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Indications/Uses
For prevention and control of bleeding in patients with Factor VIII deficiency due to hemophilia A or acquired Factor VIII deficiency. No clinical trials have as yet been conducted using Alphanate for treatment of von Willebrand's disease therefore Alphanate is not approved for this use.
Dosage/Direction for Use
Adult: Following reconstitution with the supplied diluent, Alphanate should be administered IV within 3 hrs after reconstitution to avoid the potential ill effect of any inadvertent bacterial contamination occurring during reconstitution. Alphanate may be administered by injection (plastic disposable syringes are recommended). Administer at room temperature, do not refrigerate after reconstitution and discard any unused contents into the appropriate safety container.
Antihemophilic factor potency (Factor VIII:C activity) is expressed in international units (iu) on the product label. One unit approximates the activity in 1 mL of normal human plasma. Replacement therapy studies have shown a linear dose-response relationship with a 2-2.5% increase in Factor VIII activity for each factor of 0.5 iu/kg can be calculated.
Antihemophilic factor potency (Factor VIII:C activity) is expressed in international units (iu) on the product label. One unit approximates the activity in 1 mL of normal human plasma. Replacement therapy studies have shown a linear dose-response relationship with a 2-2.5% increase in Factor VIII activity for each factor of 0.5 iu/kg can be calculated.
Warnings
Because Alphanate is made from pooled human plasma, it may carry a risk of transmitting infectious agents eg, viruses and theoretically, the Creutzieldt-Jakob disease (CJD) agent. Stringent procedures designed to reduce the risk of adventitious agent transmission have been employed in the manufacture of Alphanate, from the screening of plasma donors and the collection and testing of plasma, through the application of viral elimination/reduction steps eg, solvent detergent and heat treatment in the manufacturing process. Despite these measures, such products can still potentially transmit disease; therefore, the risk of infectious agents cannot be totally eliminated. The physician should weigh the risk and benefits of the use of Alphanate and should discuss these with the patient.
Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections particularly hepatitis C. Incubation in a solvent detergent mixture during the manufacturing process is designed to reduce the risk of transmitting viral infection. However, scientific opinion encourages hepatitis A and hepatitis B vaccinations for patients with hemophilia at birth or at the time of prognosis.
Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections particularly hepatitis C. Incubation in a solvent detergent mixture during the manufacturing process is designed to reduce the risk of transmitting viral infection. However, scientific opinion encourages hepatitis A and hepatitis B vaccinations for patients with hemophilia at birth or at the time of prognosis.
Special Precautions
General: Alphanate should not be administered at a rate exceeding 10 mL/min. Rapid administration of a Factor VIII concentrate may result in vasomotor reactions.
Some patients develop inhibitors to Factor VIII. Factor VIII inhibitors are circulating antibodies (ie, globulins) that neutralize the procoagulant activity of Factor VIII. No studies have been conducted with Alphanate to evaluate inhibitor formation. Therefore, it is not known whether there are greater, lesser or the same risks of developing inhibitors due to the use of Alphanate than there are with other antihemophilic factor preparations. Patients with these inhibitors may not respond to treatment with antihemophilic factor (human) or the response may be much less than would otherwise be expected; therefore, larger doses of antihemophilic factor (human) are often required. The management of bleeding in patients with inhibitors requires careful monitoring, especially if surgical procedures are indicated.
Nursing personnel and others who administer Alphanate should exercise appropriate caution when handling due to the risk of exposure to viral infection. Discard any unused contents into the appropriate safety container. Discard administration equipment after single use into the appropriate safety container. Do not re-sterilize components.
Some patients develop inhibitors to Factor VIII. Factor VIII inhibitors are circulating antibodies (ie, globulins) that neutralize the procoagulant activity of Factor VIII. No studies have been conducted with Alphanate to evaluate inhibitor formation. Therefore, it is not known whether there are greater, lesser or the same risks of developing inhibitors due to the use of Alphanate than there are with other antihemophilic factor preparations. Patients with these inhibitors may not respond to treatment with antihemophilic factor (human) or the response may be much less than would otherwise be expected; therefore, larger doses of antihemophilic factor (human) are often required. The management of bleeding in patients with inhibitors requires careful monitoring, especially if surgical procedures are indicated.
Nursing personnel and others who administer Alphanate should exercise appropriate caution when handling due to the risk of exposure to viral infection. Discard any unused contents into the appropriate safety container. Discard administration equipment after single use into the appropriate safety container. Do not re-sterilize components.
Risk of thromboembolic events & infections. Pregnancy.
Use in pregnancy: Animal reproduction studies have not been conducted with Alphanate. Therefore, it is not known whether it can cause fetal harm when administered to a pregnant woman or affect the reproductive capacity of a woman. Alphanate should be given to a pregnant woman only if clearly needed.
Use in children: Clinical trials for safety and effectiveness in pediatric patients ≤16 years have been conducted. Across well controlled half-life and recovery clinical trial in patients previously treated with factor VIII concentrates for hemophilia A, the one pediatric patient receiving Alphanate (solvent detergent) responded similarly when compared with 12 adult patients. No adverse events were reported in either pediatric or adult patients with Alphanate.
Use in children: Clinical trials for safety and effectiveness in pediatric patients ≤16 years have been conducted. Across well controlled half-life and recovery clinical trial in patients previously treated with factor VIII concentrates for hemophilia A, the one pediatric patient receiving Alphanate (solvent detergent) responded similarly when compared with 12 adult patients. No adverse events were reported in either pediatric or adult patients with Alphanate.
