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Peramivir Fact Sheet for Health Care Providers (cont.)

MANDATORY REQUIREMENTS FOR PERAMIVIR IV ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION

In order to mitigate the risks of using this unapproved product under EUA and to optimize the potential benefit of this therapy the following steps are required. Use of unapproved Peramivir IV under this EUA is restricted to the following (all requirements must be met):

  1. Treatment of certain patients with suspected or laboratory confirmed 2009 H1N1 virus infection or infection due to nonsubtypable influenza A virus suspected to be 2009 H1N1 based on community epidemiology. Specifically, Peramivir IV is authorized only for the following patients who are admitted to a hospital and under the care or consultation of a licensed clinician (skilled in the diagnosis and management of patients with potentially life-threatening illness and the ability to recognize and manage medication-related adverse events):
    1. Adult patients for whom therapy with an IV agent is clinically appropriate, based upon one or more of the following reasons:
      1. patient not responding to either oral or inhaled antiviral therapy, or
      2. drug delivery by a route other than IV (e.g. enteral oseltamivir or inhaled zanamivir) is not expected to be dependable or is not feasible, or
      3. the clinician judges IV therapy is appropriate due to other circumstances.
    2. Pediatric patients for whom an IV agent is clinically appropriate because:
      1. patient not responding to either oral or inhaled antiviral therapy, or
      2. drug delivery by a route other than IV (e.g. enteral oseltamivir or inhaled zanamivir) is not expected to be dependable or is not feasible
  2. Health Care Providers (to the extent practicable given the circumstances of the emergency) must document in the patient's medical record that the patient/caregiver has been: (a) given the Fact Sheet for Patients and Parents/Caregivers, (b) informed of alternatives to receiving authorized Peramivir IV, and (c) informed that Peramivir IV is an unapproved drug that is authorized for use under Emergency Use Authorization.
  3. Patients with known or suspected renal insufficiency must have creatinine clearance determined prior to Peramivir IV dose calculation and first administration.
  4. Patients with history of severe allergic reaction to any other neuraminidase inhibitor (zanamivir or oseltamivir) or any ingredient of Peramivir IV must not receive Peramivir IV.
  5. The prescribing health care provider and/or their designee is/are responsible for mandatory responses to requests from FDA, CDC or their designee for information about adverse events and medication errors following receipt of Peramivir IV. For example, health care providers and/or their designee will be asked whether Peramivir IV was administered, if a selected adverse event or medication error occurred, and if the adverse event or medication error was reported to FDA MedWatch.
  6. The prescribing health care provider and/or their designee is/are responsible for mandatory FDA MedWatch reporting of all medication errors and selected adverse events occurring during Peramivir IV treatment within 7 calendar days from the onset of the event. Selected adverse events are death; neuropsychiatric events; renal adverse events; serious skin adverse events (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis); hypersensitivity reactions adverse events (e.g., anaphylaxis, urticaria, angioedema); severe IV site or IV administration adverse events (e.g. septic phlebitis, infiltrated IV); or other serious adverse events. Serious Adverse Events are defined as: any life-threatening adverse drug experience that may prolong existing hospitalization, result in a persistent or significant disability/incapacity or a congenital anomaly or birth defect or an event that may jeopardize the patient to an extent that may require medical/surgical intervention to prevent one of the outcomes above including death [see ADVERSE REACTIONS and Medication Errors Reporting Requirements and Instructions section for details].


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