Alphanate

What is Alphanate?

• Alphanate (Antihemophilic Factor/von Willebrand Factor Complex (Human)) contains antihemophilic factor (FVIII) and von Willebrand factor (VWF), constituents of normal plasma.
• Alphanate is prepared from pooled human plasma by cryoprecipitation of FVIII, fractional solubilization, and further purification employing heparin-coupled, cross-linked agarose which has an affinity to the heparin binding domain of VWF/FVIII:C complex.

What are the uses of this medicine?

Alphanate (Antihemophilic Factor/von Willebrand Factor Complex (Human)) is used for:

• Control and prevention of bleeding in adult and pediatric patients with hemophilia A.
• Surgical and/or invasive procedures in adult and pediatric patients with von Willebrand Disease in whom desmopressin (DDAVP) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery.

How does this medicine work?

• Alphanate contains antihemophilic factor (FVIII) and von Willebrand factor (VWF), constituents of normal plasma.
• FVIII is an essential cofactor in activation of factor X leading to formation of thrombin and fibrin.
• VWF promotes platelet aggregation and platelet adhesion on damaged vascular endothelium; it also serves as a stabilizing carrier protein for the procoagulant protein FVIII.
• After administration, Alphanate temporarily replaces the missing coagulation factor VIII and von Willebrand factor needed for effective hemostasis.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Is this medicine FDA approved?

• Factor VIII was first identified in the 1940s and became available as a medication in the 1960s.
• Recombinant factor VIII was first made in 1984 and approved for medical use in the United States in 1992.

How should this medicine be used?

Recommended dosage: Treatment and Prevention of Bleeding Episodes and Excess Bleeding During and After Surgery in Patients with Hemophilia A:

• Dose (units) = body weight (kg) x desired FVIII rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL).
• Dosing frequency determined by the type of bleeding episode and the recommendation of the treating physician.

Treatment and Prevention of Excess Bleeding During and After Surgery or Other Invasive Procedures in Patients with von Willebrand Disease:

• Adults: Pre-operative dose of 60 IU VWF:RCo/kg body weight; subsequent doses of 40-60 IU VWF:RCo/kg body weight.
• Pediatric: Pre-operative dose of 75 IU VWF:RCo/kg body weight; subsequent doses of 50-75 IU VWF:RCo/kg body weight.

Administration:

• For intravenous injection after reconstitution only.
• Treatment with Alphanate should be initiated under the supervision of a physician experienced in the treatment of hemophilia.
• Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
• Do not refrigerate after reconstitution. Store reconstituted Alphanate at room temperature (not to exceed 30 °C) prior to administration, but administer intravenously within three hours.
• Use plastic disposable syringes.
• Do not administer Alphanate at a rate exceeding 10 mL/minute.
• Discard any unused contents into the appropriate safety container.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a lyophilized powder for intravenous injection after reconstitution in single dose vials containing 250, 500, 1000, 1500 IU and 2000 IU FVIII

This medicine is available in fallowing brand namesː

• Alphanate

What side effects can this medication cause?

The most common side effects of this medicine include:

• pruritus
• headache
• back pain
• paresthesia
• respiratory distress
• facial edema
• pain
• rash
• chills

• Serious adverse drug reactions (ADRs) observed in patients receiving Alphanate include anaphylaxis/hypersensitivity reactions.
• Thromboembolic events also have been observed in patients receiving Alphanate for VWD.

What special precautions should I follow?

• Anaphylaxis and severe hypersensitivity reactions are possible with Alphanate. Discontinue use of Alphanate if hypersensitivity symptoms occur, and initiate appropriate treatment.
• Development of procoagulant activity-neutralizing antibodies (inhibitors) has been detected in patients receiving FVIII-containing products. Carefully monitor patients treated with AHF products for the development of FVIII inhibitors by appropriate clinical observations and laboratory tests. If expected plasma FVIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an appropriate assay that measures FVIII inhibitor concentration.
• Thromboembolic events have been reported in von Willebrand Disease patients receiving replacement therapy with Antihemophilic Factor/von Willebrand Factor Complexes, especially in those with known risk factors for thrombosis including but not limited to elderly age, previous thrombosis, metabolic syndrome, cancer, surgery, oral contraceptive and hormone therapy, diabetes, hypertension, hyperlipidemia, smoking, and pregnancy. Consider antithrombotic measures in VWD patients at risk for thrombosis.
• Alphanate contains blood group specific isoagglutinins. Consider alternative therapy should this condition worsen despite discontinuation of Alphanate.
• Rapid administration of a FVIII concentrate may result in vasomotor reactions. Do not administer Alphanate at a rate exceeding 10 mL/minute.
• Because Alphanate is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob Disease (vCJD) agent and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
• Monitor for development of FVIII and VWF inhibitors. Perform appropriate assays to determine if FVIII and/or VWF inhibitor(s) are present if bleeding is not controlled with expected dose of Alphanate.
• To contact their healthcare provider or go to the emergency department right away if a hypersensitivity reaction occurs. Early signs of hypersensitivity reactions may include rash, hives, itching, facial swelling, tightness of the chest, and wheezing.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• It is also not known whether Alphanate can cause fetal harm when administered to a pregnant woman or affect reproductive capacity.
• Alphanate should be given to a pregnant woman only if clearly needed.

Can this medicine be used in children?

• The safety and efficacy of Alphanate have been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX

Inactive Ingredients:

• Albumin Human
• arginine
• histidine

Who manufactures and distributes this medicine?

Distr. by:

• West-Ward Pharmaceuticals Corp.
• Eatontown, NJ

What should I know about storage and disposal of this medication?

• Alphanate is stable for three years, up to the expiration date printed on its label, provided that the storage temperature does not exceed 25 °C (77 °F).
• Do not freeze.

• Dailymed label info on Alphanate
• FDA Alphanate

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