Yes

Antihemophilic Agent; Blood Product Derivative

Management of hemophilia A in patients whom a deficiency in factor VIII has been demonstrated. Can be of significant therapeutic value in patients with acquired factor VII inhibitors not exceeding 10 Bethesda units/mL.

C

Hypersensitivity to mouse protein (Monoclate-P®; Hemofil® M, Method M, Monoclonal Purified) and Antihemophilic Factor (Human); Method M, Monoclonal Purified contain trace amounts of mouse protein

Risk of viral transmission is not totally eradicated. Risk of hepatitis: Because antihemophilic factor is prepared for pooled plasma, it may contain the causative agent of viral hepatitis. Antihemophilic factor contains trace amounts of blood groups A and B isohemagglutinins; when large or frequently repeated doses are given to individuals with blood groups A, B, and AB, the patient should be monitored for signs of progressive anemia and the possibility of intravascular hemolysis should be considered.

<1%: Flushing, tachycardia, headache, nausea, vomiting, paresthesia, allergic vasomotor reactions, tightness in neck or chest

Intravascular hemolysis

Dried concentrate should be refrigerated (2°C to 8°C/36°F to 46°F) but may be stored at room temperature for up to 6 months depending upon specific product; 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; do not refrigerate after reconstitution, a precipitation may occur; Method M, monoclonal purified products should be administered within 1 hour after reconstitution

Protein (factor VIII) in normal plasma which is necessary for clot formation and maintenance of hemostasis; 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: Does not readily cross the placenta

Half-life, biphasic: 4-24 hours with a mean of 12 hours (biphasic: 12 hours is usually used for dosing interval estimates)

I.V.: Individualize dosage based on coagulation studies performed prior to and during treatment at regular intervals; 1 AHF unit is the activity present in 1 mL of normal pooled human plasma; dosage should be adjusted to actual vial size currently stocked in the pharmacy.

Surgery patients: The factor VIII level should be raised to approximately 100% by giving a preoperative dose of 50 international units/kg, to maintain hemostatic levels, repeat infusions may be necessary every 6-12 hours initially and for a total of 10-14 days until healing is complete

Formula to approximate percentage increase in plasma antihemophilic factor:

Units required = desired level increase (desired level - actual level) x plasma volume (mL)

Total blood volume (mL blood/kg) = 70 mL/kg (adults); 80 mL/kg (children)

Plasma volume = total blood volume (mL) x [1 - Hct (in decimals)]

Example: For a 70 kg adult with a Hct = 40%: plasma volume = [70 kg x 70 mL/kg] x [1 - 0.4] = 2940 mL

To calculate number of units of factor VIII needed to increase level to desired range (highly individualized and dependent on patient's condition):

Number of units = desired level increase [desired level - actual level] x plasma volume (in mL)

Example: For a 100% level in the above patient who has an actual level of 20% the number of units needed = [1 (for a 100% level) - 0.2] x 2940 mL = 2352 units

Heart rate (before and during I.V. administration); antihemophilic factor levels prior to and during treatment; in patients with circulating inhibitors, the inhibitor level should be monitored

Average normal antihemophilic factor plasma activity ranges 50% to 150%

Level to prevent spontaneous hemorrhage: 5%

Required peak postinfusion AHF activity in blood (as % of normal or units/dL plasma):

Early hemarthrosis or muscle bleed or oral bleed: 20% to 40%

More extensive hemarthrosis, muscle bleed, or hematoma: 30% to 60%

Life-threatening bleeds, such as head injury, throat bleed, severe abdominal pain

Minor surgery, including tooth extraction: 60% to 80%

Major surgery: 80% to 100% (pre- and postoperative)

None reported

None reported

No information available to require special precautions

No effects or complications reported

This medication can only be given I.V. Report sudden onset headache, rash, chest or back pain, or respiratory difficulties. Future safety: Wear some identification that you have a hemophilic condition. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Consult prescriber if breast-feeding.

Reduce rate of administration or temporarily discontinue if patient becomes tachycardiac

Injection: 10 mL, 20 mL, 30 mL

Berntorp E, "Impact of Replacement Therapy on the Evolution of HIV Infection in Hemophiliacs," Thromb Haemost, 1994, 71(6):678-83.

Berntorp E, "Plasma Product Treatment in Various Types of von Willebrand Disease," Haemostasis, 1994, 24(5):287-97.

Lusher JM, "Transfusion Therapy in Congenital Coagulopathies," Hematol Oncol Clin North Am, 1994, 8(6):1167-80.

Manucci PM, "Impact of Recombinant Factor VIII on Hemophilia Care," Vox Sang, 1994, 67(Suppl 3):49-52.

Peterson CW, "Treating Hemophilia," Am Pharm, 1994, NS34(8):57-67.

Scharrer I, Vigh T, and Aygoren-Purun E, "Experience With Haemate P in von Willebrand Disease," Haemostasis, 1994, 24(5):298-303.