antihemophilic factor (recombinant) Fc fusion protein

General

Pronunciation:
an-teye-hee-moe-feel-ik fak-tor ree-kom-bi-nant eff-cee fyoo-zhun proh-teen


Trade Name(s)

  • Eloctate

Ther. Class.
hemostatic agents

Pharm. Class.
clotting factor replacements

Indications

Control/prevent bleeding episodes, peripoperative management and routine prophylaxis of bleeding episodes in patients with Hemophilia A (congential Factor VIII deficiency).

Action

Replaces deficient antihemophilic factor (AHF, Factor VIII). Produced via recombinant DNA technology, presence of fusion protein delays degradation.

Therapeutic Effect(s):

Decreased incidence and severity of bleeding in patients with Hemophilia A.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism and Excretion: Unknown.

Half-life: Unknown; clearance is more rapid in children.

TIME/ACTION PROFILE (effects on hemostasis)

ROUTEONSETPEAKDURATION
IVrapidend of infusion6 hr-5 days†
†Depends on patient age and clinical situation.

Contraindication/Precautions

Contraindicated in:

  • Previous life-threatening hypersensitivity.

Use Cautiously in:

  • OB: Use only if clearly needed;
  • OB: Use cautiously if breastfeeding;
  • Pedi: ↑ doses/↓ interval may be required in children 2–5 yr due to ↑ clearance.

Adverse Reactions/Side Effects

CNS: malaise

MS: arthralgia

Misc: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, neutralizing antibodies

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

Anticoagulants , thrombolytics , antiplatelet agents , NSAIDs , SSRIs , and NSRIs may ↑ risk of bleeding.

Route/Dosage

One unit/kg body weight will ↑ Factor VIII level by 2%.

Control/prevention of bleeding episodes

IV: (Adults and Children ≥6 yr): Minor or moderate bleeding (requires Factor VIII level of 40–60% of normal)– 20–30 IU/kg every 24–48 hr until bleeding episode is resolved; Major bleeding (requires Factor VIII level of 80–100% of normal)– 40–50 IU/kg every 12–24 hr until bleeding episode is resolved (7–10 days).

IV: (Children <6 yr): Minor or moderate bleeding (requires Factor VIII level of 40–60% of normal)– 20–30 IU/kg every 12 hr un-24 until bleeding episode is resolved; Major bleeding (requires Factor VIII level of 80–100% of normal)– 40–50 IU/kg every 8–24 hr until bleeding episode is resolved (7–10 days).

Perioperative Management

IV: (Adults and Children ≥6 yr): Minor prodecures (requires Factor VIII level 50–80% of normal)– 25–40 IU/kg every 24 hr for 24 hr until healing is achieved; major prodecures (requires Factor VIII level 80–120% of normal)– 40–60 IU/kg pre-operatively followed by 40–50 IU/kg after 8–24 hr and then every 24 hr to maintain Factor VIII level in desired range, continued until wound healing and then for at least 7 days to maintain Factor VIII level in desired range.IV: (Children <6 yr): Minor prodecures (requires Factor VIII level 50–80% of normal)– 25–40 IU/kg every 12–24 hr for 24 hr until healing is achieved; major prodecures (requires Factor VIII level 80–120% of normal)– 40–60 IU/kg pre-operatively followed by 40–50 IU/kg after 6–24 hr and then every 24 hr to maintain Factor VIII level in desired range, continued until wound healing and then for at least 7 days to maintain Factor VIII level in desired range.

Routine prophylaxis

IV: (Adults and Children) 50 IU/kg every 4 days (range 25–65 IU/kg every 3–5 days), doses up to 80 IU/kg or more frequent doses may be required in children <6 yr.

Availability

Lyophilized powder (requires reconsititution with accompanying diluent): 250 IU Factor VIII potency/single use vial, 500 IU Factor VIII potency/single use vial, 750 IU Factor VIII potency/single use vial, 1000 IU Factor VIII potency/single use vial, 1500 IU Factor VIII potency/single use vial, 2000 IU Factor VIII potency/single use vial, 3000 IU Factor VIII potency/single use vial

Assessment

  • Assess for allergic reaction (angioedema, dyspnea, wheezing, tachycardia, urticaria, hives, chest tightness, pruritus). If symptoms occur discontinue infusion immediately and treat symtomatically.
  • Monitor for bleeding during and periodically after therapy. If bleeding does not stop, inhibitor/neutralizing antibodies may have formed.

Lab Test Considerations: Monitor plasma Factor VIII activity to confirm adequate Factor VIII levels are achieved and maintained.

  • Monitor for development of Factor VIII inhibitors. Perform Bethesda inhibitor assay if Factor VIII levels not attained or bleeding is not controlled following expected dose.

Potential Diagnoses

Implementation

IV Administration

  • IV Push: Allow medication and diluent to reach room temperature. Follow manufacturer's recommendations for preparation. Do not shake. Reconstituted solution is clear to slightly opalescent and colorless; do not administer solutions that are discolored or contain precipitate matter. Infuse as soon as possible, no longer that 3 hr after reconstitution. Protect from light; do not refrigerate reconstituted solution.
  • Rate: Infuse at no greater than 10 mL/min; determine rate by patient's comfort level.
  • Y-Site IncompatibilityDo not admix or administer in the same line with any other medication or solution.

Patient/Family Teaching

  • Instruct patient to notify health care professional immediately if bleeding recurs.
  • Advise patient to read Patient Information prior to infusion and with each Rx refill in case of changes.
  • Instruct patient to notify health care professional or go to nearest emergency department immediately if signs and symptoms of hypersensitivity reactions occur.
  • Caution patient to avoid products containing aspirin or NSAIDs; they may further impair clotting.
  • Advise patient to notify health care professional if signs and symptoms of adverse reactions or lack of a clinical response occur.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

Decreased incidence and severity of bleeding in patients with Hemophilia A.

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Citation

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TY - ELEC T1 - antihemophilic factor (recombinant) Fc fusion protein ID - 110157 Y1 - 2019 PB - Davis's Drug Guide UR - https://anesth.unboundmedicine.com/anesthesia/view/Davis-Drug-Guide/110157/all/antihemophilic_factor__recombinant__Fc_fusion_protein ER -