Praxbind (idarucizumab)

For urgent reversal of dabigatran-induced anticoagulation in patients with life-threatening or uncontrolled bleeding or in those undergoing emergency surgery/urgent procedures, the recommended dose of idarucizumab is 5 g administered in 2 divided consecutive doses (2.5 g each) by IV infusion or rapid IV injection. If clinically relevant bleeding recurs and coagulation parameters are elevated after the initial idarucizumab dose, administration of an additional 5-g dose may be considered. Similarly, patients who have elevated coagulation parameters and require a second emergency surgery/urgent procedure may be given an additional 5-g dose of idarucizumab. The safety and efficacy of repeat treatment with idarucizumab have not been well established. (See Re-elevation of Coagulation Parameters under Cautions.)

Dabigatran therapy can be reinitiated 24 hours after administration of idarucizumab; resumption of anticoagulant therapy should be considered as soon as medically appropriate. (See Thromboembolic Complications under Cautions.)

Idarucizumab is administered by IV infusion or by rapid IV (''bolus'') injection; the injection should be administered undiluted. Once idarucizumab has been withdrawn from the vial, the drug should be administered promptly. The manufacturer states that when administered by IV infusion, idarucizumab should be given as 2 consecutive doses (as rapidly as clinically feasible), with each dose administered directly from a 50-mL vial after spiking the vial with an infusion set. When administered by rapid IV injection, idarucizumab should be given as 2 separate, consecutive doses via syringe (as rapidly as clinically feasible). Some clinicians state that administration of each vial should take no longer than 5-10 minutes.

Idarucizumab injection is commercially available in single-use vials containing 2.5 g of the drug per 50 mL. The drug may be administered through an existing IV line; however, the line must be flushed with 0.9% sodium chloride injection prior to and upon completion of the idarucizumab infusion. Idarucizumab should not be admixed with any other drug, nor should any other drug be administered simultaneously in the same IV line with idarucizumab.

Vials of idarucizumab should be stored at 2-8degreesC in the original carton to protect the drug from light; vials should not be frozen or shaken. Vials may be stored at room temperature (25degreesC) for up to 48 hours if kept in the original package and protected from light, or for up to 6 hours if out of the carton and exposed to light.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Igg Antibodies And Derivatives/Efgartigimod-Alfa

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3)

DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3)

Igg Antibodies And Derivatives/Nipocalimab-Aahu

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3)

DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3)

Moderate Interaction: Assess the risk to the patient and take action as needed.

Igg Antibodies And Derivatives/Rozanolixizumab-Noli

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3)

DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3)

*None.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

Adverse effects reported in at least 5% of patients receiving idarucizumab in clinical studies include constipation and nausea. In phase 1 clinical trials, headache was reported in at least 5% of healthy individuals who received idarucizumab.

More Frequent

• Hypokalemia

Rare or Very Rare

• Bronchospastic pulmonary disease
• Pneumonia
• Thromboembolic disorder

More Frequent

• Constipation
• Delirium
• Fever
• Headache disorder
• Nausea

Rare or Very Rare

• Hyperventilation
• Pruritus of skin
• Skin rash

No enhanced messaging available.

Safety and efficacy of idarucizumab have not been established in pediatric patients.

There are no adequate and well-controlled studies of idarucizumab in pregnant women. Data from animal reproductive and developmental studies with idarucizumab are lacking. It is not known whether idarucizumab can cause fetal harm when administered to a pregnant woman or if the drug can affect reproductive capacity. Idarucizumab should be used during pregnancy only when clearly needed. Safety and efficacy of the drug during labor and delivery have not been established.

It is not known whether idarucizumab is distributed into human milk. Because many drugs are distributed into milk, the drug should be used with caution in nursing women.

The known benefits of breast-feeding should be considered along with the mother's clinical need for idarucizumab and any potential adverse effects on the breast-fed infant from the drug or underlying maternal condition.

In the RE-VERSE AD trial, 90% of patients were 65 years of age or older. While clinical experience has not revealed age-related differences in safety or efficacy, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out.