Generic drug of the therapeutic class: Haemostasis and blood
active ingredients: Fondaparinux
laboratory: Glaxo Group Ltd
Box of 10 pre-filled syringes with 0.8 mL needles
Treatment of acute deep vein thrombosis (DVT) and acute pulmonary embolism (PE) in adults, excluding hemodynamically unstable patients or patients requiring thrombolysis or pulmonary embolectomy.
Dosage ARIXTRA 10 mg / 0.8 mL Solution for injection Box of 10 pre-filled syringes with 0.8 mL needles
The recommended dosage of fondaparinux is 7.5 mg (for patients weighing between 50 and 100 kg) once daily, administered by subcutaneous injection. For patients weighing less than 50 kg, the recommended dose is 5 mg. For patients weighing more than 100 kg, the recommended dose is 10 mg.
The treatment will be continued for at least 5 days and until the appropriate dose of oral anticoagulation therapy is reached (International Normalized Ratio between 2 and 3). Concomitant oral anticoagulant therapy should be initiated as soon as possible and usually within 72 hours. The average duration of administration in clinical studies was 7 days and clinical experience beyond 10 days is limited.
Elderly - No dosage adjustment is necessary. In patients aged 75 years and older, fondaparinux should be used with caution due to age-related impairment of renal function (see Warnings and Precautions ).
Renal Insufficiency - Fondaparinux should be used with caution in patients with moderate renal impairment (see Warnings and Precautions ).
There is no experience in the subgroup of high weight (> 100 kg) patients with moderate renal impairment (creatinine clearance between 30 and 50 ml / min). In this subgroup, after an initial dosage of 10 mg once daily, a decrease in daily dosage to 7.5 mg may be considered based on pharmacokinetic modeling data (see section 4.4). employment ).
Fondaparinux should not be used in patients with severe renal impairment (creatinine clearance <30 ml / min) (see section 4.3 ).
Hepatic Impairment - No dose adjustment is required in patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, fondaparinux should be used with caution: this group of patients has not been studied (see sections Warnings and Precautions and Pharmacokinetic Properties ).
Pediatrics - The use of fondaparinux is not recommended in children under 17 years of age, given the inadequacy of the safety and efficacy data (see sections Pharmacodynamic properties and Pharmacokinetic properties ).
Fondaparinux should be injected subcutaneously deep, with the patient lying down. The injection sites should be alternated between the anterolateral and posterolateral abdominal belt, alternately on the right and left side. To avoid loss of medication when using the pre-filled syringe, do not bleed the air bubble from the syringe before performing the injection. The needle must be inserted perpendicularly throughout its length into the thickness of a skin fold made between the thumb and forefinger; this skin fold must be maintained for the duration of the injection.
For additional instructions on use, handling and disposal, see section Instructions for use, handling and disposal .
- hypersensitivity to the active substance or to any of the excipients
- clinically significant progressive bleeding
- acute bacterial endocarditis
- severe renal insufficiency (creatinine clearance <30 ml / min).
Arixtra side effects
The most common serious adverse reactions reported with fondaparinux are bleeding complications (in various locations including rare cases of intracranial / intracerebral or retroperitoneal bleeding) and anemia. Fondaparinux should be used with caution in patients with an increased risk of bleeding (see Warnings and Precautions for Use section ).
The safety of fondaparinux was evaluated in 2517 patients treated for venous thromboembolic events for an average of 7 days. The most common side effects were bleeding complications (see Warnings and Precautions section ).
Undesirable effects reported by the investigators as at least possibly related to fondaparinux are presented within each organ class in decreasing order of frequency of occurrence (very common: ≥ 1/10, frequent: ≥ 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) and severity.
MedDRA Organ Class
Undesirable effects in patients treated for venous thromboembolic events (VTE) 1
Blood and lymphatic system disorders
Frequent: bleeding (gastrointestinal, hematuria, hematoma, epistaxis, haemoptysis, utero-vaginal haemorrhage, hemarthrosis, ocular, purpura, ecchymosis)
Uncommon: anemia, thrombocytopenia.
Rare: other bleeding (hepatic, retroperitoneal, intracranial / intracerebral) thrombocythemia
Immune system disorders
Rare: allergic reaction
Metabolism and nutrition disorders
Rare: increased non-protein nitrogen (PNA) 2
Nervous system disorders
Uncommon: headache Rare: vertigo
Uncommon: nausea, vomiting.
Uncommon: abnormal liver function
Skin and subcutaneous tissue disorders
Rare: erythematous rash
General disorders and administration site conditions
Uncommon: pain, edema Rare: injection site reaction
(1) adverse effects reported in isolation were not considered unless medically relevant.
(2) ANP means non-protein nitrogen such as urea, uric acid, amino acid, etc.