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)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	end of infusion	6 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

MS: arthralgia

Neuro: malaise

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.

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 Incompatibility: Do 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.