Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
Luveris 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 hyperstimulation syndrome (OHSS) was observed in less than 6% of patients treated with Luveris. No severe OHSS was reported (see section 4.4).

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 Luveris.

Ectopic pregnancy may also occur, especially in women with a history of prior tubal disease.

List of adverse reactions
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 Luveris.

Immune system disorders
Very rare: Mild to severe hypersensitivity reactions including anaphylactic reactions and shock 
Nervous system disorders
Common: Headache

Vascular disorders
Very rare: Thromboembolism, usually associated with severe OHSS
Gastrointestinal disorders
Common: Abdominal pain, abdominal discomfort, nausea, vomiting, diarrhoea 
Reproductive system and breast disorders
Common: Mild or moderate OHSS (including associated symptomatology), ovarian cyst, breast pain, pelvic pain

General disorders and administration site conditions:
Common: Injection site reaction (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection)

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/