Use In Pregnancy & Lactation
Use in pregnancy: Animal reproduction studies have not been conducted with Alphanate. Therefore, it is not known whether it can cause fetal harm when administered to a pregnant woman or affect the reproductive capacity of a woman. Alphanate should be given to a pregnant woman only if clearly needed.
Adverse Reactions
Adverse reactions may include urticaria, fever, chills, nausea, vomiting, headache, somnolence or lethargy.
Occasionally, mild reactions occur following the administration of antihemophilic factor (human) eg, allergic reactions, chills, nausea or stinging at the infusion site. If a reaction is experienced and the patient requires additional antihemophilic factor (human), product from a different lot should be administered.
Massive doses of antihemophilic factor (human) have rarely resulted in acute hemolytic anemia, increased bleeding tendency or hyperfibrinogenemia. Alphanate contains blood group specific isoagglutins and when large and/or frequent doses are required in patients of blood groups A, B or AB, the patient should be monitored for signs of intravascular hemolysis and falling hematocrit. Should this condition occur, thus leading to progressive hemolytic anemia, the administration of serologically compatible type O red blood cells should be considered or the administration of antihemophilia factor (human) produced from group specific plasma should be considered.
Occasionally, mild reactions occur following the administration of antihemophilic factor (human) eg, allergic reactions, chills, nausea or stinging at the infusion site. If a reaction is experienced and the patient requires additional antihemophilic factor (human), product from a different lot should be administered.
Massive doses of antihemophilic factor (human) have rarely resulted in acute hemolytic anemia, increased bleeding tendency or hyperfibrinogenemia. Alphanate contains blood group specific isoagglutins and when large and/or frequent doses are required in patients of blood groups A, B or AB, the patient should be monitored for signs of intravascular hemolysis and falling hematocrit. Should this condition occur, thus leading to progressive hemolytic anemia, the administration of serologically compatible type O red blood cells should be considered or the administration of antihemophilia factor (human) produced from group specific plasma should be considered.
Storage
Store at temperatures between 2 °C and 8°C. Do not freeze to prevent damage to diluent vial. May be stored from refrigeration, record the data removed on the space provided on the carton.
conditions for details to ensure optimal shelf-life.
Action
Antihemophilic factor (human) is a constituent of normal plasma and is required for clotting. The administration of Alphanate temporarily increases the plasma level of this clotting factor, thus minimizing the hazard of hemorrhage. Following the administration of Alphanate during clinical trials, the mean in vivo half-life of Factor VIII observed in 12 adult subjects with severe hemophilia A was 17.9±9.6 hrs. In this same study, the in vivo recovery was 96.7±14.5% at 10 min post-infusion. Recovery at 10 min post-infusion was also determined as 2.4±0.4 iu FVIII rise/dL plasma per iu FVIII infused per kg body weight.
The solvent detergent treatment process has been shown by Horowitz, et al, to provide a high level of virus kill without compromising protein structure and function. The susceptibility of human pathogenic viruses eg, the human immunodeficiency viruses, hepatitis viruses, as well as marker viruses eg, sindbis virus and vesicular stomatitis virus (VSV), to inactivation by organic solvent detergent treatment has been discussed in the literature.
In vitro inactivation studies to evaluate the solvent detergent treatment step used in the manufacture of Alphanate employed an assay with a sensitivity of 2 logs of virus for the marker virus, VSV and sindbis virus. The studies demonstrated a log kill of ≥4.1 for VSV and ≥4.7 for sindbis virus, ≥11.1 logs of HIV-1 and ≥6.1 logs of HIV-2 were inactivated by the solvent detergent treatment step. The number of viral particles inactivated by the process represents the maximum amount of virus added initially to the sample, thus the results of the study indicate that all the added HIV virus was killed.
In another study, the dry heat cycle of 80°C for 72 hrs of the Alphanate manufacturing process was shown to inactivate ≥5.8 logs of hepatitis A virus (HAV).
The solvent detergent treatment process has been shown by Horowitz, et al, to provide a high level of virus kill without compromising protein structure and function. The susceptibility of human pathogenic viruses eg, the human immunodeficiency viruses, hepatitis viruses, as well as marker viruses eg, sindbis virus and vesicular stomatitis virus (VSV), to inactivation by organic solvent detergent treatment has been discussed in the literature.
In vitro inactivation studies to evaluate the solvent detergent treatment step used in the manufacture of Alphanate employed an assay with a sensitivity of 2 logs of virus for the marker virus, VSV and sindbis virus. The studies demonstrated a log kill of ≥4.1 for VSV and ≥4.7 for sindbis virus, ≥11.1 logs of HIV-1 and ≥6.1 logs of HIV-2 were inactivated by the solvent detergent treatment step. The number of viral particles inactivated by the process represents the maximum amount of virus added initially to the sample, thus the results of the study indicate that all the added HIV virus was killed.
In another study, the dry heat cycle of 80°C for 72 hrs of the Alphanate manufacturing process was shown to inactivate ≥5.8 logs of hepatitis A virus (HAV).
for pharmacodynamics and pharmacokinetics details.
MedsGo Class
Haemostatics
Features
Brand
Alphanate
Full Details
Dosage Strength
100 IU / ml (1000 IU / 10 ml)
Drug Ingredients
- Factor VIII
Drug Packaging
Lyophilized Powder for Injection (I.V.) 1's
Generic Name
Factor VIII Purified(Human)
Dosage Form
Lyophilized Powder For Injection (I.V.)
Registration Number
BR-566
Drug Classification
Prescription Drug (RX)