Anti-inhibitor Coagulant Complex

Class: Hemostatics
VA Class: BL500
Brands: Feiba VH

Introduction

Anti-inhibitor coagulant complex, also known as activated prothrombin complex concentrate (APCC) is a preparation containing precursor and activated forms of blood coagulation factors II, VII, IX, and X derived from pooled human venous plasma.3 7 14 24

Uses for Anti-inhibitor Coagulant Complex

Hemophilia A or B with Inhibitors

Management of hemorrhagic episodes in patients with hemophilia A (antihemophilic factor [factor VIII] deficiency; classic hemophilia) or hemophilia B (factor IX deficiency; Christmas disease) who have developed inhibitors (alloantibodies) to factor VIII or factor IX, respectively.2 3 4 5 7 11 12 14 15 16 20 23 24 25 28 29 33 34 35 38 42 65 72

Prevention of bleeding in patients with hemophilia A or B with inhibitors to factor VIII or IX, respectively, undergoing surgery or invasive procedures (e.g., tooth extraction, synovectomy, placement of ventricular reservoir or ventriculoperitoneal shunt, drainage of subdural, intracerebral, and intracranial hematoma).2 11 12 23 24 42 72

Management of hemophilia in patients with inhibitors may be difficult and consultation with a hemophilia treatment center is strongly recommended.13 25 38 65

Treatment of choice depends on several factors (e.g., severity and location of bleeding, type and titer of inhibitor, history of anamnestic increase in antihemophilic inhibitor levels following use of preparations containing antihemophilic factor, previous response to these preparations).13 14 16 17 22 25 38 65 66 Patients with low titers of inhibitors (e.g., <5–10 Bethesda units/mL) may be effectively treated with high dosages of coagulation factor concentrates (factor VIII or factor IX). 7 14 16 17 22 24 25 65 70 74 Bypassing agents such as anti-inhibitor coagulant complex may be necessary in other patients.13 14 16 18 25 26 28 29 32 37 65 66

Slideshow: 18 Herbal Supplements with Risky Drug Interactions

Herbal and Dietary Supplements Deserve Your Attention

The National Hemophilia Foundation’s Medical and Scientific Advisory Council (MASAC) currently recommends use of a bypassing agent in hemophilia A or B patients with inhibitors to prevent or control bleeding in settings in which clotting factor preparations would otherwise be used, including before and after surgery and physical therapy.68

Although anti-inhibitor coagulant complex is one of several options for management of hemophilic patients with inhibitors,7 13 14 16 17 18 20 22 25 28 29 38 42 65 clinical response to the drug is not always consistent or predictable,4 14 16 20 22 24 25 29 and the drug may be associated with an increased risk of thrombotic complications (e.g., disseminated intravascular coagulation [DIC], DVT, MI).20 28 29 (See Thromboembolic Events under Cautions.) In addition, because the drug is prepared using pooled human plasma, it is associated with a risk of transmission of human viruses or other infectious agents.20 32 (See Risk of Transmissible Agents in Plasma-derived Preparations under Cautions.) Because of these considerations, some clinicians suggest that anti-inhibitor coagulant complex be used only when a response to specific factor replacement therapy has not been obtained or is unlikely.13 14 16 18 25 26 28 29 32

Use only in patients with inhibitors; not indicated for treatment of bleeding resulting from coagulation factor deficiencies.22 24 28 72

Acquired Hemophilia

Has been used to manage bleeding in some patients with acquired hemophilia (i.e., those with spontaneously acquired antibodies to factor VIII [autoantibodies]). 13 16 20 22 24 25 26 29 30 31 32 64 73

Also has been used in a few nonhemophilic patients with acquired inhibitors to factors XI and XII.24

Management of acquired hemophilia not well established.26 30 31 32 Although various therapeutic options are available, no one treatment is suitable for the management of bleeding in all patients who have spontaneously acquired factor VIII inhibitors.26 30 31 32

Treatment options include immunosuppressive agents,19 26 31 64 desmopressin,16 25 43 antihemophilic factor (recombinant or human),16 20 22 25 30 31 32 40 or bypassing agents (e.g., anti-inhibitor coagulant complex, factor VIIa [recombinant], factor IX complex preparations).16 20 25 26 29 30 32 63 64

Anti-inhibitor Coagulant Complex Dosage and Administration

Administration

IV Administration

Administer by slow IV injection or IV infusion.24

Has been administered in medically supervised home treatment programs for patients with hemophilia.44

