m control dams. After weaning, rat pup body weight gain was similar in offspring from telaprevir-treated and control dams. Because of the potential for adverse reactions in nursing infants, nursing must be discontinued prior to initiation of treatment. See also the prescribing information for ribavirin.
8.4 Pediatric Use
The safety, efficacy and pharmacokinetic profile of INCIVEK in pediatric patients have not been established.
8.5 Geriatric Use
Clinical studies of INCIVEK did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In general, caution should be exercised in the administration and monitoring of INCIVEK in geriatric patients reflecting the greater frequency of decreased hepatic function, and of concomitant disease or other drug therapy [see Clinical Pharmacology (12.3) ].
8.6 Hepatic Impairment
INCIVEK is not recommended for use in patients with moderate or severe hepatic impairment (Child-Pugh B or C, score greater than or equal to 7) because no pharmacokinetic or safety data are available regarding the use of INCIVEK in HCV-infected patients with moderate or severe hepatic impairment, and appropriate doses have not been established [see Warnings and Precautions (5.8) and Clinical Pharmacology (12.3) ]. No dose adjustment of INCIVEK is necessary for patients with mild hepatic impairment (Child-Pugh A, score 5-6). Refer also to the prescribing information for peginterferon alfa and ribavirin which must be co-administered with INCIVEK.
8.7 Renal Impairment
No dose adjustment is necessary for INCIVEK in HCV-infected patients with mild, moderate or severe renal impairment. INCIVEK has not been studied in HCV-infected patients with CrCl less than or equal to 50 mL/min.
The pharmacokinetics of telaprevir were assessed after administration of a single dose of 750 mg to HCV-negative subjects with severe renal impairment (CrCl less than 30 mL/min). INCIVEK has not been studied in patients with end-stage renal disease (ESRD) or on hemodialysis [see Clinical Pharmacology (12.3) ]. Refer also to the prescribing information for peginterferon alfa and ribavirin which must be co-administered with INCIVEK.
8.8 Co-infection
The safety and efficacy of INCIVEK have not been established in patients co-infected with HCV/HIV or HCV/HBV [see Drug Interactions (7) ].
8.9 Solid Organ Transplantation
The safety and efficacy of INCIVEK have not been established in solid organ transplant patients [see Drug Interactions (7) ].
10 OVERDOSAGE
The highest documented dose administered is 1875 mg every 8 hours for 4 days in healthy subjects with INCIVEK alone. In that study, the following common adverse events were reported more frequently with the 1875 mg q8h regimen compared to the 750 mg q8h regimen: nausea, headache, diarrhea, decreased appetite, dysgeusia, and vomiting.
No specific antidote is available for overdose with INCIVEK. Treatment of overdose with INCIVEK consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. In the event of an overdose, it is reasonable to employ the standard supportive measures, such as, removing unabsorbed material from the gastrointestinal tract, employing clinical monitoring (including obtaining an electrocardiogram), and instituting supportive therapy if required.
It is not known whether telaprevir is dialyzable by peritoneal or hemod |
