Description
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.
This product is available in the following dosage forms:
- Solution
Before Using
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.
Pediatric
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.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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
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
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.
- 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:
- For prevention of deep vein thrombosis following hip fracture surgery, or hip or knee replacement surgery:
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
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
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.
CON-XXXXXXXX
