Description
Rivaroxaban is used to treat and prevent deep venous thrombosis (DVT), 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 (PE). This medicine is used for several days after hip or knee replacement surgery while you are unable to walk. It is during this time that blood clots are most likely to form. It also reduces the risk of blood clots occurring again in patients who are still at risk for DVT or PE after receiving treatment for at least 6 months.
Rivaroxaban is also used to prevent stroke and blood clots in patients with certain heart rhythm problems (eg, nonvalvular atrial fibrillation). It is also used together with aspirin to decrease the risk of serious heart problems, heart attack, and stroke in patients with coronary artery disease (a condition where the blood supply to the heart is reduced or blocked). This medicine is also used together with aspirin to lower the risk of sudden decrease in blood flow to the legs, major amputation, heart attack, or stroke in patients with peripheral artery disease (a condition where the blood flow to the legs is reduced), including patients who have had a recent surgery to improve blood flow to the legs. This medicine is also used to prevent venous thromboembolism (VTE) in certain patients that are hospitalized for an acute illness and after discharge who are at risk of getting blood clots because of decreased ability to move around (mobility) and who do not have a high risk of bleeding. It is also used to treat or reduce the risk of venous thromboembolism (VTE) after receiving at least 5 days of medicine to treat blood clots and helps prevent blood clots in patients with congenital heart disease after undergoing the Fontan procedure.
Rivaroxaban is a factor Xa inhibitor, an anticoagulant. It works by decreasing the clotting ability of the blood and helps prevent harmful clots from forming in the blood vessels.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
- Powder for Suspension
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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of rivaroxaban to treat and prevent venous thromboembolism in children and to prevent blood clots in children 2 years of age with congenital heart disease. Safety and efficacy have been established. Use is not recommended in children younger than 6 months of age who were less than 37 weeks of growth at birth, had less than 10 days of oral feeding, or weighing less than 2.6 kilograms (kg).
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rivaroxaban in the elderly. However, elderly patients are more likely to have bleeding and blood clotting problems, which may require caution and an adjustment in the dose for patients receiving rivaroxaban.
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
- Levoketoconazole
- Phenobarbital
- Primidone
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.
- Abametapir
- Abciximab
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Aceclofenac
- Acemetacin
- Acenocoumarol
- Alipogene Tiparvovec
- Alteplase, Recombinant
- Amoxicillin
- Amtolmetin Guacil
- Anagrelide
- Anistreplase
- Apalutamide
- Apixaban
- Ardeparin
- Argatroban
- Aspirin
- Atazanavir
- Avacopan
- Bemiparin
- Berotralstat
- Betrixaban
- Bivalirudin
- Boceprevir
- Bromfenac
- Bufexamac
- Cangrelor
- Caplacizumab-yhdp
- Capmatinib
- Carbamazepine
- Celecoxib
- Certoparin
- Choline Salicylate
- Cilostazol
- Citalopram
- Clonixin
- Clopidogrel
- Cobicistat
- Collagenase, Clostridium histolyticum
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.
- Amiodarone
- Betamethasone
- Clarithromycin
- Dexamethasone
- Fluconazole
- Hydrocortisone
- Methylprednisolone
- Prednisolone
- Prednisone
- Triamcinolone
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.
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:
- Antiphospholipid syndrome—Use is not recommended in patients with this condition.
- Bleeding problems, or history of or
- Blood vessel problems or
- Cancer or
- Catheter insertion in the spine or
- Liver disease, moderate or severe or
- Lung problems (eg, bleeding, bronchiectasis, pulmonary cavitation), or history of or
- Stomach or bowel ulcer or bleeding or
- Stroke, recent or history of or
- Surgery (eg, eye, brain, spine), recent or history of—Use with caution. The risk of bleeding may be increased.
- Kidney disease or
- Liver disease, moderate or severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Major bleeding, active or
- Prosthetic heart valve—Should not be used in patients with these conditions.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine should come with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
The 2.5 and 10 mg tablets can be taken with or without food. The 15 and 20 mg tablets should be taken with food. Also, take this medicine at the same time each day.
If you are unable to swallow the tablets whole:
- The 10 mg, 15 mg, or 20 mg tablets may be crushed and mixed with a small amount of applesauce. This must be taken right away followed by food.
- If you are using a nasogastric tube or gastric feeding tube: The 10 mg, 15 mg, or 20 mg tablets may be crushed and mixed in 50 milliliters (mL) of water before giving it via the tube. This must be followed by enteral feeding.
