Arixtra

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)-?-D-glucopyranosyl-(1?4)-O-?-D-glucopyranuronosyl-(1?4)-O-2-deoxy-3,6-di-O-sulfo-2-(sulfoamino)-?-D-glucopyranosyl-(1?4)-O-2-Osulfo-?-L-idopyranuronosyl-(1?4)-2-deoxy-6-O-sulfo-2-(sulfoamino)-?-D-glucopyranoside, decasodium salt.

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

ARIXTRA (fondaparinux sodium)  Structural Formula Illustration

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

Each single-dose, prefilled syringe of ARIXTRA (fondaparinux sodium) , 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.

Call your doctor at once if you have a serious side effect such as:

  • pale skin, easy bruising, nosebleeds, bleeding gums, or any bleeding that will not stop;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite;
  • swelling, weight gain, feeling short of breath;
  • urinating less than usual or not at all;
  • ...

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.

This medication should not be used if you have certain medical conditions. Before using fondaparinux, tell your doctor or pharmacist if you have: infection in the heart (bacterial endocarditis), severe kidney disease, current serious bleeding (e.g., bleeding ulcer), low platelet count because of antiplatelet antibody.

Before using fondaparinux, tell your doctor or pharmacist your medical history,...

Read All Potential Precautions of Arixtra


Arixtra Consumer (continued)

SIDE EFFECTS: Pain, bruising, redness, and swelling at the injection site may occur. Headache, nausea, vomiting, swelling of the hands/feet, or fever may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: easy bleeding/bruising.

This medication may rarely cause serious bleeding. (See also Warning section.) Tell your doctor immediately if any signs of serious bleeding occur, including: shortness of breath, coughing up blood, chest pain, cold/blue fingers or toes, unusual dizziness, fainting, fast/irregular heartbeat, joint/muscle pain, mental/mood changes (e.g., confusion), numbness/tingling, severe stomach/abdominal pain, bloody/black/tarry stool, red/pinkish urine, vomit that looks like coffee grounds.

Tell your doctor immediately if any of these rare but very serious side effects occur: dark urine, yellow eyes/skin.

Seek immediate medical attention if any of these rare but very serious side effects occur: vision problems, weakness on one side of the body, slurred speech, seizures, difficulty moving, severe/persistent headache.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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.

This medication should not be used if you have certain medical conditions. Before using fondaparinux, tell your doctor or pharmacist if you have: infection in the heart (bacterial endocarditis), severe kidney disease, current serious bleeding (e.g., bleeding ulcer), low platelet count because of antiplatelet antibody.

Before using fondaparinux, tell your doctor or pharmacist your medical history, especially of: bleeding/blood problems (e.g., low blood count/platelets), a past blood-clotting problem because of heparin (heparin-induced thrombocytopenia), certain eye problem (diabetic retinopathy), high blood pressure, kidney disease, seizures, stomach/intestinal problems (e.g., recent ulcers, colitis), stroke, recent spinal procedures or puncture, spine problems (such as spinal deformity), recent surgery (especially on the eye, brain, or spine), low body weight (less than 50 kilograms/110 pounds).

Before having surgery, tell your doctor or dentist that you are using this medication.

This medicine may cause stomach bleeding. Daily use of alcohol while using this medicine may increase your risk for stomach bleeding.

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like safety razors and nail cutters, and avoid activities such as contact sports.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for bleeding while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Arixtra Patient Information Including Side Effects

Brand Names: Arixtra

Generic Name: fondaparinux (Pronunciation: fon DAP a rin ux)

  • What is fondaparinux (Arixtra)?
  • What are the possible side effects of fondaparinux (Arixtra)?
  • What is the most important information I should know about fondaparinux (Arixtra)?
  • What should I discuss with my healthcare provider before using fondaparinux (Arixtra)?
  • How should I use fondaparinux (Arixtra)?
  • What happens if I miss a dose (Arixtra)?
  • What happens if I overdose (Arixtra)?
  • What should I avoid while using fondaparinux (Arixtra)?
  • What other drugs will affect fondaparinux (Arixtra)?
  • Where can I get more information?

What is fondaparinux (Arixtra)?

Fondaparinux prevents the formation of blood clots.

Fondaparinux is used to prevent blood clots. It is often used in people who have undergone certain types of surgery.

Fondaparinux may also be used for other purposes not listed in this medication guide.

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.

Call your doctor at once if you have a serious side effect such as:

  • pale skin, easy bruising, nosebleeds, bleeding gums, or any bleeding that will not stop;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite;
  • swelling, weight gain, feeling short of breath;
  • urinating less than usual or not at all;
  • weakness or fainting;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • sudden numbness, weakness, headache, confusion, or problems with speech, vision, or balance; or
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).

Less serious side effects may include:

  • nausea, vomiting, constipation;
  • sleep problems (insomnia);
  • mild skin rash;
  • dizziness; or
  • minor bleeding, rash, or itching where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about fondaparinux (Arixtra)?

You should not use fondaparinux if you weigh less than 110 pounds (50 kilograms), or if you have severe kidney disease, active bleeding, a low level of platelets in your blood, or an infection of the lining of your heart (also called bacterial endocarditis).

Before using fondaparinux, tell your doctor about all your medical conditions, especially kidney disease, hemophilia, a bleeding stomach ulcer, eye problems caused by diabetes, high blood pressure, a history of stroke, and any recent surgeries.

This medication comes with patient instructions for safe and effective use. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes. Ask your doctor or pharmacist if you have any questions.

Fondaparinux should not be injected into a muscle or a vein.

If you undergo a spinal tap or any type of spinal anesthesia (such as an epidural), tell the doctor ahead of time that you are using fondaparinux. You may need to stop using the medicine for a short time before having such procedures.

Call your doctor at once if you have a serious side effect such as easy bruising, bleeding that will not stop, urinating less than usual or not at all, black or bloody stools, coughing up blood, sudden numbness or weakness, confusion, or problems with speech, vision, or balance.

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