ecallantide (Rx)

Brand and Other Names:Kalbitor
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 10mg/mL per single-use 3-mL vial

Hereditary Angioedema

Indicated for treatment of acute attacks of hereditary angioedema (HAE)

30 mg (3 mL) SC administered in 3 separate 10 mg (1 mL) injections

If attack persists, may administer an additional dose of 30 mg within 24 hr

Dosage Forms & Strengths

injectable solution

  • 10mg/mL per single-use 3-mL vial

Hereditary Angioedema

Indicated for treatment of acute attacks of hereditary angioedema (HAE) in adolescents aged ≥12 yr

<12 years: Safety and efficacy not established

≥12 years: As adults; 30 mg (3 mL) SC administered in 3 separate 10 mg (1 mL) injections

If attack persists, may administer additional 30 mg dose within 24 hr

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Interactions

Interaction Checker

and ecallantide

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Headache (16.1%)

            Nausea (12.9%)

            Fatigue (11.8%)

            Diarrhea (10.6%)

            1-10% (selected)

            Upper respiratory tract infection (8.2%)

            Nasopharyngitis (5.9%)

            Vomiting (5.5%)

            Pruritus (5.1%)

            Upper abdominal pain (5.1%)

            Pyrexia (4.7%)

            Anaphylaxis (3.9%)

            Injection site reactions

            Rash

            Urticaria

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            Warnings

            Black Box Warnings

            Anaphylaxis has been reported in 3.9% of treated patients

            Because of risk for anaphylaxis, administered by healthcare professional only with medical support

            Healthcare professionals should be aware of similarity of symptoms between anaphylaxis and angioedema

            Do not administer to patient with known hypersensitivity to ecallantide

            Symptoms have included chest discomfort, flushing, pharyngeal edema, pruritus, rhinorrhea, sneezing, nasal congestion, throat irritation, urticaria, wheezing, and hypotension

            Pruritus, rash, and urticaria may also indicate hypersensitivity

            These reactions occurred within the first hour after dosing

            Contraindications

            Hypersensitivity

            Cautions

            Risk of potentially serious hypersensitivity reactions, including anaphylaxis; observe patients for an appropriate period of time after administration; do not administer to patients with known hypersensitivity to ecallantide (see Contraindications and Black Box Warnings)

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            Pregnancy & Lactation

            Pregnancy

            No information is available regarding the effects of ecallantide during labor and delivery

            Lactation

            Unknown whether ecallantide is excreted in human milk; use caution

            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.

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            Pharmacology

            Mechanism of Action

            Human plasma kallikrein inhibitor, thereby reducing conversion of kininogen to bradykinin; bradykinin production may contribute to increased vascular permeability and angioedema experienced in HAE

            Pharmacokinetics

            Half-life: 2 hr

            Vd: 26.4 L

            Peak plasma time: 2-3 hr

            Peak plasma concentration: 586 +/- 106 ng/mL

            Clearance: 153 mL/min

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            Administration

            SC Preparation

            Solution should appear clear, colorless liquid; visually inspect each vial for particulate matter and discoloration prior to administration; do not use if there is particulate matter or discoloration

            Using aseptic technique, withdraw 1 mL (10 mg) from the vial using a large bore needle; change the needle on the syringe to a needle suitable for SC injection (ie, 27-gauge)

            SC Administration

            Because of risk for anaphylaxis, administered by healthcare professional only with medical support

            Inject SC in thigh, abdomen, or upper arm

            There is no need for site rotation; injection sites should be separated by at least 2 inches (5 cm) and away from the anatomical site of attack

            Storage

            Store refrigerated at 2-8°C (36-46°F)

            Vials removed from refrigeration: Store below 30°C (86°F) and use within 14 days or return to refrigeration until use

            Protect from light until use

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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each 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.