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Antihemophilic Factor (Recombinant [Fc Fusion Protein])

Pronunciation

(an tee hee moe FIL ik FAK tor ree KOM be nant eff see FYOO zhun PRO teen)

Index Terms

  • AHF (Recombinant [Fc Fusion Protein])
  • Efmoroctocog Alfa
  • Factor VIII (Recombinant [Fc Fusion Protein])
  • rAHF (Fc Fusion Protein)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous [preservative free]:

Eloctate: 250 units (1 ea); 500 units (1 ea); 750 units (1 ea); 1000 units (1 ea); 1500 units (1 ea); 2000 units (1 ea); 3000 units (1 ea)

Brand Names: U.S.

  • Eloctate

Pharmacologic Category

  • Antihemophilic Agent

Pharmacology

Factor VIII replacement, necessary for clot formation and maintenance of hemostasis. It activates factor X in conjunction with activated factor IX; activated factor X converts prothrombin to thrombin, which converts fibrinogen to fibrin, and with factor XIII forms a stable clot.

Distribution

Vss: Children <12 years: ~0.52 to 0.59 dL/kg; Children ≥12 years, Adolescents, and Adults: ~0.50 to 0.6 dL/kg

Half-Life Elimination

Children <12 years: 12.7 to 14.9 hours; Children ≥12 years, Adolescents, and Adults: 16.4 to 19.7 hours

Special Populations: Children

Compared to adults, children have a shorter half-life and lower recovery of factor VIII; clearance (based on per kg body weight) is higher in pediatric patients.

Use: Labeled Indications

Hemophilia A:

Control and prevention of bleeding episodes: For the prevention and control of bleeding episodes in adults and children with hemophilia A.

Perioperative management: For surgical prophylaxis in adults and children with hemophilia A.

Routine prophylaxis to prevent or reduce the frequency of bleeding: For routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A.

Limitation of use: Not indicated for the treatment of von Willebrand disease.

Contraindications

Life-threatening hypersensitivity to antihemophilic factor or any component of the formulation.

Dosing: Adult

Hemophilia A: IV: Individualize dosage based on coagulation studies performed prior to treatment and at regular intervals during treatment. In general, administration of factor VIII 1 unit/kg will increase circulating factor VIII levels by ~2 units/dL.

Control and prevention of bleeding episodes or perioperative management:

Manufacturer's labeling: Refer to manufacturer's labeling for specific recommendations.

Alternate recommendations (WFH [Srivastava 2013]):

Dosage based on desired factor VIII increase (%):

To calculate dosage needed based on desired factor VIII increase (%):

[Body weight (kg) x desired factor VIII increase (%)] divided by 2 (%/units/kg) = units factor VIII required

For example:

50 kg x 30 (% increase) divided by 2 = 750 units factor VIII

Dosage based on expected factor VIII increase (%):

It is also possible to calculate the expected % factor VIII increase:

[# units administered x 2 (%/units/kg)] divided by body weight (kg) = expected % factor VIII increase

For example:

[1,400 units x 2] divided by 70 kg = 40%

World Federation of Hemophilia (WFH) treatment recommendations when no significant resource constraint exists (WFH [Srivastava 2013]):

2013 World Federation of Hemophilia Treatment Recommendations (When No Significant Resource Constraint Exists)

Site of Hemorrhage/Clinical Situation

Desired Factor VIII Level to Maintain

Duration

Note: Factor VIII level may either be expressed as units/dL or as %. Dosing frequency most commonly corresponds to the half-life of factor VIII but should be determined based on an assessment of factor VIII levels before the next dose.

Joint

40 to 60 units/dL

1 to 2 days, may be longer if response is inadequate

Superficial muscle/no neurovascular compromise

40 to 60 units/dL

2 to 3 days, sometimes longer if response is inadequate

Iliopsoas and deep muscle with neurovascular injury, or substantial blood loss

Initial: 80 to 100 units/dL

Initial: 1 to 2 days

Maintenance: 30 to 60 units/dL

Maintenance: 3 to 5 days, sometimes longer as secondary prophylaxis during physiotherapy

CNS/Head

Initial: 80 to 100 units/dL

Initial: 1 to 7 days

Maintenance: 50 units/dL

Maintenance: 8 to 21 days

Throat and neck

Initial: 80 to 100 units/dL

Initial: 1 to 7 days

Maintenance: 50 units/dL

Maintenance: 8 to 14 days

Gastrointestinal

Initial: 80 to 100 units/dL

Initial: 7 to 14 days

Maintenance: 50 units/dL

Maintenance: Not specified

Renal

50 units/dL

3 to 5 days

Deep laceration

50 units/dL

5 to 7 days

Surgery (major)

Preop: 80 to 100 units/dL

Postop: 60 to 80 units/dL

Postop: 1 to 3 days

Postop: 40 to 60 units/dL

Postop: 4 to 6 days

Postop: 30 to 50 units/dL

Postop: 7 to 14 days

Surgery (minor)

Preop: 50 to 80 units/dL

Postop: 30 to 80 units/dL

Postop: 1 to 5 days depending on procedure type

World Federation of Hemophilia (WFH) treatment recommendations when no significant resource constraint exists (Srivastava 2013):

Desired Factor VIII Level to Maintain and Duration Based on Site of Hemorrhage/Clinical Situation:

Joint: 40 to 60 units/dL for 1 to 2 days, may be longer if response is inadequate

Superficial muscle (no neurovascular compromise): 40 to 60 units/dL for 2 to 3 days, sometimes longer if response is inadequate