If your child is unable to swallow the tablets whole, you may use the oral liquid.
To use the oral liquid:
- Shake the bottle slowly for 10 seconds before each use.
- Measure the medicine with the provided oral dosing syringe.
- Ask your doctor if you should take it with or without food.
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 oral dosage form (tablets):
- For prevention of deep venous thrombosis (hip replacement surgery):
- Adults—10 milligrams (mg) once a day for 35 days. The starting dose should be taken at least 6 to 10 hours after surgery.
- Children—Use and dose must be determined by your doctor.
- For prevention of deep venous thrombosis (knee replacement surgery):
- Adults—10 milligrams (mg) once a day for 12 days. The starting dose should be taken at least 6 to 10 hours after surgery.
- Children—Use and dose must be determined by your doctor.
- For prevention of reoccurring deep venous thrombosis and pulmonary embolism:
- Adults—10 milligrams (mg) once a day with or without food after at least 6 months of treatment with a blood thinner medicine.
- Children—Use and dose must be determined by your doctor.
- For prevention of heart attack, stroke, and serious heart problems in patients with coronary artery disease:
- Adults—2.5 milligrams (mg) 2 times a day together with aspirin (75 to 100 mg once a day), taken with or without food.
- Children—Use and dose must be determined by your doctor.
- For prevention of sudden decrease in blood flow to the legs, major amputation, heart attack, and stroke in patients with peripheral artery disease:
- Adults—2.5 milligrams (mg) 2 times a day together with aspirin (75 to 100 mg once a day), taken with or without food.
- Children—Use and dose must be determined by your doctor.
- For prevention of stroke and blood clots in patients with nonvalvular atrial fibrillation:
- Adults—15 or 20 milligrams (mg) once a day, taken with the evening meal.
- Children—Use and dose must be determined by your doctor.
- For prevention of blood clots in people who are hospitalized for an acute illness:
- Adults—10 milligrams (mg) once a day in hospital and after hospital discharge for a total recommended duration of 31 to 39 days, taken with or without food.
- Children—Use and dose must be determined by your doctor.
- For treatment of deep venous thrombosis and pulmonary embolism:
- Adults—At first, 15 milligrams (mg) 2 times a day, taken with food for the first 21 days. Then, your doctor may give you 20 mg once a day, taken at the same time each day with food.
- Children—Use and dose must be determined by your doctor.
- For treatment and prevention of venous thromboembolism:
- Children 6 months of age and older weighing 30 kilograms (kg) or more—Dose is base on weight and must be determined by your doctor.
- Weighing 50 kilograms (kg) or more—20 milligrams (mg) once a day, taken with food.
- Weighing 30 kg to 49.9 kg—15 mg once a day, taken with food.
- Children 6 months of age and older weighing less than 30 kg—Use the oral suspension.
- Children younger than 6 months of age—Use and dose must be determined by your doctor.
- Children 6 months of age and older weighing 30 kilograms (kg) or more—Dose is base on weight and must be determined by your doctor.
- For prevention of blood clots in patients with congenital heart disease after Fontan procedure:
- Children 2 years of age and older weighing 50 kilograms (kg) or more—Dose is base on weight and must be determined by your doctor. The dose usually 10 milligrams (mg) once a day, taken with or without food.
- Children 2 years of age and older weighing less than 50 kg—Use the oral suspension.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For prevention of deep venous thrombosis (hip replacement surgery):
- For oral dosage form (suspension):
- For treatment and prevention of venous thromboembolism:
- Children 6 months of age and older—Dose is base on weight and must be determined by your doctor.
- Weighing 50 kilograms (kg) or more—20 milligrams (mg) once a day, taken with food.
- Weighing 30 kg to 49.9 kg—15 mg once a day, taken with food.
- Weighing 12 kg to 29.9 kg—5 mg 2 times a day, taken with food.
- Weighing 10 kg to 11.9 kg—3 mg 3 times a day, taken with food.
- Weighing 9 kg to 9.9 kg—2.8 mg 3 times a day, taken with food.
- Weighing 8 kg to 8.9 kg—2.4 mg 3 times a day, taken with food.
- Weighing 7 kg to 7.9 kg—1.8 mg 3 times a day, taken with food.
- Weighing 5 kg to 6.9 kg—1.6 mg 3 times a day, taken with food.
- Weighing 4 kg to 4.9 kg—1.4 mg 3 times a day, taken with food.
