Your healthcare provider is recommending a medication for an "off-label" use. This document explains what off-label prescribing means and ensures you have the information needed to make an informed decision about your treatment.

When the U.S. Food and Drug Administration (FDA) approves a medication, it approves it for specific uses (indications), at specific doses, for specific patient populations. "Off-label" use means using an FDA-approved medication in a way that differs from its approved labeling. This may include:

• Using a medication for a condition it was not specifically approved to treat
• Using a different dose than what is specified in the labeling
• Using a different route of administration
• Using a medication in a patient population not studied in the approval trials (e.g., different age group)

Yes. Off-label prescribing is:

• Legal: Physicians and other licensed prescribers have the legal authority to prescribe FDA-approved medications for off-label uses when, in their professional judgment, it is medically appropriate
• Common: It is estimated that 20-30% of all prescriptions are for off-label uses. In some specialties, such as oncology, dermatology, and pediatrics, off-label use is even more prevalent
• Often Supported by Evidence: Many off-label uses are well-established in medical practice and supported by scientific literature, even though the manufacturer has not pursued formal FDA approval for that specific use

(Prescriber to complete or discuss verbally with patient)

• Limited FDA Review: The FDA has not reviewed or approved this specific use. This means there may be less formal data about safety and effectiveness for your condition compared to the approved uses
• Insurance Coverage: Your insurance may not cover medications prescribed for off-label uses. You may be responsible for the full cost
• Evidence Level: The scientific evidence supporting off-label use may vary from strong (randomized controlled trials) to limited (case reports, expert opinion)
• Unknown Risks: There may be risks associated with this use that have not been fully studied or identified

• You have the right to ask questions about why this off-label use is being recommended
• You have the right to know what evidence supports this use
• You have the right to ask about FDA-approved alternatives
• You have the right to seek a second opinion
• You have the right to decline treatment

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