ARIXTRA- fondaparinux sodium injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FONDAPARINUX SODIUM (UNII: X0Q6N9USOZ) (FONDAPARINUX - UNII:J177FOW5JL)

Available from:

Physicians Total Care, Inc.

INN (International Name):

FONDAPARINUX SODIUM

Composition:

FONDAPARINUX SODIUM 5 mg in 0.4 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ARIXTRA® is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): - in patients undergoing hip fracture surgery, including extended prophylaxis; - in patients undergoing hip replacement surgery; - in patients undergoing knee replacement surgery; - in patients undergoing abdominal surgery who are at risk for thromboembolic complications. ARIXTRA is indicated for the treatment of acute deep vein thrombosis when administered in conjunction with warfarin sodium. ARIXTRA is indicated for the treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital. ARIXTRA is contraindicated in the following conditions: - Severe renal impairment (creatinine clearance [CrCl] <30 mL/min). [See Warnings and Precautions (5.2) and Use in Specific Populations (8.6).] - Active major bleeding. - Bacterial endocarditis. - Thrombocytopenia associated with a positive in vitro test for anti-platelet antib

Product summary:

ARIXTRA Injection is available in the following strengths and package sizes: 5 mg ARIXTRA in 0.4 mL single-dose prefilled syringe, affixed with a 27-gauge x ½-inch needle and an automatic needle protection system with white plunger rod. 7.5 mg ARIXTRA in 0.6 mL single-dose prefilled syringe, affixed with a 27-gauge x ½-inch needle and an automatic needle protection system with white plunger rod. Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F).

Authorization status:

New Drug Application

Summary of Product characteristics

ARIXTRA - FONDAPARINUX SODIUM INJECTION, SOLUTION
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ARIXTRA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ARIXTRA.
ARIXTRA (FONDAPARINUX SODIUM) SOLUTION FOR SUBCUTANEOUS INJECTION
INITIAL U.S. APPROVAL: 2001
WARNING: SPINAL/EPIDURAL HEMATOMAS
EPIDURAL OR SPINAL HEMATOMAS MAY OCCUR IN PATIENTS WHO ARE
ANTICOAGULATED WITH LOW MOLECULAR WEIGHT
HEPARINS (LMWH), HEPARINOIDS, OR FONDAPARINUX SODIUM AND ARE RECEIVING
NEURAXIAL ANESTHESIA OR
UNDERGOING SPINAL PUNCTURE. THESE HEMATOMAS MAY RESULT IN LONG-TERM OR
PERMANENT PARALYSIS.
CONSIDER THESE RISKS WHEN SCHEDULING PATIENTS FOR SPINAL PROCEDURES.
FACTORS THAT CAN INCREASE THE RISK OF
DEVELOPING EPIDURAL OR SPINAL HEMATOMAS IN THESE PATIENTS INCLUDE:
● USE OF INDWELLING EPIDURAL CATHETERS
● CONCOMITANT USE OF OTHER DRUGS THAT AFFECT HEMOSTASIS, SUCH AS
NON-STEROIDAL ANTI-INFLAMMATORY DRUGS
(NSAIDS), PLATELET INHIBITORS, OR OTHER ANTICOAGULANTS
● A HISTORY OF TRAUMATIC OR REPEATED EPIDURAL OR SPINAL PUNCTURE
● A HISTORY OF SPINAL DEFORMITY OR SPINAL SURGERY
MONITOR PATIENTS FREQUENTLY FOR SIGNS AND SYMPTOMS OF NEUROLOGIC
IMPAIRMENT. IF NEUROLOGIC
COMPROMISE IS NOTED, URGENT TREATMENT IS NECESSARY.
CONSIDER THE BENEFIT AND RISKS BEFORE NEURAXIAL INTERVENTION IN
PATIENTS ANTICOAGULATED OR TO BE
ANTICOAGULATED FOR THROMBOPROPHYLAXIS._ [SEE WARNINGS AND PRECAUTIONS
(5.5) AND DRUG INTERACTIONS (7).]_
INDICATIONS AND USAGE
ARIXTRA is a Factor Xa inhibitor (anticoagulant) indicated for: (1)
Prophylaxis of deep vein thrombosis (DVT) in patients undergoing hip
fracture surgery (including extended
prophylaxis), hip replacement surgery, knee replacement surgery, or
abdominal surgery. (1.1)
Treatment of DVT or acute pulmonary embolism (PE) when administered in
conjunction with warfarin. (1.2, 1.3)
DOSAGE AND ADMINISTRATION
Prophylaxis of deep vein thrombosis: ARIXTRA 2.5 mg subcutaneously
once daily after hemostasis has