Indications

Indications

This site is intended for U.S. residents 18 years of age or older.

ELIQUIS is FDA approved in children from birth and older to help treat blood clots in the veins of legs and lungs* and to reduce the risk of them happening again

*After at least 5 days of initial treatment with a blood thinner.

ELIQUIS was not studied and is not recommended in children who weigh less than 5.7 lbs (2.6 kg).

For children who weigh less than 77 lbs (35 kg), see the detailed Instructions for Use that comes with ELIQUIS SPRINKLE for oral suspension or ELIQUIS tablets for oral suspension on how to prepare and give a dose of ELIQUIS.

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Administer ELIQUIS exactly as prescribed

Always give ELIQUIS exactly as your child’s healthcare provider or pharmacist has told you. The dose of ELIQUIS is based on your child’s body weight.

Your child’s healthcare provider may need to change your child’s dose as their weight changes. Do not change your child’s dose without talking with the healthcare provider.

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If your child misses a dose

If your child misses a dose of ELIQUIS, administer it as soon as you remember on the same day. Do not administer 2 doses of ELIQUIS at the same time to make up for a missed dose. Return to the usual dosing schedule the next day.

If a child vomits or spits up within 30 minutes after taking ELIQUIS, repeat the dose. If a child vomits or spits up more than 30 minutes after taking ELIQUIS, do not repeat the dose. Continue to give the next ELIQUIS dose at the next scheduled time. Contact the healthcare provider if your child repeatedly vomits or spits up after taking ELIQUIS.

For children weighing at least 77 lbs (35 kg), if they have trouble swallowing the tablet whole, talk to your child’s healthcare provider about other ways to take ELIQUIS tablets.

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Keep the prescription filled

Do not run out of ELIQUIS. Refill your child’s prescription before you run out. Your child’s healthcare provider will decide how long your child should take ELIQUIS. Don’t change your child’s dose or stop administering ELIQUIS unless your child’s healthcare provider tells you to. Stopping ELIQUIS increases your child’s risk of having a stroke.

If your child takes too much ELIQUIS, call their healthcare provider or go to the nearest hospital emergency room right away.

Call your child’s healthcare provider right away if they fall or injure themselves, especially if they hit their head. A healthcare provider may need to check them.

To learn more, see What you should know before administering ELIQUIS to your child.

Symptoms of bleeding

ELIQUIS can cause bleeding, which can be serious, and may lead to death. This is because ELIQUIS is a blood thinner medicine
that reduces blood clotting.

CALL YOUR CHILD'S HEALTHCARE PROVIDER OR GET MEDICAL HELP RIGHT AWAY IF YOUR CHILD HAS ANY OF THESE SIGNS OR SYMPTOMS OF BLEEDING WHEN TAKING ELIQUIS:

  • Unexpected bleeding or bruising, or bleeding that lasts a long time, such as unusual bleeding from the gums, nose bleeds that happen often, or menstrual or vaginal bleeding that is heavier than normal
  • Bleeding that is severe or you cannot control
  • Red, pink, or brown urine; red or black stools (looks like tar)
  • Coughing up or vomiting blood or vomit that looks like “coffee grounds”
  • Unexpected pain, swelling, or joint pain
  • Headaches, or feeling dizzy or weak
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While taking ELIQUIS, your child may bruise more easily and it may take longer than usual for any bleeding to stop.

Tips to keep your child on schedule

To make sure ELIQUIS is administered on a regular schedule, here are some suggestions to help you keep on track:

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Set alarms or alerts

Use your watch or your smartphone.

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Create a reminder card

Post it on your fridge or somewhere you’ll see each day.

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Time around daily activity

Time your child’s medication to a daily activity, like brushing their teeth.

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Keep the medication in sight

Consider placing the medication in common areas that aren’t easily accessible to children but that you see every day, like an upper cabinet in the kitchen or medicine cabinet with a child lock.

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Make it a habit

Administer your child’s medication at the same time each morning and evening.

What you should know before administering ELIQUIS to your child

ELIQUIS is not for patients who:

  • have artificial heart valves
  • have antiphospholipid syndrome (APS), especially with positive triple antibody testing
  • currently have certain types of abnormal bleeding
  • have had a severe allergic reaction to ELIQUIS or any of the ingredients

See additional Important Safety Information below.

