after initial stimulation of the follicular growth.

This drug may also have other uses that are not listed in this information leaflet. If you would like to obtain more detailed information regarding the possible uses of this pharmaceutical product, it is best that you consult with a specialized health care professional.

Ovitrelle Warnings

Ovitrelle is not appropriate for use in female patients that are currently suffering from pituitary gland / hypothalamus tumors; allergy to any of the excipients of this medical preparation; ovarian cysts or ovarian enlargement caused by affections other than polycystic ovarian disease; vaginal bleeding with unknown causes; mammary, uterine or ovarian carcinoma; an active thromboembolic disorder. Also, this medicine should not be used if the patient has had an extrauterine pregnancy within the past 3 months. If there is no chance for a positive response to be obtained (for example if the patient is postmenopausal, or if she suffers from primary ovarian failure or from malformations / fibroids incompatible with pregnancy) the patient should not undergo treatment with Ovitrelle.

Ovitrelle Intake Guidelines

Ovitrelle is only available under the form of solution for subcutaneous administration and as such it should not be administered in any other way. Typically, administration of the injection is performed by or under the close supervision of a health care professional specialized in fertility disorders and therapies. This medicine may not be self administered, or used in the absence of a specialized health care professional. The exact administration time as well as the duration of the treatment depends on a large number of factors and as such will be determined by the supervising health care professional at the beginning or during your Ovitrelle therapy.

Ovitrelle Dosage

In most cases, the Ovitrelle dosage for oligo-ovulatory or anovulatory women is of 250 micrograms (one pre-filled syringe). This should be administered within 24 to 48 hours after achieving the optimal stimulation of the follicular growth. It is best that the patient has sexual contact on the day of the injection, as well as on the following day.

For female patients that are undergoing superovulation prior to in vitro fertilization or other assisted reproductive technique, the typical dosage is of 250 micrograms of Ovitrelle (one pre-filled syringe), administered when the optimal stimulation of the follicular growth has been achieved – as in, 24 to 48 hours after the patient received her last administration of FSH- or hMG.

The dosage may differ in some cases. These exceptions will be handled by the supervising health care specialist. If you would like to obtain further information in the event of such exceptions, it is best to ask your personal specialized physician for details.

Ovitrelle Overdose

At this time, no cases of Ovitrelle overdose have been reported. Due to the medicine being administered by or under the close supervision of a specialized health care professional as well as due to the exact quantity contained in one pre-filled syringe, an overdose with this pharmaceutical preparation is highly unlikely. However it is expected that an overdose with this medicine will cause severe ovarian hyperstimulation syndrome.

Ovitrelle Missed Dose

As Ovitrelle is administered at a certain point during your fertility therapy, under the strict supervision of a specialized health care professional, it is highly unlikely that you will miss any doses of the medicine. However, if you believe you should have already received your Ovitrelle injection, it is best that you consult with the supervising physician. He or she may also be able to provide you with further information regarding the course of your therapy.

Ovitrelle Side Effects

Several adverse reactions are possible while undergoing Ovitrelle therapy. Studies have shown that around 4% of the patients will suffer from ovarian hyperstimulation syndrome (OHS), while less than 0.5% of the patients will experience severe OHS. Vomiting and nausea may accompany the onset of this syndrome. Studies have also revealed that treatment with this drug may cause the patient to develop a thromboembolism – although this has never happened in practice so far.

In some cases, patients that have undergone Ovitrelle therapy have developed ovarian torsion, ectopic pregnancy as well as a number of other complications, but the incidence rate of such complications is also very low. These complications are also common for most of the assisted reproductive techniques.

Common side effects associated with Ovitrelle are gastrointestinal disorders such as nausea, vomiting and abdominal pain. Mild to moderate OHS, pain at the injection site or local reactions, tiredness and headaches have also been commonly reported.

More severe adverse reactions occur less often: psychiatric affections (restlessness, irritability, depression), diarrhea, severe OHS, breast pain, as well as allergic reactions. Any unexpected symptoms that you may experience during your treatment should be immediately brought to the attention of the supervising physician.

Ovitrelle Drug Reactions

At this point, there are no known pharmaceutical interactions between Ovitrelle and other drugs or medicines. However, before receiving your Ovitrelle injection it is best to inform your supervising health care professional of any other medicines you are currently taking in order to ensure that no accidental interactions occur.