fondaparinux sodium


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fondaparinux sodium

Arixtra

Pharmacologic class: Selective factor Xa inhibitor

Therapeutic class: Anticoagulant, antithrombotic

Pregnancy risk category B

Action

Selectively inhibits factor Xa, disrupting blood coagulation and inhibiting thrombin formation and thrombus development

Availability

Injection: 2.5 mg/0.5 ml in single-dose syringe

Indications and dosages

Prevention of deep-vein thrombosis after hip fracture surgery or hip or knee replacement surgery

Adults: 2.5 mg subcutaneously 6 to 8 hours after surgery, once hemostasis occurs; usual duration is 5 to 9 days (up to 11 days) given daily. After hip fracture surgery, extended prophylactic course of up to 24 additional days is recommended; some patients have tolerated a total course of 32 days.

Deep-vein thrombosis and pulmonary emboli

Adults: 5 mg subcutaneously once daily for patients weighing less than 50 kg (110 lb), 7.5 mg subcutaneously for patients weighing 50 to 100 kg (110 to 220 lb) or 10 mg subcutaneously for patients weighing more than 100 kg (220 lb) for 5 days and until therapeutic oral anticoagulant effect occurs (as shown by International Normalized Ratio of 2 to 3). Usual duration of therapy is 5 to 9 days, but may continue for up to 26 days.

Dosage adjustment

• Renal impairment

Contraindications

• Hypersensitivity to drug
• Bacterial endocarditis
• Severe renal disease
• Active major bleeding
• Patients weighing less than 50 kg (110 lb) who have undergone hip fracture, hip replacement, or knee replacement surgery

Precautions

Use cautiously in:
• diabetic retinopathy, hepatic disease, blood dyscrasias, heparin-induced thrombocytopenia, severe hypertension, alcoholism
• patients older than age 75
• pregnant or breastfeeding patients
• children (safety and efficacy not established).

Administration

Withhold for at least 6 to 8 hours after surgery, to minimize risk of major bleeding.

Give by subcutaneous injection only. Don't give I.M.
• Rotate injection sites among fatty tissue areas on left and right anterolateral and posterolateral abdominal walls.
• Don't expel air bubble from syringe; doing so may reduce amount of drug delivered.
• Listen for slight click when plunger is fully released. After drug has been injected, needle retracts and white safety indicator is visible.
• Don't mix with other injections or infusions.
• Know that when drug is used to treat deep-vein thrombosis and pulmonary emboli, concomitant warfarin treatment should begin as soon as possible (usually within 72 hours).

Adverse reactions

CNS: depression, dizziness, asthenia, headache, abnormal thinking, confusion, insomnia, neuropathy

CV: hypotension

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, dry mouth, anorexia

GU: urinary retention, urinary tract infection

Hematologic: anemia, hematoma, purpura, minor bleeding, major bleeding, thrombocytopenia, retroperitoneal hemorrhage, postoperative hemorrhage

Metabolic: hypokalemia

Skin: bullous eruption

Other: increased wound drainage, injection site bleeding, pain, edema, fever

Interactions

Drug-drug.Anticoagulants: increased risk of bleeding

Drug-herbs.Anise, astragalus, bilberry, black currant, bladder wrack, bogbean, boldo, borage, buchu, capsaicin, cat's claw, celery, chaparral, cinchona, clove oil, dandelion, dong quai, fenugreek, feverfew, garlic, ginger, ginkgo, papaya, red clover, rhubarb, safflower oil, skullcap, tan-shen: additive anticoagulant effect

St. John's wort: reduced anticoagulant effect

Patient monitoring

• Monitor CBC, platelet count, creatinine level, and renal function tests. Assess stools for occult blood.
• Monitor vital signs, temperature, and fluid intake and output.

Stay alert for bleeding tendency, especially postoperative hemorrhage.
• Check for increased wound drainage after surgery.

In patient undergoing concomitant neuraxial anesthesia or spinal puncture, watch for neurologic impairment (indicating possible spinal or epidural hematoma).

Discontinue drug if severe renal impairment occurs.

Patient teaching

Instruct patient to immediately report bleeding.
• Caution patient to avoid activities that can cause injury. Tell him to use soft toothbrush and electric razor to avoid gum and skin injury.
• Tell patient that he'll undergo regular blood testing during therapy.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and herbs mentioned above.

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References in periodicals archive ?
Ambrose Stafford, Vice President, Apicore LLC said, "We're very proud of the skill and dedication of our team who have worked tirelessly over several years to achieve this major milestone of completing the development of Fondaparinux Sodium API.
Thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of fondaparinux sodium.
Vice President of Intellectual Property for Alchemia, Michael West, said, "This patent family provides legal protection for Alchemia's processes for the synthesis of fondaparinux sodium through to 6 September 2022.
ARIXTRA is contraindicated in patients with active major bleeding, bacterial endocarditis, and patients with hypersensitivity to fondaparinux sodium.
When epidural/spinal anesthesia or spinal puncture is employed, patients anticoagulated with low-molecular-weight heparins, heparinoids or fondaparinux sodium are at risk of developing an epidural or spinal hematoma, which can result in long-term or permanent paralysis.
ARIXTRA(R) is contraindicated in patients with severe renal impairment, patients with active major bleeding, bacterial endocarditis, and patients with hypersensitivity to fondaparinux sodium.
The New Drug Application for fondaparinux sodium, the active compound in Arixtra, was submitted on February 15, 2001 in both the United States and Europe.
ARIXTRA is contraindicated in patients with severe renal impairment, patients with active major bleeding, bacterial endocarditis, and patients with hypersensitivity to fondaparinux sodium.
When epidural/spinal anesthesia or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low-molecular-weight heparins, heparinoids or fondaparinux sodium are at risk of developing an epidural or spinal hematoma, which can result in long-term or permanent paralysis.

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