Talk to your healthcare team if you or your child:

  • have or ever had bleeding problems
  • have kidney or liver problems
  • have antiphospholipid syndrome (APS)
  • Are pregnant or plan to become pregnant. It is not known if ELIQUIS will harm your unborn baby

Tell your healthcare provider right away if you become pregnant during treatment with ELIQUIS. Taking ELIQUIS during pregnancy may increase the risk of bleeding in you or your unborn baby.

Females who are able to become pregnant: talk with your healthcare provider about pregnancy planning, and your risk of severe uterine bleeding if you are treated with ELIQUIS.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if ELIQUIS passes into your breast milk. Do not breastfeed during treatment with ELIQUIS. Talk to your healthcare provider about the best way to feed your baby during treatment with ELIQUIS.

Tell your healthcare team about all the medicines you or your child take, including any:

  • prescription medicines
  • over-the-counter medicines
  • vitamins
  • herbal supplements

During treatment, make sure you talk to your healthcare team before you begin to take any new medication.

See additional Important Safety Information below.

ELIQUIS may cause serious side effects, including:

Increased risk of blood clots if you stop taking ELIQUIS

ELIQUIS lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking ELIQUIS, you may have an increased risk of a clot forming in your blood.

Do not stop taking ELIQUIS without talking to the healthcare provider who prescribed it to you.

Stopping ELIQUIS increases your risk of having a stroke.

Talk to your healthcare team before any medical procedures. ELIQUIS may need to be stopped before surgery or a medical or dental procedure. Your healthcare provider will tell you when you should stop taking ELIQUIS and when you may start taking it again. If you have to stop taking ELIQUIS, your healthcare provider may prescribe another medicine to help prevent a blood clot from forming.

Bleeding

ELIQUIS can cause bleeding, which can be serious, and may lead to death. This is because ELIQUIS is a blood thinner medicine that reduces blood clotting. While taking ELIQUIS, you may bruise more easily and it may take longer than usual for any bleeding to stop.

You may have a higher risk of bleeding if you take ELIQUIS and take other medicines that increase your risk of bleeding, such as:

  • Aspirin or asprin-containing products

  • Long-term (chronic) nonsteroidal anti-inflammatory drugs (called NSAIDs)

  • Warfarin sodium

  • Any medicine that contains heparin

  • Clopidogrel

  • Selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)

  • Other medicines to help prevent or treat blood clots

Tell your healthcare provider if you take any of these medicines.

Call your healthcare provider or get medical help right away if you or your child have any of these signs or symptoms of bleeding when taking ELIQUIS:

  • Unexpected bleeding or bruising or bleeding that lasts a long time, such as:

    • Unusual bleeding from the gums

    • Nosebleeds that happen often

    • Menstrual or vaginal bleeding that is heavier than normal

  • Bleeding that is severe or you cannot control

  • Red, pink, or brown urine

  • Red or black stools (looks like tar)

  • Coughing up or vomiting blood or blood clots

  • Vomit that looks like coffee grounds

  • Unexpected pain, swelling, or joint pain

  • Headaches

  • Feeling dizzy or weak

Spinal or epidural blood clots (hematoma)

People who take a blood thinner medicine like ELIQUIS, and have medicine injected into their spinal or epidural area, or have a spinal puncture, have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis).

Your risk of developing a spinal or epidural blood clot is higher if:

  • A thin tube called an epidural catheter is placed in your back to give you certain medicine

  • You take NSAIDs or a medicine to prevent blood from clotting

  • You have a history of difficult or repeated epidural or spinal punctures

  • You have a history of problems with your spine or have had surgery on your spine

If you take ELIQUIS and receive spinal anesthesia or have a spinal puncture, your healthcare provider should watch you closely for symptoms of spinal or epidural blood clots or bleeding.

Tell your healthcare provider right away if you have any of these signs or symptoms when taking ELIQUIS:

  • Back pain

  • Tingling, numbness, or muscle weakness, especially in your legs and feet

  • Loss of control of the bowels or bladder (incontinence)

Talk to your healthcare provider about any side effect that may be bothering you or that does not go away. These are not all of the possible side effects of ELIQUIS. Call your healthcare provider for medical advice about side effects.

You are encouraged to report any side effects to the FDA at 1-800-FDA-1088


These are not all of the possible side effects of ELIQUIS. For more information, ask your doctor or pharmacist.

See additional Important Safety Information below.