Iliopsoas and deep muscle with neurovascular injury, or substantial blood loss: Initial: 80 to 100 units/dL for 1 to 2 days; Maintenance: 30 to 60 units/dL for 3 to 5 days, sometimes longer as secondary prophylaxis during physiotherapy

CNS/head: Initial: 80 to 100 units/dL for 1 to 7 days; Maintenance: 50 units/dL for 8 to 21 days

Throat and neck: Initial: 80 to 100 units/dL for 1 to 7 days; Maintenance: 50 units/dL for 8 to 14 days

Gastrointestinal: Initial: 80 to 100 units/dL for 7 to 14 days; Maintenance: 50 units/dL (duration not specified)

Renal: 50 units/dL for 3 to 5 days

Deep laceration: 50 units/dL for 5 to 7 days

Surgery (major): Preop: 80 to 100 units/dL; Postop: 60 to 80 units/dL for 1 to 3 days; then 40 to 60 units/dL for 4 to 6 days; then 30 to 50 units/dL for 7 to 14 days

Surgery (minor): Preop: 50 to 80 units/dL; Postop: 30 to 80 units/dL for 1 to 5 days depending on procedure type

Note: Factor VIII level may either be expressed as units/dL or as %. Dosing frequency most commonly corresponds to the half-life of factor VIII but should be determined based on an assessment of factor VIII levels before the next dose.

Routine prophylaxis to prevent or reduce the frequency of bleeding episodes: IV: 50 units/kg every 4 days; at 3- to 5-day intervals, may adjust dose within the range of 25 to 65 units/kg based on patient response. Maintain trough levels between 1% and 3% above baseline, or higher, as clinically indicated.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Hemophilia A: Children and Adolescents: IV: Individualize dosage based on coagulation studies performed prior to treatment and at regular intervals during treatment. In general, administration of factor VIII 1 unit/kg will increase circulating factor VIII levels by ~2 units/dL. Children <6 years may require higher doses and/or more frequent administration.

Control and prevention of bleeding episodes or perioperative management: Refer to adult dosing.

Routine prophylaxis to prevent bleeding episodes:

Children <6 years: 50 units/kg twice weekly; at 3- to 5-day intervals, may adjust dose within the range of 25 to 65 units/kg based on patient response. More frequent or higher doses (up to 80 units/kg) may be required.

Children ≥6 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling; however, renal impairment has no bearing.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Reconstitution

If refrigerated, the dried concentrate and diluent should be warmed to room temperature before reconstitution. Gently agitate or rotate vial after adding diluent, do not shake vigorously. Refer to product specific labeling for reconstitution instructions and for detailed information regarding compatibility with administration sets.

Administration

IV: Infuse at a rate of ≤10 mL/minute (maximum: 10 mL/minute)

According to the World Federation of Hemophilia (WFH), infuse by slow IV injection at a rate not to exceed 3 mL/minute (adults) or 100 units/minute (young children) (WFH [Srivastava 2013]).

Storage

Prior to reconstitution, store refrigerated at 2°C to 8°C (36°F to 46°F); do not freeze. May also store at room temperature (not to exceed 30°C [86°F]) up to 6 months; do not return to refrigerator. Store in original package to protect from light. Use within 3 hours of reconstitution; do not refrigerate after reconstitution.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

<1% (Limited to important or life-threatening): Antibody development (Factor VIII inhibitor development), arthralgia, back pain, bradycardia, chest pain, cough, dizziness, dysgeusia, feeling hot, headache, hot flash, hypertension, joint swelling, lower abdominal pain, malaise, myalgia, procedural hypotension, sensation of cold, skin rash, venous pain (postinjection)

Warnings/Precautions

Concerns related to adverse effects:

• Antibody formation: The development of factor VIII antibodies has been reported with antihemophilic factors; monitor for signs of formation of antibodies to factor VIII; may occur at any time but more common in young children with severe hemophilia. Suspect factor VIII antibodies if the plasma factor VIII level does not increase as expected or if bleeding is not controlled after administration.

• Hypersensitivity reactions: Allergic hypersensitivity reactions (including anaphylaxis) may occur; discontinue if hypersensitivity symptoms occur and administer appropriate treatment.

Dosage form specific issues:

• Sucrose: May contain sucrose.

Other warnings/precautions:

• Dose requirements: The dosage requirement will vary in patients with factor VIII inhibitors; optimal treatment should be determined by clinical response.

Monitoring Parameters

Heart rate and blood pressure (before and during IV administration); plasma factor VIII activity prior to and during treatment; development of factor VIII inhibitors; signs of bleeding; hemoglobin, hematocrit; hypersensitivity reactions

Pregnancy Considerations

Animal reproduction studies have not been conducted. Factor VIII concentrations may increase in pregnant women with coagulation disorders. Pregnant women should have clotting factors monitored, particularly at 28 and 34 weeks gestation and prior to invasive procedures. Prophylaxis may be needed if concentrations are <50 units/mL at term and treatment should continue for 3 to 5 days postpartum depending on route of delivery. Because parvovirus infection may cause hydrops fetalis or fetal death, a recombinant product is preferred if prophylaxis or treatment is needed. The neonate may also be at an increased risk of bleeding following delivery and should be tested for the coagulation disorder (Kadir 2009; Lee 2006).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, loss of strength and energy, injection site irritation, muscle pain, or joint pain. Have patient report immediately to prescriber dizziness, passing out, sensation of cold, shortness of breath, difficulty swallowing, flushing, nausea, vomiting, agitation, tachycardia, chills, pale skin, mouth discoloration, angina, wheezing, or burning or numbness feeling (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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