Lutropin alfa interacts in the following cases:
A certain degree of ovarian enlargement is an expected effect of controlled ovarian stimulation. It is more commonly seen in women with polycystic ovarian syndrome and usually regresses without treatment.
In distinction to uncomplicated ovarian enlargement, OHSS is a condition 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.
Mild manifestations of OHSS may include abdominal pain, abdominal discomfort and distension, or enlarged ovaries. Moderate OHSS may additionally present with nausea, vomiting, ultrasound evidence of ascites or marked ovarian enlargement.
Severe OHSS further includes symptoms such as severe ovarian enlargement, weight gain, dyspnoea or oliguria. Clinical evaluation may reveal signs such as hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, pleural effusions, or acute pulmonary distress. Very rarely, severe OHSS may be complicated by ovarian torsion or thromboembolic events, such as pulmonary embolism, ischaemic stroke or myocardial infarction.
Independent risk factors for developing OHSS include young age, lean body mass, polycystic ovarian syndrome, higher doses of exogenous gonadotropins, high absolute or rapidly rising serum estradiol levels and previous episodes of OHSS, large number of developing ovarian follicles and large number of oocytes retrieved in ART cycles.
Adherence to recommended lutropin alfa and FSH dosage and regimen of administration can minimise the risk of ovarian hyperstimulation. Monitoring of stimulation cycles by ultrasound scans as well as estradiol measurements are recommended to early identify risk factors.
There is evidence to suggest that hCG plays a key role in triggering OHSS and that the syndrome may be more severe and more protracted if pregnancy occurs. Therefore, if signs of ovarian hyperstimulation occur, it is recommended that hCG be withheld and the patient be advised to refrain from coitus or use barrier contraceptive methods for at least 4 days. As OHSS may progress rapidly (within 24 hours) or over several days to become a serious medical event, patients should be followed for at least two weeks after hCG administration.
Mild or moderate OHSS usually resolves spontaneously. If severe OHSS occurs, it is recommended that gonadotropin treatment be stopped if still ongoing and that the patient be hospitalised and appropriate therapy be started.
Ovarian torsion has been reported after treatment with other gonadotropins. This may be associated with other risk factors such as OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, previous or current ovarian cyst and polycystic ovarian syndrome. Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.
In patients undergoing induction of ovulation, the incidence of multiple pregnancy and births is increased compared with natural conception. The majority of multiple conceptions are twins. Multiple pregnancy, especially high order, carry an increased risk of adverse maternal and perinatal outcomes.
To minimise the risk of higher order multiple pregnancy, careful monitoring of ovarian response is recommended.
In patients undergoing Assisted Reproductive Technology (ART) procedures the risk of multiple pregnancy is related mainly to the number of embryos replaced, their quality and the patient age.
Women with a history of tubal disease are at risk of ectopic pregnancy, whether the pregnancy is obtained by spontaneous conception or with fertility treatments. The prevalence of ectopic pregnancy after ART was reported to be higher than in the general population.
In women with recent or ongoing thromboembolic disease or women with generally recognised risk factors for thromboembolic events, such as personal or family history, thrombophilia or severe obesity (body mass index >30 kg/m²), treatment with gonadotropins may further increase the risk for aggravation or occurrence of such events. In these women, the benefits of gonadotropin administration need to be weighed against the risks. It should be noted however, that pregnancy itself, as well as OHSS, also carries an increased risk of thromboembolic events.
In patients with porphyria or a family history of porphyria, lutropin alfa may increase the risk of an acute attack. Deterioration or a first appearance of this condition may require cessation of treatment.
There is no indication for the use of lutropin alfa during pregnancy. Data on a limited number of exposed pregnancies indicate no adverse reactions of gonadotropins on pregnancy, embryonal or foetal development, parturition or postnatal development following controlled ovarian stimulation. No teratogenic effect of lutropin alfa has been observed in animal studies. In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of lutropin alfa.
Lutropin alfa is not indicated during breast-feeding.
Lutropin alfa is indicated for the stimulation of follicular development, in association with FSH.
Lutropin alfa has no or negligible influence on the ability to drive and use machines.
Lutropin alfa is used for the stimulation of follicular development in association with follitropin alfa. In this context, it is difficult to attribute adverse reactions to any one of the substances used.
In a clinical trial, mild and moderate injection site reactions (bruising, pain, redness, itching or swelling) were reported in 7.4% and 0.9% of the injections, respectively. No severe injection site reactions were reported.
Ovarian Hyper-Stimulation Syndrome (OHSS) was observed in less than 6% of patients treated with lutropin alfa. No severe OHSS was reported.
In rare instances, adnexal torsion (a complication of ovarian enlargement), and haemoperitoneum have been associated with human menopausal gonadotropin therapy. Although these adverse reactions were not observed, there is the possibility that they may also occur with lutropin alfa.
Ectopic pregnancy may also occur, especially in women with a history of prior tubal disease.
The following definitions apply to the frequency terminology used hereafter: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), frequency not known (cannot be estimated from the available data). The following adverse reactions may be observed after administration of lutropin alfa.
Very rare: Mild to severe hypersensitivity reactions including anaphylactic reactions and shock.
Common: Headache
Very rare: Thromboembolism, usually associated with severe OHSS
Common: Abdominal pain, abdominal discomfort, nausea, vomiting, diarrhoea.
Common: Mild or moderate OHSS (including associated symptomatology), ovarian cyst, breast pain, pelvic pain
Common: Injection site reaction (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection)
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