FONDAPARINUX SODIUM

COMMON BRAND NAME(S): Arixtra

GENERIC NAME(S): FONDAPARINUX SODIUM

Description: Fondaparinux is an anticoagulant that works by inhibiting one of the steps necessary for the formation of blood clots, which helps prevent clots from developing or worsening.

Pharmacokinetics:

Absorption: Rapidly and completely absorbed. Bioavailability: 100%. Time to peak plasma concentration: 2-3 hr.

Distribution: Volume of distribution: 7-11 L. Plasma protein binding: ≥94% (mainly to antithrombin III).

Excretion: Via urine (64-77% as unchanged drug). Elimination half-life: 17-21 hr.

Uses

Fondaparinux is used to treat serious blood clots in the legs and/or lungs. It is usually used with another “blood thinner” medication (warfarin). If untreated, blood clots can travel to the lungs, heart, or brain, causing serious (possibly fatal) breathing problems, heart attack, or stroke. This drug may also be used to prevent blood clots after certain surgeries with an increased risk of blood clots (such as hip fracture, abdominal, knee/hip replacement).

Fondaparinux is known as a “blood thinner” (anticoagulant). It is a drug similar to heparin that works by blocking certain natural substances in the blood that cause clotting.

OTHER USES:

This medication may also be used to treat certain types of heart attack and a specific type of chest pain called unstable angina.

How to use fondaparinux subcutaneous:

Read the Patient Information Leaflet if available from your pharmacist before you start using fondaparinux and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection under the skin of the stomach/abdomen as directed by your doctor, usually once daily. Do not inject into a muscle. The dosage and length of treatment are based on your medical condition and response to treatment. The dosage may also be based on your weight. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Do not mix any other medication in the same injection. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. To minimize bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

When treating a blood clot, another “blood thinner” (warfarin) is usually started within 3 days after you start using fondaparinux. Your doctor will direct you to use both of these medications until the warfarin is working well. Do not stop either of these medications until your doctor directs you to stop.

To prevent blood clots due to surgery, your doctor may direct you to start using this medication after surgery (such as 6 to 8 hours after knee/hip replacement surgery) and continue for several days. Follow your doctor’s directions closely. Starting this medication too soon after surgery may increase the risk of serious bleeding.

This medication may also be given by injection into a vein by a health care professional, as directed by your doctor.

Warnings

People using this medication may bleed near the spinal cord after certain spinal procedures. Bleeding in this area can cause paralysis that lasts a long time or could become permanent. Talk with your doctor about the benefits and risks before any spinal procedure. Your doctor may direct you to stop this medication for a certain amount of time before and after the procedure. Carefully follow your doctor’s directions.

The risk of bleeding may be higher if you have a deformed spine, or have had spinal procedures/surgery before (such as epidural catheter placement, difficult epidural/spinal puncture), or are taking other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, “blood thinners” such as warfarin/rivaroxaban, nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen). Tell your doctor right away if you notice symptoms such as back pain, leg numbness/tingling/weakness, loss of control of the bowels or bladder (incontinence).

Pregnancy Risk: Category B (No proven risk for pregnancy)

Side Effects

You should check with your doctor immediately if any of these side effects occur when taking fondaparinux:

More common

Pale skin
troubled breathing with exertion
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
convulsions
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
shortness of breath
sore throat
sores, ulcers, or white spots on the lips or in the mouth
sudden sweating

If any of the following symptoms of overdose occur while taking fondaparinux, get emergency help immediately:

Symptoms of overdose

Abdominal or stomach pain or swelling
bruising or purple areas on the skin
coughing up blood
decreased alertness
headache
joint pain or swelling
nosebleeds

Some of the side effects that can occur with fondaparinux may not need medical attention:

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
tightness in the chest
unusual changes to site of surgery

wound drainage, increased

Precautions

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 problem (diabetic retinopathy), high blood pressure, kidney disease, seizures, stomach/intestinal problems (such as 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 about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Limit alcohol while taking this drug because it may increase the risk of stomach bleeding.

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

Older adults may be more sensitive to the side effects of this drug, especially bleeding.

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 unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Some products that may interact with this drug include: mifepristone, other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ketorolac, “blood thinners” such as rivaroxaban).

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (NSAIDs such as ibuprofen, naproxen, aspirin) which can increase the risk of bleeding when used with fondaparinux. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

Overdose & Brands

If overdose is suspected, contact a poison control center or emergency room immediately.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as complete blood count, kidney function tests, tests to check for blood in the stool) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Each prefilled syringe can be used only once; discard any unused portion.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Brands

Available Brands

Arixtra [ Aspen ]