Reconstitution

Prior to reconstitution, allow lyophilized powder and diluent supplied by manufacturer (sterile water for injection) to warm to room temperature (≤37°C).24

Reconstitute according to manufacturer’s directions.24

Gently swirl solution to dissolve powder completely.24

Do not refrigerate reconstituted solution.24

Administer immediately and complete infusion within 3 hours after reconstitution.24

Use plastic Luer lock syringes to administer the drug; proteins such as anti-inhibitor coagulant complex may adhere to glass.24

Rate of Administration

Individualize infusion rates based on patient response; do not exceed 2 units/kg per minute.24

Dosage

Dosage of anti-inhibitor coagulant complex not well defined; carefully individualize based on clinical response (e.g., pain relief, reduced swelling, joint mobilization).22 24 29 41

Response to the drug varies depending on type of hemorrhage and shows considerable interindividual variation; response does not necessarily correlate with patient’s inhibitor titer.3 24 41

There is no laboratory test that can reliably be used to monitor effectiveness of anti-inhibitor coagulant complex therapy.16 22 24 29 41 (See Laboratory Monitoring under Cautions.)

Dosage of Feiba VH is expressed in terms of Feiba VH units of activity.9 24

Feiba VH is standardized by its ability to shorten the aPTT of plasma containing antihemophilic factor inhibitors; potency is expressed in terms of Feiba units of activity.9 24 One unit of activity is the amount of Feiba VH that shortens the aPTT of reference plasma containing a high titer of antihemophilic factor inhibitor to 50% of the blank value.24 72

Dosages of 50–100 units/kg generally recommended.24

Pediatric Patients

Manufacturer states that no data are available regarding use of the drug in neonates.24

Hemophilia A or B with Inhibitors
Joint Hemorrhage
IV

50 units/kg every 12 hours; may increase to 100 units/kg every 12 hours if necessary.24 Continue until clinical improvement achieved.24

Mucous Membrane Bleeding
IV

50 units/kg every 6 hours; carefully monitor hematocrit and observe for visible bleeding.24 May increase to 100 units/kg every 6 hours for 2 doses, if bleeding continues; do not exceed 200 units/kg daily.24

Serious Soft Tissue Hemorrhage (e.g., Retroperitoneal Bleeding)
IV

100 units/kg every 12 hours up to a maximum of 200 units/kg daily.24

Other Severe Hemorrhage (e.g., CNS Bleeding)
IV

100 units/kg every 12 hours; if needed, administer every 6 hours until clear evidence of clinical improvement achieved.24

Adults

Hemophilia A or B with Inhibitors
Joint Hemorrhage
IV

50 units/kg every 12 hours; may increase to 100 units/kg every 12 hours if necessary.24 Continue until clinical improvement achieved.24

Mucous Membrane Bleeding
IV

50 units/kg every 6 hours; carefully monitor hematocrit and observe for visible bleeding.24 May increase to 100 units/kg every 6 hours for 2 doses, if bleeding continues; do not exceed 200 units/kg daily.24

Serious Soft Tissue Hemorrhage (e.g., Retroperitoneal Bleeding)
IV

100 units/kg every 12 hours up to a maximum of 200 units/kg daily.24

Other Severe Hemorrhage (e.g., CNS Bleeding)
IV

100 units/kg every 12 hours; if needed, administer every 6 hours until clear evidence of clinical improvement achieved.24

Prescribing Limits

Pediatric Patients

Hemophilia A or B with Inhibitors
IV

Maximum 100 units/kg as a single dose; do not exceed 200 units/kg daily.24

High dosages should be given only if absolutely necessary and with close monitoring for DIC and acute coronary ischemia.24 (See Thromboembolic Events under Cautions.)

Do not exceed maximum injection or infusion rate of 2 units/kg per minute.24

Adults

Hemophilia A or B with Inhibitors
IV

Maximum 100 units/kg as a single dose; do not exceed 200 units/kg daily.24 64

High dosages should be given only if absolutely necessary and with close monitoring for DIC and acute coronary ischemia.24 (See Thromboembolic Events under Cautions.)

