About This Content

This information provides a clinical overview of the key considerations covered by the Aubagio (teriflunomide) Dose Calculator. It is intended to supplement, not replace, the calculator's outputs and the full prescribing information. Teriflunomide is an oral immunomodulatory drug used for the treatment of relapsing forms of multiple sclerosis (MS).

Outputs Explained

The calculator provides two primary outputs based on user-selected parameters:

  • Standard Dosing Recommendation: This section outlines the appropriate daily dose for teriflunomide based on the patient's hepatic function. It highlights contraindications for patients with severe hepatic impairment.
  • Accelerated Elimination Protocol: This details the regimen for rapidly clearing teriflunomide from the body. This is critical in situations like planned pregnancy or severe adverse reactions. The protocol provides specific dosing for either cholestyramine or activated charcoal over an 11-day period.

How to Use the Calculator

To use the tool effectively, a clinician must provide the following information:

  1. Hepatic Function: Select the patient's current liver function status (Normal, Mild, Moderate, or Severe). This is a mandatory input as teriflunomide carries a black box warning for hepatotoxicity and is contraindicated in severe hepatic impairment.
  2. Accelerated Elimination Agent: If rapid washout is needed, choose between the two available agents: cholestyramine (8 g TID) or activated charcoal (50 g BID). The choice may depend on availability, patient tolerance, and clinical setting.

Dosing Overview

For the treatment of relapsing forms of multiple sclerosis, the standard administration of teriflunomide is as follows:

  • Available Doses: 7 mg or 14 mg, taken orally once daily.
  • Administration: The tablets can be taken with or without food.
  • Dose Selection: The choice between the 7 mg and 14 mg dose involves a risk-benefit assessment. The 14 mg dose may provide greater efficacy in reducing relapse rates, while the 7 mg dose may offer a better safety profile, particularly regarding side effects like hair thinning (alopecia) and diarrhea.
  • Hepatic Impairment: No dose adjustment is needed for mild hepatic impairment. However, teriflunomide is not recommended for patients with moderate hepatic impairment and is contraindicated in those with severe hepatic impairment.

Switching Medications

Due to its long half-life (approximately 18-19 days), special considerations are required when switching to or from teriflunomide.

  • Switching to Teriflunomide: After discontinuing another MS therapy, the waiting period before starting teriflunomide depends on the previous drug's half-life and mechanism of action to avoid overlapping immunosuppressive effects.
  • Switching from Teriflunomide: When discontinuing teriflunomide to start another therapy, the accelerated elimination procedure is strongly recommended to minimize the time the patient is without effective treatment and to reduce plasma concentrations before starting a new agent, especially one that is also hepatotoxic or myelosuppressive.

Missed Dose

If a patient misses a dose of teriflunomide, they should take it as soon as they remember. However, if it is almost time for the next scheduled dose, they should skip the missed dose and resume their regular once-daily schedule. Patients should be instructed not to take two doses at the same time to make up for a missed dose.

Safety Alerts

FDA Black Box Warnings

  • HEPATOTOXICITY: Teriflunomide can cause severe and sometimes fatal liver injury. Liver function tests (ALT, AST, and bilirubin) must be obtained at baseline and monitored monthly for the first six months of treatment.
  • EMBRYO-FETAL TOXICITY: Teriflunomide is contraindicated for use in pregnant women and in females of reproductive potential who are not using effective contraception. It may cause major birth defects. Pregnancy must be ruled out before starting treatment, and an accelerated elimination procedure must be used in any woman who becomes pregnant while taking the drug.

Frequently Asked Questions (FAQ)

Why is hepatic function a critical input for the calculator?

Teriflunomide is metabolized by the liver and carries a Black Box Warning for severe hepatotoxicity. The drug is contraindicated in patients with severe hepatic impairment, and its use is not recommended in moderate impairment. The calculator uses this input to determine if the drug is safe to recommend.

What is the purpose of the accelerated elimination protocol?

Teriflunomide has a very long half-life and can remain in the blood for months after discontinuation. The accelerated elimination protocol uses agents like cholestyramine or activated charcoal to bind teriflunomide in the gastrointestinal tract, interrupting its recirculation and removing it from the body in about 11 days, instead of up to 2 years.

When is accelerated elimination necessary?

It is necessary in cases of severe adverse events, a patient's decision to become pregnant (in both females and males), or when switching to another disease-modifying therapy to minimize washout time.

Is there a difference between cholestyramine and activated charcoal for elimination?

Both are effective. Cholestyramine is typically dosed at 8 grams every 8 hours, while activated charcoal is dosed at 50 grams every 12 hours. The choice can depend on formulary availability, cost, and patient tolerability, as both can cause gastrointestinal side effects like constipation.

How do I confirm the elimination procedure was successful?

You must verify that the teriflunomide plasma concentration is below 0.02 mg/L. This requires two separate tests performed at least 14 days apart. If the level is still high, the 11-day treatment course may need to be repeated.

Can a patient take the 7 mg and 14 mg doses interchangeably?

No. Patients should stick to the dose prescribed by their healthcare provider. The dose is selected based on a balance of desired efficacy and potential side effects, and should not be altered without medical consultation.

Why is there a pregnancy warning for men taking teriflunomide?

Teriflunomide is present in semen. While the risk is considered low, it is recommended that men wishing to father a child should discontinue the drug and undergo the accelerated elimination procedure to minimize any potential fetal risk.

Does the calculator require a loading dose?

No, and this reflects the standard prescribing information for teriflunomide. A loading dose is not required for treatment initiation.

References

The information presented is based on established clinical guidelines and prescribing information. For complete details, consult these primary sources:

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