Idarucizumab

Idarucizumab is a prescription medication used to reverse the blood-thinning effects of Pradaxa for emergency procedures and in life-threatening or uncontrolled bleeding.

Idarucizumab belongs to a group of drugs called anticoagulant reversal agents. It works by binding to the Pradaxa (dabigatran) drug compound to neutralize its blood-thinning effects.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of idarucizumab include low potassium (hypokalemia), confusion, constipation, fever and pneumonia.

Idarucizumab is a prescription medication used in patients who are taking the anticoagulant Pradaxa (dabigatran) and reversal of this medication is needed for emergency surgery/procedures as well as during life-threatening or uncontrolled bleeding.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with idarucizumab. See the “Idarucizumab Precautions” section.

Common side effects of idarucizumab include the following:

• headache
• low potassium (hypokalemia)
• confusion
• constipation
• fever
• pneumonia

This is not a complete list of idarucizumab side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been reported by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with idarucizumab including the following:

• Blood clots. Idarucizumab reverses Pradaxa so patients are at exposed to the thrombotic risk (blood clots) of the underlying disease that Pradaxa is being given for. Your doctor will resume Pradaxa as soon as medically appropriate. Pradaxa treatment can be initiated 24 hours after administration of idarucizumab.
• Recurrence of bleeding and increase in coagulation parameters. Some patients may require an additional dose of idarucizumab. 
• Hypersensitivity reactions (serious allergic reaction). These may include fever, difficulty breathing due to tightening of the airways, hyperventilation, rash, and itching, Your doctor will discontinue idarucizumab if this occurs. 
• Hereditary Fructose Intolerance to Sorbitol Excipient. Idarucizumab contains sorbitol. Patients with hereditary fructose intolerance may be at risk of adverse reactions such as low blood sugar, low phosphate, metabolic acidosis, increase in uric acid, and acute liver failure. Tell your doctor if have hereditary fructose intolerance. 

Do not take idarucizumab if you are allergic to idarucizumab or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of idarucizumab, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking idarucizumab, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to idarucizumab or to any of its ingredients
• have hereditary fructose intolerance
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no adequate and well-controlled studies of idarucizumab in animals or in pregnant women. It is also not known if idarucizumab can cause harm to the fetus. Idarucizumab should be given to a pregnant woman only if clearly needed. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if idarucizumab crosses into human milk. There are no data on the effects of idarucizumab on the breastfed child or on milk production. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, your doctor and you will decide if the benefits outweigh the risk of using idarucizumab.

Idarucizumab is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended dose Praxbind (idarucizumab) is 5 grams. 

If idarucizumab is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.