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Victrelis Prescribing Information

This information is not for clinical use. These highlights do not include all the information needed to use Victrelis safely and effectively. Before taking Victrelis please consult with your doctor. See full prescribing information for Victrelis.

Indications And Usage

VICTRELIS® (boceprevir) is indicated for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy, including prior null responders, partial responders, and relapsers [see Clinical Studies (14)]. The following points should be considered when initiating VICTRELIS for treatment of chronic hepatitis C infection: VICTRELIS must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin. The efficacy of VICTRELIS has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors. Poorly interferon responsive patients who were treated with VICTRELIS in combination with peginterferon alfa and ribavirin have a lower likelihood of achieving a sustained virologic response (SVR), and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin [see Microbiology (12.4) and Clinical Studies (14)]. VICTRELIS is a hepatitis C virus (HCV) NS3/4A protease inhibitor 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, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy, including prior null responders, partial responders, and relapsers. (1) VICTRELIS must not be used as a monotherapy and should only be used in combination with peginterferon alfa and ribavirin. (1) The efficacy of VICTRELIS has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors. (1)

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Dosage And Administration

Table 1 Duration of Therapy in Patients Without Cirrhosis Who Are Previously Untreated or Who Previously Failed Interferon and Ribavirin Therapy
ASSESSMENT TREATMENT FUTILITY If the patient has HCV-RNA results greater than or equal to 1000 IU/mL at TW8, then discontinue three-medicine regimen. If the patient has HCV-RNA results greater than or equal to 100 IU/mL at TW12, then discontinue three-medicine regimen. If the patient has confirmed, detectable HCV-RNA at TW24, then discontinue three-medicine regimen. (HCV-RNA Results"Not Detected" refers to HCV-RNA assay results reported as "Target Not Detected" or "HCV-RNA Not Detected". In clinical trials, HCV-RNA in plasma was measured using a Roche COBAS® TaqMan® assay with a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. See Warnings and Precautions (5.7) for a description of HCV-RNA assay recommendations.) RECOMMENDATION
At Treatment Week 8 At Treatment Week 24
Previously Untreated Patients Not Detected Not Detected Complete three-medicine regimen at TW28.
Detected Not Detected Continue all three medicines and finish through TW36; and then Administer peginterferon alfa and ribavirin and finish through TW48.
Previous Partial Responders or Relapsers See Clinical Studies (14) for definitions of previous response to interferon and ribavirin therapy. Not Detected Not Detected Complete three-medicine regimen at TW36.
Detected Not Detected Continue all three medicines and finish through TW36; and then Administer peginterferon alfa and ribavirin and finish through TW48.
Previous Null Responders Detected or Not Detected Not Detected Continue all three medicines and finish through TW48.

Dosage Forms And Strengths

VICTRELIS 200 mg Capsules, red-colored cap with the Merck logo printed in yellow ink, and a yellow-colored body with "314" printed in red ink. Capsules: 200 mg (3)

Contraindications

Contraindications to peginterferon alfa and ribavirin also apply to VICTRELIS combination treatment. Refer to the respective prescribing information for a list of the contraindications for peginterferon alfa and ribavirin. VICTRELIS in combination with peginterferon alfa and ribavirin is contraindicated in: Pregnant women and men whose female partners are pregnant because of the risks for birth defects and fetal death associated with ribavirin [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. Patients with a history of a hypersensitivity reaction to boceprevir [see Warnings and Precautions (5.5)]. Coadministration with drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events, including those in Table 2, is contraindicated [see Drug Interactions (7)]. Coadministration with potent CYP3A4/5 inducers, where significantly reduced boceprevir plasma concentrations may be associated with reduced efficacy, including those in Table 2, is contraindicated [see Drug Interactions (7)]. Table 2 Drugs that are contraindicated with VICTRELIS Drug Class Drugs Within Class that are Contraindicated With VICTRELIS Clinical Comments Alpha 1-Adrenoreceptor antagonists Alfuzosin, doxazosin, silodosin, tamsulosin Potential for alpha 1-adrenoreceptor antagonist-associated adverse events, such as hypotension and priapism Anticonvulsants Carbamazepine, phenobarbital, phenytoin May lead to loss of virologic response to VICTRELIS Antimycobacterial Agents Rifampin May lead to loss of virologic response to VICTRELIS. Ergot Derivatives Dihydroergotamine, ergonovine, ergotamine, methylergonovine Potential for acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues. GI Motility Agent Cisapride Potential for cardiac arrhythmias. Herbal Products St. John's wort (Hypericum perforatum) May lead to loss of virologic response to VICTRELIS. HMG-CoA Reductase Inhibitors Lovastatin, simvastatin Potential for myopathy, including rhabdomyolysis. Oral Contraceptives Drospirenone Potential for hyperkalemia. PDE5 enzyme Inhibitor REVATIO® (sildenafil) or ADCIRCA® (tadalafil) when used for the treatment of pulmonary arterial hypertensionSee Drug Interactions, Table 5 for coadministration of sildenafil and tadalafil when dosed for erectile dysfunction. Potential for PDE5 inhibitor-associated adverse events, including visual abnormalities, hypotension, prolonged erection, and syncope. Neuroleptic Pimozide Potential for cardiac arrhythmias. Sedative/Hypnotics Triazolam; orally administered midazolamSee Drug Interactions, Table 5 for parenterally administered midazolam. Prolonged or increased sedation or respiratory depression. All contraindications to peginterferon alfa and ribavirin also apply since VICTRELIS must be administered with peginterferon alfa and ribavirin. (4) Because ribavirin may cause birth defects and fetal death, boceprevir in combination with peginterferon alfa and ribavirin is contraindicated in pregnant women and in men whose female partners are pregnant. (4) Contraindicated in patients with a history of a hypersensitivity reaction to boceprevir. (4) Coadministration with drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated. (4) Coadministration with potent CYP3A4/5 inducers where significantly reduced boceprevir plasma concentrations may be associated with reduced efficacy is contraindicated. (4)

