icatibant (Rx)

Brand and Other Names:Firazyr, Sajazir
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Dosing & Uses

AdultPediatric

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 30-mg injections may be administered at intervals of at least 6 hr

Not to exceed 3 injections/24 hr

Dosage Modifications

Hepatic or renal impairment: No dosage adjustment required

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

and icatibant

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     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Contraindicated (0)

              Serious - Use Alternative (6)

              • axicabtagene ciloleucel

                icatibant, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • brexucabtagene autoleucel

                icatibant, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • ciltacabtagene autoleucel

                icatibant, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • idecabtagene vicleucel

                icatibant, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • lisocabtagene maraleucel

                icatibant, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • tisagenlecleucel

                icatibant, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              Monitor Closely (13)

              • benazepril

                icatibant decreases effects of benazepril by pharmacodynamic antagonism. Use Caution/Monitor. Icatibant has potential to have a pharmacodynamic interaction with ACE inhibitors where it may attenuate the antihypertensive effect of ACE inhibitors.

              • captopril

                icatibant decreases effects of captopril by pharmacodynamic antagonism. Use Caution/Monitor. Icatibant has potential to have a pharmacodynamic interaction with ACE inhibitors where it may attenuate the antihypertensive effect of ACE inhibitors.

              • enalapril

                icatibant decreases effects of enalapril by pharmacodynamic antagonism. Use Caution/Monitor. Icatibant has potential to have a pharmacodynamic interaction with ACE inhibitors where it may attenuate the antihypertensive effect of ACE inhibitors.

              • fosinopril

                icatibant decreases effects of fosinopril by pharmacodynamic antagonism. Use Caution/Monitor. Icatibant has potential to have a pharmacodynamic interaction with ACE inhibitors where it may attenuate the antihypertensive effect of ACE inhibitors.

              • isavuconazonium sulfate

                icatibant and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • moexipril

                icatibant decreases effects of moexipril by pharmacodynamic antagonism. Use Caution/Monitor. Icatibant has potential to have a pharmacodynamic interaction with ACE inhibitors where it may attenuate the antihypertensive effect of ACE inhibitors.

              • ofatumumab SC

                ofatumumab SC, icatibant. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

              • ozanimod

                ozanimod, icatibant. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration with immunosuppressive therapies may increase the risk of additive immune effects during therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs in order to avoid unintended additive immunosuppressive effects.

              • perindopril

                icatibant decreases effects of perindopril by pharmacodynamic antagonism. Use Caution/Monitor. Icatibant has potential to have a pharmacodynamic interaction with ACE inhibitors where it may attenuate the antihypertensive effect of ACE inhibitors.

              • quinapril

                icatibant decreases effects of quinapril by pharmacodynamic antagonism. Use Caution/Monitor. Icatibant has potential to have a pharmacodynamic interaction with ACE inhibitors where it may attenuate the antihypertensive effect of ACE inhibitors.

              • ramipril

                icatibant decreases effects of ramipril by pharmacodynamic antagonism. Use Caution/Monitor. Icatibant has potential to have a pharmacodynamic interaction with ACE inhibitors where it may attenuate the antihypertensive effect of ACE inhibitors.

              • siponimod

                siponimod and icatibant both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • trandolapril

                icatibant decreases effects of trandolapril by pharmacodynamic antagonism. Use Caution/Monitor. Icatibant has potential to have a pharmacodynamic interaction with ACE inhibitors where it may attenuate the antihypertensive effect of ACE inhibitors.

              Minor (0)

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                Adverse Effects

                Suspected Adverse Reactions

                Report suspected adverse reactions to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

                >10%

                Injection site reactions (97%)

                1-10%

                Pyrexia (4%)

                Transaminase increased (4%)

                Dizziness (3%)

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                Warnings

                Contraindications

                None

                Cautions

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

                Advise patients not to drive or use machinery if they feel tired or dizzy

                Drug interaction overview

                • ACE inhibitors
                  • Monitor closely
                  • Icatibant, a bradykinin B2 receptor antagonist, may attenuate the antihypertensive effect of ACE inhibitors

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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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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                icatibant subcutaneous
                -
                30 mg/3 mL solution
                icatibant subcutaneous
                -
                30 mg/3 mL solution
                icatibant subcutaneous
                -
                30 mg/3 mL solution
                icatibant subcutaneous
                -
                30 mg/3 mL solution
                icatibant subcutaneous
                -
                30 mg/3 mL solution
                icatibant subcutaneous
                -
                30 mg/3 mL solution

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                icatibant subcutaneous

                ICATIBANT - INJECTION

                (eye-KAT-i-bant)

                COMMON BRAND NAME(S): Firazyr

                USES: Icatibant is used to treat sudden attacks of a certain immune system condition passed down through families called hereditary angioedema (HAE). Although this medication is not a cure for HAE, icatibant may lessen the symptoms of an attack such as rapid swelling and pain of the hands, arms, feet, legs, face, tongue, and upper airway. When attacks involve the stomach/intestines, symptoms may include abdominal pain/cramps, diarrhea, constipation, or vomiting. Attacks may happen at any time. However, stress, injury, or illness may trigger attacks in some people.Icatibant works by blocking the action of a natural substance in the body called bradykinin. Bradykinin is thought to cause the symptoms of an HAE attack.

                HOW TO USE: Read the Patient Information Leaflet before you start using icatibant and each time you get a refill. If you are giving this medication to yourself at home, learn all preparation and usage instructions in the product package and from your health care professional. Your health care professional will also teach you how to recognize the symptoms of a sudden attack of HAE. If any of the information is unclear, consult your health care professional.Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin.Inject this medication under the skin in the stomach/abdominal area as directed by your doctor, usually over at least 30 seconds. If your symptoms continue or come back, you may give another dose after at least 6 hours. Do not use more than 3 doses in 24 hours.If you have a sudden HAE attack of your throat area/voice box/upper airway (larynx), give yourself an injection of icatibant and then get medical help right away. This type of attack may lead to a blocked airway and serious breathing trouble.Learn how to store and discard medical supplies safely.Tell your doctor if your symptoms do not improve or if they worsen.

                SIDE EFFECTS: Fever or dizziness may occur. Injection site reactions (such as redness, burning, swelling, bruising, irritation, pain) may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                PRECAUTIONS: Before using icatibant, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

                OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                NOTES: Do not share this medication with others.

                MISSED DOSE: Not applicable.

                STORAGE: Store at room temperature in a cool place or in the refrigerator. Do not freeze. Store this drug in the manufacturer's carton until you are ready to use it. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

                Information last revised February 2022. Copyright(c) 2022 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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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.
                OR Other Restrictions
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