Fraxiparine

Drug name: Fraxiparine


Other names used:

• Nadroparin®

Active Ingredients: Nadroparin

Therapeutic actions: Fraxiparine is a low molecular weight heparin made by depolymerisation of standard heparin. It is a glycosaminoglycan with a mean molecular weight around 4,500 daltons. It possesses a high ratio of anti-Xa activity to anti-IIa activity. Fraxiparine has both immediate and prolonged antithrombotic action.

Indications: Prophylaxis of thromboembolic disorders (particularly deep vein thrombosis and pulmonary embolism) in general surgery and in orthopedic surgery.
Treatment of deep vein thrombosis.
Prevention of clotting during hemodialysis.

Contraindications and cautions: Nadroparin must not be administered by the i.m. route. Hypersensitivity to nadroparin. Injuries to and operations on the CNS, eyes and ears. History of thrombocytopenia occurring with nadroparin, or in patients in whom an in vitro platelet aggregation test is positive in the presence of nadroparin. Severe uncontrolled hypertension. Signs of hemorrhage or increased risk of hemorrhage in relation with hemostasis disorders, except for disseminated intravascular coagulation not induced by heparin. Organic lesion which is likely to bleed (such as active peptic ulceration). Acute infective endocarditis. Hemorrhagic cerebrovascular event. tag_WarningWarnings

Adverse effects: The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
Bleeding: As with other low molecular weight heparin preparations, nadroparin increases the risk of overt or concealed hemorrhage, especially in patients with other risk factors (see Contraindications).
The most common side effect of nadroparin was the development of injection site hematomas, which occurred at a frequency of about 5%. Other bleeding side effects were rare in clinical trials and ranged in severity from minor local hematomas to major hemorrhagic events, including death. Frequently, the first signs of bleeding include epistaxis, hematuria or melena. Petechiae or unexpected bruising may precede overt hemorrhage. Bleeding may be from any site and may be difficult to detect; e.g., retroperitoneal bleeding. In surgical patients, bleeding may occur from the surgical site. Established risk factors for bleeding in response to heparin and low molecular weight heparins include the use of platelet inhibiting medication, chronic heavy alcohol consumption, serious concurrent illness, renal failure, and advanced age. Patients taking low molecular weight heparins who experience noticeable prolongation of APTT, are at risk for bleeding. Frequently this is associated with plasma anti-Xa activity of 2 IU/mL or more.
Thrombocytopenia: Rare cases of thrombocytopenia, sometimes thrombogenic, have been reported (see Precautions). Other infrequent serious side effects include: cutaneous necrosis, usually occurring at the injection site, which has been reported both with unfractionated heparin and with low molecular weight heparins; it is preceded by purpura or infiltrated or painful erythematous blotches, which may or may not be manifested by systemic upset. In such cases, treatment should be discontinued immediately.
Cutaneous or generalized hypersensitivity reactions requiring discontinuation of treatment.
Other adverse events which occur occasionally at an incidence similar to that of treatment with unfractionated heparin include: elevations in transaminases (AST and ALT) which are transient and has not been correlated to long-term effects on liver function; reversible hypoaldosteronism which may be associated with hyperkalemia and/or hyponatremia.
The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

Interactions: Tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine.
ASA and other salicylate drugs, nonsteroidal anti-inflammatory drugs increase the risk of hemorrhage due to the effect on platelets. Similarly, antiplatelet drugs increase the risk of hemorrhage due to the inhibition of the platelet function (see also Precautions).
Pregnancy and Lactation: Clinical experience of use in pregnant women is limited. Animals studies have not shown any teratogenic or fetotoxic effects. Clinical data concerning transplacental passage are limited; therefore, use of nadroparin during pregnancy is not advised unless the therapeutic benefits outweigh the possible risks. There are no clinical data concerning excretion in breast milk. Mothers receiving nadroparin should avoid breast-feeding.
Children: There are no trials to support the use of nadroparin in children. Therefore, the use of nadroparin is not advised unless the therapeutic benefits outweigh the possible risks.
Knee Surgery: Knee replacement is a delicate surgery, and may carry a greater risk of both deep vein thrombosis (DVT) and clinically important bleeding than hip replacement surgery. For this reason it is important to ensure appropriate dosing of this drug in this patient population.

Additional Information: DO NOT SHARE THIS MEDICINE with others. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS PRODUCT, as well as syringes and needles, if needed during treatment, out of the reach of children. Do not reuse needles, syringes, or other materials.