icatibant (Rx)

Brand and Other Names:Firazyr
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

SC injection, prefilled syringe

  • 30mg (10 mg/mL)

Hereditary Angioedema

Bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE)

3 mL (30 mg) SC in abdominal area

If response inadequate or symptoms recur, additional injection of 30 mg may be administered at intervals of at least 6 hr

Do not exceed a total of 3 injections/24 hr

Dosage Modifications

Hepatic or renal impairment: No dosage adjustment required

<18 years: Safety and efficacy not established

Limited information is available for patients >65 years old

Increased Cmax and AUC in elderly patients (particularly women) have been observed

Differences in efficacy and safety between elderly and younger patients have not been identified, no dose adjustment recommended

Hereditary Angioedema

Bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE)

3 mL (30 mg) SC in abdominal area

If response inadequate or symptoms recur, additional injection of 30 mg may be administered at intervals of at least 6 hr

Do not exceed a total of 3 injections/24 hr

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Interactions

Interaction Checker

and icatibant

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Injection site reactions (97%)

            1-10%

            Pyrexia (4%)

            Transaminase increased (4%)

            Dizziness (3%)

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            Given the potential for airway obstruction during acute laryngeal HAE attacks, patients should be advised to seek medical attention in an appropriate healthcare facility immediately in addition to treatment

            Patients should be advised not to drive or use machinery if they feel tired or dizzy

            Report suspected adverse reactions to Shire Human Genetic Therapies at OnePath phone # 1-866-888-0660 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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            Pregnancy & Lactation

            Pregnancy

            Available data from published literature and pharmacovigilance database use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes

            Animal data

            • In animal reproduction studies, therapy administered by the subcutaneous route during period of organogenesis, did not cause structural abnormalities in rats or rabbits; however, premature birth and abortion were observed in rabbits at doses approximately 0.025 times the maximum recommended human dose (MRHD) and higher
            • Decreased embryofetal survival was observed in rabbits at a subcutaneous dose that was 13 times the MRHD
            • In a pre- and post-natal development study in rats, delayed parturition was observed at subcutaneous doses 0.5 times the MRHD and higher, which resulted in deaths of dams at doses 2 times the MRHD and higher
            • Fetal death and early pup deaths were observed with doses 2 times the MRHD

            Lactation

            There are no data on presence of icatibant in human milk, effects on breastfed infant, or on milk production

            The drug and its M2 metabolite were found in rat milk following subcutaneous administration; when a drug is present in animal milk, it is likely drug will be present in human milk; however, systemic absorption in infants is not expected after oral exposure through breast milk

            Developmental and health benefits of breastfeeding should be considered along with mother's clinical need for drug and any potential adverse effects on breastfed child from drug or from underlying maternal condition

            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

            Competitive antagonist selective for bradykinin B2 receptor

            Bradykinin formation results in vascular leakage and edema, the most recognizable symptoms of hereditary angioedema

            Absorption

            Bioavailability: 97%

            Peak Plasma Time: 45 minutes

            Duration: Inhibits symptoms caused by bradykinin for 6 hr on average

            Peak Plasma Concentration: 974 ng/mL

            AUC: 2165 ng•hr/mL

            Distribution

            Vd: 20-37 L

            Metabolism

            Extensively metabolized by proteolytic enzymes to inactive metabolites primarily excreted in urine

            No evidence of clinically relevant inhibition or induction of CYP450 enzymes

            Elimination

            Half-life elimination: 1.4 hr

            Plasma clearance: 245 mL/min

            Excretion: Urine

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            Administration

            SC Administration

            Dose may be self-administered by patient after training under the guidance of a healthcare professional or dose can be administered by a healthcare professional

            Inspect visually for particulate matter and discoloration prior to administration; do not administer if product contains particulates or is discolored

            Attach provided 25 gauge needle to syringe hub and screw on securely; do not use a different needle

            Disinfect injection site

            Administer by subcutaneous (SC) injection over at least 30 sec

            Storage

            Refrigerate between 2-25°C (36-77°F)

            Store in carton until time of administration

            Do not freeze

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            Formulary

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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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.