- Weighing 3 kg to 3.9 kg—0.9 mg 3 times a day, taken with food.
- Weighing 2.6 kg to 2.9 kg—0.8 mg 3 times a day, taken with food.
- Children younger than 6 months of age and weighing less than 2.6 kg—Use and dose must be determined by your doctor.
- Children 6 months of age and older—Dose is base on weight and must be determined by your doctor.
- For prevention of blood clots in patients with congenital heart disease after Fontan procedure:
- Children 2 years of age and older—Dose is base on weight and must be determined by your doctor.
- Weighing 50 kilograms (kg) or more—10 milligrams (mg) once a day, taken with or without food.
- Weighing 30 kg to 49.9 kg—7.5 mg once a day, taken with or without food.
- Weighing 20 kg to 29.9 kg—2.5 mg 2 times a day, taken with or without food.
- Weighing 12 kg to 19.9 kg—2 mg 2 times a day, taken with or without food.
- Weighing 10 kg to 11.9 kg—1.7 mg 2 times a day, taken with or without food.
- Weighing 8 kg to 9.9 kg—1.6 mg 2 times a day, taken with or without food.
- Weighing 7 kg to 7.9 kg—1.1 mg 2 times a day, taken with or without food.
- Children younger than 2 years of age of age and weighing less than 7 kg—Use and dose must be determined by your doctor.
- Children 2 years of age and older—Dose is base on weight and must be determined by your doctor.
- For treatment and prevention of venous thromboembolism:
Missed Dose
This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.
Once-daily dosing: If you miss a dose, take it as soon as you can on the same day. Then take your regularly scheduled dose the next day.
Twice-daily dosing to prevent serious heart or blood vessel problems (2.5 mg tablet): If you miss a dose, skip the missed dose and take your next dose at your usual time.
Twice-daily dosing to treat a blood clot (oral liquid or 15 mg tablet): If you miss a dose, take it as soon as you can on the same day. You may take 2 doses at the same time to make up for the missed dose. Then take your regularly scheduled doses the next day.
Thrice-daily dosing: If you miss a dose, skip the missed dose, then take your regularly scheduled doses the next day.
Oral liquid: If your child vomits or spits up right after or within 30 minutes after taking the medicine, give another dose. If it is more than 30 minutes, give the next dose at the regular time. Call your doctor right away if your child vomits or spits out the medicine repeatedly.
Storage
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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
You may store the crushed tablet with applesauce or water mixture for up to 4 hours.
Throw away the oral liquid 60 days after opening.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests will be needed to check for unwanted effects. Be sure to keep all appointments.
You may bleed or bruise more easily while you are using this medicine. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Be careful when using sharp objects, including razors and fingernail clippers. Avoid nose picking and forceful nose blowing.
Make sure any doctor or dentist who treats you knows that you are using this medicine.
This medicine 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.
Check with your doctor right away if you have a decreased urine output, confusion, dizziness, nausea, rapid weight gain, swelling of the face, ankles, or hands, or unusual tiredness or weakness after receiving the medicine. These may be symptoms of a serious kidney problem.
Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
Do not suddenly stop taking this medicine without first checking with your doctor. Doing so, may increase your risk of having a stroke.
Make sure your doctor knows if you are pregnant or planning to become pregnant during treatment with 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 (eg, St. John's wort) 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
- Back pain
- bleeding gums
- bloody stools
- bowel or bladder dysfunction
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- coughing up blood
- difficulty with breathing or swallowing
- dizziness
- headache
- increased menstrual flow or vaginal bleeding
- leg weakness
- nosebleeds
- numbness
- paralysis
- prolonged bleeding from cuts
- red or black, tarry stools
- red or dark brown urine
- vomiting of blood or material that looks like coffee grounds
Less common
- Fainting
- pain in the arms or legs
- wound secretion
Rare
- Burning feeling while urinating
- difficult or painful urination
Incidence not known
- Blistering, peeling, or loosening of the skin
- blurred vision
- chest tightness
- chills
- clay-colored stools
- cough
- dark urine
- diarrhea
- fast or irregular heartbeat
- fever with or without chills
- general feeling of tiredness or weakness
- hives, itching, skin rash
- hoarseness
- joint or muscle pain
- loss of appetite
- lower back or side pain
- nausea
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red skin lesions, often with a purple center
- red, irritated eyes
- severe headache
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- stomach pain or swelling
- unpleasant breath odor
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
- yellow eyes or skin
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:
Less common
- Blisters
- muscle spasm
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
