VIRAZOLE® (Ribavirin for Inhalation Solution, USP) as Treatment for RSV


For Full Prescribing Information For VIRAZOLE® (click here).

At the first sign of illness, physicians can test for RSV infection using a rapid diagnostic test (see Diagnosing RSV) and monitor symptoms to determine disease severity. Early and aggressive treatment with an antiviral has been proven to decrease the morbidity associated with RSV in high-risk young children.30

Virazole

Ribavirin by aerosol is the only antiviral agent approved for treatment of severe RSV disease in infants and children.28 The commercial name for ribavirin is VIRAZOLE®, manufactured by ICN Pharmaceuticals, Inc.

VIRAZOLE (ribavirin for inhalation solution, USP) is a broad-spectrum antiviral with virustatic effects, inhibiting RSV replication during the active replication phase. It also significantly improves arterial blood oxygenation, decreases illness severity, and decreases viral shedding.31 VIRAZOLE achieves maximum antiviral effect before the viral load is at its peak--usually within three days of onset of symptoms.

Chart: Virazole Features and Benefits

Adverse Events Profile
The most common adverse events attributed to VIRAZOLE given to infants were rash, and reversible skin irritation.33 Sudden deterioration of respiratory function (bronchospasm) has been associated with initiation of aerosolized VIRAZOLE in infants and function should be carefully monitored.

Administration
Administration of VIRAZOLE is confined strictly to the hospital setting and is delivered via a small particle aerosol generator (SPAG®-2). VIRAZOLE aerosol is NOT to be administered with any other aerosol-generating device or together with other aerosolized medications. The aerosol is delivered to the patient through an oxygen hood, oxygen tent or face mask attached to the generator.

Spag-2

The use of aerosolized VIRAZOLE in patients requiring mechanical ventilator assistance should be undertaken only by physicians and support staff familiar with the specific ventilator being used and this mode of administration of the drug. Strict attention must be paid to procedures that have been shown to minimize the accumulation of drug precipitate, which can result in mechanical ventilator dysfunction and associated increased pulmonary pressures.

For additional information on the administration of VIRAZOLE, please refer to Resources for Healthcare Providers. There you will be able to order your copy of the SPAG®-2 User's Guide.

Dosing
The standard treatment regimen is 20 mg/mL given 12 to 18 hours per day for three to seven days. It is important to note that VIRAZOLE is part of a total treatment program that includes standard supportive respiratory care, correction of fluid imbalance, and nutritional management.

The recommended dosage regimen for those who require mechanical ventilation is the same as for those who do not. Either a pressure or volume-cycle ventilator may be used in conjunction with the SPAG-2.

Routine Procedures and Precautions for Hospital Staff
Because VIRAZOLE is administered as an aerosol, direct exposure by the health professional should be avoided or minimized. Although studies conclude that exposure up to 100 times that of the typical occupational exposure resulted in very low body-fluid concentrations, health professionals should nonetheless remain cautious. VIRAZOLE should be administered in well-ventilated rooms and the SPAG unit should be turned off 5 to 10 minutes prior to patient handling.

As an additional precaution, the use of a mask designed to block absorption of particles less than 1 micron in diameter is suggested, and pregnant women should be advised to avoid contact with VIRAZOLE.

Of 358 adverse events reported by 152 healthcare personnel exposed to VIRAZOLE, the most common were: headache (51% of reports), conjunctivitis (32%), rhinitis, nausea, rash, dizziness, pharyngitis, and lacrimation (10% to 20% each). Several cases of bronchospasm and/or chest pain were also reported, usually in individuals with known underlying reactive airway disease (RAD). Most signs and symptoms resolved themselves in minutes to hours of discontinuing exposure to aerosolized VIRAZOLE. It is unknown whether these symptoms were due to drug exposure or RSV infection. At dosage levels exceeding human therapeutic levels, VIRAZOLE has been shown to produce testicular lesions in rodents and to be teratogenic in animal species in which adequate studies have been conducted (rodents and rabbits).33

For Full Prescribing Information For VIRAZOLE® (click here).

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Treating Mild RSV at Home
Treating Severe RSV in the Hospital
Virazole as Treatment / Prescribing Information
Patient Support Materials
Physician's Guide
Spag-2 User's Guide