emicizumab (Rx)

Brand and Other Names:Hemlibra, emicizumab-kxwh
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, IV solution (single-dose vials)

  • 30mg/mL
  • 60mg/0.4 mL
  • 105mg/0.7 mL
  • 150mg/mL

Hemophilia A

Indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A with or without factor VIII inhibitors

Loading dose: 3 mg/kg SC qWeek for the first 4 weeks

Maintenance dose

  • 1.5 mg/kg SC qWeek, OR
  • 3 mg/kg SC q2Weeks, OR
  • 6 mg/kg SC q4Weeks

Selection of maintenance dose based on healthcare provider preference with consideration of regimens that may increase patient adherence

Discontinue prophylactic use of bypassing agents 1 day before starting prophylaxis

Prophylactic use of factor VIII (FVIII) products may be continued during first week of prophylaxis

See also Administration

Dosage Modifications

Renal impairment

  • Mild-to-moderate (CrCl 30-89 mL/min): Pharmacokinetics are not affected

Hepatic impairment

  • Mild-to-moderate (total bilirubin 1X to ≤3X ULN and any AST): Pharmacokinetics are not affected

Dosage Forms & Strengths

injection, IV solution (single-dose vials)

  • 30mg/mL
  • 60mg/0.4 mL
  • 105mg/0.7 mL
  • 150mg/mL

Hemophilia A

Indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients aged newborn and older with hemophilia A with or without factor VIII inhibitors

Loading dose: 3 mg/kg SC qWeek for the first 4 weeks

Maintenance dose

  • 1.5 mg/kg SC qWeek, OR
  • 3 mg/kg SC q2Weeks, OR
  • 6 mg/kg SC q4Weeks

Selection of maintenance dose based on healthcare provider preference with consideration of regimens that may increase patient adherence

Discontinue prophylactic use of bypassing agents 1 day before starting prophylaxis

Prophylactic use of factor VIII (FVIII) products may be continued during first week of prophylaxis

See also Administration

Dosage Modifications

Renal impairment

  • Mild-to-moderate (CrCl 30-89 mL/min): Pharmacokinetics are not affected

Hepatic impairment

  • Mild-to-moderate (total bilirubin 1X to ≤3X ULN and any AST): Pharmacokinetics are not affected

Dosing Considerations

Self-administration is not recommended for children <7 years

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Interactions

Interaction Checker

and emicizumab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Injection site reaction (22%)

            Headache (15%)

            Arthralgia (15%)

            Injection site erythema (11%)

            1-10%

            Pyrexia (6%)

            Diarrhea (6%)

            Injection site pruritus (4%)

            Injection site pain (4%)

            <1%

            Rhabdomyolysis

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            Warnings

            Black Box Warnings

            Thrombotic microangiopathy and thromboembolism

            • Cases of thrombotic microangiopathy (TMA) and thrombotic events reported when, on average, a cumulative amount of >100 U/kg/24 hr of activated prothrombin complex concentrate (aPCC) was administered for ≥24 hr to patients receiving emicizumab-kxwh prophylaxis
            • Monitor the development of thrombotic microangiopathy and thrombotic events if aPCC is administered
            • Discontinue aPCC and suspend emicizumab-kxwh if symptoms occur

            Contraindications

            None

            Cautions

            Cases of TMA reported from clinical trials; improvement was seen within 1 week following discontinuation of aPCC (see Black Box Warnings)

            Thrombotic events reported from clinical trials when on average a cumulative amount of >100 U/kg/24 hr of aPCC was administered for ≥24 hr to patients receiving emicizumab-kxwh prophylaxis; no thrombotic event required anticoagulation therapy; evidence of improvement or resolution seen within one month following discontinuation of aPCC; consider benefits and risks of emicizumab-kxwh if aPCC must be used in patients receiving the drug or resuming prophylaxis following complete resolution of thrombotic event; monitor for development of thromboembolism when administering aPCC (see Black Box Warnings)

