Factor VIIa

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Protocol for Factor VIIa Use in Adult Patients at University of Michigan Hospital

 

General Comments

Factor VIIa promotes local hemostasis through the extrinsic pathway of the coagulation cascade. Factor VIIa is complexed with tissue factor leading to activation of the coagulation cascade and the generation of thrombin ultimately leading to a stable fibrin clot.

All Factor VII use will be concurrently monitored by the High Impact Drug Monitoring Service. Emergent use of Factor VII in the setting of life-threatening bleed will be reviewed for compliance with guidelines. All non-emergent use of Factor VII will require approval of the Hematology Service.

How supplied and Cost

Vial sizes / Cost:

• 1000mcg $1,050
• 2000mcg $2,100
• 5000mcg $5,250

For 75kg patient and dose of 80mcg/kg = 6000mcg = $6,300

ALL DOSES SHOULD BE ROUNDED TO THE NEAREST 1000MCG DOSE

Indications: See Table 1.

General Contraindications (specific contraindications for each condition listed in Table 1):

1. Hypersensitivity to mouse, bovine, or hamster proteins
2. Hypersensitivity to recombinant factor VIIa or product components

General Exclusions:

1. Pregnancy (Exception: Patients with Factor VII deficiency at delivery)
2. Futile care
3. Normal coagulation profile
4. Prophylaxis for potential bleeds (Exception: Patients with hemophilia and Factor VIII or IX inhibitor)
5. Bleeding tumors in patients who are not surgical candidates for correction
6. Long-standing bleeding such as angiodysplasia or mucositis following chemotherapy
7. Treatment of platelet-related bleeding disorders

Warnings/Precautions:

1. Increased risk of thrombotic events
   • Risk factors include:
     • History of CAD
     • History of venous or arterial thrombosis
     • Crush injury
     • Disseminated intravascular coagulation (DIC)
     • Septicemia
     • ECMO or VAD
     • After cardiac surgery
     • Cerebral vascular disease
     • Treatment with aPCCs/PCCs (activated or non-activated prothrombin complex concentrates)
2. Signs or symptoms of coagulation system activation or thrombosis

Drug Interactions:

1. Avoid simultaneous use of activated prothrombin complex concentrates or prothrombin complex concentrates.

Adverse Events:

1. Hemorrhage
2. Fever
3. Hemarthrosis
4. Fibrinogen plasma decreased
5. Hypertension
6. Allergic reaction
7. DIC
8. Fibrinolysis increased
9. Decreased prothrombin
10. Abnormal renal function
11. Thrombosis

 

*A higher incidence of thromboembolic serious adverse events (myocardial and cerebral infarctions) was reported in patients with intracerebral hemorrhage (ICH) who received 40-160 mcg/kg of Factor VIIa compared to placebo-treated patients. The routine use of Factor VIIa for the reduction of hematoma growth after ICH is not currently recommended, until the safety profile of this agent is better established in the setting of ICH.

Monitoring:

1. Platelets, fibrinogen, PT, aPTT
2. Monitor for clinical signs of bleeding such as pain, swelling, joint circumference for hemarthrosis

Condition	Indications	Specific Contraindications	Administration
Factor VIII or IX inhibitor	Vigorous bleeding, impending compartment syndrome, or bleeding in critical location Persistent bleeding, not life or limb threatening Before invasive procedures	See General Contraindications & exclusions	Dose: 90 mcg/kg Q2-3hr until patient hemostasis is achieved, then less frequently thereafter, round dose to nearest 1000mcg. Dose frequency and duration of Factor VIIa therapy based on achievement of hemostasis and bleeding risk
Hepatic Failure	For urgent intracranial pressure monitor (ICP) placement in patients with acute or chronic liver failure who have a coagulopathy refractory to fresh frozen plasma.  For post-operative refractory bleeding in liver failure patients who have received an ICP monitor	Budd-Chiari Known or suspected malignancy  History of DVT or PE Pregnancy Hypersensitivity to Vitamin K	Four units of FFP previously administered with persistent INR > 1.5 Cryoprecipitate to be given for patients with fibrinogen < 1000mg/dL immediately before Factor VIIa Dose: 80mcg/kg Factor VIIa IV bolus over 2 to 5 minutes immediately prior to ICP placement (provides up to 4 hour window to place ICP monitor), round to nearest 1000mcg.
Closed Space Bleeding (traumatic)	For emergent isolated traumatic head injury with evidence of expanding bleed in patients on coumadin or LMWH	Isolated traumatic head injury without evidence of expanding bleed.	Dose:  40-90 mcg/kg  Factor VIIa as IV bolus over 2 to 5 minutes x one dose, round dose to the nearest 1000mcg.
Closed Space Bleeding (other)	For emergent retroperitoneal bleed in patients on coumadin or LMWH after significant clotting factor replacement	Retroperitoneal bleed in patients not on coumadin or LMWH	Dose:  40-90 mcg/kg  Factor VIIa as IV bolus over 2 to 5 minutes x one dose, round dose to the nearest 1000mcg.
Trauma	For severe multiple trauma patients with ongoing bleeding and coagulopathy despite surgical interventions and continued infusions of plasma (>6units FFP) and ≥ 10 units of PRBS in 6 hours	Active gastrointestinal bleeding Acidosis (pH<7.1) Hypothermia Platelet count <50,000	At least 10 units PRBC, 8 units of plasma and > 6 units of FFP unless patient has known Factor VII deficiency or plasma therapy is likely to be too slow or directly life threatening.   Dose:  100mcg/kg Factor VIIa as IV bolus over 2 to 5 minutes x one dose, round dose to the nearest 1000mcg
Post-partum and Post-hysterectomy	For post-partum and post-hysterectomy bleeding after significant clotting factor replacement	See General Contraindication & exclusions	Dose:  60mcg/kg Factor VIIa as IV bolus over 2 to 5 minutes x one dose, round dose to the nearest 1000mcg
Need for Acute Anticoagulant Reversal	For serious bleed associated with prolonged INR after significant clotting factor replacement	See General Contraindication & exclusions	Dose: 1000mcg x one dose
Uncontrolled hemorrhage associated with surgery	For uncontrolled hemorrhage associated with surgery (except for abdominal and large joint replacement orthopedic surgery) after significant clotting factor replacement	See General Contraindication & exclusions	Dose: 40-90 mcg/kg Factor VIIa as IV bolus over 2 to 5 minutes x one dose, round dose to the nearest 1000mcg