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:

Mylan Institutional LLC

INN (International Name):

FONDAPARINUX SODIUM

Composition:

FONDAPARINUX SODIUM 2.5 mg in 0.5 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): 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: Available data from published literature and postmarketing reports have not reported a clear association with fondaparinux sodium and adverse developmental outcomes. Fondaparinux sodium plasma concentrations obtained from four women treated with ARIXTRA during pregnancy and their newborn infants demonstrated low placental transfer of fondaparinux sodium (see Data). There are risks to the mother associated with untreated venous thromboembolism in pregnancy and a risk of hemorrhage in the mother and fetus associated with use of anticoagulants (see

Product summary:

ARIXTRA (fondaparinux sodium injection, USP) is available in the following strengths: 2.5 mg ARIXTRA in 0.5 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod. NDC 67457-592-10 10 Single Unit Syringes 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. NDC 67457-593-04 10 Single Unit Syringes 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. NDC 67457-594-06 10 Single Unit Syringes 10 mg ARIXTRA in 0.8 mL single-dose prefilled syringe, affixed with a 27-gauge x ½‑inch needle and an automatic needle protection system with white plunger rod. NDC 67457-595-08 10 Single Unit Syringes Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Discard unused portion. PHARMACIST: Dispense a Patient Information Leaflet with each prescription.

Authorization status:

New Drug Application

Summary of Product characteristics

ARIXTRA- FONDAPARINUX SODIUM INJECTION, SOLUTION
MYLAN INSTITUTIONAL LLC
----------
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 INJECTION), FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2001
WARNING: SPINAL/EPIDURAL HEMATOMAS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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:
•
•
•
•
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
(5.1) AND DRUG INTERACTIONS (7)]._
INDICATIONS AND USAGE
ARIXTRA is a Factor Xa inhibitor (anticoagulant) indicated for:
•
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Single-dose, prefilled syringes containing 2.5 mg, 5 mg, 7.5 mg, or 10
mg of fondaparinux sodium. (3)
CONTRAINDICATIONS
ARIXTRA is contraindicated in the following conditions: (4)
•
•
•
•
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
Prophylaxis of deep vein thrombosis (DVT) in patients undergoing hip
fracture surgery (including extended
prophyla