Warning and Cautions

Use of VICTRELIS with Ribavirin and Peginterferon alfa: Embryofetal Toxicity (Use with Ribavirin and Peginterferon Alfa): Ribavirin may cause birth defects and fetal death; avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to therapy; use two or more forms of contraception, and have monthly pregnancy tests. (5.1) Anemia - The addition of VICTRELIS to peginterferon alfa and ribavirin is associated with an additional decrease in hemoglobin concentrations compared with peginterferon alfa and ribavirin alone. (5.2) Neutropenia - The addition of VICTRELIS to peginterferon alfa and ribavirin may result in worsening of neutropenia associated with peginterferon alfa and ribavirin therapy alone. (5.3) Hypersensitivity – Serious acute hypersensitivity reactions (e.g., urticaria, angioedema) have been observed during combination therapy with VICTRELIS, peginterferon alfa and ribavirin. (5.5) 5.1 Embryofetal Toxicity (Use with Ribavirin and Peginterferon Alfa) Ribavirin may cause birth defects and/or death of the exposed fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin therapy should not be started unless a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Refer to the prescribing information for ribavirin for additional information. Women of childbearing potential and men must use at least two forms of effective contraception during treatment and for at least 6 months after treatment has concluded. One of these forms of contraception can be a combined oral contraceptive product containing at least 1 mg of norethindrone. Oral contraceptives containing lower doses of norethindrone and other forms of hormonal contraception have not been studied or are contraindicated. Routine monthly pregnancy tests must be performed during this time [see Contraindications (4) and Drug Interactions (7)]. 5.2 Anemia (Use with Ribavirin and Peginterferon Alfa) Anemia has been reported with peginterferon alfa and ribavirin therapy. The addition of VICTRELIS to peginterferon alfa and ribavirin is associated with an additional decrease in hemoglobin concentrations. Complete blood counts (with white blood cell differential counts) should be obtained pretreatment, and at Treatment Weeks 2, 4, 8, and 12, and should be monitored closely at other time points, as clinically appropriate. If hemoglobin is less than 10 g per dL, a decrease in dosage of ribavirin is recommended; and if hemoglobin is less than 8.5 g per dL, discontinuation of ribavirin is recommended [see Adverse Reactions (6.1) and Clinical Studies (14)]. If ribavirin is permanently discontinued for management of anemia, then peginterferon alfa and VICTRELIS must also be discontinued [see Dosage and Administration (2.3)]. Refer to the prescribing information for ribavirin for additional information regarding dose reduction and/or discontinuation. In clinical trials with VICTRELIS, the proportion of subjects who experienced hemoglobin values less than 10 g per dL and less than 8.5 g per dL was higher in subjects treated with the combination of VICTRELIS with PegIntron®/REBETOL® than in those treated with PegIntron/REBETOL alone (see Table 4). With the interventions used for anemia management in the clinical trials, the average additional decrease of hemoglobin was approximately 1 g per dL. In clinical trials, the median time to onset of hemoglobin less than 10 g per dL from the initiation of therapy was similar among subjects treated with the combination of VICTRELIS and PegIntron/REBETOL (71 days with a range of 15-337 days), compared to those who received PegIntron/REBETOL (71 days with a range of 8-337 days). Certain adverse reactions consistent with symptoms of anemia, such as dyspnea, exertional dyspnea, dizziness and syncope were reported more frequently in subjects who received the combination of VICTRELIS with PegIntron/REBETOL than in those treated with PegIntron/REBETOL alone [see Adverse Reactions (6.1)]. In clinical trials with VICTRELIS, dose modifications (generally of PegIntron/REBETOL) due to anemia occurred twice as often in subjects treated with the combination of VICTRELIS with PegIntron/REBETOL (26%) compared to PegIntron/REBETOL (13%). The proportion of subjects who discontinued study drug due to anemia was 1% in subjects treated with the combination of VICTRELIS with PegIntron/REBETOL and 1% in subjects who received PegIntron/REBETOL. The use of erythropoiesis stimulating agents (ESAs) was permitted for management of anemia, at the investigator's discretion, with or without ribavirin dose reduction in the Phase 2 and 3 clinical trials. The proportion of subjects who received an ESA was 43% in those treated with the combination of VICTRELIS with PegIntron/REBETOL compared to 24% in those treated with PegIntron/REBETOL alone. The proportion of subjects who received a transfusion for the management of anemia was 3% of subjects treated with the combination of VICTRELIS with PegIntron/REBETOL compared to less than 1% in subjects who received PegIntron/REBETOL alone. Thromboembolic events have been associated with ESA use in other disease states; and have also been reported with peginterferon alfa use in hepatitis C patients. Thromboembolic events were reported in