About This Information
This section provides supplemental information related to the Cosentyx® Dosing Calculator calculator. The content covers the tool’s intended use, a summary of dosing regimens, and answers to frequently asked questions. This information is for educational purposes and is not a substitute for clinical judgment or the full Prescribing Information.
Outputs Explained
Based on the inputs provided, the calculator determines a recommended subcutaneous dosing regimen. The output includes:
- Loading Dose: The initial, higher-frequency dosing schedule to quickly achieve therapeutic levels. This is typically administered weekly for the first five weeks (Weeks 0, 1, 2, 3, and 4).
- Maintenance Dose: The ongoing dosing schedule after the loading phase is complete, typically administered every 4 weeks.
- Specific Dose Strength: The amount of secukinumab in milligrams (e.g., 75 mg, 150 mg, or 300 mg) for each injection.
How to Use the Calculator
To determine the appropriate dosing regimen, follow these steps:
- Select Indication: Choose the condition being treated from the dropdown menu (e.g., Plaque Psoriasis, Psoriatic Arthritis).
- Select Patient Population: Specify whether the patient is an adult or a pediatric patient (≥ 6 years).
- Enter Patient Weight: For pediatric indications, patient weight is required to determine the correct dose. Enter the value and select the unit (kg or lbs).
- Answer Conditional Questions: For certain indications like Psoriatic Arthritis, you may be asked additional questions, such as the presence of coexistent moderate-to-severe plaque psoriasis or whether to use a loading dose.
- Calculate: Click the “Calculate” button to view the recommended regimen.
Dosing Overview
The following table summarizes the recommended subcutaneous dosing for approved indications based on the Prescribing Information. Doses of 300 mg are administered as two 150 mg injections.
| Indication | Patient Population | Loading Dose | Maintenance Dose |
|---|---|---|---|
| Plaque Psoriasis (PsO) | Adults | 300 mg at Weeks 0, 1, 2, 3, 4 | 300 mg every 4 weeks |
| Plaque Psoriasis (PsO) | Pediatric (≥6 yrs, ≥50 kg) | 150 mg at Weeks 0, 1, 2, 3, 4 | 150 mg every 4 weeks |
| Plaque Psoriasis (PsO) | Pediatric (≥6 yrs, <50 kg) | 75 mg at Weeks 0, 1, 2, 3, 4 | 75 mg every 4 weeks |
| Psoriatic Arthritis (PsA) | Adults | Optional: 150 mg at Weeks 0, 1, 2, 3, 4 | 150 mg every 4 weeks |
| PsA with coexistent PsO | Adults | 300 mg at Weeks 0, 1, 2, 3, 4 | 300 mg every 4 weeks |
| Ankylosing Spondylitis (AS) & nr-axSpA | Adults | Optional: 150 mg at Weeks 0, 1, 2, 3, 4 | 150 mg every 4 weeks |
| Hidradenitis Suppurativa (HS) | Adults | 300 mg at Weeks 0, 1, 2, 3, 4 | 300 mg every 4 weeks |
| Enthesitis-Related Arthritis (ERA) | Pediatric (≥6 yrs) | 75 mg (<50 kg) or 150 mg (≥50 kg) at Weeks 0, 1, 2, 3, 4 | 75 mg or 150 mg every 4 weeks (weight-based) |
Switching Medications
The decision to switch a patient to or from Cosentyx requires careful clinical evaluation. This includes assessing the patient’s previous treatment history, disease activity, and potential risks. There are no standardized washout periods; timing should be based on the properties of the previous medication and the patient’s clinical status. Always consult the full Prescribing Information for both medications.
Missed Dose Instructions
If a patient misses a dose of Cosentyx, they should be advised to take it as soon as they remember. The next dose should then be administered at the regularly scheduled time. Patients should not take a double dose to make up for a missed one. Instructing patients on proper administration and adherence is key to treatment success.
Safety Alerts
Cosentyx is an immunosuppressant that can increase the risk of infections. Evaluate patients for tuberculosis (TB) infection prior to initiating treatment. Monitor for signs and symptoms of infection during and after treatment. Other important safety information includes warnings for inflammatory bowel disease, and potential for hypersensitivity reactions.
Frequently Asked Questions (FAQ)
1. Why is patient weight required for pediatric dosing but not for adults?
Pediatric dosing for Plaque Psoriasis and Enthesitis-Related Arthritis is weight-based to ensure appropriate exposure and efficacy in a growing body. Adult dosing for approved indications is fixed and has been established in clinical trials across a range of adult body weights.
2. How is the 300 mg dose of Cosentyx administered?
A 300 mg dose is administered as two separate 150 mg subcutaneous injections.
3. What is the recommended dose for an adult with Psoriatic Arthritis (PsA) who also has moderate-to-severe Plaque Psoriasis (PsO)?
For patients with PsA and coexistent moderate-to-severe PsO, the recommended regimen is 300 mg, which is the same as the approved dose for Plaque Psoriasis.
4. Is a loading dose always necessary for Psoriatic Arthritis or Ankylosing Spondylitis?
No. For PsA (without coexistent PsO) and AS, a loading dose is optional and may be considered by the clinician. The maintenance dose of 150 mg every 4 weeks can be initiated without a loading phase.
5. What does “nr-axSpA” stand for?
nr-axSpA stands for Non-Radiographic Axial Spondyloarthritis.
6. Does this calculator apply to the intravenous (IV) formulation of Cosentyx?
No, this calculator and the information provided are based on the subcutaneous (injection) administration of Cosentyx. Refer to the specific Prescribing Information for the IV formulation for dosing instructions.
7. For which pediatric age group is this dosing information applicable?
The pediatric dosing information for Plaque Psoriasis and Enthesitis-Related Arthritis applies to patients aged 6 years and older.
8. What should I do if the calculator does not show an option for my patient’s specific condition?
The calculator only includes indications for which dosing regimens are clearly defined in the U.S. Prescribing Information. For any unlisted conditions or off-label use, consult clinical guidelines and the full PI.
9. Where can I find the most current Prescribing Information?
The most up-to-date Prescribing Information can be found on the manufacturer’s website, at Drugs@FDA, or by using the links in the References section below.
References
- Cosentyx (secukinumab) Full Prescribing Information. Novartis Pharmaceuticals Corporation.
- Drugs@FDA: Cosentyx FDA Approval Information. U.S. Food and Drug Administration.
- Cosentyx HCP Official Website. Novartis.
- European Medicines Agency (EMA): Cosentyx (secukinumab).
