Pronunciation:

fon-da-PAR-in-ux

Brand Names:

• Arixtra

Dosage Forms:

• Solution

Warnings:

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 NSAIDs, platelet inhibitors, or other anticoagulants, a history of traumatic or repeated epidural or spinal puncture, and a history of spinal deformity or spinal surgery. Optimal timing between the administration of fondaparinux and neuraxial procedures is not known. Monitor patients frequently for signs and symptoms of neurologic impairment. If neurologic compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis .

Classifications:

Therapeutic—

Anticoagulant

Pharmacologic—

Factor Xa Inhibitor

Uses of This Medicine:

Fondaparinux injection is used to prevent deep vein thrombosis, a condition in which harmful blood clots form in the blood vessels of the legs. These blood clots can travel to the lungs and can become lodged in the blood vessels of the lungs, causing a condition called pulmonary embolism. This medicine is used for several days after hip fracture surgery, hip or knee replacement surgery, and in some cases following abdominal or stomach surgery, while you are unable to walk. It is during this time that blood clots are most likely to form.

Fondaparinux injection is also used together with warfarin to treat acute deep vein thrombosis (blood clot in the leg) and pulmonary embolism (blood clot in the lung). It is also used to treat venous thromboembolism (blood clot in the vein).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of fondaparinux injection to treat blood clots in the vein in children younger than 1 year of age weighing less than 10 kilograms (kg) and to treat other conditions in children. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fondaparinux in the elderly. However, elderly patients are more likely to have bleeding problems and age-related kidney problems, which may require caution or an adjustment in the dose for patients receiving fondaparinux.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Defibrotide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab
• Aceclofenac
• Acemetacin
• Alipogene Tiparvovec
• Alteplase, Recombinant
• Amtolmetin Guacil
• Anagrelide
• Anistreplase
• Apixaban
• Argatroban
• Aspirin
• Bemiparin
• Betrixaban
• Bivalirudin
• Bromfenac
• Bufexamac
• Cangrelor
• Caplacizumab-yhdp
• Celecoxib
• Chamomile
• Choline Salicylate
• Cilostazol
• Citalopram
• Clonixin
• Clopidogrel
• Collagenase, Clostridium histolyticum
• Curcumin
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Desvenlafaxine
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyridamole
• Dipyrone
• Drotrecogin Alfa
• Droxicam
• Edoxaban
• Enoxaparin
• Epoprostenol
• Eptifibatide
• Escitalopram
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Garlic
• Ginkgo
• Heparin
• Ibrutinib
• Ibuprofen
• Iloprost
• Indomethacin
• Inotersen
• Ketoprofen
• Ketorolac
• Levomilnacipran
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Milnacipran
• Minocycline
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nintedanib
• Omadacycline
• Orlistat
• Oxaprozin
• Oxyphenbutazone
• Papaya
• Parecoxib
• Paroxetine
• Pentosan Polysulfate Sodium
• Phenylbutazone
• Piketoprofen
• Piracetam
• Piroxicam
• Pranoprofen
• Prasugrel
• Proglumetacin
• Propyphenazone
• Proquazone
• Reteplase, Recombinant
• Rivaroxaban
• Rofecoxib
• Sarecycline
• Selexipag
• Sertraline
• St John's Wort
• Streptokinase
• Sulfinpyrazone
• Sulindac
• Tan-Shen
• Tenecteplase
• Tenoxicam
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Trazodone
• Treprostinil
• Turmeric
• Urokinase
• Valdecoxib
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Chondroitin
• Coenzyme Q10
• Dong Quai
• Ginger
• Vitamin A

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Avocado

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems or
• Blood vessel problems or
• Catheter insertion in the spine or
• Diabetic retinopathy (eye problem) or
• Hypertension (high blood pressure), uncontrolled or
• Liver disease or
• Stomach or bowel problems (eg, ulcers), active or
• Stroke, recent or history of or
• Surgery (eg, eye, brain, or spine), recent or history of—Use with caution. The risk of bleeding may be increased.

• Heart infection or
• Kidney disease, severe or
• Major bleeding, active or
• Thrombocytopenia (low platelet count in the blood) or
• Weight of less than 50 kilograms (kg)—Should not be used in patients with these conditions.

• Kidney disease—Use with caution. The effects may be increased because of slower removal from the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot under your skin, usually in the stomach.

