Advertisement

Topics

These highlights do not include all the information needed to use COPEGUS safely and effectively. See full prescribing information for COPEGUS. COPEGUS (ribavirin) Tablets Initial U.S. Approval: 2002 | Copegus

13:50 EDT 24th July 2014 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

COPEGUS (ribavirin) monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication.

The primary clinical toxicity of ribavirin is hemolytic anemia. The anemia associated with ribavirin therapy may result in worsening of cardiac disease and lead to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with COPEGUS [see Warnings and Precautions (5.2), Adverse Reactions (6.1), and Dosage and Administration (2.3)].

Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. In addition, ribavirin has a multiple dose half-life of 12 days, and it may persist in non-plasma compartments for as long as 6 months. Therefore, ribavirin, including COPEGUS, is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of therapy in both female patients and in female partners of male patients who are taking ribavirin therapy. At least two reliable forms of effective contraception must be utilized during treatment and during the 6-month post treatment follow-up period [see Contraindications (4), Warnings and Precautions (5.1), and Use in Specific Populations (8.1)].

COPEGUS in combination with PEGASYS (peginterferon alfa-2a) is indicated for the treatment of patients 5 years of age and older with chronic hepatitis C (CHC) virus infection who have compensated liver disease and have not been previously treated with interferon alpha.

The following points should be considered when initiating COPEGUS combination therapy with PEGASYS:

COPEGUS should be taken with food. COPEGUS should be given in combination with PEGASYS; it is important to note that COPEGUS should never be given as monotherapy. See PEGASYS Package Insert for all instructions regarding PEGASYS dosing and administration.

Adult Patients

The recommended dose of COPEGUS tablets is provided in Table 1 . The recommended duration of treatment for patients previously untreated with ribavirin and interferon is 24 to 48 weeks.

The daily dose of COPEGUS is 800 mg to 1200 mg administered orally in two divided doses. The dose should be individualized to the patient depending on baseline disease characteristics (e.g., genotype), response to therapy, and tolerability of the regimen (see Table 1 ).

Table 1 PEGASYS and COPEGUS Dosing Recommendations
Hepatitis C Virus (HCV) Genotype PEGASYS DoseSee PEGASYS Package Insert for further details on PEGASYS dosing and administration, including dose modification in patients with renal impairment.
(once weekly)
COPEGUS Dose
(daily)
Duration
Genotypes 2 and 3 showed no increased response to treatment beyond 24 weeks (see Table 10 ).
Data on genotypes 5 and 6 are insufficient for dosing recommendations.
Genotypes 1, 4 180 mcg <75 kg = 1000 mg
≥75 kg = 1200 mg
48 weeks
48 weeks
Genotypes 2, 3 180 mcg 800 mg 24 weeks

Pediatric Patients

PEGASYS is administered as 180 mcg/1.73m × BSA once weekly subcutaneously, to a maximum dose of 180 mcg, and should be given in combination with ribavirin. The recommended treatment duration for patients with genotype 2 or 3 is 24 weeks and for other genotypes is 48 weeks.

COPEGUS should be given in combination with PEGASYS. COPEGUS is available only as a 200 mg tablet and therefore the healthcare provider should determine if this sized tablet can be swallowed by the pediatric patient. The recommended doses for COPEGUS are provided in Table 2 . Patients who initiate treatment prior to their 18 birthday should maintain pediatric dosing through the completion of therapy.

Table 2 COPEGUS Dosing Recommendations for Pediatric Patients
Body Weight in kilograms (kg) COPEGUS Daily Doseapproximately 15 mg/kg/day COPEGUS Number of Tablets
23 – 33 400 mg/day 1 × 200 mg tablet A.M.
1 × 200 mg tablet P.M.
34 – 46 600 mg/day 1 × 200 mg tablet A.M.
2 × 200 mg tablets P.M.
47 – 59 800 mg/day 2 × 200 mg tablets A.M.
2 × 200 mg tablets P.M.
60 – 74 1000 mg/day 2 × 200 mg tablets A.M.
3 × 200 mg tablets P.M.
≥75 1200 mg/day 3 × 200 mg tablets A.M.
3 × 200 mg tablets P.M.

Adult Patients

The recommended dose for treatment of chronic hepatitis C in patients coinfected with HIV is PEGASYS 180 mcg subcutaneous once weekly and COPEGUS 800 mg by mouth daily for a total duration of 48 weeks, regardless of HCV genotype.

Adult and Pediatric Patients

If severe adverse reactions or laboratory abnormalities develop during combination COPEGUS/PEGASYS therapy, the dose should be modified or discontinued, if appropriate, until the adverse reactions abate or decrease in severity. If intolerance persists after dose adjustment, COPEGUS/PEGASYS therapy should be discontinued. Table 3 provides guidelines for dose modifications and discontinuation based on the patient's hemoglobin concentration and cardiac status.

COPEGUS should be administered with caution to patients with pre-existing cardiac disease. Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped [see Warnings and Precautions (5.2)].

The guidelines for COPEGUS dose modifications outlined in this table also apply to laboratory abnormalities or adverse reactions other than decreases in hemoglobin values.

