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All about: Fondaparinux Sodium

Big Image Pronouncation: (fon-dah-PAH-rin-uck SO-dee-uhm)
Class: Selective factor XA inhibitor

Trade Names:
Arixtra
- Injection 2.5 mg per 0.5 mL
- Injection 5 mg per 0.4 mL
- Injection 7.5 mg per 0.6 mL
- Injection 10 mg per 0.8 mL

Mechanism of Action

Pharmacology

Selective inhibition of antithrombin III (ATIII), which potentiates the innate neutralization of factor Xa by ATIII. Neutralization of factor Xa interrupts the blood coagulation cascade and inhibits thrombin formation and thrombus development.

Pharmacokinetics

Absorption

Following subcutaneous administration, rapidly and completely absorbed. C max is 0.34 mg/L and is reached in about 2 h. Peak steady-state plasma level is 0.39 to 0.5 mg/L and is reached approximately 3 h postdose.

Distribution

Distributes primarily in the blood and to a minor extent in extravascular fluid. Protein binding is at least 94%, specifically to ATIII, and does not bind significantly to other plasma proteins.

Metabolism

Because the majority of the drug is eliminated unchanged in the urine, the metabolism has not been studied.

Elimination

Up to 77% of an administered dose is eliminated unchanged in the urine within 72 h. Elimination t ½ is 17 to 21 h.

Special Populations

Renal Function Impairment

Elimination is prolonged.

Elderly

Elimination is prolonged in patients older than 75 yr of age.

Weight

Total Cl is decreased approximately 30% in patients weighing less than 50 kg.

Indications and Usage

Prophylaxis of deep vein thrombosis (DVT) that may lead to pulmonary embolism in patients undergoing hip fracture surgery including extended prophylaxis, hip replacement surgery, knee replacement surgery, or abdominal surgery (when at risk for thromboembolic complications); in conjunction with warfarin, fondaparinux is indicated for the treatment of acute DVT and acute pulmonary embolism (PE).

Contraindications

Patients with severe renal impairment (Ccr less than 30 mL/min); body weight less than 50 kg; active major bleeding, bacterial endocarditis; thrombocytopenia associated with positive in vitro test for antiplatelet antibody in the presence of fondaparinux; hypersensitivity to any component of the product.

Dosage and Administration

DVT Prophylaxis
Adults

Subcutaneous 2.5 mg once daily. After hemostasis is established, give the initial dose 6 to 8 h after surgery. Usual duration of therapy is 5 to 9 days (up to 11 days following hip or knee replacement surgery or up to 10 days following abdominal surgery). An extended prophylaxis course of up to 24 additional days (up to 32 days total) is recommended following hip fracture surgery.

Acute DVT and Acute PE Treatment
Adults

Subcutaneous 5 mg if body weight less than 50 kg, 7.5 mg if body weight 50 to 100 kg, and 10 mg if body weight more than 100 kg, given once daily. Continue treatment for at least 5 days and until a therapeutic oral anticoagulant effect is established (INR 2 to 3). Initiate coadministration of warfarin as soon as possible, usually within 72 h. Usual duration of therapy is 5 to 9 days (up to 26 days).

General Advice

  • Fondaparinux cannot be used interchangeably with heparin, low molecular weight heparins, or heparinoids.
  • For subcutaneous administration only. Not for intradermal, IM, IV, or intra-arterial administration.
  • Administer initial dose 6 to 8 h after surgery.
  • Prescribed dose is administered every 24 h.
  • Multiple concentrations are available in prefilled syringes. Double check syringe concentration and prescribed dose to reduce chance of administering wrong dose of medication. Ensure that dose is determined based on body weight when fondaparinux is being used to treat an acute pulmonary embolus or DVT.
  • Follow manufacturer's instructions for preparing syringe, administering dose, and discarding used syringe. To avoid loss of medication do not expel air bubble from syringe before administration.
  • Administer prescribed dose, rotating injection sites between left and right anterolateral or left and right posterolateral abdominal wall.
  • Do not administer if solution is cloudy, discolored, or contains particulate matter. A slight yellow coloration is normal.
  • Do not mix with other injections or infusions.

Storage/Stability

Store prefilled syringes at controlled room temperature (59° to 86°F).

Drug Interactions

Agents that increase the risk of hemorrhage (eg, other anticoagulants, NSAIDs, platelet inhibitors)

Discontinue prior to administration of fondaparinux.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Hypotension (4%); hypertension (2%).

CNS

Headache, insomnia (5%); dizziness (4%); confusion (3%).

