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Incivo is a brand name for Telaprevir. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: INCIVO, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis): - who are treatment-naïve; - who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment with INCIVO should be initiated and monitored by a physician experienced in the management of chronic hepatitis C. ) with food. Alternatively, 750 mg (two 375 mg tablets) can be taken orally every 8 hours (q8h) with food. The total daily dose is 6 tablets (2,250 mg).
Taking INCIVO without food or without regard to the dosing interval may result in decreased plasma concentrations of telaprevir which could reduce the therapeutic effect of INCIVO. INCIVO should be administered in conjunction with ribavirin and either peginterferon alfa-2a or -2b.
1 regarding the selection of peginterferon alfa-2a or -2b. Medicinal product no longer authorised 3 Duration of treatment – Treatment-naïve adults and prior treatment relapsers Treatment with INCIVO must be initiated in combination with peginterferon alfa and ribavirin and administered for 12 weeks (see figure 1).
- Patients with undetectable hepatitis C virus ribonucleic acid (HCV RNA) (target not detected) at weeks 4 and 12 receive an additional 12 weeks of peginterferon alfa and ribavirin alone for a total treatment duration of 24 weeks. - Patients with detectable HCV RNA at either weeks 4 or 12 receive an additional 36 weeks of peginterferon alfa and ribavirin alone for a total treatment duration of 48 weeks.
1).
Figure 1:
Duration of treatment for treatment-naïve patients and prior treatment relapsers HCV RNA levels should be monitored at weeks 4 and 12 to determine treatment duration. 1). Detectable HCV RNA below the lower limit of assay quantification should not be used as a substitute for “undetectable” (target not detected), for making decisions on treatment duration, as this may lead to an insufficient duration of therapy and higher relapse rates.
See table 1 for Guidelines for Discontinuation of INCIVO, Peginterferon Alfa, and Ribavirin Treatment. Duration of treatment – Previously treated adults with prior partial or prior null response Treatment with INCIVO must be initiated in combination with peginterferon alfa and ribavirin and administered for 12 weeks, followed by peginterferon alfa and ribavirin therapy alone (without INCIVO) for a total treatment duration of 48 weeks (see figure 2).
Figure 2:
8.
Medicinal product no longer authorised 7 Moderate rash:
Diffuse rash ≤ 50% of body surface area Monitor for progression or systemic symptoms until the rash is resolved. Consider consultation with a specialist in dermatology. For moderate rash that progresses, permanent discontinuation of INCIVO should be considered.
If the rash does not improve within 7 days following INCIVO discontinuation, ribavirin should be interrupted. Interruption of ribavirin may be required sooner if the rash worsens despite discontinuation of telaprevir. Peginterferon alfa may be continued unless interruption is medically indicated.
For moderate rash that progresses to severe (≥ 50% body surface area), permanently discontinue INCIVO (see below).
Severe rash:
Extent of rash > 50% of body surface area or associated with vesicles, bullae, ulcerations other than SJS Permanently discontinue INCIVO immediately. Consultation with a specialist in dermatology is recommended. Monitor for progression or systemic symptoms until the rash is resolved.
Peginterferon alfa and ribavirin may be continued. If improvement is not observed within 7 days of INCIVO discontinuation, sequential or simultaneous interruption or discontinuation of ribavirin and/or peginterferon alfa should be considered.
If medically indicated, earlier interruption or discontinuation of peginterferon alfa and ribavirin may be needed. Serious skin reactions including rash with systemic symptoms, progressive severe rash, suspicion or diagnosis of generalised bullous eruption, DRESS, SJS/TEN, acute generalized exanthematous pustulosis, erythema multiforme Permanent and immediate discontinuation of INCIVO, peginterferon alfa, and ribavirin.
Severe rash Severe, potentially life-threatening and fatal skin reactions have been reported with INCIVO combination treatment. 8). Fatal cases have been reported in patients with progressive rash and systemic symptoms who continued to receive INCIVO combination treatment after a serious skin reaction was identified.
4% receiving peginterferon alfa and ribavirin. Available data suggest that peginterferon alfa, and perhaps also ribavirin, may contribute to the frequency and severity of rash associated with INCIVO combination treatment. 6% of patients discontinued INCIVO combination treatment for rash events compared to none of those receiving peginterferon alfa and ribavirin.
