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Arixtra

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Arixtra

ARIXTRA
(fondaparinux sodium) Injection

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 antiinflammatory 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 and DRUG INTERACTIONS]

DRUG DESCRIPTION

ARIXTRA (fondaparinux sodium) Injection is a sterile solution containing fondaparinux sodium. It is a synthetic and specific inhibitor of activated Factor X (Xa). Fondaparinux sodium is methyl O-2-deoxy-6-O-sulfo-2-(sulfoamino)-α-D-glucopyranosyl-(1→4)-O-β-D-glucopyranuronosyl-(1→4)-O-2-deoxy-3,6-di-O-sulfo-2-(sulfoamino)- α -D-glucopyranosyl-(1→4)-O-2-Osulfo- α -L-idopyranuronosyl-(1→4)-2-deoxy-6-O-sulfo-2-(sulfoamino)- α -D-glucopyranoside, decasodium salt.

The molecular formula of fondaparinux sodium is C31H43N3Na10O49S8 and its molecular weight is 1728. The structural formula is provided below:

ZOLOFT® (sertraline hydrochloride) Structural Formula Illustration

ARIXTRA is supplied as a sterile, preservative-free injectable solution for subcutaneous use.

Each single-dose, prefilled syringe of ARIXTRA, affixed with an automatic needle protection system, contains 2.5 mg of fondaparinux sodium in 0.5 mL, 5.0 mg of fondaparinux sodium in 0.4 mL, 7.5 mg of fondaparinux sodium in 0.6 mL, or 10.0 mg of fondaparinux sodium in 0.8 mL of an isotonic solution of sodium chloride and water for injection. The final drug product is a clear and colorless to slightly yellow liquid with a pH between 5.0 and 8.0.

What are the possible side effects of fondaparinux (Arixtra)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using fondaparinux and call your doctor at once if you have a serious side effect such as:

  • unusual bleeding (nose, mouth, vagina, or rectum), bleeding from wounds or needle injections, any bleeding that will not stop;
  • easy bruising, purple or red pinpoint spots under your skin;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • black or...

Read All Potential Side Effects and See Pictures of Arixtra »

What are the precautions when taking fondaparinux sodium (Arixtra)?

See also Warning section.

Before using fondaparinux, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as dry natural rubber/latex in the needle cover on the prefilled syringe), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using fondaparinux, tell your doctor or pharmacist your medical history, especially of: infection in the heart (bacterial endocarditis), current serious bleeding (such as bleeding ulcer), low platelet count because of antiplatelet antibody, bleeding/blood problems (such as low blood count/platelets), a past blood-clotting problem because of heparin (heparin-induced thrombocytopenia), a certain eye...

Read All Potential Precautions of Arixtra »

Last reviewed on RxList: 7/29/2014
This monograph has been modified to include the generic and brand name in many instances.

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