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ALPHANATE is a brand name for Von Willebrand Factor, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Adverse Drug Reaction Overview Allergic reactions (which may include angioedema, chest tightness, hypotension, rash, nausea, vomiting, paresthesia, restlessness, wheezing and dyspnea), have been observed with ALPHANATE (antihemophilic factor/von Willebrand factor complex [human]).
These may sometimes progress to anaphylaxis. Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Clinical Trial Adverse Drug Reactions Safety data were obtained from a single large prospective clinical trial with ALPHANATE in von Willebrand Disease involving 81patients being treated for bleeding episodes and/or prophylaxis prior to surgery.
A retrospective chart review study for 39 patients with von Willebrand Disease was performed. Additionally, a post-market study in 23 patients for another indication, evaluating long-term safety has been conducted. 1 (median 10, range 2 - 17) for the repeated dose treatment.
The results from these studies involved a total of 2116 infusions. 5) Abnormal Hematologic and Clinical Chemistry Findings Standard hematology and chemistry evaluations were performed in all clinical trials described above. There were no issues identified for any laboratory parameter in any of the studies, which was assessed as being related to treatment with ALPHANATE.
Post-Market Adverse Drug Reactions There is over 40 years post-market experience with ALPHANATE and its predecessor products from the same manufacturer. The most common post-marketing ADRs reported include allergic/hypersensitivity reactions, nausea, fever, joint pain, fatigue, and infusion site pain.
Adverse events reported in post-market usage have been consistent with those observed in the prospective clinical study. DRUG INTERACTIONS Drug-Drug Interactions No interactions of human coagulation factor VIII or von Willebrand factor products with other medicinal products are known.
Drug-Food Interactions Interactions of human coagulation factor VIII or von Willebrand factor products with foods have not been evaluated, but none are known or suspected. Drug-Herb Interactions Interactions of human coagulation factor VIII or von Willebrand factor products with herbs have not been evaluated, but none are known or suspected.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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ALPHANATE® Product Monograph Page 8 of 25 Drug-Laboratory Interactions There were no issues raised for any laboratory parameters in any of the studies conducted with ALPHANATE (antihemophilic factor/von Willebrand factor complex [human]).
Drug-Lifestyle Interactions ALPHANATE has no or negligible influence on the ability to drive and use machines. DOSAGE AND ADMINISTRATION Dosing Considerations For intravenous injection only, following reconstitution. Treatment with ALPHANATE (antihemophilic factor/von Willebrand factor complex [human]) should be initiated under the supervision of a physician experienced in the treatment of hemostatic disorders.
Generally, 1 IU/kg VWF:RCo raises the circulating level of VWF:RCo by 2%. 4 IU/ml (40%) should be achieved. Each vial of ALPHANATE contains von Willebrand Factor:Ristocetin Cofactor (VWF:RCo), which is expressed on the label in International Units (IU) VWF:RCo/vial for the treatment of VWD.
Additionally, ALPHANATE contains the antihemophilic factor (AHF) potency (FVIII:C activity) expressed on the label in IU FVIII/vial. Recommended Dose and Dosage Adjustment Prevention and treatment of hemorrhage or surgical bleeding in Patients with von Willebrand Disease Dosage and duration of treatment depend on the severity of the VWF deficiency, the location and extent of bleeding, and the patient’s clinical condition.
Careful control of replacement therapy is especially important in cases of major surgery or life-threatening bleeding episodes. The dose recommendations apply to both adult and pediatric patients. ALPHANATE® Product Monograph Page 9 of 25 Table 2 - ALPHANATE Dosing Guidelines for Patients with von Willebrand Disease Indicated Use VWF:RCo Dose Target levels Safety / Monitoring Bleeding Episode – initial dose 40 to 60 IU/kg 80-120 mg/dL Peak and trough activity levels of both FVIII:C and VWF:RCo should be taken at least once daily, and neither should exceed 150 IU/dL .
Bleeding Episode – subsequent doses * 40 - 60 IU/kg 80-120 mg/dL Surgical Prophylaxis (1 hour pre-op) 60 – 75 IU/kg 120-150 mg/dL Post-Operative* 40 – 60 IU/kg 80-120 mg/dL * additional doses should be re-administered based on clinical judgement at 12 - 24 hour intervals to maintain hemostasis until healing occurs.
The dose and duration of the treatment depend on the clinical status of the patient, the type and severity of bleeding, and both VWF:RCo and FVIII:C levels. Dosing may be reduced in post-operative patients after the 3rd post-operative day.
Treatment guidelines above typically apply to all VWD types, although an initial dose of up to 80 IU/kg of VWF may be required, especially in patients with type 3 von Willebrand disease where maintenance of adequate levels may require greater doses than in other types of von Willebrand disease.
When using a FVIII-containing von Willebrand […]