4% of patients had suspected Drug Rash with Eosinophilia and Systemic Symptoms (DRESS). 1% of patients had Stevens-Johnson Syndrome (SJS). All of these reactions resolved with treatment discontinuation. DRESS presents as a rash with eosinophilia associated with one or more of the following features: fever, lymphadenopathy, facial oedema, and internal organ involvement (hepatic, renal, pulmonary).
It may appear at any time after start of treatment, although the majority of cases appeared between six and ten weeks after the start of treatment with INCIVO. Prescribers should ensure that patients are fully informed about the risk of severe rashes, and to consult with their prescriber immediately if they develop a new rash or worsening of an existing rash.
All rashes should be monitored for progression and until the rash is resolved. The rash may take several weeks to resolve. Other medicinal products associated with severe cutaneous reactions should be used with caution during administration of INCIVO combination treatment to avoid potential confusion as to which medicinal product could be contributing to a severe cutaneous reaction.
In the case of a serious skin reaction, discontinuation of other medicinal products known to be associated with serious skin reactions should be considered. 8.
1. Concomitant administration with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. 5). g. rifampicin, St John's wort (Hypericum perforatum), carbamazepine, phenytoin and phenobarbital and thus may lead to lower exposure and loss of efficacy of INCIVO.
Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin for a list of their contraindications since INCIVO must be used in combination with peginterferon alfa and ribavirin.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Duration of treatment for previously treated patients with prior partial or prior null response HCV RNA levels should be monitored at weeks 4 and 12. Medicinal product no longer authorised 4 All patients Since it is highly unlikely that patients with inadequate viral responses will achieve a sustained virologic response (SVR), it is recommended that patients with HCV RNA > 1,000 IU/ml at week 4 or week 12 discontinue therapy (refer to table 1).
Table 1:
Guidelines for discontinuation of INCIVO, Peginterferon Alfa, and Ribavirin treatment Medicinal products HCV RNA > 1,000 IU/ml at week 4 of treatmenta HCV RNA > 1,000 IU/ml at week 12 of treatmenta INCIVO Permanently discontinue INCIVO treatment completed Peginterferon alfa and Ribavirin Permanently discontinue a treatment with INCIVO, peginterferon alfa, and ribavirin.
1). In the Phase 3 studies, none of the patients with HCV RNA > 1,000 IU/ml at either week 4 or week 12 achieved SVR with continued peginterferon alfa and ribavirin treatment. In treatment-naïve patients in the Phase 3 studies, 4/16 (25%) patients with HCV RNA levels between 100 IU/ml and 1,000 IU/ml at week 4 achieved SVR.
In patients with HCV RNA between 100 IU/ml and 1,000 IU/ml at week 12, 2/8 (25%) achieved an SVR. In prior null responders, consideration should be given to conduct an additional HCV RNA test between weeks 4 and 12. If the HCV RNA concentration is > 1,000 IU/ml, INCIVO, peginterferon alfa, and ribavirin should be discontinued.
For patients receiving a total of 48 weeks of treatment, peginterferon alfa and ribavirin should be discontinued if HCV RNA is detectable at week 24 or week 36. INCIVO must be taken with peginterferon alfa and ribavirin to prevent treatment failure.
To prevent treatment failure, the dose of INCIVO must not be reduced or interrupted. If INCIVO treatment is discontinued due to adverse drug reactions or because of insufficient virologic response, INCIVO treatment should not be reinitiated.
4). ), in case a dose of INCIVO is missed within 6 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of INCIVO with food as soon as possible. If the missed dose is noticed more than 6 hours after the time INCIVO should be taken, the missed dose should be skipped and the patient should resume the normal dosing schedule.
When administered every 8 hours (q8h), in case a dose of INCIVO is missed within 4 hours of the time it is usually taken, patients should be […]
Consult with a specialist in dermatology. If discontinued due to a skin reaction, INCIVO must not be restarted. Refer also to the Summary of Product Characteristics for peginterferon alfa and ribavirin for severe skin reactions associated with these products.
Anaemia In placebo-controlled Phase 2 and 3 clinical trials, the overall incidence and severity of anaemia increased with INCIVO combination treatment compared to peginterferon alfa and ribavirin alone. Haemoglobin values of < 10 g/dl were observed in 34% of patients who received INCIVO combination treatment and in 14% of patients who received peginterferon alfa and ribavirin.
