rate or severe hepatic impairment (Child-Pugh B or C, score greater than or equal to 7) or patients with decompensated liver disease. Refer to prescribing information for peginterferon alfa and ribavirin which must be co-administered with INCIVEK [see Use in Specific Populations: Hepatic Impairment (8.6)].
6 ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the label:
-
Pregnancy: Use with Ribavirin and Peginterferon alfa [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1), and Patient Counseling Information (17.1)]
-
Serious Skin Reactions/Rash [see Warnings and Precautions (5.2 and 5.3)]
-
Anemia [see Warnings and Precautions (5.4)]
INCIVEK must be administered with peginterferon alfa and ribavirin. Refer to their respective prescribing information for their associated adverse reactions.
6.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety assessment is based on data from pooled adequate and well-controlled clinical trials including 1797 subjects who received INCIVEK combination treatment and 493 who received peginterferon alfa and ribavirin.
Serious adverse drug reactions occurred in 3% of subjects who received INCIVEK combination treatment compared to none of the subjects treated with peginterferon alfa and ribavirin. The most frequent serious adverse events in subjects treated with INCIVEK combination treatment were skin disorders (rash and/or pruritus) and anemia [see Warnings and Precautions (5.2, 5.3, and 5.4)]. Fourteen percent of subjects discontinued INCIVEK due to adverse drug reactions. Rash, anemia, fatigue, pruritus, nausea, and vomiting were the most frequent adverse drug reactions leading to discontinuation of INCIVEK.
INCIVEK was administered in combination with peginterferon alfa and ribavirin. The following table lists adverse drug reactions that occurred in INCIVEK-treated subjects with an incidence at least 5% greater than in subjects receiving peginterferon alfa and ribavirin alone (Table 4).
Table 4: Clinical Adverse Drug Reactions Reported with at Least 5% Higher Frequency Among Subjects Receiving INCIVEK
|
|
INCIVEK, peginterferon alfa, and ribavirin Combination Treatment
N=1797 |
Peginterferon alfa and ribavirin
N=493 |
|
|
|
Rash* |
56% |
34% |
|
Fatigue |
56% |
50% |
|
Pruritus |
47% |
28% |
|
Nausea |
39% |
28% |
|
Anemia* |
36% |
17% |
|
Diarrhea |
26% |
17% |
|
Vomiting |
|