            Drug interactions overview

            • Clinical experience suggests that a drug interaction exists with emicizumab-kxwh and aPCC; possible for hypercoagulability with recombinant factor VIIa (rFVIIa) or Factor VIII (FVIII) with emicizumab-kxwh based on preclinical experiments
            • Drug laboratory test interactions
              • Intrinsic pathway clotting-based laboratory tests were affected; therefore these laboratory tests should not be used in monitoring emicizumab-kxwh; due to the long half-life of the drug, effects on coagulation essays may persist for up to 6 months after last dose
              • Results affected by emicizumab: Activated aPTT; Bethesda assays (clotting-based) for FVIII inhibitor titers; one-stage, aPTT-based, single-factor assays; aPTT-based activated protein C resistance (APC-R); and activated clotting time
              • Results unaffected by emicizumab: Bethesda assays (bovine chromogenic) for FVIII inhibitor titers; thrombin time; one-stage, prothrombin time-based, single-factor assays; chromogenic-based single-factor assays other than FVIII; immuno-based assays (eg, ELISA, turbidimetric methods); and genetic tests of coagulation factors (eg, factor V Leiden, prothrombin 20210)
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            Pregnancy

            Pregnancy

            No data are available regarding use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage

            Unknown whether treatment can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity

            Should be used during pregnancy only if the potential benefit for the mother outweighs the risk to the fetus

            Women of childbearing potential should use contraception during treatment

            Lactation

            No information is available regarding the presence of emicizumab-kxwh in human milk, the effects on the breastfed child, or the effects on milk production

            Human IgG is known to be present in human milk

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            Bispecific factor IXa- and factor X-directed antibody that bridges activated factor IX and factor X in order to restore the function of missing activated factor VIII necessary for effective hemostasis

            Absorption

            Peak plasma concentration, steady-state: 55.1 mcg/mL (1.5 mg/kg-dose); 58.3 mcg/mL (3 mg/kg-dose); 67 mcg/mL (6 mg/kg-dose)

            AUC, steady-state: 376 mcg/mL·day (1.5 mg/kg-dose); 752 mcg/mL·day (3 mg/kg-dose); 1503 mcg/mL·day (6 mg/kg-dose)

            Bioavailability, 1 mg/kg dose: 80.4-93.1%

            Observed similar pharmacokinetic profiles following SC administration in the abdomen, upper arm, and thigh

            Distribution

            Vd: 10.4L

            Excretion

            Clearance: 0.27 L/day

            Half-life: 26.9 days

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            Administration

            SC Preparation

            Visually inspect vial for particulate matter and discoloration prior to administration; solution appears colorless to slightly yellow; do not use if particulate matter is visible or product is discolored

            Do not use different vials of different concentrations when combining vials to administer prescribed dose

            SC administration

            SC use only

            Administer doses of up to 1 mL with a 1-mL syringe (graduation 0.01 mL)

            Administer doses >1 mL to ≤2 mL with a 2-mL or 3-mL syringe (graduation 0.1 mL)

            Use a transparent polypropylene or polycarbonate syringe with Luer-Lok tip, sterile, for injection only, single-use, latex-free, nonpyrogenic, and commercially available in the United States

            Rotate injection sites (upper outer arms, thighs, or any quadrant of abdomen) from previous injection

            Do not inject into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact

            Administration into the upper outer arm should only be performed by a caregiver or healthcare provider

            Discard any unused drug remaining

            Missed dose

            • Administer as soon as possible prior to day of next scheduled dose, and then resume usual weekly dosing schedule
            • Do not double doses to make up for a missed dose

            Storage

            Unopened vials

            • Store in refrigerator at 2-8°C (36-46°F) in original carton to protect from light; do not freeze; do not shake
            • If necessary, unopened vials may be stored at room temperature and then returned to refrigeration; temperature should not exceed 30°C (86°F) for up to 7 days

            Open vials: Discard immediately once opened

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.