Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
The most commonly reported adverse reactions are local injection site reactions such as erythema, swelling and pruritus that are usually transient in nature and mild in intensity. In clinical trials, these effects were observed with a frequency of 9.4% following multiple injections of Cetrotide 0.25 mg.

Mild to moderate OHSS (WHO grade I or II) have been commonly reported and should be considered as an intrinsic risk of the stimulation procedure. Inversely, severe OHSS remains uncommon.

Uncommonly, cases of hypersensitivity reactions including pseudo-allergic/anaphylactoid reactions have been reported.
List of adverse reactions
The adverse reactions reported below are classified according to frequency of occurrence as follows: 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).

Immune system disorders
Uncommon:     Systemic allergic/pseudo-allergic reactions including life-threatening anaphylaxis.

Nervous system disorders
Uncommon:     Headache
Gastrointestinal disorders
Uncommon:        Nausea

Reproductive system and breast disorders
Common:        Mild to moderate OHSS (WHO grade I or II) can occur which is an intrinsic risk of the stimulation procedure (see section 4.4).
Uncommon: Severe OHSS (WHO grade III).

General disorders and administration site conditions
Common:         Local reactions at the injection site (e.g. erythema, swelling and pruritus).

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/