Peramivir

Peramivir is an antiviral drug which is being evaluted in phase III clinical trials for treatment of Swine flu. It is a neuraminidase inhibitor, an enzyme that is critical to the replication and spread of influenza virus within the host. Peramivir: Structure After the emergency use authorization (EUA) by the FDA on October 23, 2009, it is available for use in treatment of certain hospitalized patients with known or suspected 2009 H1N1 influenza. This is the first Emergency use authorization (EUA) that has been issued for a yet to be approved drug. It is not to be used for the treatment of seasonal influenza A or B virus infections, for outpatients with acute uncomplicated 2009 H1N1 virus infection or for pre- or post-exposure chemoprophylaxis (prevention) of influenza.

Mandatory requirements for administration under EUA


In order to mitigate the risks of using this unapproved product under Emegency Use Authorization (EUA) and to optimize the potential benefit of this therapy the following steps are required. Use of unapproved Peramivir IV under 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):

a. Adult patients for whom therapy with an IV agent is clinically appropriate, based upon one or more of the following reasons:
i. patient not responding to either oral or inhaled antiviral therapy, or
ii. 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
iii. the clinician judges IV therapy is appropriate due to other circumstances.

b. Pediatric patients for whom an IV agent is clinically appropriate because:
i. patient not responding to either oral or inhaled antiviral therapy, or
ii. 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 reporting of all medication errors and selected adverse events occurring during Peramivir IV treatment within 7 calendar days from the onset of the event to FDA.

Authorized use

Peramivir injection is authorized for use under an EUA for treatment of certain patients with suspected or laboratory confirmed 2009 H1N1 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:
a. Adult patients for whom therapy with an IV agent is clinically appropriate, based upon one or more of the following reasons:
i. patient not responding to either oral or inhaled antiviral therapy, or
ii. 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
iii. the clinician judges IV therapy is appropriate due to other circumstances.

b. Pediatric patients for whom an IV agent is clinically appropriate because:
i. patient not responding to either oral or inhaled antiviral therapy, or
ii .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.

Dosage and Administration

The standard adult dose of Peramivir is 600 mg once a day, administered intravenously for 5 to 10 days. Initial treatment courses are for 5 to 10 days duration. Treatment beyond 10 days is permitted depending on clinical presentation such as critical illness (e.g., respiratory failure or intensive care unit admission), continued viral shedding or unresolved clinical influenza illness. The compatibility of Peramivir injection with IV solutions and medications other than Sodium Chloride Injection, USP is not known. The clinician should use clinical judgment regarding administration of concomitant medications during infusion based on the individual patient's medical situation. To the extent possible, Peramivir IV should not be administered simultaneously with another intravenous medication. All patients with known or suspected renal insufficiency must have creatinine clearance determined and dosing of Peramivir IV adjusted accordingly.

Heparin lock

Before infusion of Peramivir IV via a heparin lock, the port should be flushed with 3-5 mLs of sterile saline. After the infusion of Peramivir IV is complete, the port should be flushed again with sterile saline and then heparin can be added to maintain patency of this catheter.

Single or multilumen catheter

If other medications are also administered via a single lumen catheter or a single lumen of a multilumen catheter, at least 10 mLs of sterile saline should be administered between the infusion of any other medication and the administration of Peramivir IV to assure that all medication is flushed from the catheter tubing before Peramivir IV is administered. Peramivir IV may be piggybacked into an existing saline infusion line. Where possible, the saline infusion rate should be reduced to assure that Peramivir IV is infused over 30 minutes for adults and over 60 minutes for pediatric patients.

It should not be administered as an intramuscular (IM) injection. There is no information available specific to patients receiving extracorporeal membrane oxygenation (ECMO) on Peramivir exposure or pharmacokinetics and administration of Peramivir IV in patients receiving peritoneal dialysis.

Dosage forms and strengths

Intravenous (IV) Injection:
• Each vial of Peramivir injection contains 200 mg per 20 mL (10 mg per mL)

Contraindications

Do not use Peramivir IV in patients with history of severe allergic reaction to any other neuraminidase inhibitors (Relenza or Tamiflu) or any ingredient of Peramivir IV

Warnings and precautions

Gastrointestinal Side Effects:
Patients should be monitored for development of diarrhea and have appropriate evaluation and/or treatment, as indicated, including evaluation for other causes of diarrhea as clinically warranted.
Bacterial Infections:
Serious bacterial infections may begin with influenza-like symptoms or may coexist with or develop as complications during the course of influenza illness. Patients should be monitored, evaluated and treated for suspected bacterial infections as clinically warranted while being treated with Peramivir IV. Consult an infectious disease specialist when appropriate.
Allergic Reactions:
Serious allergic-like reactions have not been reported in clinical trials in patients receiving Peramivir to date. However, allergic-like reactions, including oropharyngeal edema, serious skin rashes and anaphylaxis have been reported with use of neuraminidase inhibitors including Relenza (zanamivir) and Tamiflu (oseltamivir). Peramivir IV should be stopped and appropriate treatment
instituted if an allergic reaction occurs or is suspected.
Neuropsychiatric Events:
Influenza infection itself can be associated with a variety of neurologic and behavioral symptoms which can include events such as seizures, hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without clinically apparent severe disease.



about                    contact us              disclaimer             faqs                    privacy           LifeHugger © 2008-2017