Do not exceed maximum injection or infusion rate of 2 units/kg per minute.24

Cautions for Anti-inhibitor Coagulant Complex

Contraindications

  • Patients with normal coagulation function.24 72

Warnings/Precautions

Warnings

Risk of Transmissible Agents in Plasma-derived Preparations

Improved donor screening and current viral-inactivating procedures (e.g., vapor-heat treatment) have reduced, but not completely eliminated risk of pathogen transmission with plasma-derived anti-inhibitor coagulant complex.4 20 22 24 26 32 38 72

No cases of HIV, hepatitis A virus (HAV), hepatitis B virus (HBV) or hepatitis C virus (HCV) transmission reported to date from commercially available anti-inhibitor coagulant complex.70 72 However, possibility exists for transmission of these human viruses and other infectious agents (e.g., Creutzfeldt-Jakob disease [CJD], variant CJD [vCJD]).4 20 24 26 32 38 46 48 53

Current viral-depleting methods are less effective against viruses that do not have a lipid envelope (e.g., parvovirus B19, HAV).24 Such viruses have been identified in plasma-derived clotting factors.38 46 Monitor for signs and symptoms of parvovirus B19 and hepatitis A infections during therapy.24 (See Advice to Patients.)

Carefully weigh risk of pathogen transmission versus benefits of anti-inhibitor coagulant complex prior to initiating therapy.4 24 32

Report any suspected anti-inhibitor coagulant complex-associated infections to the manufacturer, FDA, and CDC.24 38 51 52

Risk of Hepatitis

Risk of hepatitis A or hepatitis B infection.24 38

Monitor closely for signs and symptoms of hepatitis A during therapy.24 (See Advice to Patients.)

Hepatitis B vaccine is recommended for all individuals with hemophilia or other congenital bleeding disorders at birth or at time of diagnosis.38 47 Immunization with hepatitis A vaccine is recommended for all individuals ≥1 year of age with a coagulation disorder.38 71

Individuals receiving blood or plasma infusions may develop signs and symptoms of other viral infections, particularly non-A or non-B hepatitis.24

Risk of HIV Infection

Potential vehicle for HIV transmission.4 26 38

No reports to date of HIV seroconversion with currently available plasma-derived clotting factor preparations.38

Risk of Creutzfeldt-Jakob Disease

Theoretic possibility of transmitting causative agent of CJD or vCJD.24 48 53 Several probable cases of vCJD transmission reported from transfusion of human RBCs.53 69 For further information on CJD and vCJD precautions related to blood and blood products, consult the FDA’s guidance for industry ().48

Risk of West Nile Virus Infection

Evidence of West Nile Virus (WNV) transmission through transplanted organs (e.g., heart, liver, kidney) and blood products.51 52 54 55 56 However, WNV transmission through commercially available plasma-derived clotting factors unlikely due to current viral-inactivating procedures.52

For further information on WNV precautions related to blood and blood products, consult the FDA’s guidance for industry ().52

Thromboembolic Events

Risk of thromboembolic events.14 22 24 41 70 72 DIC and MI reported, particularly in patients with preexisting thrombotic risk factors (e.g., cardiovascular disease, obesity, dyslipidemia) and/or those receiving high dosages.22 24 41 64 70 72

Closely monitor for manifestations of thromboembolic complications (e.g., changes in BP or pulse rate, respiratory distress, chest pain, cough).7 22 24 Decreased fibrinogen concentration, decreased platelet count, presence of fibrin-fibrinogen degradation products, and substantially prolonged thrombin time, PT, or aPTT may be indicative of DIC.24 Do not exceed maximum recommended dosages.24 (See Prescribing Limits under Dosage and Administration.) If evidence of thrombosis or DIC occurs, discontinue drug immediately and initiate appropriate therapy.24

Non-hemophilic patients with acquired factor VIII, IX, or XII inhibitors may have concurrent risk of increased bleeding and thrombosis.24

Do not use in patients with substantial signs of DIC or fibrinolysis.22 24 72

Anamnestic Response

Possible anamnestic response to trace amounts of factor VIII contained in anti-inhibitor coagulant complex.24 25 34 35 41 42 70 72 Anamnestic response (defined as an increase of preinfusion inhibitor titers to >50% following administration of anti-inhibitor coagulant complex) observed in up to 30% of patients; some patients received recent (within 2 weeks) treatment with factor VIII or factor IX concentrates.24 72 No effect on clinical response observed.24 72

Sensitivity Reactions

Hypersensitivity Reactions

Possible hypersensitivity reaction (ranging from mild, transient urticarial rash to anaphylactoid reaction).24 42

