About Avsola (infliximab-axxq) Dosing

This information provides context for the Avsola (infliximab-axxq) Dosing Calculator. Avsola is a biosimilar to Remicade (infliximab) and is administered as an intravenous infusion. Dosing is weight-based and varies according to the specific indication, requiring careful calculation to ensure patient safety and therapeutic efficacy. The standard concentration after reconstitution is 10 mg/mL.

Outputs Explained

The calculator provides the following key outputs for administration planning:

• Total Dose to Administer (mg): The precise, weight-based dose (Patient Weight in kg × Dose in mg/kg) that the patient should receive.
• Total Number of Vials Required: Avsola is supplied in 100 mg single-dose vials. This calculation determines the minimum number of vials needed by rounding the total dose up to the nearest 100 mg.
• Total Volume to Withdraw (mL): The volume of reconstituted Avsola solution (10 mg/mL) needed to achieve the total calculated dose.
• Total Wasted Product (mg): The amount of reconstituted drug remaining in the final vial after the required volume has been withdrawn.

How to Use the Calculator

Follow these steps to ensure accurate dose calculation:

1. Select Clinical Indication: Choose the appropriate FDA-approved indication from the dropdown menu, as dosing schedules and amounts differ.
2. Enter Patient Weight: Input the patient’s current weight. Ensure the correct unit (kg or lbs) is selected, as the tool will convert lbs to kg for the calculation.
3. Choose Dose Type: Select “Induction Dose” for the initial loading series (Weeks 0, 2, and 6) or “Maintenance Dose” for subsequent, regularly scheduled infusions.
4. Select Dose Level (if applicable): For certain indications like Crohn’s Disease and Rheumatoid Arthritis, an escalated dose (e.g., 10 mg/kg) may be selected for patients with an inadequate response, based on clinical judgment.

Dosing Overview

Avsola administration follows a two-phase schedule for most indications:

• Induction Phase: An initial series of three doses is administered at Week 0, Week 2, and Week 6 to establish therapeutic levels of the drug.
• Maintenance Phase: Following induction, doses are administered at regular intervals to maintain therapeutic levels. This is typically every 8 weeks, with the exception of Ankylosing Spondylitis (every 6 weeks).

Switching and Interchangeability

Avsola is an interchangeable biosimilar to Remicade. A healthcare professional may switch a patient from Remicade to Avsola. This decision should be made based on clinical judgment and in accordance with local regulations. No additional induction doses are typically needed when switching a patient who is stable on infliximab maintenance therapy.

Missed Dose Protocol

If a patient misses a scheduled maintenance dose of Avsola, they should contact their healthcare provider immediately. The provider will determine the best course of action and schedule the next infusion. Patients should not attempt to “double up” on doses.

Safety Alerts

Avsola has a Boxed Warning regarding the risk of serious infections and malignancies. Patients should be tested for latent tuberculosis (TB) prior to starting therapy and monitored for signs of infection during treatment. Healthcare providers should consult the full Prescribing Information for a complete list of warnings, precautions, and adverse events.

Frequently Asked Questions (FAQ)

Why is the maintenance schedule for Ankylosing Spondylitis different?

The approved maintenance schedule for Ankylosing Spondylitis is every 6 weeks, which differs from the more common 8-week interval for other indications. This is based on the clinical trial data that established its efficacy for this condition.

What does dose escalation mean?

For certain indications like adult Crohn’s Disease or Rheumatoid Arthritis, if a patient’s response to the standard dose is inadequate, the Prescribing Information allows for an increase in the dose (e.g., to 10 mg/kg) or an increase in the frequency of administration. The calculator allows for modeling the 10 mg/kg dose escalation.

How is the number of vials calculated?

The total dose in mg is divided by 100 (since each vial contains 100 mg). The result is always rounded up to the next whole number to ensure enough drug is available for reconstitution. For example, a calculated dose of 350 mg would require 4 vials.

Can this calculator be used for patients under 6 years of age?

No. The safety and effectiveness of Avsola have not been established in pediatric patients with Ulcerative Colitis or Crohn’s Disease under 6 years of age, or for other pediatric indications.

What happens if I enter weight in pounds (lbs)?

The calculator automatically converts the weight from pounds to kilograms (kg) using the standard conversion factor (1 kg ≈ 2.20462 lbs) before calculating the final dose.

Why is there “Wasted Product”?

Because Avsola comes in 100 mg vials and dosing is weight-based, it is rare that the calculated dose is an exact multiple of 100. Any reconstituted drug left in the final vial after withdrawing the precise dose is considered wasted product and must be discarded.

Does this tool replace the official Prescribing Information?

No. This tool is for educational and informational purposes only. It is not a substitute for clinical judgment or the official, FDA-approved Prescribing Information, which should always be the primary reference.

What is the final infusion volume?

The total volume of reconstituted Avsola solution should be diluted in a 250 mL infusion bag of 0.9% Sodium Chloride Injection, USP, prior to administration. Lower volumes may be considered for pediatric patients weighing 35 kg or less.

References

• AVSOLA (infliximab-axxq) Prescribing Information. U.S. Food and Drug Administration.
• Avsola Healthcare Professional Website. Amgen Inc.
• Biologic Therapy. Crohn’s & Colitis Foundation.
• Clinical Practice Guidelines. American College of Rheumatology.