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Victrelis

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Victrelis

Victrelis

Victrelis Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Victrelis (boceprevir) is a protease inhibitor indicated for the treatment of chronic hepatitis C. The drug recently approved (May, 2011) by the Federal Drug Administration (FDA). Victrelis must not be used as a single therapy and should only be used in combination with peginterferon alfa and ribavirin in adult patients with liver disease. The most commonly reported side effects in adult subjects were fatigue, anemia, nausea, and headache.

Victrelis is available in 200 mg capsules. The dose of Victrelis is 800 mg (four 200-mg capsules) three times daily (every 7-9 hours) with a meal or light snack (use only in combination with perinterferon alfa and ribavirin (see other Side Effects Drug Center information sites for use of these drugs); dosages may vary based on the patient's condition. Victrelis may not interact well with certain antibiotics, antidepressants, calcium channel blockers, and certain gout medications. Ribavirin (to be used in combination) with Victrelis may cause birth defects and/or death of the exposed fetus and should not be used by women who are pregnant or by men whose female partners are pregnant. It is not known whether Victrelis is excreted into human breast milk. For nursing mothers, 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. Pregnancy should not be attempted until 6 months after Victrelis has been stopped. Other serious side effects are severe anemia, neutropenia, and thromboembolic events. Victrelis has not been studied in children.

Our Victrelis Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Victrelis in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using boceprevir and call your doctor at once if you have a serious side effect such as:

  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
  • fever, chills, body aches, flu symptoms, sores in your mouth and throat.

Less serious side effects may include:

  • feeling weak, tired, or irritable;
  • headache, dizziness;
  • nausea, vomiting, loss of appetite;
  • diarrhea;
  • dry skin, hair loss;
  • altered sense of taste;
  • joint pain;
  • sleep problems (insomnia); or
  • mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Victrelis (Boceprevir Capsules) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Victrelis FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

See peginterferon alfa and ribavirin Package Inserts for description of adverse reactions associated with their use.

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:

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]. 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 RESPOND2 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 and Clinical Studies; see Package Insert for ribavirin]. If ribavirin is permanently discontinued, then peginterferon alfa and VICTRELIS must also be discontinued [see DOSAGE AND ADMINISTRATION].

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 x 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 Package Inserts for peginterferon alfa and ribavirin]. If peginterferon alfa is permanently discontinued, then ribavirin and VICTRELIS must also be discontinued [see DOSAGE AND ADMINISTRATION].

Table 4 : Selected Hematological Parameters

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
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 (x 109/L)
< 0.75 31 18 26 13
< 0.5 8 4 7 4
Platelets (x 109/L)
< 50 3 1 4 0
< 25 < 1 0 0 0

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]

Gastrointestinal Disorders: mouth ulceration, stomatitis

Infections and Infestations: pneumonia, sepsis

Skin and Subcutaneous Tissue Disorders: angioedema, urticaria [see WARNINGS AND PRECAUTIONS]; drug rash with eosinophilia and systemic symptoms (DRESS) syndrome, exfoliative rash, exfoliative dermatitis, Stevens-Johnson syndrome, toxic skin eruption, toxicoderma

Read the entire FDA prescribing information for Victrelis (Boceprevir Capsules) »

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