If severe hypersensitivity reaction or anaphylaxis occurs, discontinue drug immediately and initiate appropriate therapy (e.g., antihistamines, glucocorticoids).24 Treat shock with usual methods.24

Latex Sensitivity

Packaging components of Feiba VH may contain natural latex proteins;24 take appropriate precautions if injection is handled by or administered to individuals with a history of natural latex sensitivity.60 61

General Precautions

Laboratory Monitoring

There is no laboratory test that can reliably be used to monitor efficacy of anti-inhibitor coagulant complex therapy.24 70 72 Tests used to control efficacy (e.g., aPTT, whole blood clotting time [WBCT], thrombelastography [TEG]) do not correlate with clinical outcomes.24

Do not attempt to normalize laboratory values by exceeding recommended dosages of anti-inhibitor coagulant complex; increased risk of DIC observed with high dosages.24 (See Thromboembolic Events under Cautions.)

Specific Populations

Pregnancy

Category C.24

Lactation

Not known whether anti-inhibitor coagulant complex is distributed into human milk.73

Pediatric Use

Safety and efficacy not established in neonates.24 43

Transient hypofibrinogenemia reported in a few children receiving anti-inhibitor coagulant complex therapy.7 22 Some clinicians recommend monitoring fibrinogen levels prior to and during therapy in children.43 44 45

Geriatric Use

Possible increased risk of thrombotic complications in geriatric patients.73

Common Adverse Effects

Chills,72 fever,72 nausea,72 dizziness,72 taste alteration,72 minor chest pain and tightness,72 drowsiness,72 breathing discomfort.72

Interactions for Anti-inhibitor Coagulant Complex

Specific Drugs

Drug

Interaction

Comments

Antifibrinolytics (e.g., tranexamic acid, aminocaproic acid)

No specific interaction reported24 72

Allow ≥12 hours to elapse between discontinuance of anti-inhibitor coagulant complex and initiation of antifibrinolytic agent24 72

Anti-inhibitor Coagulant Complex Pharmacokinetics

Absorption

Bioavailability

Following IV administration, increased levels of coagulation factors occur within 10–30 minutes.14

Generally results in approximately equivalent increases in factors II, VII, IX, and X concentrations.14

Distribution

Extent

Not known whether distributed into human milk.73

Stability

Storage

Parenteral

Powder for Infusion

2–8°C; avoid freezing to prevent damage to diluent vial.24

May store at room temperature ≤25°C for up to 6 months; do not refrigerate after storage at room temperature.24 Use solution within 3 hours of reconstitution.24

Actions

  • Contains precursor and activated forms of factors II, VII, IX, and X; principally activated form of factor VII and non-activated forms of factors II, IX, and X.13 14 24 25 72

  • Exact mechanism of action not established, but appears to be multifactorial, involving simultaneous bypassing action in the common, intrinsic, and extrinsic coagulation pathways.7 9 13 14 16 18 22 25 42 72

  • Efficacy of anti-inhibitor coagulant complex may be related in part to the presence of activated factors (e.g., factor Xa and/or factor VIIa), which leads to more complete factor X activation in conjunction with tissue factor, phospholipid, and ionic calcium, thus allowing the coagulation process to proceed beyond those stages where factor VIII is needed.13 22 24 42

Advice to Patients

  • Importance of discontinuing therapy and immediately informing clinician if hives, urticaria, chest tightness, hypotension, wheezing, or other manifestations of hypersensitivity reactions or anaphylaxis occur.24

  • Risk for transmission of parvovirus B19 and/or hepatitis A.24 Importance of informing clinician if symptoms of potential parvovirus B19 infection (fever, drowsiness, chills and rhinorrhea followed by rash and joint pain about 2 weeks later) or hepatitis A infection (low grade fever, anorexia, nausea, vomiting, fatigue, jaundice, dark urine, abdominal pain) occur.24

  • Importance of informing clinician if allergy to latex exists.24

  • Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., cardiovascular disease, thromboembolic disease).24 72

  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.24

  • Importance of informing patients of other important precautionary information.24 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Anti-inhibitor Coagulant Complex (Human)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For injection, for IV use

number of units indicated on label

Feiba VH (with sterile water for injection diluent; heat-treated, vapor method; may contain natural latex components in packaging; available with BAXJECT needleless transfer device)

Baxter

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions July 18, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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