Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The most commonly reported serious adverse reactions reported with fondaparinux are bleeding complications (various sites including rare cases of intracranial/ intracerebral and retroperitoneal bleedings). Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage (see section 4.4).

The safety of fondaparinux has been evaluated in:
- 3,595 patients undergoing major orthopaedic surgery of the lower limbs treated up to 9 days (Arixtra 2.5 mg/0.5 ml)
- 327 patients undergoing hip fracture surgery treated for 3 weeks following an initial prophylaxis of 1 week (Arixtra 2.5 mg/0.5 ml)
- 1,407 patients undergoing abdominal surgery treated up to 9 days (Arixtra 2.5 mg/0.5 ml) - 425 medical patients who are at risk for thromboembolic complications treated up to 14 days (Arixtra 2.5 mg/0.5 ml)
- 10,057 patients undergoing treatment of UA or NSTEMI ACS (Arixtra 2.5 mg/0.5 ml) - 6,036 patients undergoing treatment of STEMI ACS (Arixtra 2.5 mg/0.5 ml) - 2,517 patients treated for Venous Thrombo-Embolism and treated with fondaparinux for an average of 7 days (Arixtra 7.5 mg/0.6 ml).

These adverse reactions should be interpreted within the surgical or medical context of the indications.
The adverse event profile reported in the ACS program is consistent with the adverse drug reactions identified for VTE prophylaxis.

Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, <1/1,000), very rare (<1/10,000).
System organ class        common                     uncommon                  rare MedDRA
(≥ 1/100, <1/10)           (≥ 1/1,000, <1/100)       (≥ 1/10,000, <1/1,000) Infections and                                                                 post-operative wound infestations                                                                   infections anaemia, post-operative    thrombocytopenia,         retroperitoneal
Blood and lymphatic haemorrhage,               thrombocythaemia,         bleeding*,
system disorders uterovaginal               platelet abnormal,        hepatic, intracranial/ haemorrhage*,              coagulation disorder      intracerebral bleeding* haemoptysis,
haematuria,
haematoma, gingival bleeding, purpura,
epistaxis,
gastrointestinal bleeding,
hemarthrosis*,
ocular bleeding*,
bruise* allergic reaction
Immune system
(including very rare disorders reports of angioedema,
anaphylactoid/ anaphylactic reaction) hypokalaemia, non-
Metabolism and protein- nutrition disorders nitrogen (Npn) increased1* headache                  anxiety, confusion,
Nervous system dizziness, somnolence,
disorders vertigo hypotension
Vascular disorders
Respiratory, thoracic                                dyspnoea                  coughing and mediastinal disorders
Gastrointestinal                                     nausea, vomiting           abdominal pain, disorders                                                                       dyspepsia, gastritis, constipation, diarrhoea
Hepatobiliary disorders                              abnormal liver function bilirubinaemia tests, hepatic enzymes increased
Skin and subcutaneous                                rash erythematous, tissue disorders                                     pruritus oedema, oedema             reaction at injection
General disorders and peripheral, pain, fever, site,
administration site chest pain, wound          leg pain, fatigue,
conditions secretion                  flushing,
syncope, hot flushes,
oedema genital
(1)
Npn stands for non-protein-nitrogen such as urea, uric acid, amino acid, etc.
* ADRs occurred at higher dose 7.5 mg/0.6 ml.
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 Additionally, you can also report to Padagis via the following address: Padagis.co.il