Dermatologic

Rash (8%); purpura (4%); bullous eruption, surgical site reaction (3%); bruise (1%); injection site bleeding; pruritus.

EENT

Epistaxis (1%).

GI

Nausea (11%); constipation (9%); vomiting (6%); diarrhea (3%); dyspepsia (2%); abdominal pain (1%).

Genitourinary

UTI (4%); urinary retention (3%).

Hematologic

Anemia (20%); postoperative hemorrhage (4%); major bleeding, minor bleeding (3%); decreased prothrombin (1%); reoperation caused by bleeding (0.3%); thrombocytopenia.

Lab Tests

Asymptomatic elevations in ALT (3%) and AST (2%).

Metabolic

Edema (9%); hypokalemia (4%).

Respiratory

Coughing, pneumonia (2%).

Miscellaneous

Fever (14%); increased wound drainage, postoperative wound infection (5%); hematoma (3%); pain (2%); back, chest, or leg pain (1%).

Precautions

Warnings

When epidural/spinal anesthesia or spinal puncture is employed in patients anticoagulated with fondaparinux, the risk of developing an epidural or spinal hematoma, which can result in long-term or permanent paralysis, is increased. The risk is increased with postoperative use of indwelling epidural catheters or concomitant use of other drugs affecting hemostasis such as NSAIDs. Monitor frequently for signs/symptoms of neurologic impairment (eg, midline back pain, numbness or weakness in lower extremities, bowel and/or bladder dysfunction).


Monitor

Perform periodic CBCs (including platelet count), serum creatinine level, and stool occult blood tests during course of therapy. Assess patient for signs/symptoms of bleeding. Closely monitor patients for signs/symptoms of neurologic impairment.

Anti-factor Xa activity

The anti-factor Xa activity of fondaparinux can be measured by anti-Xa assay using fondaparinux as the calibrator.


Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Elderly

Use with caution.

Renal Function

Risk of hemorrhage increases with increasing renal impairment. Periodically assess renal function during therapy. Discontinue fondaparinux immediately if severe renal impairment (Ccr less than 30 mL/min) is noted.

Special Risk Patients

Use with caution in the elderly and in patients with bleeding diathesis, uncontrolled arterial hypertension, or history of recent GI ulceration, diabetic retinopathy, hemorrhage, history of heparin-induced thrombocytopenia.

Body weight

Use with caution in patients with low body weight (less than 50 kg) for the treatment of pulmonary embolism and DVT.

First dose/hemorrhage risk

To reduce risk of hemorrhage, administer fondaparinux according to recommended regimen, especially with respect to the timing of the first dose after surgery. Administration of first dose before 6 h after surgery (hip fracture, hip replacement, knee replacement, abdominal surgery) has been associated with an increased risk of major bleeding.

Hemorrhage

Use with caution in conditions of increased risk of hemorrhage (eg, congenital bleeding disorder, active ulcerative GI disease). Discontinue any agent that could increase risk of hemorrhage prior to initiating fondaparinux therapy. If coadministration cannot be avoided, ensure patient is monitored closely with clinical assessment for bleeding. Discontinue fondaparinux if unexpected changes in coagulation parameters or major bleeding occurs.

Thrombocytopenia

May occur. Closely monitor any degree of thrombocytopenia. Discontinue fondaparinux if platelet count falls below 100,000/mm 3 .

Overdosage

Symptoms

Hemorrhagic complications.

Patient Information

  • Advise patient or caregiver that medication usually is prepared and administered by a health care professional in a health care setting, but self-injection is possible if approved by health care provider.
  • Instruct patient to immediately report any signs or symptoms of bleeding (eg, black, tarry stools, blood in the urine, dizziness when standing, excessive bruising, nosebleed, paleness).
  • Instruct patient to immediately report any signs or symptoms of blood clot extension or new blood clot formation (eg, fainting, pain and/or swelling of leg, sudden chest pain, unexplained shortness of breath or difficulty breathing).
  • Instruct patient who has had a spinal puncture, or who has an indwelling epidural catheter, to immediately report any of the following: bowel and/or bladder dysfunction, midline back pain, numbness or weakness in lower extremities.
  • Instruct patient to report any injection site reactions (eg, bleeding, redness, swelling).
  • Self-injection
  • If self-injection or home administration has been approved, teach patient or caregiver how to store, prepare, and administer the dose, and dispose of used equipment and supplies.
  • Caution patient not to change the dose or stop taking unless advised by health care provider.

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