Fondaparinux Sodium (Page 2 of 13)

3 DOSAGE FORMS AND STRENGTHS

Injection: Single-dose, prefilled syringes containing either 2.5 mg, 5 mg, 7.5 mg, or 10 mg of fondaparinux sodium.

4 CONTRAINDICATIONS

Fondaparinux sodium injection is contraindicated in the following conditions:

Severe renal impairment (creatinine clearance [CrCl] <30 mL/min) [see Warnings and Precautions (5.3) and Use in Specific Populations (8.6)].
Active major bleeding.
Bacterial endocarditis.
Thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of fondaparinux sodium.
Body weight <50 kg (venous thromboembolism [VTE] prophylaxis only) [see Warnings and Precautions (5.4)].
History of serious hypersensitivity reaction (e.g., angioedema, anaphylactoid/anaphylactic reactions) to fondaparinux sodium.

5 WARNINGS AND PRECAUTIONS

5.1 Neuraxial Anesthesia and Post-operative Indwelling Epidural Catheter Use

Spinal or epidural hematomas, which may result in long-term or permanent paralysis, can occur with the use of anticoagulants and neuraxial (spinal/epidural) anesthesia or spinal puncture. The risk of these events may be higher with post-operative use of indwelling epidural catheters or concomitant use of other drugs affecting hemostasis such as NSAIDs [see Boxed Warning]. In the postmarketing experience, epidural or spinal hematoma has been reported in association with the use of fondaparinux sodium by subcutaneous (SC) injection. Optimal timing between the administration of fondaparinux sodium and neuraxial procedures is not known. Monitor patients undergoing these procedures for signs and symptoms of neurologic impairment such as midline back pain, sensory and motor deficits (numbness, tingling, or weakness in lower limbs), and bowel or bladder dysfunction. Consider the potential risks and benefits before neuraxial intervention in patients anticoagulated or who may be anticoagulated for thromboprophylaxis.

5.2 Hemorrhage

Fondaparinux sodium increases the risk of hemorrhage in patients at risk for bleeding, including conditions such as congenital or acquired bleeding disorders, active ulcerative and angiodysplastic gastrointestinal disease, hemorrhagic stroke, uncontrolled arterial hypertension, diabetic retinopathy, or shortly after brain, spinal, or ophthalmological surgery. Cases of elevated aPTT temporally associated with bleeding events have been reported following administration of fondaparinux sodium (with or without concomitant administration of other anticoagulants) [see Adverse Reactions (6.5)].

Do not administer agents that enhance the risk of hemorrhage with fondaparinux sodium unless essential for the management of the underlying condition, such as vitamin K antagonists for the treatment of VTE. If co-administration is essential, closely monitor patients for signs and symptoms of bleeding.

Do not administer the initial dose of fondaparinux sodium earlier than 6 to 8 hours after surgery. Administration earlier than 6 hours after surgery increases risk of major bleeding [see Dosage and Administration (2) and Adverse Reactions (6.1)].

5.3 Renal Impairment and Bleeding Risk

Fondaparinux sodium increases the risk of bleeding in patients with impaired renal function due to reduced clearance [see Clinical Pharmacology (12.4)].

The incidence of major bleeding by renal function status reported in clinical trials of patients receiving fondaparinux sodium for VTE surgical prophylaxis is provided in Table 1. In these patient populations, the following is recommended:

Do not use fondaparinux sodium for VTE prophylaxis and treatment in patients with CrCl <30 mL/min [see Contraindications (4)].
Fondaparinux sodium may cause prolonged anticoagulation in patients with CrCl 30 to 50 mL/min.
Table 1. Incidence of Major Bleeding in Patients Treated With Fondaparinux Sodium by Renal Function Status for Surgical Prophylaxis and Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE)
CrCl = creatinine clearance.
*
Hip fracture, hip replacement, and knee replacement surgery prophylaxis.

Degree of Renal Impairment

Population

Timing of Dose

Normal

%

(n/N)

Mild

%

(n/N)

Moderate

%

(n/N)

Severe

%

(n/N)

CrCl (mL/min)

≥80

≥50 — <80

≥30 — <50

<30

Orthopedic surgery *

Overall

1.6%

(25/1,565)

2.4%

(31/1,288)

3.8%

(19/504)

4.8%

(4/83)

6-8 hours after surgery

1.8%

(16/905)

2.2%

(15/675)

2.3%

(6/265)

0%

(0/40)

Abdominal surgery

Overall

2.1%

(13/606)

3.6%

(22/613)

6.7%

(12/179)

7.1%

(1/14)

6-8 hours after surgery

2.1%

(10/467)

3.3%

(16/481)

5.8%

(8/137)

7.7%

(1/13)

DVT and PE

Treatment

0.4%

(4/1,132)

1.6%

(12/733)

2.2%

(7/318)

7.3%

(4/55)

Assess renal function periodically in patients receiving fondaparinux sodium. Discontinue the drug immediately in patients who develop severe renal impairment while on therapy. After discontinuation of fondaparinux sodium, its anticoagulant effects may persist for 2 to 4 days in patients with normal renal function (i.e., at least 3 to 5 half-lives). The anticoagulant effects of fondaparinux sodium may persist even longer in patients with renal impairment [see Clinical Pharmacology (12.4)].

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