About this Information

This section provides supplementary clinical context for the Octagam Dose Calculator. It details the tool's outputs, usage instructions, and an overview of the dosing regimens for Chronic Immune Thrombocytopenic Purpura (ITP) and Dermatomyositis (DM) based on the product's prescribing information. This information is intended for healthcare professionals and should not replace clinical judgment.

Outputs

After entering the patient's weight and selecting an indication, the calculator provides the following key outputs for a complete treatment course:

  • Total Dose (g): The total grams of Immune Globulin Intravenous (Human), 10% required, calculated as 2 g/kg of actual body weight.
  • Daily Dose (g): The recommended dose in grams to be administered per day. For ITP, this is a 2-day regimen. For DM, it is divided over 2 to 5 days.
  • Daily Volume (mL): The corresponding volume of Octagam® 10% solution needed for each daily infusion.
  • Vial Combination: An optimized list of required vials (e.g., 20 mL, 50 mL, 100 mL, 200 mL, 300 mL) to prepare the daily dose with minimal waste.
  • Infusion Rate Schedule: A patient-specific table outlining the recommended titration schedule in mL/hour, starting from the initial rate and progressing to the maximum tolerated rate.

How to Use

To use the calculator, follow these steps:

  1. Enter Patient Weight: Input the patient's actual body weight into the designated field.
  2. Select Weight Unit: Choose either kilograms (kg) or pounds (lbs) from the dropdown menu. The tool will automatically convert lbs to kg for the calculation.
  3. Select Indication: Choose the appropriate indication for use—either Chronic Immune Thrombocytopenic Purpura (ITP) or Dermatomyositis (DM).
  4. Specify Infusion Duration (for DM only): If DM is selected, specify if the total 2 g/kg dose should be divided over 2, 3, 4, or 5 consecutive days.
  5. Calculate: Press the "Calculate" button to generate the complete dosing and administration plan.

Dosing Overview

The dosing for Octagam® 10% is based on the patient's body weight and the specific indication, as outlined in the prescribing information.

Chronic Immune Thrombocytopenic Purpura (ITP)

The recommended dose is 1 g/kg per day for 2 consecutive days, resulting in a total dose of 2 g/kg. The administration schedule is fixed for this indication.

Dermatomyositis (DM)

The recommended total dose is 2 g/kg, administered in divided doses over 2 to 5 consecutive days. The initial infusion course is typically divided over 2 days (1 g/kg/day), but clinicians may adjust the administration schedule based on patient tolerance and clinical context.

Switching

When switching between different Immune Globulin Intravenous (Human) (IVIg) products, exercise caution. IVIg products are not bioequivalent and may differ in their formulation, manufacturing process, osmolality, and immunoglobulin A (IgA) content. Always consult the full prescribing information for both the previous and new product. Re-evaluation of the patient's tolerability, including adjustments to the infusion rate, may be necessary.

Missed Dose

Octagam® 10% for ITP and DM is administered as a course over consecutive days in a monitored healthcare setting. A missed dose is unlikely in this context. If an interruption in the treatment schedule occurs, healthcare providers should refer to their institution's protocol or consult the product's prescribing information to determine the appropriate course of action for resuming the infusion schedule.

Safety Alerts

Treatment with IVIg products, including Octagam® 10%, carries potential risks. Key warnings and precautions include, but are not limited to:

  • Thrombosis: Thrombotic events have been reported. Monitor patients with known risk factors.
  • Renal Dysfunction/Failure: Acute renal dysfunction, osmotic nephrosis, and death may occur. Ensure patients are not volume-depleted before administration.
  • Hypersensitivity: Severe hypersensitivity reactions can occur. Have epinephrine available immediately to treat any acute anaphylactic reaction.
  • Aseptic Meningitis Syndrome (AMS): AMS has been reported and typically begins within several hours to 2 days following IVIg treatment.

This is not a complete list of potential adverse events. Always refer to the full Prescribing Information before administration.

FAQ

Frequently Asked Questions

1. Why is the total dose (2 g/kg) the same for both ITP and DM?
The FDA-approved prescribing information for Octagam® 10% specifies a total therapeutic dose of 2 g/kg for both indications, though the administration schedule differs.

2. Does the calculator use ideal or actual body weight?
The calculations are based on the patient's actual body weight, as is standard practice for IVIg dosing according to the product label.

3. How does the tool determine the optimal number of vials?
The calculator uses an algorithm to determine the most efficient combination of available vial sizes (30g, 20g, 10g, 5g, 2g) to meet the daily dose requirement, aiming to minimize product waste.

4. Can this calculator be used for other IVIg products or concentrations?
No. This tool is specifically designed for Octagam® 10% (100 mg/mL) solution. Do not use it for other products, including Octagam® 5%, as infusion rates and volumes will differ.

5. What is the maximum infusion rate recommended by the calculator?
The maximum rate for a tolerated patient is 4.0 mg/kg/min for both ITP and DM, which is converted to a patient-specific mL/hour rate.

6. Why are the initial infusion rates different for ITP and DM?
The prescribing information specifies different initial titration schedules. The rate for DM (0.5 mg/kg/min) is lower than for ITP (1.0 mg/kg/min) to ensure patient tolerability, which is reflected in the calculator's output.

7. What if the patient's weight is only available in pounds (lbs)?
The calculator includes a unit selector. If you choose "lbs", the tool automatically converts the weight to kilograms (kg) using the standard conversion factor (1 kg ≈ 2.20462 lbs) before performing dose calculations.

8. How is the ITP regimen administered?
The standard regimen for ITP is 1 g/kg administered daily for two consecutive days. The calculator defaults to this 2-day schedule.

9. Is this tool a replacement for the official Prescribing Information?
No. This calculator is an educational and support tool. All calculations and treatment decisions must be verified against the official, most current Prescribing Information and guided by independent clinical judgment.

References

  1. Octagam 10% [prescribing information]. Paramus, NJ: Octapharma USA Inc.; 2023. https://www.octagam10.com/pi/
  2. U.S. Food and Drug Administration. Drugs@FDA: FDA-Approved Drugs - Octagam 10%. https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
  3. Octapharma USA. Octagam 10% for Healthcare Professionals. https://www.octagam10.com/hcp/
  4. Dalakas MC. Intravenous immunoglobulin in the treatment of autoimmune neuromuscular diseases: a status report. Muscle Nerve. 2004;30(5):555-574. https://pubmed.ncbi.nlm.nih.gov/15389682/
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