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FDA Announcement, Oct 2003 Norvir Package Insert Changes
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Revisions were recently made to the product labeling for Norvir (ritonavir) 100mg soft gelatin capsules and Norvir (ritonavir) 80mg/mL oral solution, marketed by Abbott Laboratories. The changes address a Phase IV commitment to develop appropriate labeling for patients with hepatic insufficiency. Changes were also made to the Drug Interaction tables, including new information on the co-administration of Warfarin. Other revisions include minor editorial changes such as renumbering of tables and consolidation of information into specific sections. The new information is summarized in the Portable Document Format (pdf) file attached below.
Summary of recent changes to product labeling for Norvir (ritonavir) 100mg soft gelatin capsules and Norvir (ritonavir) 80mg/mL oral solution
1. CLINICAL PHARMACOLOGY section: Special Populations subsection: The Hepatic Insufficiency subsection under the Special Population subsection has been changed to read: Hepatic Insufficiency: Dose-normalized steady-state ritonavir concentrations in subjects with mild hepatic insufficiency (400 mg BID, were similar to those in control subjects dosed with 500 mg BID. Dose-normalized steady-state ritonavir exposures in subjects with moderate hepatic impairment (400 mg BID, n=6) were about 40% lower than those in subjects with normal hepatic function (500 mg BID, n=6). Protein binding of ritonavir was not statistically significantly affected by mild or moderately impaired hepatic function. No dose adjustment is recommended in patients with mild or moderate hepatic impairment. However, health care providers should be aware of the potential for lower ritonavir concentrations in patients with moderate hepatic impairment and should monitor patient response carefully. Ritonavir has not been studied in patients with severe hepatic impairment.
2. In table 5: Drugs that should not be coadministered with NORVIR, the ergot derivative statement was expanded to read the following:
Ergot Derivatives:
dihydroergotamine, ergonovine, ergotamine, methylergonovine
CONTRAINDICATED due to potential for serious and/or life-threatening reactions such as acute ergot toxicity characterized by vasospasm and ischemia of the extremities and other tissues including the central nervous system
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4. Regarding Table 7: Predicted Drug Interactions: Use With Caution, Dose Decrease of Coadministered Drug May Be Needed the following changes were made.
---The antifungal drug itraconazole was added
---The steroid drug fluticasone was added
---The HMG CoA reductase inhibitor cerivastatin was removed since it is no longer marketed in the United States
---The immunosuppressant drug rapamycin was renamed to the more widely used name sirolimus.
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