Chemical formula: C₄₂H₆₅N₁₁O₁₂S₂ Molecular mass: 979.426 g/mol
Urofollitropin interacts in the following cases:
Impaired fertility was observed in rats which were treated with high doses of recombinant follitropin for prolonged time. Repeat dose toxicity studies in rats and dogs have demonstrated that high doses of urofollitropin have the potential to impair fertility due to follicular atresia and cysts in the ovaries.
Ovarian Hyperstimulation Syndrome (OHSS) is a medical event distinct from uncomplicated ovarian enlargement. OHSS is a syndrome that can manifest itself with increasing degrees of severity. It comprises marked ovarian enlargement, high serum sex steroids, and an increase in vascular permeability which can result in an accumulation of fluid in the peritoneal, pleural and, rarely, in the pericardial cavities.
The following symptomatology may be observed in severe cases of OHSS: abdominal pain, abdominal distension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptoms including nausea, vomiting and diarrhoea. Clinical evaluation may reveal hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, haemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events.
Excessive ovarian response to gonadotropin treatment seldom gives rise to OHSS unless hCG is administered to trigger ovulation. Therefore in cases of ovarian hyperstimulation it is prudent to withhold hCG and advise the patient to refrain from coitus or to use barrier methods for at least 4 days. OHSS may progress rapidly (within 24 hours to several days) to become a serious medical event, therefore patients should be followed for at least two weeks after the hCG administration.
Adherence to recommended BRAVELLE dosage, regimen of administration and careful monitoring of therapy will minimise the incidence of ovarian hyperstimulation and multiple pregnancy. In ART, aspiration of all follicles prior to ovulation may reduce the occurrence of hyperstimulation.
OHSS may be more severe and more protracted if pregnancy occurs. Most often, OHSS occurs after hormonal treatment has been discontinued and reaches its maximum at about seven to ten days following treatment. Usually, OHSS resolves spontaneously with the onset of menses.
If severe OHSS occurs, gonadotropin treatment should be stopped if still ongoing, the patient hospitalised and specific therapy for OHSS started.
This syndrome occurs with higher incidence in patients with polycystic ovarian disease.
Multiple pregnancy, especially high order, carries an increased risk of adverse maternal and perinatal outcomes.
In patients undergoing ovulation induction with gonadotropins, the incidence of multiple pregnancy is increased compared with natural conception. The majority of multiple conceptions are twins. To minimise the risk of multiple pregnancy, careful monitoring of ovarian response is recommended.
In patients undergoing ART procedures the risk of multiple pregnancy is related mainly to the number of embryos replaced, their quality and the age of the patient. The patient should be advised of the potential risk of multiple births before starting treatment.
Women with generally recognised risk factors for thromboembolic events, such as personal or family history, severe obesity (Body Mass Index >30 kg/m²) or thrombophilia, may have an increased risk of venous or arterial thromboembolic events, during or following treatment with gonadotropins. In these women, the benefits of gonadotropin administration need to be weighed against the risks. It should be noted however, that pregnancy itself also carries an increased risk of thromboembolic events.
Urofollitropin is contraindicated in women who are pregnant.
To date no teratogenic risk has been reported when gonadotropins are used clinically for controlled ovarian hyperstimulation. Data on exposed pregnancies are insufficient. Animal experiments did not reveal teratogenic effects.
Urofollitropin is contraindicated in women who are lactating.
No studies on the effects on the ability to drive and use machines have been performed. However, urofollitropin is unlikely to have influence on the patient’s performance to drive and use machines.
The most commonly reported adverse events during treatment with urofollitropin in clinical trials are headache and abdominal pain, both occurring in 10% of patients followed by nausea, vaginal haemorrhage, OHSS and abdominal distension, each occurring in 5 to 9% of patients. The table below displays the adverse events occurring in more than 1% of the patients treated with urofollitropin in clinical trials according to organ class and frequency.
Very common (>1/10)
Common (>1/100, <1/10)
Common: Urinary tract infection, nasopharyngitis
Very common: Headache
Common: Hot flushes
Very common: Abdominal pain
Common: Nausea, vomiting, abdominal distension, abdominal discomfort, diarrhoea, constipation
Common: Rash
Common: Muscle spasms
Common: Vaginal haemorrhage, OHSS, pelvic pain, breast tenderness, vaginal discharge
Common: Pain, injection site pain and reactions (redness, bruising, swelling and/or itching)
As complications of OHSS, venous thromboembolic events and ovarian torsion might occur.
Allergic, local or generalized skin reactions and delayed-type hypersensitivity have been reported with the use of gonadotropin preparations. Repeated exposure to urofollitropin has not been investigated in clinical trials.
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