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Overview: Yulzety is an anticoagulant (blood thinner) used to treat or prevent blood clots. It is also used to reduce the risk of stroke in people with a type of irregular heartbeat known as atrial fibrillation. Yulzety works by blocking a protein that helps your blood clot. The most common side effect is bleeding, which can range from mild to severe. Contact your health care provider or get help right away if you have bleeding that does not stop, vomit or cough up blood, or pass bloody or black stool. Yulzety is a liquid that you swallow.

Uses

What is Yulzety used for?

Yulzety (rivaroxaban) is commonly used for the following conditions.

  • Prevention of stroke and blood clots in people with a certain type of irregular heartbeat, called atrial fibrillation (AFib), that is not caused by a heart valve problem
  • Prevention of blood clots in people after knee or hip replacement surgery, or in certain people who are staying in the hospital or recently discharged from the hospital and are at risk of a blood clot
  • Treatment of blood clots in your legs (deep vein thrombosis or DVT) or lungs (pulmonary embolism or PE)
  • Reducing the risk of another blood clot after treating a previous blood clot
  • Treatment and prevention of blood clots in certain children
  • Prevention of blood clots in children with congenital heart disease after a certain heart surgery (Fontan procedure)

Yulzety may also be used for other conditions as determined by your health care provider.

How does Yulzety work (mechanism of action)?

Yulzety is a blood thinner (anticoagulant) that works by blocking a protein in your body called factor Xa to help keep your blood from clotting.

How is Yulzety supplied (dosage forms)?

Brands and other names

  • Yulzety

Dosage forms and strengths

  • 2 mg/mL, 4 mg/mL oral suspension

How should I store Yulzety?

Yulzety should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Store the bottle with the oral dosing syringe that comes with it. Throw away any liquid left in the bottle 60 days after opening it. Use the new syringe supplied with each new bottle.

Side Effects

What are the most common side effects of Yulzety?

The most common side effects of Yulzety are listed below. Tell your health care provider if you have any of these side effects that bother you.

There may be other side effects of Yulzety that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Yulzety?

While less common, the most serious side effects of Yulzety are described below, along with what to do if they happen.

Bleeding. Yulzety can increase your risk of severe bleeding that can lead to death. You may bruise more easily, and bleeding may take longer to stop. Some people with serious bleeding may need a blood transfusion or surgery. Contact your health care provider or get medical help right away if you or your child have any of the following signs of bleeding while taking Yulzety.

  • Unexpected bleeding or bleeding that lasts a long time, including frequent nosebleeds or unusual gum bleeding
  • Menstrual bleeding that is heavier than normal or other unusual vaginal bleeding
  • Severe bleeding or bleeding you cannot control
  • Red, pink, or brown urine (pee)
  • Bright red or black stools (looks like tar)
  • Coughing up blood or blood clots
  • Vomiting blood or vomit that looks like coffee grounds
  • Headaches or feeling dizzy or weak
  • Pain, swelling, or new drainage around wounds
  • Pain in your upper left belly, below your left ribs, or at the tip of your left shoulder, or discomfort throughout your belly

Severe Allergic Reactions. Yulzety may cause allergic reactions, which can be serious. Stop taking Yulzety and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Warnings & Precautions

Who should not use Yulzety?

Allergies to Ingredients. People who are allergic to any of the following should not take Yulzety.

  • Rivaroxaban
  • Yulzety
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Yulzety.

Active Bleeding. Do not take Yulzety without talking to your health care provider if you have any abnormal or unusual bleeding.

What should I know about Yulzety before using it?

Do not take Yulzety unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Yulzety with other people, even if they have the same condition as you. It may harm them.

Keep Yulzety out of the reach of children.

Do not stop taking or change your dose of Yulzety unless your health care provider tells you to do so. Stopping Yulzety too early can result in blood clots or a stroke. Refill your prescription before you run out.

Yulzety is not the same as other rivaroxaban products. Using the wrong product or dose could increase the risk of side effects. Always double check the label to make sure you have the correct product and dose. Contact your pharmacy or health care provider if you have questions about your medicine.

Gently shake the bottle for 30 seconds before each dose. Do not shake it too fast, which can cause foam. Use only the oral syringe supplied with your bottle to measure and give each dose. Do not use a household spoon or a different oral syringe. Contact your pharmacist or other health care provider if the syringe is missing, lost, or damaged. After each dose, rinse the syringe with tap water after each use and let it air dry. Do not put it in the dishwasher.

