What is this medication?

RIVAROXABAN (ri va ROX a ban) prevents or treats blood clots. It belongs to a group of medications called blood thinners.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Xarelto Granules

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Antiphospholipid antibody syndrome
• Bleeding disorders
• Bleeding in the brain
• Blood clots
• Kidney disease
• Liver disease
• Prosthetic heart valve
• Recent or planned spinal or epidural procedure
• Stomach bleeding
• Take medications that treat or prevent blood clots
• An unusual or allergic reaction to rivaroxaban, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. For your therapy to work as well as possible, take each dose exactly as prescribed on the prescription label. Do not skip doses. Skipping doses or stopping this medicine can increase your risk of a blood clot. Keep taking this medication unless your care team tells you to stop. Shake well before using. Use a specially marked oral syringe, spoon, or dropper to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Take this medication with food.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as newborns for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you take your medication once a day and miss a dose, take it as soon as you can on the same day. If it is not the same day, skip that dose and take your next dose at the normal time. Do not take double or extra doses.

If you take your medication twice a day and miss a dose, take it as soon as you can on the same day. A missed morning dose can be taken together with the evening dose. A missed evening dose can only be taken later that same evening.

If you take your medication 3 times a day and miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

Do not take this medication with any of the following:

• Defibrotide

This medication may also interact with the following:

• Aspirin and aspirin-like medications
• Certain antibiotics like erythromycin and clarithromycin
• Certain medications for fungal infections like ketoconazole and itraconazole
• Certain medications for seizures like carbamazepine, phenytoin
• Certain medications that treat or prevent blood clots like warfarin, enoxaparin, dalteparin, apixaban, dabigatran, and edoxaban
• NSAIDS, medications for pain and inflammation, like ibuprofen or naproxen
• Rifampin
• Ritonavir
• SNRIs, medications for depression, like desvenlafaxine, duloxetine, levomilnacipran, venlafaxine
• SSRIs, medications for depression, like citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline
• St. John's wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. You may need blood work done while you are taking this medication. Your condition will be monitored carefully while you are receiving this medication. It is important not to miss any appointments.

Avoid sports and activities that might cause injury while you are using this medication. Severe falls or injuries can cause unseen bleeding. Be careful when using sharp tools or knives. Consider using an electric razor. Take special care brushing or flossing your teeth. Report any injuries, bruising, or red spots on the skin to your care team.

Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the medications and doses you take on the card.

Tell your dentist and dental surgeon that you are taking this medication. You should not have major dental surgery while on this medication. See your dentist to have a dental exam and fix any dental problems before starting this medication. Take good care of your teeth while on this medication. Make sure you see your dentist for regular follow-up appointments.

If you are going to need surgery or other procedure, tell your care team that you are using this medication.

Do not become pregnant while taking this medication. Women should inform their care team if they wish to become pregnant or think they might be pregnant. There is potential for serious harm to an unborn child. Talk to your care team for more information.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Bleeding in the brain—severe headache, stiff neck, confusion, dizziness, change in vision, numbness or weakness of the face, arm, or leg, trouble speaking, trouble walking, vomiting
• Heavy periods

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Do not freeze. Keep this medication in the original container. Get rid of any unused medication after it expires or 60 days after mixing, whichever is first.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, pour the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.