Victrelis 200 mg hard capsules
Each hard capsule contains 200 mg of boceprevir.
Excipient with known effect: each capsule contains 56 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
Hard capsule.
Each capsule has a yellowish-brown, opaque cap with an "MSD" logo imprinted in red ink and off-white, opaque body with the code "314" imprinted in red ink.
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.
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.
Patients without cirrhosis who are previously untreated or who have failed previous therapy
The following dosing recommendations differ for some subgroups from the dosing studied in the Phase 3 trials (see section 5.1).
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
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Previously Untreated Patients
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ASSESSMENT*
(HCV-RNA Results†)
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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.
† In clinical trials, HCV-RNA in plasma was measured with the Roche COBAS Taqman 2.0 assay with a limit of detection of 9.3 IU/mL and a limit of quantification of 25 IU/mL.
‡This regimen has only been tested in subjects who have failed previous therapy who were late responders (see section 5.1).
|
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. (Refer to the stopping rule in Table 1 for all patients.)
o The duration of the tritherapy after the first 4 weeks of bitherapy should not be less than 32 weeks. Given the incremental risk of adverse events with Victrelis (anaemia notably); in case the patient cannot tolerate the treatment, consideration could be given to pursue with 12 weeks of bitherapy for the final 12 weeks of treatment instead of tritherapy (see sections 4.8 and 5.1). For additional information on use of Victrelis in patients with advanced liver disease, see section 4.4.
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 an