An adult caregiver should give Yulzety to a child. Your child's dose depends on their weight, so their health care provider will check their weight and dose regularly.

If your child vomits or spits up within 30 minutes after taking Yulzety, give a new full dose. If this happens more than 30 minutes after the dose, do not give it again. Give the next dose at the usual time. Contact your child's health care provider right away if vomiting or spitting up keeps happening.

If you or your child have trouble swallowing or receive medicines through a feeding tube, ask your health care provider for instructions. Yulzety can be given through certain feeding tubes that lead into the stomach. It should not be given through a tube that releases medicine farther down the digestive tract.

People who are 65 or older can be at greater risk for some side effects from Yulzety, including bleeding. Contact your health care provider about your risks if you are in this age group.

What should I tell my health care provider before using Yulzety?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Yulzety is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have or have had any of the following.

  • Bleeding problems
  • Kidney or liver problems
  • An artificial heart valve
  • A clotting problem called antiphospholipid syndrome
  • Problems with your spine or planned surgery on your spine

Planned Procedures. Tell all of your health care providers that you or your child are taking Yulzety. Contact the health care provider who prescribed Yulzety to find out whether you should stop taking it before any surgery, medical, or dental procedure. Your health care provider will tell you when to stop and restart it. 

Other Medicines and Supplements. Yulzety may interact with other medicines and supplements. Before taking Yulzety, tell your health care provider about any prescription or over-the-counter medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how Yulzety could affect pregnancy or harm a fetus. Yulzety may increase the risk of bleeding in you or the fetus, including during labor or delivery. Tell your health care provider right away if you are pregnant or plan to become pregnant. Your health care provider will let you know if you should take Yulzety while you are pregnant or trying to get pregnant. If you have any signs of bleeding or blood loss during pregnancy, tell your health care provider right away.

Breastfeeding. Yulzety passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should take Yulzety while breastfeeding.

How can I get more information about Yulzety?

For more information about Yulzety, you can visit the drugmaker’s website at www.rosemontpharmaceuticals.com or call them at 844-638-2235.

Interactions

Does Yulzety interact with foods or drinks?

If you take Yulzety for atrial fibrillation, take it with your evening meal. If you take a 15 milligram (mg) or 20 mg dose to treat blood clots in your legs or lungs, take it with food at the same time each day. You can take a 10 mg dose to prevent blood clots with or without food. Ask your pharmacist or other health care provider if you are unsure how to take your dose.

For children, give Yulzety with food when it is used to treat blood clots or keep them from happening again. When it is used to prevent blood clots after the Fontan procedure, it can be given with or without food. Follow your child's health care provider's instructions.

It is not known if drinking alcohol will affect Yulzety. Ask your health care provider about alcohol use during treatment.

Does Yulzety interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Yulzety.

  • Aspirin, which is in many prescription and OTC products, including those for pain, swelling, and fever
  • A blood thinner, such as enoxaparin, heparin, or warfarin, which is a medicine used to treat or prevent blood clots
  • An antiplatelet medicine, such as clopidogrel (Plavix), ticagrelor (Brilinta), aspirin/dipyridamole, or cilostazol, which is a medicine used to prevent blood clots
  • A medicine used to control your heart rate or rhythm (antiarrhythmic)
  • A nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen, naproxen, and others, which is in many prescription and OTC products for pain, swelling, and fever
  • A selective serotonin reuptake inhibitor (SSRI), such as fluoxetine, paroxetine, or sertraline, which is a medicine commonly used for anxiety and depression
  • A serotonin and norepinephrine reuptake inhibitor (SNRI), such as duloxetine or venlafaxine, which is a medicine commonly used for anxiety and depression
  • Ketoconazole, a medicine used for fungal infections
  • A medicine for HIV, AIDS, or hepatitis C
  • A macrolide antibiotic, such as clarithromycin or erythromycin (Ery-Tab and others), which is a medicine used for bacterial infections
  • A medicine for seizures, such as carbamazepine, phenytoin, or phenobarbital
  • St. John’s wort, which is a supplement that may be used for depression
  • Rifampin, which is a medicine commonly used to treat an infection called tuberculosis

Many other medicines may alter the blood levels of Yulzety. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Yulzety. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Yulzety?

If you or someone else has used too much Yulzety, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Yulzety?

Missing doses of Yulzety can put you at risk for blood clots. It is important not to miss or skip doses.

If you miss a dose, contact your prescriber or pharmacist for next steps. Your instructions for what to do vary depending on your dosing schedule and whether the dose is for an adult or child.