Adverse reactions : תופעות לוואי

4.8 Undesirable effects

The most frequently reported adverse drug reactions (ADR) during treatment with MENOPUR in clinical trials are Ovarian Hyperstimulation Syndrome (OHSS), abdominal pain, headache, abdominal distension, and injection site pain.
None of these ADRs have been reported with an incidence rate of more than 5%.The table below displays the main ADR in women treated with MENOPUR in clinical trials distributed by system organ classes (SOCs) and frequency. ADRs seen during post-marketing experience are mentioned with unknown frequency 


System Organ Class          Common                 Uncommon               Rare               Unknown (> 1/100 to < 1/10)    (> 1/1,000 to <        (> 1/10,000 to <
1/100)                 1/1,000)
Eye disorders                                                                                Visual disorders Gastrointestinal disorders Abdominal pain,    Vomiting, Abdominal
Abdominal          discomfort,
distension, Nausea Diarrhoea
General disorders and       Injection site         Fatigue administration site         reactions a condition
Immune system disorders                                                                      Hypersensitivity reactions b
Investigations
Musculoskeletal &                                                                            Musculoskeletal pain c connective tissue disorders
Nervous system disorders Headache                  Dizziness
Reproductive system         OHSS , Pelvic d              Ovarian cyst, Breast                      Ovarian torsion d disorders                      paine                 complaints f
Skin and subcutaneous                                                       Acne, Rash           Pruritus, Urticaria tissue disorders
Vascular Disorders                                   Hot flush

 a
Most frequently reported injection site reaction was injection site pain.
b
Cases of localised or generalised allergic reactions , including anaphylactic reaction, along with associated symptomatology have been reported rarely.
c
Musculoskeletal pain includes arthralgia, back pain, neck pain and pain in extremities.
d
Gastrointestinal symptoms associated with OHSS such as abdominal distension and discomfort, nausea, vomiting, diarrhoea have been reported with MENOPUR in clinical trials. In cases of severe OHSS ascites and pelvic fluid collection, pleural effusion, dyspnoea, oliguria, thromboembolic events and ovarian torsion have been reported as rare complications.
e
Pelvic pain includes ovarian pain and adnexa uteri pain.
f
Breast complaints include breast pain, breast tenderness, breast discomfort, nipple pain and breast swelling.

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. Healthcare professionals are asked to report any suspected adverse reactions to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/