About this Calculator

The Recombinate [Antihemophilic Factor (Recombinant)] dose calculator is a clinical support tool designed to assist healthcare professionals in determining the appropriate dosage for patients with Hemophilia A. It provides calculations for both on-demand treatment of bleeding episodes and for routine prophylaxis to prevent bleeds, based on established dosing principles.

Outputs Explained

After entering the required patient information, the calculator provides a clear summary of the recommended dosing strategy. The key outputs include:

  • Total Calculated Dose: The precise dose in International Units (IU) required to achieve the desired Factor VIII level, calculated based on patient weight and the target increase.
  • Recommended Vial Combination: A practical suggestion for which available vial strengths to combine to most closely achieve the calculated dose, aiming to minimize waste and the number of administrations.
  • Total Administered Dose: The final dose in IU that will be delivered by using the recommended vial combination. This may be slightly higher than the calculated dose due to rounding up to the nearest available vial size.
  • Expected Factor VIII Peak: An estimate of the patient’s peak Factor VIII plasma concentration (%) after the infusion of the administered dose. This is only shown for on-demand calculations.

How to Use the Tool

To ensure accurate results, follow these steps when inputting patient data:

  1. Enter Patient Weight: Input the patient’s current body weight and select the appropriate unit (kg or lbs).
  2. Select Calculation Mode: Choose “On-Demand Treatment” for active bleeds or “Prophylaxis” for routine preventive dosing.
  3. For On-Demand Treatment:
    • Select the Bleed Severity from the presets (Minor, Moderate, Major) to automatically populate the desired Factor VIII level, or choose “Custom” to enter a specific target percentage.
    • Optionally, enter the patient’s Current Factor VIII Level if known; otherwise, the tool assumes a baseline of <1%.
  4. For Prophylaxis:
    • Enter the prescribed Prophylactic Dose and specify if the value is in IU/kg or a Total IU amount.
  5. Select Available Vials: Check the boxes corresponding to the Recombinate vial strengths available in your clinic or pharmacy. This is crucial for an accurate vial combination recommendation.

Dosing Overview

The dosage and duration of treatment depend on the severity of the Factor VIII deficiency, the location and extent of bleeding, and the patient’s clinical condition.

On-Demand Treatment: The required dose is calculated using the established formula:
Dose (IU) = Body Weight (kg) × Desired Factor VIII Increase (% of normal) × 0.5 (IU/kg per % increase)

Prophylaxis: A common prophylactic regimen for previously treated patients (PTPs) is 25 IU/kg of body weight every other day. Regimens may be adjusted based on the individual patient’s response and clinical needs.

Switching to Recombinate

When switching a patient from another Factor VIII product, the dosing regimen should be guided by their clinical history, response to previous treatments, and the treating physician’s judgment. Close monitoring for inhibitor development is recommended, especially in previously untreated patients (PUPs).

Missed Dose

For patients on a prophylactic regimen, if a dose is missed, it should be administered as soon as it is remembered. The subsequent doses should then be rescheduled to maintain the correct interval from the most recent dose. Patients should not administer a double dose to make up for a missed one. Advise patients to contact their healthcare provider or hemophilia treatment center for specific guidance.

Safety Alerts

Healthcare professionals should be aware of the following potential adverse reactions and safety considerations:

  • Hypersensitivity Reactions: Allergic-type hypersensitivity reactions, including anaphylaxis, are possible. Patients should be informed of the early signs such as hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
  • Inhibitor Development: The formation of neutralizing antibodies (inhibitors) to Factor VIII is a known complication. Patients should be monitored regularly for the development of inhibitors through appropriate clinical observations and laboratory tests.
  • Monitoring: During treatment, it is recommended to perform periodic plasma Factor VIII activity level assays to confirm that adequate levels have been achieved and are maintained.

Frequently Asked Questions

Why is the “Total Administered Dose” different from the “Calculated Dose”?

The calculated dose is a precise medical requirement. Since medication comes in fixed-strength vials, it’s often impossible to match this dose exactly. The tool recommends a vial combination that meets or slightly exceeds the calculated dose to ensure therapeutic efficacy, resulting in the “Total Administered Dose.”

How does the calculator determine the vial combination?

The algorithm prioritizes using the largest available vial sizes first to meet the bulk of the required dose. This strategy helps minimize the total number of vials needed for reconstitution and administration, simplifying the infusion process.

What happens if I don’t enter a “Current Factor VIII Level”?

If this field is left blank, the calculator assumes a baseline Factor VIII level of less than 1%, which is typical for patients with severe Hemophilia A.

Is this calculator suitable for patients with Factor VIII inhibitors?

No. This tool is intended for patients without inhibitors to Factor VIII. Patients with inhibitors require specialized treatment with bypassing agents or immune tolerance induction, which this calculator does not address.

Why did the “Desired Factor VIII Level” field become read-only?

When you select a pre-defined Bleed Severity (e.g., “Minor,” “Moderate”), the tool automatically populates the corresponding clinically recommended target Factor VIII level. To enter a different value, you must select “Custom” from the severity dropdown.

What if my available vial strength is not listed in the options?

The calculator can only recommend combinations from the vial strengths selected. If a strength is not available as a checkbox, you cannot include it in the calculation.

Does this tool account for individual patient pharmacokinetic (PK) differences?

No, the calculator uses a standard population-based PK formula (an in vivo recovery of 2% per IU/kg). Individual patient PK profiles may vary, and dose adjustments should be made based on clinical response and laboratory measurements.

How often should prophylactic doses be administered?

While the prescribing information suggests a starting regimen of 25 IU/kg every other day, the frequency can be adjusted by a physician to two or three times weekly based on the patient’s bleeding phenotype and lifestyle.

References

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