About This Calculator

This educational guide provides supplementary information for the Hadlima (adalimumab-bwwd) Dosing Calculator. The calculator is designed to help healthcare professionals determine the appropriate FDA-approved induction and maintenance dosing schedules for various indications. It is based on the official Prescribing Information and should not replace clinical judgment.

Outputs

After inputting the required patient parameters, the calculator provides the following information:

• Recommended Dosing Regimen: Clear guidance on both induction and maintenance doses.
• Induction Schedule: Specifies the dose for Day 1 and, where applicable, for Day 15.
• Maintenance Schedule: Details the recommended maintenance dose and administration frequency (e.g., 40 mg every other week).
• Weight-Based Dosing: For pediatric indications, the output is tailored to the patient's specific weight band.
• Clinical Notes: Includes important context, such as recommendations for dose escalation or concomitant therapy, as described in the Prescribing Information.

How to Use

To use the calculator, follow these simple steps:

1. Select Indication: Choose the appropriate FDA-approved indication from the dropdown menu for either adult or pediatric patients.
2. Enter Patient Age: Input the patient's age in years. The tool will validate if the age is within the approved range for the selected indication.
3. Enter Patient Weight (if required): For indications where dosing is weight-based (primarily pediatric), the weight field will appear. Enter the patient's weight and select the unit (kg or lbs).
4. Calculate: Click the "Calculate" button to view the recommended dosing regimen based on the provided information. The "Reset" button clears all fields.

Dosing Overview

Hadlima (adalimumab-bwwd) is administered via subcutaneous injection. Dosing regimens vary significantly based on the indication and patient population.

• Induction Dosing: For conditions like Crohn's Disease, Ulcerative Colitis, and Hidradenitis Suppurativa, a higher induction dose is required to establish therapeutic levels quickly. This typically involves a dose on Day 1 followed by a second, smaller dose on Day 15.
• Maintenance Dosing: Following induction, patients transition to a lower, regular maintenance dose. The most common maintenance dose for adults is 40 mg every other week, though weekly dosing may be required for some conditions or in cases of inadequate response.
• Pediatric Dosing: Dosing in pediatric patients is typically based on body weight, with specific dose recommendations for different weight bands.

Switching

This calculator does not provide guidance on switching from other biologics to Hadlima. The decision to switch therapies, including the determination of an appropriate loading dose or washout period, should be based on clinical judgment, the specific agents involved, and current clinical guidelines. Always consult the full Prescribing Information for Hadlima and the drug being discontinued.

Missed Dose

If a patient misses a dose of Hadlima, they should be advised to inject the missed dose as soon as they remember. They should then take their next dose at the regularly scheduled time. This re-establishes the dosing schedule. Patients should not take two doses at the same time to make up for a missed one.

Safety Alerts

Frequently Asked Questions (FAQ)

• Why is weight required for pediatric indications but not most adult ones?
  Dosing for children and adolescents is weight-based to ensure appropriate drug exposure, as their metabolism and body size differ from adults. Most adult indications have a fixed dose that has been proven effective across a wide range of adult body weights.
• Does the calculator account for concomitant methotrexate (MTX) use in Rheumatoid Arthritis?
  The calculator provides the standard dosing. However, it displays a note from the Prescribing Information recommending consideration of weekly dosing for patients not on concomitant MTX.
• What should I do if my pediatric patient's weight is on the border of a dosing band?
  The calculator uses the defined weight bands from the Prescribing Information. Clinical judgment is required for borderline cases. Generally, the dose for the band the patient falls into should be used.
• Can this tool be used for off-label indications?
  No. This calculator is strictly for educational purposes and only includes FDA-approved indications and dosing regimens as listed in the Hadlima Prescribing Information.
• What version of the Prescribing Information is this calculator based on?
  The calculator logic and data are based on the full Prescribing Information dated July 2023.
• Does the calculator provide guidance on dose escalation?
  The calculator output includes notes where the PI suggests considering dose escalation (e.g., from every other week to weekly) for patients who experience a decrease in response. It does not determine if a specific patient needs escalation.
• What are the available formulations for Hadlima shown in the tool?
  The tool's notes mention the available formulations: a 40 mg/0.4 mL Pen and Pre-filled Syringe, and a 20 mg/0.2 mL Pre-filled Syringe.
• What if a calculated dose is 10 mg?
  As noted by the calculator, doses other than 20 mg or 40 mg (such as 10 mg for low-weight pediatric JIA) require the use of an alternative adalimumab product, as Hadlima is not available in a 10 mg formulation.

References

• HADLIMA (adalimumab-bwwd) Full Prescribing Information. U.S. Food and Drug Administration. Revised: 07/2023.
• Hadlima HCP Website. Organon.
• Drugs@FDA Database. U.S. Food and Drug Administration.