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Victrelis is a brand name for Boceprevir. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Victrelis is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy (see sections 4.4 and 5.1).
Verbatim from this product's EMA label. Tap a section to expand.
Treatment with Victrelis should be initiated and monitored by a physician experienced in the management of chronic hepatitis C. Posology Victrelis must be administered in combination with peginterferon alfa and ribavirin. The Summary of Product Characteristics of peginterferon alfa and ribavirin (PR) must be consulted prior to initiation of therapy with Victrelis.
The recommended dose of Victrelis is 800 mg administered orally three times daily (TID) with food (a meal or light snack). Maximum daily dose of Victrelis is 2,400 mg. Administration without food could be associated with a net loss of efficacy due to sub-optimal exposure.
Medicinal product no longer authorised 3 Table 1 Duration of therapy using Response-Guided Therapy (RGT) guidelines in patients without cirrhosis who are previously untreated or who have failed previous therapy to interferon and ribavirin therapy Previously Untreated Patients ASSESSMENT* (HCV-RNA Results†) ACTION At Treatment Week 8 At Treatment Week 24 Undetectable Undetectable Treatment duration = 28 weeks 1.
Administer peginterferon alfa and ribavirin for 4 weeks, and then 2. Continue with all three medicines (peginterferon alfa and ribavirin [PR] + Victrelis) and finish through Treatment Week 28 (TW 28). Detectable Undetectable Treatment duration = 48 weeks‡ 1.
Administer peginterferon alfa and ribavirin for 4 weeks, and then 2. Continue with all three medicines (PR + Victrelis) and finish through TW 36; and then 3. Administer peginterferon alfa and ribavirin and finish through TW 48. Patients Who have Failed Previous Therapy Undetectable Undetectable Treatment duration = 48 weeks 1.
Administer peginterferon alfa and ribavirin for 4 weeks, and then 2. Continue with all three medicines (PR + Victrelis) and finish through TW 36, and then 3. Administer peginterferon alfa and ribavirin and finish through TW 48. Detectable Undetectable *Stopping rules If the patient has hepatitis C virus ribonucleic acid (HCV-RNA) results greater than or equal to 1,000 IU/mL at TW 8; then discontinue three-medicine regimen.
If the patient has HCV-RNA results greater than or equal to 100 IU/mL at TW 12; then discontinue three-medicine regimen. If the patient has confirmed, detectable HCV-RNA at TW 24; then discontinue three-medicine regimen. 3 IU/mL and a limit of quantification of 25 IU/mL.
1). 4), nausea, headache, and dysgeusia. The most common reason for dose reduction was anaemia, which occurred more frequently in subjects receiving the combination of Victrelis with peginterferon alfa-2b and ribavirin than in subjects receiving peginterferon alfa-2b and ribavirin alone.
Tabulated list of adverse reactions Adverse reactions are listed by System Organ Class (see Table 3). 4), drug rash with eosinophilia and systemic symptoms (DRESS) syndrome, Stevens-Johnson syndrome Musculoskeletal and connective tissue disorders […]
4. 1). Missed doses If a patient misses a dose and it is less than 2 hours before the next dose is due, the missed dose should be skipped. If a patient misses a dose and it is 2 or more hours before the next dose is due, the patient should take the missed dose with food and resume the normal dosing schedule.
Dose reduction Dose reduction of Victrelis is not recommended. If a patient has a serious adverse reaction potentially related to peginterferon alfa and/or ribavirin, the peginterferon alfa and/or ribavirin dose should be reduced. Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin for additional information about how to reduce and/or discontinue the peginterferon alfa and/or ribavirin dose.
Victrelis must not be administered in the absence of peginterferon alfa and ribavirin. Stopping rules Discontinuation of therapy is recommended in all patients with 1) HCV-RNA levels of greater than or equal to 1,000 IU per mL at TW 8; or 2) HCV-RNA levels of greater than or equal to 100 IU per mL at TW 12; or 3) confirmed, detectable HCV-RNA levels at TW 24.
Special populations Elderly Clinical studies of boceprevir did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 2). 2). Hepatic impairment No dose adjustment of Victrelis is required for patients with mild, moderate or severe hepatic impairment.
2). Medicinal product no longer authorised 5 Paediatric population The safety and efficacy of Victrelis in children aged below 18 years have not yet been established. No data are available. Method of administration To obtain the hard capsules the foil of the blister should be peeled off.
Victrelis is to be taken orally with food (a meal or light snack). 1. Patients with autoimmune hepatitis. 5). 6). Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin for additional information. 4 Special warnings and precautions for use Anaemia The onset of anaemia has been reported with peginterferon alfa and ribavirin therapy by Treatment Week 4.
1. Patients with autoimmune hepatitis. 5). 6). Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin for additional information.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Medicinal product no longer authorised 4 All cirrhotic patients and null responders - Recommended treatment duration is 48 weeks: 4 weeks of bitherapy with peginterferon alfa+ ribavirin + 44 weeks of tritherapy with peginterferon alfa + ribavirin + Victrelis.
) o The duration of the tritherapy after the first 4 weeks of bitherapy should not be less than 32 weeks. 1). For additional information on use of Victrelis in patients with advanced liver disease, see section
8). In clinical trials with the combination of Victrelis, peginterferon alfa-2b and ribavirin compared to peginterferon alfa-2b and ribavirin alone, the median time from the initiation of therapy to onset of haemoglobin less than 10 g/dL was similar (71 days with a range of 15-337 days, and 71 days with a range of 8-337 days, respectively).
Complete blood counts (with white blood cell differential counts) should be obtained at pretreatment, and at Treatment Weeks 2, 4, 8, 12 and should be monitored closely at other time points, as clinically appropriate. 8). 1). Refer to the Summary of Product Characteristics for ribavirin for information regarding dose reduction and/or discontinuation of ribavirin.
If permanent discontinuation of ribavirin is required, then peginterferon alfa and Victrelis must also be discontinued. 1). Medicinal product no longer authorised 6 The frequency of severe or life threatening infections tends to be higher in boceprevir-containing arms than the control arm.
Complete blood counts (with white blood cell differential counts) should be obtained at pretreatment, and at Treatment Weeks 2, 4, 8, 12, and should be monitored closely at other time points, as clinically appropriate. Decreases in neutrophil counts may require dose reduction of peginterferon alfa or discontinuation of therapy.
If permanent discontinuation of peginterferon alfa is required, then ribavirin and Victrelis must also be discontinued. Prompt evaluation and treatment of infections is recommended.
Combined use with peginterferon alfa–2a as compared to alfa–2b:
As […]