Nervous System Disorders
Dizziness 19 16 16 10
Psychiatric Disorders
Insomnia 34 34 30 24
Irritability 22 23 21 13
Respiratory, Thoracic, and Mediastinal Disorders
Dyspnea Exertional 8 8 11 5
Skin and Subcutaneous Tissue Disorders
Alopecia 27 27 22 16
Dry Skin 18 18 22 9
Rash 17 19 16 6
Other Important Adverse Reactions Reported in Clinical Trials
Among subjects (previously untreated subjects or those who failed previous therapy) who received VICTRELIS in combination with peginterferon alfa and ribavirin, the following adverse drug reactions were reported. These events are notable because of their seriousness, severity, or increased frequency in subjects who received VICTRELIS in combination with peginterferon alfa and ribavirin compared with subjects who received only peginterferon alfa and ribavirin.
Gastrointestinal Disorders
Dysgeusia (alteration of taste) was an adverse event reported at an increased frequency in subjects receiving VICTRELIS in combination with peginterferon alfa and ribavirin compared with subjects receiving peginterferon alfa and ribavirin alone (Table 3). Adverse events such as dry mouth, nausea, vomiting and diarrhea were also reported at an increased frequency in subjects receiving VICTRELIS in combination with peginterferon alfa and ribavirin.
Laboratory Values
Changes in selected hematological parameters during treatment of adult subjects with the combination of VICTRELIS with PegIntron and REBETOL are described in Table 4.
Hemoglobin
Decreases in hemoglobin may require a decrease in dosage/interruption or discontinuation of ribavirin [see Warnings and Precautions (5.2) and Clinical Studies (14); see Package Insert for ribavirin].
Neutrophils and Platelets
The proportion of subjects with decreased neutrophil and platelet counts was higher in the VICTRELIS-containing arms compared to subjects receiving PegIntron/REBETOL alone. Three percent of subjects receiving the combination of VICTRELIS with PegIntron/REBETOL had platelet counts of less than 50 × 109/L compared to 1% of subjects receiving PegIntron/REBETOL alone. Decreases in neutrophils or platelets may require a decrease in dosage or interruption of peginterferon alfa, or discontinuation of therapy [see Package Inserts for peginterferon alfa and ribavirin].
Table 4 Selected Hematological Parameters Previously Untreated
(SPRINT-1 & SPRINT-2) Previous Treatment Failures
(RESPOND-2)
Percentage of Subjects Reporting Selected Hematological Parameters Percentage of Subjects Reporting Selected Hematological Parameters
Hematological Parameters VICTRELIS + PegIntron + REBETOL
(n=1225) PegIntron + REBETOL
(n=467) VICTRELIS + PegIntron + REBETOL
(n=323) PegIntron + REBETOL
(n=80)
Hemoglobin (g/dL)
<10 49 29 49 25
<8.5 6 3 10 1
Neutrophils (× 109/L)
<0.75 31 18 26 13
<0.5 8 4 7 4
Platelets (× 109/L)
<50 3 1 4 0
<25 <1 0 0 0
7 DRUG INTERACTIONS
See also Contraindications (4), Warnings and Precautions (5.4), and Clinical Pharmacology (12.3).
7.1 Potential for VICTRELIS to Affect Other Drugs
Boceprevir is a strong inhibitor of CYP3A4/5. Drugs metabolized primarily by CYP3A4/5 may have increased exposure when administered with VICTRELIS, which could increase or prolo |