This medicine comes with a patient information leaflet and patient instructions. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

It may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand exactly how to use the medicine.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems.

Check the liquid in the prefilled syringe. It should be clear to colorless. Do not use it if it is discolored or if you see particles in it. Do not use it if it is cracked, broken, bent, or has a leak.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (prefilled syringe):
  • For prevention of deep vein thrombosis following hip fracture surgery, or hip or knee replacement surgery:
    • Adults—2.5 milligrams (mg) injected under the skin once a day for 5 to 9 days. The first dose is given 6 to 8 hours after surgery.
    • Children—Use and dose must be determined by your doctor.
  • For prevention of deep vein thrombosis following stomach surgery:
    • Adults—2.5 milligrams (mg) injected under the skin once a day for 5 to 9 days. The first dose is given 6 to 8 hours after surgery.
    • Children—Use and dose must be determined by your doctor.
  • For treatment of deep vein thrombosis and pulmonary embolism:
    • Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 5 to 10 milligrams (mg) injected under the skin once a day for at least 5 days.
    • Children—Use and dose must be determined by your doctor.
  • For treatment of venous thromboembolism:
    • Children 1 year of age and older—Dose is based on body weight and must be determined by your doctor. At first, 0.1 milligram (mg) per kilogram (kg) of body weight injected under the skin once a day. For patients weighing more than 20 kilograms (kg), doses should be rounded to the nearest prefilled syringe available. There is no available prefilled syringe for patients weighing 10 kg to 20 kg:
      • Weighing 60 kilograms (kg) or more—7.5 milligrams (mg) per 0.6 milliliters (mL) injected under the skin once a day.
      • Weighing 40 kg to 60 kg—5 mg per 0.4 mL injected under the skin once a day.
      • Weighing 20 kg to 40 kg—2.5 mg per 0.5 mL injected under the skin once a day.
      • Weighing 10 kg to 20 kg—Dose should be exact and rounded to the nearest 0.1 mg.
    • Children younger than 1 year of age weighing less than 10 kg—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away prefilled syringe that has been left at room temperature for more than 4 hours.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests will be needed to check for unwanted effects. Be sure to keep all appointments.

Fondaparinux may cause bleeding problems. This risk is higher if you have a catheter in your back for pain medicine or anesthesia (sometimes called an "epidural"), or if you have kidney problems. The risk of bleeding increases if your kidney problems get worse. Check with your doctor right away if you have any unusual bleeding or bruising, black, tarry stools, bleeding gums, blood in the urine or stools, tingling, numbness, or weakness of the lower legs, or pinpoint red spots on your skin.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed more easily. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using fondaparinux several days before having surgery or medical tests.

This medicine may increase your risk of having spinal or epidural blood clots when it is used together with certain other medicines or procedures. Check with your doctor right away if you have midline back pain, numbness, tingling, or weakness in the legs or feet, or loss of control of the bowel or bladder (incontinence).

The needle guard of the prefilled syringe of this medicine contains natural rubber (a derivative of latex). Tell your doctor if you have a latex allergy before using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Pale skin

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Black, tarry stools

bladder pain

bleeding gums

blood in the urine or stools

blurred vision

chest pain

chills

collection of blood under the skin

confusion

cough

decreased or cloudy urine

deep, dark purple bruise

difficult, burning, or painful urination

dizziness

dry mouth

fainting or lightheadedness when getting up from a lying or sitting position

fever

frequent urge to urinate

increased thirst

irregular heartbeat

itching, pain, redness, or swelling at the injection site

loss of appetite

lower back or side pain

muscle pain or cramps

nausea or vomiting

numbness or tingling in the hands, feet, or lips

pinpoint red spots on the skin

red, tender, or oozing skin at incision

seizures

sore throat

sores, ulcers, or white spots on the lips or in the mouth

sudden sweating

Incidence not known

Back pain

bowel or bladder dysfunction

chest tightness

difficulty with swallowing

fast heartbeat

hives, itching, or skin rash

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

leg weakness

numbness

paralysis

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Bruising or purple areas on the skin

coughing up blood

decreased alertness

headache

joint pain or swelling

nosebleeds

stomach pain or swelling

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Difficulty having a bowel movement

swelling

trouble sleeping

Less common

Acid or sour stomach

belching

diarrhea

heartburn

indigestion

pain

skin blisters

stomach discomfort, upset, or pain

unusual changes to site of surgery

wound drainage, increased

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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