About This Tool

This Hyrimoz (adalimumab-adaz) Dosing Calculator is designed to assist healthcare professionals in determining the appropriate dosing regimen based on the FDA-approved prescribing information. It considers patient-specific factors such as indication, age, and weight to provide guidance on induction and maintenance dosing schedules.

Outputs

After entering the required patient data, the calculator provides a recommended dosing regimen, which includes:

• Induction Dose: The initial, higher dose required to rapidly achieve therapeutic levels, particularly for conditions like Crohn's Disease, Ulcerative Colitis, and Hidradenitis Suppurativa.
• Maintenance Dose: The ongoing dose and frequency (e.g., 40 mg every other week or every week) for long-term management of the condition.
• Dosing Schedule: A timeline for administration, such as doses on Day 1, Day 15, and Day 29.
• Important Notes: Clinical considerations, such as the need for concomitant methotrexate (MTX) or warnings for specific patient populations.

How to Use

To use the calculator, please follow these steps:

1. Select Indication: Choose the specific inflammatory condition for which Hyrimoz is being prescribed from the dropdown menu.
2. Enter Patient Age: Input the patient's age in years. This is critical as some indications have age restrictions.
3. Enter Patient Weight: For pediatric and adolescent indications, patient weight is required as dosing is weight-based. You can enter the weight in kilograms (kg) or pounds (lbs).
4. Specify Methotrexate Use: For Rheumatoid Arthritis, indicate whether the patient is on concomitant MTX, as this may influence dosing frequency recommendations.
5. Calculate Dose: Click the "Calculate Dose" button to generate the specific regimen.

Dosing Overview

Hyrimoz dosing is highly specific to the indication. While many adult conditions like Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis use a standard maintenance dose of 40 mg every other week, others require a more complex induction phase.

For example, adult Crohn's Disease and Ulcerative Colitis begin with a 160 mg induction dose on Day 1, followed by 80 mg on Day 15, before settling into a 40 mg maintenance dose. In contrast, adult Hidradenitis Suppurativa follows a similar induction but moves to a more frequent 40 mg weekly dosing schedule for maintenance.

Pediatric dosing is typically weight-based, with different tiers for patients across various weight brackets (e.g., 10 to <15 kg, 15 to <30 kg, ≥30 kg).

Switching

The decision to switch a patient from another biologic to Hyrimoz, or between adalimumab biosimilars, rests on clinical judgment. Factors to consider include prior treatment response, adverse events, and patient preference. A washout period may or may not be necessary. Always consult the full prescribing information and relevant clinical guidelines when considering a switch in therapy.

Missed Dose

If a patient misses a dose of Hyrimoz, they should be instructed to administer the injection as soon as they remember. They should then take their next dose at their regular scheduled time. This will re-establish the correct dosing schedule. Patients should not take two doses at the same time to make up for a missed one.

Safety Alerts

Hyrimoz (adalimumab-adaz) has a Boxed Warning regarding serious infections and malignancy.

• Serious Infections: Patients treated with adalimumab are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), invasive fungal infections, and other opportunistic pathogens.
• Tuberculosis (TB): All patients should be evaluated for TB risk factors and tested for latent TB infection prior to initiating treatment. Treatment for latent TB should be initiated prior to starting Hyrimoz.
• Malignancy: Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products.

Frequently Asked Questions (FAQ)

• Why is patient weight required for some indications but not others?
  Dosing for several pediatric and adolescent indications (JIA, Pediatric CD, Adolescent HS, Pediatric UV) is weight-based to ensure proper exposure. For most adult indications, a fixed dose is used.
• Does this calculator account for concomitant methotrexate (MTX) use?
  Yes, for Rheumatoid Arthritis (RA), the tool allows you to specify MTX use. For patients with an inadequate response not on MTX, an increase in dosing frequency may be considered.
• What is the difference between the induction and maintenance dose?
  The induction dose is a higher initial dose used to quickly control inflammation. The maintenance dose is a lower, regular dose used for long-term disease management.
• How is the 160 mg induction dose administered?
  The 160 mg dose cannot be given as a single injection. It can be administered as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days.
• Why is the maintenance dose for Hidradenitis Suppurativa weekly instead of every other week?
  Clinical trials for Hidradenitis Suppurativa demonstrated the efficacy of a 40 mg weekly maintenance dosing schedule, which is more frequent than for many other adalimumab indications.
• Can I use this calculator for Humira® or other adalimumab biosimilars?
  No. This tool is based specifically on the FDA-approved Prescribing Information for Hyrimoz (adalimumab-adaz). While dosing is often similar, you must consult the specific label for any other product.
• What happens if I enter an age or weight outside the approved range?
  The calculator will display a warning message indicating that Hyrimoz is not indicated or that the patient's parameters fall outside the approved range for that specific condition.
• Does the tool provide guidance on all available Hyrimoz presentations?
  The tool's output notes provide general guidance on how different doses can be achieved using available syringe and pen presentations (e.g., 10mg, 20mg, 40mg, 80mg).

References

• Hyrimoz (adalimumab-adaz) Full Prescribing Information. Sandoz Inc. Last accessed October 2023.
• FDA Drugs@FDA: Hyrimoz (adalimumab-adaz) Label Information.
• Hyrimoz Healthcare Professional Website. Sandoz Inc.
• Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Rheumatol. 2016 Jan;68(1):1-26.