Ribavirin Prescribing Information
SUDDEN DETERIORATION OF RESPIRATORY FUNCTION HAS BEEN ASSOCIATED WITH INITIATION OF AEROSOLIZED RIBAVIRIN FOR INHALATION SOLUTION, USP USE IN INFANTS. Respiratory function should be carefully monitored during treatment. If initiation of aerosolized Ribavirin for Inhalation Solution, USP treatment appears to produce sudden deterioration of respiratory function, treatment should be stopped and reinstituted only with extreme caution, continuous monitoring, and consideration of concomitant administration of bronchodilators.
USE OF AEROSOLIZED RIBAVIRIN FOR INHALATION SOLUTION, USP IN PATIENTS REQUIRING MECHANICAL VENTILATOR ASSISTANCE SHOULD BE UNDERTAKEN ONLY BY PHYSICIANS AND SUPPORT STAFF FAMILIAR WITH THIS MODE OF ADMINISTRATION AND THE SPECIFIC VENTILATOR BEING USED. 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. These procedures include the use of bacteria filters in series in the expiratory limb of the ventilator circuit with frequent changes (every 4 hours), water column pressure release valves to indicate elevated ventilator pressures, frequent monitoring of these devices and verification that ribavirin crystals have not accumulated within the ventilator circuitry, and frequent suctioning and monitoring of the patient (see Description of Studies).
Those administering aerosolized Ribavirin for Inhalation Solution, USP in conjunction with mechanical ventilator use should be thoroughly familiar with detailed descriptions of these procedures as outlined in the SPAG-2 Instructions for Use.
SUDDEN DETERIORATION OF RESPIRATORY FUNCTION HAS BEEN ASSOCIATED WITH INITIATION OF AEROSOLIZED RIBAVIRIN FOR INHALATION SOLUTION, USP USE IN INFANTS. Respiratory function should be carefully monitored during treatment. If initiation of aerosolized Ribavirin for Inhalation Solution, USP treatment appears to produce sudden deterioration of respiratory function, treatment should be stopped and reinstituted only with extreme caution, continuous monitoring, and consideration of concomitant administration of bronchodilators.
USE OF AEROSOLIZED RIBAVIRIN FOR INHALATION SOLUTION, USP IN PATIENTS REQUIRING MECHANICAL VENTILATOR ASSISTANCE SHOULD BE UNDERTAKEN ONLY BY PHYSICIANS AND SUPPORT STAFF FAMILIAR WITH THIS MODE OF ADMINISTRATION AND THE SPECIFIC VENTILATOR BEING USED. 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. These procedures include the use of bacteria filters in series in the expiratory limb of the ventilator circuit with frequent changes (every 4 hours), water column pressure release valves to indicate elevated ventilator pressures, frequent monitoring of these devices and verification that ribavirin crystals have not accumulated within the ventilator circuitry, and frequent suctioning and monitoring of the patient (see Description of Studies).
Those administering aerosolized Ribavirin for Inhalation Solution, USP in conjunction with mechanical ventilator use should be thoroughly familiar with detailed descriptions of these procedures as outlined in the SPAG-2 Instructions for Use.
Ribavirin for Inhalation Solution, USP is contraindicated in individuals who have shown hypersensitivity to the drug or its components, and in women who are or may become pregnant during exposure to the drug. Ribavirin has demonstrated significant teratogenic and/or embryocidal potential in all animal species in which adequate studies have been conducted (rodents and rabbits). Therefore, although clinical studies have not been performed, it should be assumed that Ribavirin for Inhalation Solution, USP may cause fetal harm in humans. Studies in which the drug has been administered systemically demonstrate that ribavirin is concentrated in the red blood cells and persists for the life of the erythrocyte.
Ribavirin for Inhalation Solution, USP is indicated for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to RSV. Treatment early in the course of severe lower respiratory tract infection may be necessary to achieve efficacy.
Only severe RSV lower respiratory tract infection should be treated with Ribavirin for Inhalation Solution, USP. The vast majority of infants and children with RSV infection have disease that is mild, self-limited, and does not require hospitalization or antiviral treatment. Many children with mild lower respiratory tract involvement will require shorter hospitalization than would be required for a full course of Ribavirin for Inhalation Solution, USP aerosol (3 to 7 days) and should not be treated with the drug. Thus the decision to treat with Ribavirin for Inhalation Solution, USP should be based on the severity of the RSV infection. The presence of an underlying condition such as prematurity, immunosuppression or cardiopulmonary disease may increase the severity of clinical manifestations and complications of RSV infection.
Use of aerosolized Ribavirin for Inhalation Solution, USP in patients requiring mechanical ventilator assistance should be undertaken only by physicians and support staff familiar with this mode of administration and the specific ventilator being used (see
SUDDEN DETERIORATION OF RESPIRATORY FUNCTION HAS BEEN ASSOCIATED WITH INITIATION OF AEROSOLIZED RIBAVIRIN FOR INHALATION SOLUTION, USP USE IN INFANTS. Respiratory function should be carefully monitored during treatment. If initiation of aerosolized Ribavirin for Inhalation Solution, USP treatment appears to produce sudden deterioration of respiratory function, treatment should be stopped and reinstituted only with extreme caution, continuous monitoring, and consideration of concomitant administration of bronchodilators.