5 g/dl were observed in 8% of INCIVO combination treatment compared to 2% of patients receiving peginterferon alfa and ribavirin. A decrease in haemoglobin levels occurs during the first 4 weeks of treatment, with lowest values reached at the end of INCIVO dosing.
Haemoglobin values gradually improve after completion of INCIVO dosing. 4, Laboratory tests). Ribavirin dose reduction is the preferred strategy for managing treatment-emergent anaemia. Refer to the Summary of Product Characteristics for ribavirin for information regarding dose reduction and/orMedicinal product no longer authorised 8 discontinuation of ribavirin.
If ribavirin is permanently discontinued for the management of anaemia, INCIVO must also be permanently discontinued. If INCIVO is discontinued for anaemia, patients may continue treatment with peginterferon alfa and ribavirin. Ribavirin may be restarted per the dosing modification guidelines for ribavirin.
The dose of INCIVO must not be reduced, and INCIVO must not be restarted if discontinued. Pregnancy and contraception requirements Because INCIVO must be used in combination with peginterferon alfa and ribavirin, the contraindications and warnings applicable to those medicinal products are applicable to combination therapy.
Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin, therefore, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients.
Female patients of childbearing potential and their male partners as well as male patients and their female partners must use 2 effective contraceptive methods during INCIVO treatment and afterwards as recommended in the Summary of Product Characteristics for ribavirin, and as described below.
5). During this time, female patients of childbearing potential should use two effective non-hormonal methods of contraception. Two months after completion of INCIVO treatment, hormonal contraceptives are again appropriate as one of the two required effective methods of birth control.
6. 1). Exposure at this dose was comparable to the exposure in HCV-infected patients receiving a dose of 750 mg INCIVO every 8 hours plus peginterferon alfa and ribavirin. The potential clinical significance of these findings is uncertain.
INCIVO should be used with caution with Class Ic antiarrhythmics propafenone and flecainide, including appropriate clinical and ECG monitoring. Caution is recommended when prescribing […]
Medicinal product no longer authorised 7 Moderate rash:
Diffuse rash ≤ 50% of body surface area Monitor for progression or systemic symptoms until the rash is resolved. Consider consultation with a specialist in dermatology. For moderate rash that progresses, permanent discontinuation of INCIVO should be considered.
If the rash does not improve within 7 days following INCIVO discontinuation, ribavirin should be interrupted. Interruption of ribavirin may be required sooner if the rash worsens despite discontinuation of telaprevir. Peginterferon alfa may be continued unless interruption is medically indicated.
For moderate rash that progresses to severe (≥ 50% body surface area), permanently discontinue INCIVO (see below).
Severe rash:
Extent of rash > 50% of body surface area or associated with vesicles, bullae, ulcerations other than SJS Permanently discontinue INCIVO immediately. Consultation with a specialist in dermatology is recommended. Monitor for progression or systemic symptoms until the rash is resolved.
Peginterferon alfa and ribavirin may be continued. If improvement is not observed within 7 days of INCIVO discontinuation, sequential or simultaneous interruption or discontinuation of ribavirin and/or peginterferon alfa should be considered.
If medically indicated, earlier interruption or discontinuation of peginterferon alfa and ribavirin may be needed. Serious skin reactions including rash with systemic symptoms, progressive severe rash, suspicion or diagnosis of generalised bullous eruption, DRESS, SJS/TEN, acute generalized exanthematous pustulosis, erythema multiforme Permanent and immediate discontinuation of INCIVO, peginterferon alfa, and ribavirin.
Consult with a specialist in dermatology. If discontinued due to a skin reaction, INCIVO must not be restarted. Refer also to the Summary of Product Characteristics for peginterferon alfa and ribavirin for severe skin reactions associated with these products.
Anaemia In placebo-controlled Phase 2 and 3 clinical trials, the overall incidence and severity of anaemia increased with INCIVO combination treatment compared to peginterferon alfa and ribavirin alone. Haemoglobin values of < 10 g/dl were observed in 34% of patients who received INCIVO combination treatment and in 14% of patients who received peginterferon alfa and ribavirin.
5 g/dl were observed in 8% of INCIVO combination treatment compared to 2% of patients receiving peginterferon alfa and ribavirin. A decrease in haemoglobin levels occurs during the first 4 weeks of treatment, with lowest values reached at the end of INCIVO dosing.
Haemoglobin values gradually improve after completion of INCIVO dosing. 4, Laboratory tests). Ribavirin dose reduction is the preferred strategy for […]