Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Clinical use of Puregon by the intramuscular or subcutaneous routes may lead to local reactions at the site of injection (3% of all patients treated). The majority of these local reactions are mild and transient in nature.
Generalised hypersensitivity reactions have been observed uncommonly (approximately 0.2% of all patients treated with follitropin beta). Cases of anaphylactic reactions (including those requiring hospitalisation) have been reported in the post-marketing setting.


Treatment of females:
In approximately 4% of the women treated with follitropin beta in clinical trials, signs and symptoms related to ovarian hyperstimulation syndrome (OHSS) have been reported (see section 4.4). Adverse reactions related to this syndrome include pelvic pain and/or congestion, abdominal pain and/or distension, breast complaints and ovarian enlargement.

The table below lists the adverse reactions with follitropin beta reported in clinical trials and post-marketing surveillance in females, according to system organ class and frequency; common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and not known (cannot be estimated from available data).



SOC                               Frequency                          Adverse reaction Immune system disorders           Not known                          Anaphylactic reactions Nervous system disorders          Common                             Headache Gastrointestinal disorders        Common                             Abdominal distension Abdominal pain
Uncommon                           Abdominal discomfort
Constipation
Diarrhoea
Nausea
Reproductive system and           Common                             OHSS breast disorders                                                     Pelvic pain Uncommon                           Breast complaints1
Metrorrhagia
Ovarian cyst
Ovarian enlargement
Ovarian torsion
Uterine enlargement
Vaginal haemorrhage
General disorders and             Common                             Injection site reaction2 administration site conditions
Uncommon                                   Generalised hypersensitivity reaction3
1. Breast complaints include tenderness, pain and/or engorgement and nipple pain 2. Local reactions at the site of injection include: bruising, pain, redness, swelling and itching
3. Generalised hypersensitivity reaction include erythema, urticaria, rash and pruritus 

In addition, ectopic pregnancy, miscarriage and multiple gestations have been reported. These are considered to be related to ART or subsequent pregnancy.
In rare instances, thromboembolism has been associated with follitropin beta / hCG therapy as with other gonadotrophins.

Treatment of males:
The table below lists the adverse reactions with follitropin beta reported in a clinical trial in males (30 patients dosed) and post-marketing surveillance, according to system organ class and frequency; common (≥ 1/100 to < 1/10) and not known (cannot be estimated from available data).

SOC                                       Frequency1                                 Adverse reaction Immune system disorders                   Not known                                  Anaphylactic reactions Nervous system disorders                  Common                                     Headache Skin and subcutaneous                     Common                                     Acne tissue disorders                                                                     Rash Reproductive system and                   Common                                     Epididymal cyst breast disorders                                                                     Gynaecomastia General disorders and                     Common                                     Injection site reaction2 administration site conditions
1.   Adverse reactions that are reported only once are listed as common because a single report raises the frequency above 1%.
2.   Local reactions at the site of injection include induration and pain.


Side effects can be reported to the Ministry of Health by using the online form for reporting side effects in the homepage of the ministry of health website www.health.gov.il or by entering the following link: https://sideeffects.health.gov.il