General

Pronunciation:
too-rok-to-cogal–fa

Trade Name(s)

• Novoeight
• Zonovate 

Trade Name(s)

• Antihemophilic factor (recombinant)

Ther. Class.
hemostatic agents
none assigned

Pharm. Class.
clotting factor replacements

Indications

Prevention/control of bleeding in patients with hemphilia A

Action

• Replaces deficient factor VIII in hemophilia A.
• Recombinant product is synthesized in genetically engineered Chinese hamster ovary cell line.

Therapeutic Effect(s):

Decreased incidence and severity of bleeding and sequelae of bleeding in hemophilia A

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism and Excretion: Used up in clotting process.

Half-life:  Adults– 11–12 hr;  children– 7.7–10 hr

TIME/ACTION PROFILE (effect on clotting)

Contraindication/Precautions

Contraindicated in:

• Life-threatening hypersensitivity to turoctcog alfa or any of its components, including hamster protein.

Use Cautiously in:

• OB:  Use during pregnancy only if clearly needed;
• Lactation: Use only if clearly indicated;
• Pedi:  Clearance in more rapid in children (↑ dose or more frequent dosing may be necessary).

Adverse Reactions/Side Effects

GI: ↑ liver enzymes

Local: injection site reactions

Misc: hypersensitivity reactions including anaphylaxis, fever, presence of activity-neutralizing antibodies

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

Interactions

Drug-Drug

Concurrent use of  any drugs that ↑ increase bleeding risk  including  anticoagulants  antiplatelet agents  aspirin  NSAIDs  or  thrombolytics  is contraindicated.

Route/Dosage

General dosing

IV (Adults and Children):  General dosing– Dose required (IU) = body weight (kg) x Desired Factor VIII increase (IU/dL or % normal) x 0.5 (IU/kg per IU/dL).

Control/prevention of bleeding episodes

IV (Adults and Children):    Minor bleeding (early hemarthrosis, minor muscle or oral bleeding)– 20–40% of normal Factor VIII level required every 12–24 hr for at least one day until resolution of bleeding,  Moderate bleeding (muscle bleeding, bleeding into the oral cavity, mild head trauma)– 30–60% of normal Factor VIII level required every 12–24 hr until pain/disability resolves (3–4 days),  Major bleeding (life/limb–threatening hemorrhage, GI bleeding, intracranial/intra-abdominal/intrathoracic bleeding, fractures)– 60–100% of normal Factor VIII level required every 8–24 hr until resolution of bleeding (7–10 days).

Perioperative management

IV (Adults and Children):  Minor procedures (including tooth extraction)– 30–60 % of normal Factor VIII level required every 24 hr for one day until healing achieved;  Major procedures– 80–100 % of normal Factor VIII level required every 8–24 hr pre- and post-operative until adequate wound healing achieved then continue for 7–10 days maintaining 30–60% of normal activity.

Routine prophylaxis

IV (Adults and Children  ≥12 yr): 20–50 IU/kg three times weekly or 20–40 IU/kg every other day.

IV (Children  <12 yr): 25–60 IU/kg three times weekly or 25–50 IU/kg every other day.

Availability

Lyophilized powder for injection(requires reconstitution): 250 IU single use vial, 500 IU single use vial, 1000 IU single use vial, 1500 IU single use vial, 2000 IU single use vial, 3000 IU single use vial

Assessment

• Monitor for signs and symptoms of hypersensitivity reactions or anaphylaxis (angioedema, chest tightness, dyspnea, wheezing, urticaria, pruritus). Discontinue Immediately and symptomatic treatment.

Lab Test Considerations: Monitor plasma factor VIII activity levels by one-stage clotting assay or chromogenic substrate assay to confirm adequate factor VIII levels have been achieved and maintained, when clinically indicated.

• Monitor patients for development of inhibitors. If expected plasma levels of factor VIII activity are not attained, or if bleeding is not controlled with appropriate dose, test for factor VIII inhibitors. Determine inhibitor levels in Bethesda Units.

Potential Diagnoses

• Ineffective tissue perfusion (Indications) 

Implementation

• Accidental needle stick with a needle contaminated with blood can transmit infectious viruses including HIV (AIDS) and hepatitis. Obtain immediate medical attention if injury occurs.
• Turcoctocog alfa can be infused at a hemophilia treatment center, at a health care professional's office or in the patient's home, with training.

Patient/Family Teaching

• Instruct patient in correct method for self-administration and care of equipment. If a dose is missed, omit and administer next dose as scheduled. Do not stop using without consulting health care professional. Advise patient to read  Patient Product Information  before using and with each refill; new information may be available.
• Caution patient to notify health care professional immediately if signs and symptoms of hypersensitivity reactions or anaphylaxis (rashes, hives, difficulty breathing, shortness of breath, wheezing, chest or throat tightness, difficulty swallowing, swelling of lips and tongue, light-headedness, dizziness, loss of consciousness, pale and cold skin, fast heart beat, low BP, red or swollen face or hands) occur.
• Advise patient to notify health care professional if lack of response occurs.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Advise patient to notify health care professional of treatment regimen prior to medical treatment or surgery.
• Instruct patient to consult with health care professional prior to traveling. While traveling, patients should be advised to bring an adequate supply of turoctocog alfa based on their current treatment regimen.
• Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

Control and prevention of bleeding in patients with hemophilia A.