clinical trials with VICTRELIS among subjects receiving the combination of VICTRELIS with PegIntron/REBETOL, and among those receiving PegIntron/REBETOL alone, regardless of ESA use. No definite causality assessment or benefit risk assessment could be made for these events due to the presence of confounding factors and lack of randomization of ESA use. A randomized, parallel-arm, open-label clinical trial was conducted in previously untreated CHC subjects with genotype 1 infection to compare use of an ESA versus ribavirin dose reduction for initial management of anemia during therapy with VICTRELIS in combination with peginterferon alfa-2b and ribavirin. Similar SVR rates were reported in subjects who were randomized to receive ribavirin dose reduction compared to subjects who were randomized to receive an ESA. In this trial, use of ESAs was associated with an increased risk of thromboembolic events including pulmonary embolism, acute myocardial infarction, cerebrovascular accident, and deep vein thrombosis compared to ribavirin dose reduction alone. The treatment discontinuation rate due to anemia was similar in subjects randomized to receive ribavirin dose reduction compared to subjects randomized to receive ESA (2% in each group). The transfusion rate was 4% in subjects randomized to receive ribavirin dose reduction and 2% in subjects randomized to receive ESA. Ribavirin dose reduction is recommended for the initial management of anemia. 5.3 Neutropenia (Use with Ribavirin and Peginterferon Alfa) In Phase 2 and 3 clinical trials, seven percent of subjects receiving the combination of VICTRELIS with PegIntron/REBETOL had neutrophil counts of less than 0.5 × 109 per L compared to 4% of subjects receiving PegIntron/REBETOL alone (see Table 4). Three subjects experienced severe or life-threatening infections associated with neutropenia, and two subjects experienced life-threatening neutropenia while receiving the combination of VICTRELIS with PegIntron/REBETOL. Complete blood counts (with white blood cell differential counts) should be obtained at pretreatment, and at Treatment Weeks 2, 4, 8, and 12, and should be monitored closely at other time points, as clinically appropriate. Decreases in neutrophil counts may require dose reduction or discontinuation of peginterferon alfa and ribavirin. If peginterferon alfa and ribavirin are permanently discontinued, then VICTRELIS must also be discontinued [see Dosage and Administration (2.3)]. Refer to the prescribing information for peginterferon alfa and ribavirin for additional information regarding dose reduction or discontinuation. 5.4 Pancytopenia (Use with Ribavirin and Peginterferon Alfa) Serious cases of pancytopenia have been reported postmarketing in patients receiving VICTRELIS in combination with peginterferon alfa and ribavirin. Complete blood counts (with white blood cell differential counts) should be obtained at pretreatment, and at Treatment Weeks 2, 4, 8, and 12, and should be monitored closely at other time points, as clinically appropriate. Refer to the prescribing information for ribavirin and peginterferon alfa for guidelines for discontinuation of therapy based on laboratory parameters. 5.5 Hypersensitivity Serious acute hypersensitivity reactions (e.g., urticaria, angioedema) have been observed during combination therapy with VICTRELIS, peginterferon alfa and ribavirin. If such an acute reaction occurs, combination therapy should be discontinued and appropriate medical therapy immediately instituted [see Contraindications (4) and Adverse Reactions (6.2)]. 5.6 Drug Interactions See Table 2 for a listing of drugs that are contraindicated for use with VICTRELIS due to potentially life-threatening adverse events, significant drug interactions or loss of virologic activity [see Contraindications (4)]. Please refer to Table 5 for established and other potentially significant drug interactions [see Drug Interactions (7.3)]. 5.7 Laboratory Tests HCV-RNA levels should be monitored at Treatment Weeks 4, 8, 12, and 24, at the end of treatment, during treatment follow-up, and for other time points as clinically indicated. Use of a sensitive real-time reverse-transcription polymerase chain reaction (RT-PCR) assay for monitoring HCV-RNA levels during treatment is recommended. The assay should have a lower limit of HCV-RNA quantification of equal to or less than 25 IU per mL, and a limit of HCV-RNA detection of approximately 10 to 15 IU per mL. For the purposes of assessing Response-Guided Therapy milestones, a confirmed "detectable but below limit of quantification" HCV-RNA result should not be considered equivalent to an "undetectable" HCV-RNA result (reported as "Target Not Detected" or "HCV-RNA Not Detected"). Complete blood count (with white blood cell differential counts) should be obtained at pretreatment, and at Treatment Weeks 2, 4, 8, and 12, and should be monitored closely at other time points, as clinically appropriate. Refer to the prescribing information for peginterferon alfa and ribavirin for pre-treatment, on-treatment and post-treatment laboratory testing recommendations including hematology, biochemistry (including hepatic function tests), and pregnancy testing requirements.

Adverse Reactions

See the peginterferon alfa and ribavirin prescribing information for description of adverse reactions associated with their use. The most commonly reported adverse reactions (greater than 35% of subjects) in clinical trials in adult subjects receiving the combination of VICTRELIS with PegIntron and REBETOL were fatigue, anemia, nausea, headache and dysgeusia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of VICTRELIS cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following serious and otherwise important adverse drug reactions (ADRs) are discussed in detail in another section of the labeling: Anemia [see Warnings and Precautions (5.2)] Neutropenia [see Warnings and Precautions (5.3)] Pancytopenia [see Warnings and Precautions (5.4)] Hypersensitivity [see Contraindications (4) and Warnings and Precautions (5.5)] The most commonly reported adverse reactions (more than 35% of subjects regardless of investigator's causality assessment) in adult subjects were fatigue, anemia, nausea, headache, and dysgeusia when VICTRELIS was used in combination with PegIntron and REBETOL. The safety of the combination of VICTRELIS 800 mg three times daily with PegIntron/REBETOL was assessed in 2095 subjects with chronic hepatitis C in one Phase 2, open-label trial and two Phase 3, randomized, double-blind, placebo-controlled clinical trials. SPRINT-1 (subjects who were previously untreated) evaluated the use of VICTRELIS in combination with PegIntron/REBETOL with or without a four-week lead-in period with PegIntron/REBETOL compared to PegIntron/REBETOL alone. SPRINT-2 (subjects who were previously untreated) and RESPOND-2 (subjects who had failed previous therapy) evaluated the use of VICTRELIS 800 mg three times daily in combination with PegIntron/REBETOL with a four-week lead-in period with PegIntron/REBETOL compared to PegIntron/REBETOL alone [see Clinical Studies (14)]. The population studied had a mean age of 49 years (3% of subjects were older than 65 years of age), 39% were female, 82% were white and 15% were black. During the four week lead-in period with PegIntron/REBETOL in subjects treated with the combination of VICTRELIS with PegIntron/REBETOL, 28/1263 (2%) subjects experienced adverse reactions leading to discontinuation of treatment. During the entire course of treatment, the proportion of subjects who discontinued treatment due to adverse reactions was 13% for subjects receiving the combination of VICTRELIS with PegIntron/REBETOL and 12% for subjects receiving PegIntron/REBETOL alone. Events resulting in discontinuation were similar to those seen in previous studies with PegIntron/REBETOL. Only anemia and fatigue were reported as events that led to discontinuation in more than 1% of subjects in any arm. Adverse reactions that led to dose modifications of any drug (primarily PegIntron and REBETOL) occurred in 39% of subjects receiving the combination of VICTRELIS with PegIntron/REBETOL compared to 24% of subjects receiving PegIntron/REBETOL alone. The most common reason for dose reduction was anemia, which occurred more frequently in subjects receiving the combination of VICTRELIS with PegIntron/REBETOL than in subjects receiving PegIntron/REBETOL alone. Serious adverse events were reported in 11% of subjects receiving the combination of VICTRELIS with PegIntron/REBETOL and in 8% of subjects receiving PegIntron/REBETOL. Adverse events (regardless of investigator's causality assessment) reported in greater than or equal to 10% of subjects receiving the combination of VICTRELIS with PegIntron/REBETOL and reported at a rate of greater than or equal to 5% than PegIntron/REBETOL alone in SPRINT-1, SPRINT-2, and RESPOND-2 are presented in Table 3. Table 3 Adverse Events Reported in ≥10% of Subjects Receiving the Combination of VICTRELIS with PegIntron/REBETOL and Reported at a Rate of ≥5% than PegIntron/REBETOL alone Adverse Events Previously Untreated (SPRINT-1 and SPRINT-2) Previous Treatment Failures (RESPOND-2) Percentage of Subjects Reporting Adverse Events Percentage of Subjects Reporting Adverse Events Body System Organ Class VICTRELIS + PegIntron + REBETOL (n=1225) PegIntron + REBETOL (n=467) VICTRELIS + PegIntron + REBETOL (n=323) PegIntron + REBETOL (n=80) Median Exposure (days) 197 216 253 104 Blood and Lymphatic System Disorders Anemia 50 30 45 20 Neutropenia 25 19 14 10 Gastrointestinal Disorders Nausea 46 42 43 38 Dysgeusia 35 16 44 11 Diarrhea 25 22 24 16 Vomiting 20 13 15 8 Dry Mouth 11 10 15 9 General Disorders and Administration Site Conditions Fatigue 58 59 55 50 Chills 34 29 33 30 Asthenia 15 18 21 16 Metabolism and Nutrition Disorders Decreased Appetite 25 24 26 16 Musculoskeletal and Connective Tissue Disorders Arthralgia 19 19 23 16 Nervous System Disorders Dizziness 19 16 16 10 Psychiatric Disorders Insomnia 34 34 30 24 Irritability 22 23 21 13 Respiratory, Thoracic, and Mediastinal Disorders Dyspnea Exertional 8 8 11 5 Skin and Subcutaneous Tissue Disorders Alopecia 27 27 22 16 Dry Skin 18 18 22 9 Rash 17 19 16 6 Other Important Adverse Reactions Reported in Clinical Trials Among subjects (previously untreated subjects or those who failed previous therapy) who received VICTRELIS in combination with peginterferon alfa and ribavirin, the following adverse drug reactions were reported. These events are notable because of their seriousness, severity, or increased frequency in subjects who received VICTRELIS in combination with peginterferon alfa and ribavirin compared with subjects who received only peginterferon alfa and ribavirin. Gastrointestinal Disorders Dysgeusia (alteration of taste) was an adverse event reported at an increased frequency in subjects receiving VICTRELIS in combination with peginterferon alfa and ribavirin compared with subjects receiving peginterferon alfa and ribavirin alone (Table 3). Adverse events such as dry mouth, nausea, vomiting and diarrhea were also reported at an increased frequency in subjects receiving VICTRELIS in combination with peginterferon alfa and ribavirin. Laboratory Values Changes in selected hematological parameters during treatment of adult subjects with the combination of VICTRELIS with PegIntron and REBETOL are described in Table 4. Hemoglobin Decreases in hemoglobin may require a decrease in dosage or discontinuation of ribavirin [see Warnings and Precautions (5.2) and Clinical Studies (14)] [see prescribing information for ribavirin]. If ribavirin is permanently discontinued, then peginterferon alfa and VICTRELIS must also be discontinued [see Dosage and Administration (2.3)]. Neutrophils and Platelets The proportion of subjects with decreased neutrophil and platelet counts was higher in subjects treated with VICTRELIS in combination with PegIntron/REBETOL compared to subjects receiving PegIntron/REBETOL alone. Three percent of subjects receiving the combination of VICTRELIS with PegIntron/REBETOL had platelet counts of less than 50 × 109 per L compared to 1% of subjects receiving PegIntron/REBETOL alone. Decreases in neutrophils or platelets may require a decrease in dosage or interruption of peginterferon alfa, or discontinuation of therapy [see prescribing information for peginterferon alfa and ribavirin]. If peginterferon alfa is permanently discontinued, then ribavirin and VICTRELIS must also be discontinued [see Dosage and Administration (2.3)]. Table 4 Selected Hematological Parameters Previously Untreated (SPRINT-1 and SPRINT-2) Previous Treatment Failures (RESPOND-2) Percentage of Subjects Reporting Selected Hematological Parameters Percentage of Subjects Reporting Selected Hematological Parameters Hematological Parameters VICTRELIS + PegIntron + REBETOL (n=1225) PegIntron + REBETOL (n=467) VICTRELIS + PegIntron + REBETOL (n=323) PegIntron + REBETOL (n=80) Hemoglobin (g/dL) <10 49 29 49 25 <8.5 6 3 10 1 Neutrophils (× 109/L) <0.75 31 18 26 13 <0.5 8 4 7 4 Platelets (× 109/L) <50 3 1 4 0 <25 <1 0 0 0 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of VICTRELIS in combination with peginterferon alfa and ribavirin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and Lymphatic System Disorders: agranulocytosis, pancytopenia, thrombocytopenia [see Warnings and Precautions (5.4)] Gastrointestinal Disorders: mouth ulceration, stomatitis Infections and Infestations: pneumonia, sepsis Skin and Subcutaneous Tissue Disorders: angioedema, urticaria [see Warnings and Precautions (5.5)]; drug rash with eosinophilia and systemic symptoms (DRESS) syndrome, exfoliative rash, exfoliative dermatitis, Stevens-Johnson syndrome, toxic skin eruption, toxicoderma

Drug Interactions

[See Contraindications (4), Warnings and Precautions (5.6), and Clinical Pharmacology (12.3).] VICTRELIS is a strong inhibitor of CYP3A4/5 and is partly metabolized by CYP3A4/5. The potential for drug-drug interactions must be considered prior to and during therapy. (4, 7, 12.3) 7.1 Potential for VICTRELIS to Affect Other Drugs Boceprevir is a strong inhibitor of CYP3A4/5. Drugs metabolized primarily by CYP3A4/5 may have increased exposure when administered with VICTRELIS, which could increase or prolong their therapeutic and adverse effects. Boceprevir does not inhibit CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP2E1 in vitro. In addition, boceprevir does not induce CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or CYP3A4/5 in vitro. Boceprevir is a potential inhibitor of p-glycoprotein (P-gp) based on in vitro studies. In a drug interaction trial conducted with digoxin, VICTRELIS had limited p-glycoprotein inhibitory potential at clinically relevant concentrations. 7.2 Potential for Other Drugs to Affect VICTRELIS Boceprevir is primarily metabolized by aldo-ketoreductase (AKR). In drug interaction trials conducted with AKR inhibitors diflunisal and ibuprofen, boceprevir exposure did not increase to a clinically significant extent. VICTRELIS may be coadministered with AKR inhibitors. Boceprevir is partly metabolized by CYP3A4/5. It is also a substrate for p-glycoprotein. Coadministration of VICTRELIS with drugs that induce or inhibit CYP3A4/5 could decrease or increase exposure to boceprevir. 7.3 Established and Other Potential Significant Drug Interactions Table 5 provides recommendations based on established or potentially clinically significant drug interactions. VICTRELIS is contraindicated with drugs that are potent inducers of CYP3A4/5 and drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events [see Contraindications (4)]. Table 5 Established and Other Potentially Significant Drug Interactions Concomitant Drug Class: Drug Name Effect on Concentration of Boceprevir or Concomitant Drug Recommendations Antiarrhythmics: amiodarone, bepridil, propafenone, quinidine ↑ antiarrhythmics Coadministration with VICTRELIS has the potential to produce serious and/or life-threatening adverse events and has not been studied. Caution is warranted and therapeutic concentration monitoring of these drugs is recommended if they are used concomitantly with VICTRELIS. digoxin ↑ digoxin Digoxin concentrations increased when administered with VICTRELIS [see Clinical Pharmacology (12.3)]. Measure serum digoxin concentrations before initiating VICTRELIS. Continue monitoring digoxin concentrations; consult the digoxin prescribing information for information on titrating the digoxin dose. Anticoagulant: warfarin ↑ or ↓ warfarin Concentrations of warfarin may be altered when co-administered with VICTRELIS. Monitor INR closely. Antidepressants: trazodone, desipramine ↑ trazodone ↑ desipramine Plasma concentrations of trazodone and desipramine may increase when administered with VICTRELIS, resulting in adverse events such as dizziness, hypotension and syncope. Use with caution and consider a lower dose of trazodone or desipramine. escitalopram ↓escitalopram Exposure of escitalopram was slightly decreased when coadministered with VICTRELIS. Selective serotonin reuptake inhibitors such as escitalopram have a wide therapeutic index, but doses may need to be adjusted when combined with VICTRELIS. Antifungals: ketoconazoleThese combinations have been studied; see Clinical Pharmacology (12.3) for magnitude of interaction., itraconazole, posaconazole, voriconazole ↑ boceprevir ↑ itraconazole ↑ ketoconazole ↑ posaconazole ↑ voriconazole Plasma concentrations of ketoconazole, itraconazole, voriconazole or posaconazole may be increased with VICTRELIS. When coadministration is required, doses of ketoconazole and itraconazole should not exceed 200 mg/day. Anti-gout: colchicine ↑ colchicine Significant increases in colchicine levels are expected; fatal colchicine toxicity has been reported with other strong CYP3A4 inhibitors. Patients with renal or hepatic impairment should not be given colchicine with VICTRELIS. Treatment of gout flares (during treatment with VICTRELIS): 0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (half tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Prophylaxis of gout flares (during treatment with VICTRELIS): If the original regimen was 0.6 mg twice a day, reduce dose to 0.3 mg once a day. If the original regimen was 0.6 mg once a day, reduce the dose to 0.3 mg once every other day. Treatment of familial Mediterranean fever (FMF) (during treatment with VICTRELIS): Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day). Anti-infective: clarithromycin ↑ clarithromycin Concentrations of clarithromycin may be increased with VICTRELIS; however, no dosage adjustment is necessary for patients with normal renal function. Antimycobacterial: rifabutin ↓ boceprevir ↑ rifabutin Increases in rifabutin exposure are anticipated, while exposure of boceprevir may be decreased. Doses have not been established for the 2 drugs when used in combination. Concomitant use is not recommended. Calcium Channel Blockers such as: amlodipine, diltiazem, felodipine, nifedipine, nicardipine, nisoldipine, verapamil ↑ calcium channel blockers Plasma concentrations of calcium channel blockers may increase when administered with VICTRELIS. Caution is warranted and clinical monitoring is recommended. Corticosteroid, systemic: dexamethasone ↓ boceprevir Coadministration of VICTRELIS with CYP3A4/5 inducers may decrease plasma concentrations of boceprevir, which may result in loss of therapeutic effect. Therefore, this combination should be avoided if possible and used with caution if necessary. prednisone ↑ prednisone Concentrations of prednisone and its active metabolite, prednisolone, increased when administered with VICTRELIS [see Clinical Pharmacology (12.3)]. No dose adjustment of prednisone is necessary when co-administered with VICTRELIS. Patients receiving prednisone and VICTRELIS should be monitored appropriately. Corticosteroid, inhaled: budesonide, fluticasone ↑ budesonide ↑ fluticasone Concomitant use of inhaled budesonide or fluticasone with VICTRELIS may result in increased plasma concentrations of budesonide or fluticasone, resulting in significantly reduced serum cortisol concentrations. Avoid coadministration if possible, particularly for extended durations. Endothelin Receptor Antagonist: bosentan ↑ bosentan Concentrations of bosentan may be increased when coadministered with VICTRELIS. Use with caution and monitor closely. HIV Integrase Inhibitor: raltegravir ↔ raltegravir No dose adjustment required for VICTRELIS or raltegravir. HIV Non-Nucleoside Reverse Transcriptase Inhibitors: efavirenz ↓ boceprevir Plasma trough concentrations of boceprevir were decreased when VICTRELIS was coadministered with efavirenz, which may result in loss of therapeutic effect. Avoid combination. etravirine ↓ etravirine Concentrations of etravirine decreased when coadministered with VICTRELIS. The clinical significance of the reductions in etravirine pharmacokinetic parameters has not been directly assessed. rilpivirine ↑ rilpivirine Concomitant administration of rilpivirine with VICTRELIS increased the exposure to rilpivirine. No dose adjustment of VICTRELIS or rilpivirine is recommended. HIV Protease Inhibitors: atazanavir/ritonavir ↓ atazanavir ↓ ritonavir Concomitant administration of boceprevir and atazanavir/ritonavir resulted in reduced steady-state exposures to atazanavir and ritonavir. Coadministration of atazanavir/ritonavir and boceprevir is not recommended. darunavir/ritonavir ↓ darunavir ↓ ritonavir ↓ boceprevir Concomitant administration of boceprevir and darunavir/ritonavir resulted in reduced steady-state exposures to boceprevir, darunavir and ritonavir. Coadministration of darunavir/ritonavir and boceprevir is not recommended. lopinavir/ritonavir ↓ lopinavir ↓ ritonavir ↓ boceprevir Concomitant administration of boceprevir and lopinavir/ritonavir resulted in reduced steady-state exposures to boceprevir, lopinavir and ritonavir. Coadministration of lopinavir/ritonavir and boceprevir is not recommended. ritonavir ↓ boceprevir When boceprevir is administered with ritonavir alone, boceprevir concentrations are decreased. HMG-CoA Reductase Inhibitors: atorvastatin ↑ atorvastatin Exposure to atorvastatin was increased when administered with VICTRELIS. Use the lowest effective dose of atorvastatin, but do not exceed a daily dose of 40 mg when coadministered with VICTRELIS. pravastatin ↑ pravastatin Concomitant administration of pravastatin with VICTRELIS increased exposure to pravastatin. Treatment with pravastatin can be initiated at the recommended dose when coadministered with VICTRELIS. Close clinical monitoring is warranted. Immunosuppressants: cyclosporine tacrolimus sirolimus ↑cyclosporine Dose adjustments of cyclosporine should be anticipated when administered with VICTRELIS and should be guided by close monitoring of cyclosporine blood concentrations, and frequent assessments of renal function and cyclosporine-related side effects. tacrolimus ↑tacrolimus Concomitant administration of VICTRELIS with tacrolimus requires significant dose reduction and prolongation of the dosing interval for tacrolimus, with close monitoring of tacrolimus blood concentrations and frequent assessments of renal function and tacrolimus-related side effects. sirolimus ↑sirolimus Concomitant administration of VICTRELIS with sirolimus requires significant dose reduction and prolongation of the dosing interval for sirolimus, with close monitoring of sirolimus blood concentrations and frequent assessments of renal function and sirolimus-related side effects. Inhaled beta-agonist: salmeterol ↑ salmeterol Concurrent use of inhaled salmeterol and VICTRELIS is not recommended due to the risk of cardiovascular events associated with salmeterol. Narcotic Analgesic/Opioid Dependence: methadone ↓ R-methadone Plasma concentrations of R-methadone decreased when coadministered with VICTRELIS [see Clinical Pharmacology (12.3)]. The observed changes are not considered clinically relevant. No dose adjustment of methadone or VICTRELIS is recommended. Individual patients may require additional titration of their methadone dosage when VICTRELIS is started or stopped to ensure clinical effect of methadone. buprenorphine/naloxone ↑ buprenorphine/naloxone Plasma concentrations of buprenorphine and naloxone increased when coadministered with VICTRELIS [see Clinical Pharmacology (12.3)]. The observed changes are not considered clinically relevant. No dose adjustment of buprenorphine/naloxone or VICTRELIS is recommended. Oral hormonal contraceptives: drospirenone/ethinyl estradiol ↑ drospirenone ↓ ethinyl estradiol Concentrations of drospirenone increased in the presence of boceprevir. Thus, the use of drospirenone-containing products is contraindicated during treatment with VICTRELIS due to potential for hyperkalemia [see Contraindications (4)]. norethindrone/ethinyl estradiol ↓ ethinyl estradiol ↔ norethindrone Concentrations of ethinyl estradiol decreased in the presence of boceprevir. Norethindrone Cmax decreased 17% in the presence of boceprevir [see Clinical Pharmacology (12.3)]. Coadministration of VICTRELIS with a combined oral contraceptive containing ethinyl estradiol and at least 1 mg of norethindrone is not likely to alter the effectiveness of this combined oral contraceptive [see Use in Specific Populations (8.1)]. Patients using estrogens as hormone replacement therapy should be clinically monitored for signs of estrogen deficiency. PDE5 inhibitors: sildenafil, tadalafil, vardenafil ↑ sildenafil ↑ tadalafil ↑ vardenafil Increases in PDE5 inhibitor concentrations are expected, and may result in an increase in adverse events, including hypotension, syncope, visual disturbances, and priapism. Use of REVATIO® (sildenafil) or ADCIRCA® (tadalafil) for the treatment of pulmonary arterial hypertension (PAH) is contraindicated with VICTRELIS [see Contraindications (4)]. Use of PDE5 inhibitors for erectile dysfunction: Use with caution in combination with VICTRELIS with increased monitoring for PDE5 inhibitor-associated adverse events. Do not exceed the following doses: Sildenafil: 25 mg every 48 hours Tadalafil: 10 mg every 72 hours Vardenafil: 2.5 mg every 24 hours Proton Pump Inhibitor: omeprazole ↔ omeprazole No dose adjustment of omeprazole or VICTRELIS is recommended. Sedative/hypnotics: alprazolam; IV midazolam ↑ midazolam ↑ alprazolam Close clinical monitoring for respiratory depression and/or prolonged sedation should be exercised during coadministration of VICTRELIS. A lower dose of IV midazolam or alprazolam should be considered.

Use In Specific Populations

Safety and efficacy have not been studied in the following populations: Patients with decompensated cirrhosis (8.7); and Organ transplant recipients (8.8) 8.1 Pregnancy VICTRELIS must be administered in combination with peginterferon alfa and ribavirin [see Dosage and Administration (2)]. Pregnancy Category X: Use with Ribavirin and Peginterferon Alfa Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin; and therefore ribavirin is contraindicated in women who are pregnant and in the male partners of women who are pregnant [see Contraindications (4) and Warnings and Precautions (5.1)] [see prescribing information for ribavirin]. Interferons have abortifacient effects in animals and should be assumed to have abortifacient potential in humans [see prescribing information for peginterferon alfa]. Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients while taking this combination. Women of childbearing potential and their male partners should not receive ribavirin unless they are using effective contraception (two reliable forms) during treatment with ribavirin and for 6 months after treatment. One of these reliable forms of contraception can be a combined oral contraceptive product containing at least 1 mg of norethindrone. Oral contraceptives containing lower doses of norethindrone and other forms of hormonal contraception have not been studied or are contraindicated [see Contraindications (4) and Warnings and Precautions (5.1)]. In case of exposure during pregnancy, a Ribavirin Pregnancy Registry has been established to monitor maternal-fetal outcomes of pregnancies in female patients and female partners of male patients exposed to ribavirin during treatment and for 6 months following cessation of treatment. Physicians and patients are encouraged to report such cases by calling 1-800-593-2214. Pregnancy Category B: VICTRELIS VICTRELIS must not be used as a monotherapy [see Indications and Usage (1)]. There are no adequate and well-controlled studies with VICTRELIS in pregnant women. No effects on fetal development have been observed in rats and rabbits at boceprevir AUC exposures approximately 11.8- and 2.0-fold higher, respectively, than those in humans at the recommended dose of 800 mg three times daily [see Nonclinical Toxicology (13.1)]. 8.3 Nursing Mothers It is not known whether VICTRELIS is excreted into human breast milk. Levels of boceprevir and/or metabolites in the milk of lactating rats were slightly higher than levels observed in maternal blood. Peak blood concentrations of boceprevir and/or metabolites in nursing pups were less than 1% of those of maternal blood concentrations. Because of the potential for adverse reactions from the drug in nursing infants, a decision must be made whether to discontinue nursing or discontinue treatment with VICTRELIS, taking into account the importance of the therapy to the mother. 8.4 Pediatric Use The safety, efficacy, and pharmacokinetic profile of VICTRELIS in pediatric patients have not been studied. 8.5 Geriatric Use Clinical studies of VICTRELIS did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, caution should be exercised in the administration and monitoring of VICTRELIS in geriatric patients due to the greater frequency of decreased hepatic function, concomitant diseases and other drug therapy [see Clinical Pharmacology (12.3)]. 8.6 Renal Impairment No dosage adjustment of VICTRELIS is required for patients with any degree of renal impairment [see Clinical Pharmacology (12.3)]. 8.7 Hepatic Impairment No dose adjustment of VICTRELIS is required for patients with mild, moderate or severe hepatic impairment [see Clinical Pharmacology (12.3)]. Safety and efficacy of VICTRELIS have not been studied in patients with decompensated cirrhosis. In published observational studies of patients with compensated cirrhosis treated with first generation HCV protease inhibitors, including boceprevir, in combination with peginterferon alfa and ribavirin, platelet count < 100,000/mm3 and serum albumin < 3.5 g/dL were baseline characteristics that were identified as predictors of death or serious complications (severe infection or hepatic decompensation) during therapy. The potential risks and benefits of VICTRELIS in combination with peginterferon alfa and ribavirin should be carefully considered before initiating therapy in patients with compensated cirrhosis who have platelet count < 100,000/mm3 and serum albumin < 3.5 g/dL at baseline. If therapy is initiated, close monitoring for signs of infections and worsening liver function is warranted. [See the prescribing information for peginterferon alfa for use in patients with hepatic decompensation.] 8.8 Organ Transplantation The safety and efficacy of VICTRELIS alone or in combination with peginterferon alfa and ribavirin for the treatment of chronic hepatitis C genotype 1 infection in liver or other organ transplant recipients have not been studied. For data regarding drug-drug interactions with immunosuppressants, see Drug Interactions (7.3) and Clinical Pharmacology (12.3).

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