USE OF AEROSOLIZED RIBAVIRIN FOR INHALATION SOLUTION, USP IN PATIENTS REQUIRING MECHANICAL VENTILATOR ASSISTANCE SHOULD BE UNDERTAKEN ONLY BY PHYSICIANS AND SUPPORT STAFF FAMILIAR WITH THIS MODE OF ADMINISTRATION AND THE SPECIFIC VENTILATOR BEING USED. 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. These procedures include the use of bacteria filters in series in the expiratory limb of the ventilator circuit with frequent changes (every 4 hours), water column pressure release valves to indicate elevated ventilator pressures, frequent monitoring of these devices and verification that ribavirin crystals have not accumulated within the ventilator circuitry, and frequent suctioning and monitoring of the patient (see Description of Studies).
Those administering aerosolized Ribavirin for Inhalation Solution, USP in conjunction with mechanical ventilator use should be thoroughly familiar with detailed descriptions of these procedures as outlined in the SPAG-2 Instructions for Use.
BEFORE USE, READ THOROUGHLY THE BAUSCH HEALTH SMALL PARTICLE AEROSOL GENERATOR SPAG-2 INSTRUCTIONS FOR USE FOR SMALL PARTICLE AEROSOL GENERATOR OPERATING INSTRUCTIONS. AEROSOLIZED RIBAVIRIN FOR INHALATION SOLUTION, USP HAS NOT BEEN TESTED WITH ANY OTHER AEROSOL GENERATING DEVICE.
The recommended treatment regimen is 20 mg/mL Ribavirin for Inhalation Solution, USP as the starting solution in the drug reservoir of the SPAG-2 unit, with continuous aerosol administration for 12-18 hours per day for 3 to 7 days. Using the recommended drug concentration of 20 mg/mL the average aerosol concentration for a 12 hour delivery period would be 190 mcg/L of air. Aerosolized Ribavirin for Inhalation Solution, USP should not be administered in a mixture for combined aerosolization or simultaneously with other aerosolized medications.
Ribavirin for Inhalation Solution, USP should be delivered to an infant oxygen hood from the SPAG®-2 aerosol generator. Administration by face mask or oxygen tent may be necessary if a hood cannot be employed (see SPAG-2 Instructions for Use). However, the volume and condensation area are larger in a tent and this may alter delivery dynamics of the drug.
The recommended dose and administration schedule for infants 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. In either case, patients should have their endotracheal tubes suctioned every 1-2 hours, and their pulmonary pressures monitored frequently (every 2-4 hours). For both pressure and volume ventilators, heated wire connective tubing and bacteria filters in series in the expiratory limb of the system (which must be changed frequently, i.e., every 4 hours) must be used to minimize the risk of Ribavirin for Inhalation Solution, USP precipitation in the system and the subsequent risk of ventilator dysfunction. Water column pressure release valves should be used in the ventilator circuit for pressure cycled ventilators, and may be utilized with volume cycled ventilators (see SPAG-2 INSTRUCTIONS FOR USE FOR DETAILED INSTRUCTIONS).
Ribavirin for Inhalation Solution, USP is supplied as 6 grams of lyophilized powder per 100 mL vial for aerosol administration only. By sterile technique, reconstitute drug with
BEFORE USE, READ THOROUGHLY THE BAUSCH HEALTH SMALL PARTICLE AEROSOL GENERATOR SPAG-2 INSTRUCTIONS FOR USE FOR SMALL PARTICLE AEROSOL GENERATOR OPERATING INSTRUCTIONS. AEROSOLIZED RIBAVIRIN FOR INHALATION SOLUTION, USP HAS NOT BEEN TESTED WITH ANY OTHER AEROSOL GENERATING DEVICE.
The recommended treatment regimen is 20 mg/mL Ribavirin for Inhalation Solution, USP as the starting solution in the drug reservoir of the SPAG-2 unit, with continuous aerosol administration for 12-18 hours per day for 3 to 7 days. Using the recommended drug concentration of 20 mg/mL the average aerosol concentration for a 12 hour delivery period would be 190 mcg/L of air. Aerosolized Ribavirin for Inhalation Solution, USP should not be administered in a mixture for combined aerosolization or simultaneously with other aerosolized medications.
Ribavirin for Inhalation Solution, USP is contraindicated in individuals who have shown hypersensitivity to the drug or its components, and in women who are or may become pregnant during exposure to the drug. Ribavirin has demonstrated significant teratogenic and/or embryocidal potential in all animal species in which adequate studies have been conducted (rodents and rabbits). Therefore, although clinical studies have not been performed, it should be assumed that Ribavirin for Inhalation Solution, USP may cause fetal harm in humans. Studies in which the drug has been administered systemically demonstrate that ribavirin is concentrated in the red blood cells and persists for the life of the erythrocyte.
The description of adverse reactions is based on events from clinical studies (approximately 200 patients) conducted prior to 1986, and the controlled trial of aerosolized Ribavirin for Inhalation Solution, USP conducted in 1989-1990. Additional data from spontaneous post-marketing reports of adverse events in individual patients have been available since 1986.
Clinical studies of interactions of Ribavirin for Inhalation Solution, USP with other drugs commonly used to treat infants with RSV infections, such as digoxin, bronchodilators, other antiviral agents, antibiotics or anti-metabolites, have not been conducted. Interference by Ribavirin for Inhalation Solution, USP with laboratory tests has not been evaluated.