Ribavirin - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Ribavirin. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
WARNING: EMBRYO-FETAL TOXICITY, HEMOLYTIC ANEMIA, and MONOTHERAPY NOT RECOMMENDED Significant teratogenic and embryocidal effects have been demonstrated in all animal species exposed to ribavirin. In addition, ribavirin has a multiple-dose half-life of 12 days and may persist in non-plasma compartments for as long as 6 months. Therefore, ribavirin therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Avoid pregnancy and use effective contraception during therapy and for 9 months after completion of treatment in female patients and for 6 months in female partners of male patients who are taking ribavirin therapy. [see Contraindications , Warnings and Precautions , Use in Specific Populations (8.1, 8.3 ), and Nonclinical Toxicology ]. Hemolytic anemia has been reported with ribavirin therapy. The anemia associated with ribavirin therapy may result in worsening of cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with ribavirin [see Dosage and Administration , Warnings and Precautions , and Adverse Reactions ]. Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication [see Warnings and Precautions ]. WARNING: EMBRYO-FETAL TOXICITY, HEMOLYTIC ANEMIA, and MONOTHERAPY NOT RECOMMENDED See full prescribing information for complete boxed
5 WARNINGS AND PRECAUTIONS Embryo-Fetal Toxicity: May cause fetal harm.
Patients should have a negative pregnancy test prior to therapy and use effective contraception and undergo periodic pregnancy tests. ( 5.1 , 8.1 , 8.3 ) Patients exhibiting the following conditions should be closely monitored and may require dose reduction or discontinuation of therapy: Hemolytic anemia may occur with a significant initial drop in hemoglobin.
Pulmonary infiltrates or pulmonary function impairment.
New or worsening ophthalmologic disorders.
Severe decreases in neutrophil and platelet counts, and hematologic, endocrine (e.g., TSH), and hepatic abnormalities.
Dental/periodontal disorders reported with combination therapy.
Concomitant administration of azathioprine.
Weight loss and growth inhibition reported during combination therapy in pediatric patients.
Long-term growth inhibition (height) reported in some patients.
Monotherapy with ribavirin is not permitted.
5.1 Embryo-Fetal Toxicity Ribavirin capsules may cause birth defects, miscarriage or stillbirth.
Ribavirin therapy should not be started until a report of a negative pregnancy test has been obtained immediately prior to planned initiation of therapy.
Female patients should use effective contraception and have periodic monitoring with pregnancy tests during treatment and during the 9-month period after treatment has been stopped.
Male patients and their female partners should use effective contraception during treatment and during the 6-month period after treatment has been stopped.
Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients.
Ribavirin has demonstrated significant teratogenic and embryocidal effects in all animal species tested.
These effects occurred at doses as low as one twentieth of the recommended human dose of ribavirin. [see Boxed Warning , Contraindications , and Use in Specific Populations (8.1 , 8.3) ].
5.2 Anemia Hemolytic anemia was observed in approximately 10% of ribavirin/INTRON A-treated subjects in clinical trials.
The anemia associated with ribavirin occurs within 1 to 2 weeks of initiation of therapy.
Because the initial drop in hemoglobin may be significant, obtain hemoglobin or hematocrit levels before the start of treatment and at Week 2 and Week 4 of therapy, or more frequently if clinically indicated.
Patients should then be followed as clinically appropriate [see Dosage and Administration (2.5 , 2.6) ].
Fatal and nonfatal myocardial infarctions have been reported in patients with anemia caused by ribavirin.
Patients should be assessed for underlying cardiac disease before initiation of ribavirin therapy.
Patients with pre-existing cardiac disease should have electrocardiograms administered before treatment and should be appropriately monitored during therapy.
If there is any deterioration of cardiovascular status, therapy should be suspended or discontinued [see Dosage and Administration (2.5 , 2.6) ].
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