factor VIII

Factor VIII, human plasma-derived is a specialized protein in blood that plays a role in the clotting (coagulation) process. Deficiency in factor VIII can lead to uncontrolled bleeding even with minor injuries. Coagulation factor VIII is obtained by isolating it from the plasma and purifying it. Plasma is the liquid component of blood that serves as the medium for transporting all the blood components including blood cells, enzymes, gases, and nutrients to all the organs and the metabolic wastes for elimination through the lungs and kidneys.

Human plasma-derived factor VIII is used to maintain the necessary levels of the particular factor in individuals with hemophilia A, a hereditary bleeding disorder caused by deficiency in factor VIII. Factor VIII is infused in hemophilia A patients after an injury to increase its levels and prior to surgical procedures to prevent excessive bleeding.

Factor VIII used for infusion is a highly purified concentrate of factor VIII: C, the coagulant portion of the factor VIII complex. Factor VIII: C acts as a cofactor to factor IX and the two together activate factor X and the cascade of the coagulation process for the formation of a blood clot, including conversion of prothrombin to thrombin, aggregation of platelets and conversion of fibrinogen to fibrin, the tough protein that forms the scaffolding for the blood clot.

• Do not administer human plasma-derived factor VIII to patients with known hypersensitivity to mouse protein.
• The factor VIII solution must be administered at a rate of less than 10 mL/minute.
• The risk of a blood clot blocking a blood vessel (thromboembolic event) increases with each administration of factor VIII.
• Patients may develop neutralizing antibodies to factor VIII.
• Dose requirements will vary in patients with factor VIII inhibitors, adjust accordingly.
• Although factor VIII is derived from donor plasma that is screened for viral and other diseases that can be transmitted and undergo a process for further reducing the risk of viral infections, all plasma products still carry a potential for viral infections. Apprise patients of the risk of infection and the symptoms to watch for, and advise them to report symptoms immediately.

Common side effects of factor VIII, human plasma-derived include:

• Increased factor VIII inhibitors
• Stinging at the injection site
• Inflammation at the injection site
• Chest tightness
• Headache
• Fever
• Chills
• Lethargy
• Blurred vision
• Taste disorder (dysgeusia)
• Hypersensitivity reactions

Less common side effects of factor VIII, human plasma-derived include:

• Abdominal pain
• Severe allergic reaction (anaphylaxis)
• Slow heart rate (bradycardia)
• Chest pain
• Low blood pressure (hypotension)
• Rapid heart rate (tachycardia)
• Chills
• Drowsiness (somnolence)
• Fatigue
• Flushing
• Swelling (edema)
• Facial edema
• Cough
• Bronchospasm
• Shortness of breath (dyspnea)
• Shortness of breath (dyspnea)
• Rapid and deep breathing (hyperventilation)
• Bluish color of the skin due to deficient oxygen in the blood (cyanosis)
• Excessive sweating (hyperhidrosis)
• Diarrhea
• Nausea
• Vomiting
• Skin rash
• Hives (urticaria)
• Itching (pruritus)
• Red eye (ocular hyperemia)
• Visual impairment
• Irritability
• Musculoskeletal pain

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Solution Reconstituted

• 250 IU
• 500 IU
• 1000 IU
• 1500 IU

Adult and Pediatric:

Hemophilia A

• Minor hemorrhage: 15 IU/kg loading dose to achieve FVIII: C plasma level 30% of normal; THEN may administer half of the loading dose once daily or once every 12 hours for 1-2 days if a second infusion is necessary
• Moderate hemorrhage/minor surgery: 25 IU/kg loading dose to achieve FVIII: C plasma level 50% of normal; THEN administer FVIII: C 15 IU/kg intravenous (IV) every 8-12 hours for 1-2 days to maintain plasma levels of FVIII: C at 30% of normal; repeat dose once daily or once every 12 hours for up to 7 days or until adequate wound healing achieved
• Severe hemorrhage/major surgery: 40-50 IU/kg loading dose THEN administer FVIII: C 20-25 IU/kg IV every 8-12 hours to maintain plasma levels of FVIII: C at 80-100% of normal for 7 days; continue dose once daily or every 12 hours for up to 7 days to maintain FVIII: C levels at 30% to 50% normal

Administration

• Administer at 2 mL/minute, with a maximum rate of 10 mL/minute
• Monitor for tachycardia
• Monitor Factor VIII levels

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Factor VIII, human plasma-derived has no listed severe, serious, moderate, or mild interactions with other drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider about all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or healthcare provider if you have any questions about the medication.

• Factor VIII levels should be closely monitored during pregnancy because pregnant hemophilia A patients have an increased risk for bleeding with invasive procedures, spontaneous miscarriage, pregnancy termination, and delivery.
• There are no animal reproductive studies and it is not known if factor VIII, human plasma-derived, can cause fetal harm. Factor VIII should be used in pregnant women only if maternal benefits justify the risks to the fetus.
• It is not known if factor VIII administered to a nursing mother is excreted in breastmilk. Use with caution.

• Report to your physician immediately if you develop:
  • Hypersensitivity symptoms such as hives, wheezing, tightness of chest, low blood pressure (hypotension), or anaphylaxis.
  • Symptoms of parvovirus B19 infection which may include fever, drowsiness, chills, and runny nose followed two weeks later by a rash and joint pain.
  • Symptoms of hepatitis A infection such as poor appetite, tiredness, low-grade fever, nausea, vomiting, abdominal pain, dark urine, and yellowing of skin.