Idarucizumab

Idarucizumab is used in patients treated with dabigatran (Pradaxa) when reversal of the anticoagulant effects is needed for emergency surgery or urgent procedures, or in the event of life-threatening or uncontrolled bleeding.

Idarucizumab is available under the following different brand names: Praxbind.

Dosages of Idarucizumab:

Dosage Forms and Strengths

Intravenous Solution

• 2.5g/50mL vial

Dosage Considerations – Should be Given as Follows:

Dabigatran Reversal

• Humanized monoclonal antibody fragment (Fab) indicated in patients treated with dabigatran (Pradaxa) when reversal of the anticoagulant effects is needed for emergency surgery or urgent procedures, or in the event of life-threatening or uncontrolled bleeding
• 5 g intravenously (IV), provided as 2 separate vials each containing 2.5 g/50 mL
• Limited data support the administration of an additional 5 g

Dosage Considerations – Should be Given as Follows:

Dosage Modifications

• Renal impairment: Renal impairment did not impact the reversal effect of idarucizumab; no dosage adjustment was required
• Hepatic impairment: Not studied
• Safety and efficacy not established in pediatric patients

Common side effects of Idarucizumab include:

• Low blood potassium (hypokalemia)
• Delirium
• Constipation
• Fever
• Pneumonia
• Headache

Other side effects of idarucizumab include:

• Blood clots
• Hypersensitivity

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

• Idarucizumab has no listed severe interactions with other drugs.
• Idarucizumab has no listed serious interactions with other drugs.
• Idarucizumab has no listed moderate interactions with other drugs.
• Idarucizumab has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains idarucizumab. Do not take Praxbind if you are allergic to idarucizumab or any ingredients contained in this drug.

Contraindications

• None

Effects of Drug Abuse

• No information is available.

Short-Term Effects

• See "What Are Side Effects Associated with Using Idarucizumab?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Idarucizumab?"

Cautions

• Patients treated with dabigatran have underlying disease states that predispose them to thromboembolic events; reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease; to reduce this risk, resume anticoagulant therapy as soon as medically appropriate
• There is an insufficient clinical experience to evaluate the risk of hypersensitivity to idarucizumab; discontinue if a serious hypersensitivity reaction occurs
• Caution with hereditary fructose intolerance; the recommended dose of idarucizumab contains 4 g sorbitol as an excipient; when prescribing to patients with hereditary fructose intolerance, consider the combined daily metabolic load of sorbitol/fructose from all sources; administration of sorbitol in these patients is known to cause serious adverse reactions, including fatal reactions including hypoglycemia, hypophosphatemia, metabolic acidosis, increase in uric acid, and acute liver failure with a breakdown of excretory and synthetic function

Re-elevation of coagulation parameters

• In a limited number of patients in the clinical program, between 12-24 hours after administrating idarucizumab 5 g, elevated coagulation parameters (e.g., aPTT, ECT) have been observed
• If reappearance of clinically relevant bleeding together with elevated coagulation parameters is observed after administering idarucizumab 5 g, administration of an additional 5 g dose may be considered
• Similarly, patients who require a second emergency surgery/urgent procedure and have elevated coagulation parameters may receive an additional 5-g dose
• The safety and effectiveness of repeat treatment with idarucizumab have not been established

Pregnancy and Lactation

• There are no adequate and well-controlled studies of idarucizumab in pregnant women to inform on associated risks. Animal reproductive and development studies have not been conducted; it is also not known whether idarucizumab can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Idarucizumab has not been studied for use during labor and delivery. Consult your doctor.
• It is unknown if idarucizumab is distributed in human breast milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for idarucizumab, and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition.