Antihemophilic factor human

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Storage

Parenteral

Alphanate: ≤25°C (avoid freezing).122 Store reconstituted solution at room temperature (≤30°C); use within 3 hours of reconstitution.122

Hemofil-M: 2–8°C (avoid freezing to prevent damage to the diluent vial) or at room temperature ≤30°C up to expiration date.153 Do not refrigerate after reconstitution; use solution within 3 hours of reconstitution.153

Humate-P: ≤25°C up to expiration date; avoid freezing.133 Do not refrigerate after reconstitution; use solution within 3 hours of reconstitution.133

Koate DVI: 2–8°C (avoid freezing to prevent damage to the diluent vial); may store at room temperature ≤25°C up to 6 months.158 Do not refrigerate after reconstitution; use solution within 3 hours of reconstitution.158

Monoclate-P: 2–8°C (avoid freezing to prevent damage to the diluent vial) up to expiration date or store at room temperature ≤25°C for up to 6 months.167 Use solution within 3 hours of reconstitution.167

• Antihemophilic factor (human) preparations are concentrates of factor VIII derived from pooled human plasma.153 158 167 Antihemophilic factor/von Willebrand factor complex (human) preparations are concentrates of factor VIII and von Willebrand factor prepared from pooled human plasma.122 133

• Factor VIII is essential for blood clotting and maintenance of hemostasis.110 122 123 134 153 154 155 160 175 194

• Patients with hemophilia A (classic hemophilia) have decreased levels of endogenous factor VIII or dysfunctional factor VIII, resulting in a bleeding tendency and clinical manifestations such as bleeding into soft tissues, muscles, and weight-bearing joints.110 123 134 160 175 194

• Decreased levels of endogenous factor VIII also may occur in patients with von Willebrand disease who have levels of vWF that are insufficient for in vivo stabilization of factor VIII.123 134 176 177

• Clinical severity and frequency of bleeding in patients with hemophilia A correlate with the degree of deficiency in factor VIII activity.110 123 134 154 194 Patients with mild hemophilia A generally have >5% of normal activity, those with moderate disease generally have 1–5% of normal activity, and those with severe disease have <1% of normal activity.110 123 160 194

• Administration of antihemophilic factor (human) or antihemophilic factor/von Willebrand factor complex (human) increases plasma levels of factor VIII and temporarily corrects the coagulation defect in patients with hemophilia A.122 153 158 160 194

• Provides exogenous source of von Willebrand factor (Alphanate, Humate-P); decreases bleeding time and temporarily corrects coagulation defect in patients with von Willebrand disease.122 133 Von Willebrand factor promotes platelet adhesion and aggregation on damaged vascular endothelium; binds noncovalently to factor VIII, and stabilizes and protects factor VIII from degradation.110 133 154 160 175 194 223

• Prepared using different methods (e.g., precipitation, gel filtration, chromatography, nanofiltration) to isolate and purify factor VIII and von Willebrand factor (for Alphanate and Humate-P).122 133 153 158 167

• Undergoes viral inactivation processes (solvent/detergent, heat treatment [pasteurization, dry heat]) to reduce risk of viral transmission.122 133 153 158 159 167 246

Use antihemophilic factor as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a vein.
• This medicine may be given at home.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Follow how to use as you have been told by the doctor or read the package insert.
• Wash your hands before and after use.
• This medicine needs to be mixed before use. Follow how to mix as you were told by the doctor.
• Use within 3 hours of making.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Throw away any part of opened vial not used after use.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

• AHF (Human)
• Factor VIII (Human)
• Koate DVI

• Antihemophilic Agent
• Blood Product Derivative

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 Elimination

Mean: 14.8 to 17.5 hours

Store under refrigeration, 2°C to 8°C (36°F to 46°F); avoid freezing. Use within 3 hours of reconstitution. Do not refrigerate after reconstitution, precipitation may occur.

Hemofil M: May also be stored at room temperature not to exceed 30°C (86°F).

Koate; Monoclate-P: May also be stored at 25°C (77°F) for ≤6 months. Store in original package to protect from light.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience anxiety, headache, or abdominal pain. Have patient report immediately to prescriber signs of parvovirus B19 or hepatitis A infection (chills, severe fatigue, rhinorrhea, rash, joint pain, lack of appetite, nausea, vomiting, abdominal pain, or jaundice), shortness of breath, severe dizziness, passing out, burning or numbness feeling, agitation, blurred vision, severe nausea, vomiting, flushing, severe loss of strength and energy, tachycardia, or angina (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Commonly reported side effects of antihemophilic factor include: pruritus, skin rash, and urticaria. See below for a comprehensive list of adverse effects.