Ribavirin (inhaled)
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNINGS 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 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 (SEE WARNINGS ). 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 (SEE WARNINGS ). RIBAVIRIN FOR INHALATION SOLUTION, USP IS NOT INDICATED FOR USE IN ADULTS.
PHYSICIANS AND PATIENTS SHOULD BE AWARE THAT RIBAVIRIN HAS BEEN SHOWN TO PRODUCE TESTICULAR LESIONS IN RODENTS AND TO BE TERATOGENIC IN ALL ANIMAL SPECIES IN WHICH ADEQUATE STUDIES HAVE BEEN CONDUCTED (RODENTS AND RABBITS) (SEE CONTRAINDICATIONS ).
Handling and access
NIOSH hazardous drug
Table 2NIOSH lists ribavirin as a hazardous drug. AHFS class: 8:18.32 nucleosides and nucleotides.
- Meets the NIOSH definition of a hazardous drug (carcinogenicity, developmental or reproductive toxicity, organ toxicity at low doses, or genotoxicity) without MSHI or a Group 1 or 2A carcinogen classification.
- Only a developmental and/or reproductive hazard: precautions matter most for workers who are pregnant, breastfeeding, or trying to conceive.
Handle with the precautions your facility uses for hazardous drugs (USP <800>). NIOSH's Managing Hazardous Drug Exposures lists controls by drug form and activity.
Nucleoside Analog Antiviral
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
Prepare this dose
Your numbers for ribavirin (inhaled). Take vial strength, diluent, and limits from the label below.
Enter a dose to see draw volume, final concentration, and rates.
DOSAGE AND ADMINISTRATION 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. Non-Mechanically Ventilated Infants Ribavirin for Inhalation Solution, USP should be delivered to an infant oxygen hood from the SPAG ® -2 aerosol generator.
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). Method of Preparation 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 a minimum of 75 mL of Sterile Water for Injection, USP or Inhalation in the original 100 mL glass vial. Shake well . Transfer to the clean, sterilized 500 mL SPAG-2 reservoir and further dilute to a final volume of 300 mL with Sterile Water for Injection, USP or Inhalation. The final concentration should be 20 mg/mL.
Important: This water should NOT have had any antimicrobial agent or other substance added. The solution should be inspected visually for particulate matter and discoloration prior to administration. Solutions that have been placed in the SPAG-2 unit should be discarded at least every 24 hours and when the liquid level is low before adding newly reconstituted solution.
Drug interactions
Check ribavirin (inhaled) against a medication listLabel text (1 paragraph)
Drug Interactions 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.
Contraindications
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.
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
E*Likelihood score E*: Unproven although suspected rare cause of clinically apparent liver injury.
Ribavirin is a nucleoside analogue and antiviral agent used in therapy of chronic hepatitis C and other flavivirus infections. Ribavirin has not been associated with clinically apparent liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
Ribavirin has demonstrated significant teratogenic and/or embryocidal potential in all animal species in which adequate studies have been conducted. Teratogenic effects were evident after single oral doses of 2.5 mg/kg or greater in the hamster, and after daily oral doses of 0.3 and 1.0 mg/kg in the rabbit and rat, respectively (estimated human equivalent doses of 0.12 and 0.14 mg/kg, based on body surface area adjustment for the adult). Malformations of the skull, palate, eye, jaw, limbs, skeleton, and gastrointestinal tract were noted. The incidence and severity of teratogenic effects increased with escalation of the drug dose. Survival of fetuses and offspring was reduced.
Ribavirin caused embryolethality in the rabbit at daily oral dose levels as low as 1 mg/kg. No teratogenic effects were evident in the rabbit and rat administered daily oral doses of 0.1 and 0.3 mg/kg, respectively with estimated human equivalent doses of 0.01 and 0.04 mg/kg, based on body surface area adjustment (see Pharmacokinetics ). These doses are considered to define the No Observable Teratogenic Effects Level (NOTEL) for ribavirin in the rabbit and rat. Following oral administration of ribavirin in the pregnant rat (1.0 mg/kg) and rabbit (0.3 mg/kg), mean plasma levels of drug ranged from 0.10-0.20 µ M [0.024-0.049 µ /mL] at 1 hour after dosing, to undetectable levels at 24 hours.
At 1 hour following the administration of 0.3 or 0.1 mg/kg in the rat and rabbit (NOTEL), respectively, mean plasma levels of drug in both species were near or below the limit of detection (0.05 µ M; see Pharmacokinetics ). Although clinical studies have not been performed, Ribavirin for Inhalation Solution, USP may cause fetal harm in humans. As noted previously, ribavirin is concentrated in red blood cells and persists for the life of the cell. Thus the terminal half-life for the systemic elimination of ribavirin is essentially that of the half-life of circulating erythrocytes.
The minimum interval following exposure to Ribavirin for Inhalation Solution, USP before pregnancy may be safely initiated is unknown (see CONTRAINDICATIONS , WARNINGS , and Information for Health Care Personnel ).
Lactation
Lactation Ribavirin for Inhalation Solution, USP has been shown to be toxic to lactating animals and their offspring. It is not known if Ribavirin for Inhalation Solution, USP is excreted in human milk.
Breastfeeding (LactMed)
Ribavirin has not been studied in nursing mothers being treated for hepatitis C infection. However, ribavirin is given directly to infants by inhalation to treat respiratory syncytial virus (RSV) infection. The amount in milk is likely to be lower than the doses received by infants treated with ribavirin for RSV infection. Hepatitis C is not transmitted through breastmilk and breastmilk has been shown to inactivate hepatitis C virus (HCV). However, the Centers for Disease Control recommends that mothers with HCV infection should consider abstaining from breastfeeding if their nipples are cracked or bleeding. It is not clear if this warning would apply to mothers who are being treated for hepatitis C. Infants born to mothers with HCV infection should be tested for HCV infection;
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Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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