Vasola Special Precautions

Route of administration: Fondaparinux sodium must not be administered intramuscularly (see DOSAGE & ADMINISTRATION).
Haemorrhage: Fondaparinux sodium like other anticoagulants must be used with caution in conditions with an increased risk of haemorrhage, (such as congenital or acquired bleeding disorders, active ulcerative gastrointestinal disease, recent intracranial haemorrhage, shortly after brain, spinal or ophthalmic surgery).
Prevention and treatment VTE: Other medical products enhancing the risk of haemorrhage, with the exception of vitamin K antagonists used concomitantly for the treatment of VTE, should not be administered with Fondaparinux sodium. If co-administration is essential, close monitoring is recommended (see INTERACTIONS).
Prevention of VTE following surgery (timing of first Fondaparinux injection): The timing of the first injection requires strict adherence. The first dose should be given no earlier than 6 hours following surgical closure, and only after haemostasis has been established. Administration before 6 hours has been associated with an increased risk of major bleeding. Patients groups at particular risk are those from 75 years of age, body weight of less than 50 kg, or renal impairment with creatinine clearance less than 50 mL/min.
Spinal/epidural anaesthesia/spinal puncture: Epidural or spinal haematomas that may result in long-term or permanent paralysis can occur with the use of anticoagulant and spinal/epidural anaesthesia or spinal puncture. The risk of these rare events may be higher with post-operative use of indwelling epidural catheters or the concomitant use of other medicinal products affecting haemostasis.
Low body weight: Patients with body weight less than 50 kg are at increased risk of bleeding. Elimination of Fondaparinux sodium decreases with weight decrease. Fondaparinux sodium should be used with caution in these patients (see DOSAGE & ADMINISTRATION).
Heparin Induced Thrombocytopenia: Fondaparinux sodium does not bind to platelet factor 4 and does not cross-react with sera from patients with Heparin Induced Thrombocytopenia (HIT)-type II. It should be used with caution in patients with a history of HIT. The efficacy and safety of Fondaparinux sodium have not been formally studied in HIT-type II. Rare spontaneous reports of HIT in patients treated with Fondaparinux sodium have been received. To date a causal association between treatment with Fondaparinux sodium and the occurrence of HIT has not been established.
Effects on Ability to Drive and Use Machines: No studies on the effect on the ability to drive and to use machines have been performed.
Renal impairment: The plasma clearance of fondaparinux decreases with the severity of renal impairment, and is associated with an increased risk of haemorrhage.
Patients with renal impairment, particularly those with a creatinine clearance of less than 30 mL/min are at increased risk of both major bleeding episodes and VTE.
Prevention of VTE: There are limited clinical data available for the use of fondaparinux for prevention of VTE in patients with creatinine clearance less than 20 mL/min. Therefore, Fondaparinux sodium is not recommended for prevention of VTE in these patients (see DOSAGE & ADMINISTRATION).
Treatment of VTE: There are limited clinical data available for the use of fondaparinux for treatment of VTE in patients with creatinine clearance of less than 30 mL/min. Therefore, Fondaparinux sodium is not recommended for the treatment of VTE in these patients (see DOSAGE & ADMINISTRATION).
Severe hepatic impairment: In patients with an elevation in prothrombin time, the use of Fondaparinux sodium should be considered with caution, because of an increased risk of bleeding due to a possible deficiency of coagulation factors in patients with severe hepatic impairment (see DOSAGE & ADMINISTRATION).
Use in Elderly: The elderly population is at increased risk of bleeding. As renal function generally decreases with age, elderly patients may show reduced elimination and increased exposure of Fondaparinux sodium. Fondaparinux sodium should be used with caution in elderly patients (see DOSAGE & ADMINISTRATION).