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Pharmacologic class: Selective factor Xa inhibitor
Therapeutic class: Anticoagulant, antithrombotic
Pregnancy risk category B
Selectively inhibits factor Xa, disrupting blood coagulation and inhibiting thrombin formation and thrombus development
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.
• Renal impairment
• 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
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).
☞ 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).
CNS: depression, dizziness, asthenia, headache, abnormal thinking, confusion, insomnia, neuropathy
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
Skin: bullous eruption
Other: increased wound drainage, injection site bleeding, pain, edema, fever
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
• 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.
☞ 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.
Pharmacologic: active factor x inhibitors
Time/action profile (anticoagulant effect)
|Subcut||rapid||3 hr||24 hr|
Adverse Reactions/Side Effects
Central nervous system
- ↑ liver enzymes
- urinary retention
- bullous eruption
- bleeding (most frequent)
Fluid and Electrolyte
- hypersensitivity reactions including angioedema (life-threatening)
- ↑ wound drainage
Drug-Drug interactionRisk of bleeding may be ↑ by concurrent use of warfarin or drugs that affect platelet function, including aspirin, NSAIDs, dipyridamole, some cephalosporins, valproates, clopidogrel, ticlopidine, abciximab, eptifibatide, tirofiban, and dextran.↑ risk of bleeding with arnica, chamomile, clove, dong quai, feverfew, garlic, ginger, gingko, Panax ginseng, and others.
Treatment of DVT/PE
Prevention of DVT/PE
Availability (generic available)
- Assess for signs of bleeding and hemorrhage (bleeding gums; nosebleed; unusual bruising; black, tarry stools; hematuria; fall in hematocrit; sudden drop in BP; guaiac positive stools); bleeding from surgical site. Notify health care professional if these occur.
- Assess for evidence of additional or increased thrombosis. Symptoms will depend on area of involvement. Monitor neurological status frequently for signs of impairment, especially in patients with indwelling epidural catheters for administration of analgesia or with concomitant use of drugs affecting hemostasis (NSAIDs, platelet inhibitors, other anticoagulants). Risk is increased by traumatic or repeated epidural or spinal puncture. May require urgent treatment.
- Lab Test Considerations: Monitor platelet count closely; may cause thrombocytopenia. If platelet count is <100,000/mm3, discontinue fondaparinux.
- Fondaparinux is not accurately measured by prothrombin time (PT), activated thromboplastin time (aPTT), or international standards of heparin or low-molecular-weight heparins. If unexpected changes in coagulation parameters or major bleeding occurs, discontinue fondaparinux.
- Monitor CBC, serum creatinine levels, and stool occult blood tests routinely during therapy.
- May cause asymptomatic ↑ in AST and ALT. Elevations are fully reversible and not associated with ↑ in bilirubin.
- May cause ↑ aPTT temporally associated with bleeding with or without concomitant administration of other anticoagulants and thrombocytopenia with thrombosis similar to heparin-induced thrombocytopenia, with or without exposure to heparin or low-molecular-weight heparins.
Potential Nursing DiagnosesIneffective tissue perfusion (Indications)
Risk for injury (Side Effects)
- Fondaparinux cannot be used interchangeably with heparin, low-molecular-weight heparins, or heparinoids as they differ in manufacturing process, anti-Xa and anti-IIa activity, units, and dose. Each of these medications has its own instructions for use.
- Initial dose should be administered 6-8 hr after surgery. Administration before 6 hr after surgery has been associated with risk of major bleeding.
- Subcutaneous: Administer subcut only into fatty tissue, alternating sites between right and left anterolateral or posterolateral abdominal wall. Inject entire length of needle at a 45° or 90° angle into a skin fold held between thumb and forefinger; hold skin fold throughout injection. Do not aspirate or massage. Rotate sites frequently. Do not administer IM because of danger of hematoma formation. Solution should be clear; do not inject solution containing particulate matter. Do not mix with other injections.
- Fondaparinux is provided in a single-dose prefilled syringe with an automatic needle protection system. Do not expel air bubble from prefilled syringe before injection to prevent loss of drug.
- Advise patient to report any symptoms of unusual bleeding or bruising, dizziness, itching, rash, fever, swelling, or difficulty breathing to health care professional immediately.
- Instruct patient not to take aspirin or NSAIDs without consulting health care professional during therapy.
- Prevention and treatment of deep vein thrombosis and pulmonary embolism.
ArixtraA selective factor-Xa-inhibiting synthetic heparin anticoagulant, which is a pentasaccharide that covers the active site of heparin specific for antithrombin III.
Prophylaxis of deep vein thrombosis (DVT) and PEs in hospitalised patients, including those with hip fractures and injuries, or patients undergoing total hip or total knee replacement surgery; it may be used to manage heparin-induced thrombocytopaenia (HIT).
Bleeding, thrombocytopaenia, local reactions, increased aminotransferases.