Table 3 COPEGUS Dose Modification Guidelines in Adults and Pediatrics
Body weight in kilograms (kg) Laboratory Values
Hemoglobin <10 g/dL in patients with no cardiac disease, or

Decrease in hemoglobin of ≥2 g/dL during any 4 week period in patients with history of stable cardiac disease
Hemoglobin <8.5 g/dL in patients with no cardiac disease, or

Hemoglobin <12 g/dL despite 4 weeks at reduced dose in patients with history of stable cardiac disease
Adult Patients older than 18 years of age
Any weight 1 × 200 mg tablet A.M.
2 × 200 mg tablets P.M.
Discontinue COPEGUS
Pediatric Patients 5 to 18 years of age
23 – 33 kg 1 × 200 mg tablet A.M. Discontinue COPEGUS
34 – 46 kg 1 × 200 mg tablet A.M.
1 × 200 mg tablet P.M.
47 – 59 kg 1 × 200 mg tablet A.M.
1 × 200 mg tablet P.M.
60 – 74 kg 1 × 200 mg tablet A.M.
2 × 200 mg tablets P.M.
≥75 kg 1 × 200 mg tablet A.M.
2 × 200 mg tablets P.M.

Adult Patients

Once COPEGUS has been withheld due to either a laboratory abnormality or clinical adverse reaction, an attempt may be made to restart COPEGUS at 600 mg daily and further increase the dose to 800 mg daily. However, it is not recommended that COPEGUS be increased to the original assigned dose (1000 mg to 1200 mg).

Pediatric Patients

Upon resolution of a laboratory abnormality or clinical adverse reaction, an increase in COPEGUS dose to the original dose may be attempted depending upon the physician's judgment. If COPEGUS has been withheld due to a laboratory abnormality or clinical adverse reaction, an attempt may be made to restart COPEGUS at one-half the full dose.

The total daily dose of COPEGUS should be reduced for patients with creatinine clearance less than or equal to 50 mL/min; and the weekly dose of PEGASYS should be reduced for creatinine clearance less than 30 mL/min as follows in Table 4 [see Use in Specific Populations (8.7), Pharmacokinetics (12.3), and PEGASYS Package Insert].

The dose of COPEGUS should not be further modified in patients with renal impairment. If severe adverse reactions or laboratory abnormalities develop, COPEGUS should be discontinued, if appropriate, until the adverse reactions abate or decrease in severity. If intolerance persists after restarting COPEGUS, COPEGUS/PEGASYS therapy should be discontinued.

No data are available for pediatric subjects with renal impairment.

Table 4 Dosage Modification for Renal Impairment
Creatinine Clearance PEGASYS Dose
(once weekly)
COPEGUS Dose
(daily)
30 to 50 mL/min 180 mcg Alternating doses, 200 mg and 400 mg every other day
Less than 30 mL/min 135 mcg 200 mg daily
Hemodialysis 135 mcg 200 mg daily

Discontinuation of PEGASYS/COPEGUS therapy should be considered if the patient has failed to demonstrate at least a 2 log reduction from baseline in HCV RNA by 12 weeks of therapy, or undetectable HCV RNA levels after 24 weeks of therapy.

PEGASYS/COPEGUS therapy should be discontinued in patients who develop hepatic decompensation during treatment [see Warnings and Precautions (5.3)].

COPEGUS (ribavirin) is available as a light pink to pink colored, flat, oval-shaped, film-coated tablet for oral administration. Each tablet contains 200 mg of ribavirin.

COPEGUS (ribavirin) is contraindicated in:

COPEGUS and PEGASYS combination therapy is contraindicated in patients with:

Significant adverse reactions associated with COPEGUS/PEGASYS combination therapy include severe depression and suicidal ideation, hemolytic anemia, suppression of bone marrow function, autoimmune and infectious disorders, ophthalmologic disorders, cerebrovascular disorders, pulmonary dysfunction, colitis, pancreatitis, and diabetes.

The PEGASYS Package Insert should be reviewed in its entirety for additional safety information prior to initiation of combination treatment.

COPEGUS may cause birth defects and/or death of the exposed fetus. Ribavirin has demonstrated significant teratogenic and/or embryocidal effects in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of ribavirin.

COPEGUS therapy should not be started unless a report of a negative pregnancy test has been obtained immediately prior to planned initiation of therapy. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Patients should be instructed to use at least two forms of effective contraception during treatment and for 6 months after treatment has been stopped. Pregnancy testing should occur monthly during COPEGUS therapy and for 6 months after therapy has stopped [see Boxed Warning, Contraindications (4), Use in Specific Populations (8.1), and Patient Counseling Information (17)].

The primary toxicity of ribavirin is hemolytic anemia, which was observed in approximately 13% of all COPEGUS/PEGASYS-treated subjects in clinical trials. Anemia associated with COPEGUS occurs within 1 to 2 weeks of initiation of therapy. Because the initial drop in hemoglobin may be significant, it is advised that hemoglobin or hematocrit be obtained pretreatment and at week 2 and week 4 of therapy or more frequently if clinically indicated. Patients should then be followed as clinically appropriate. Caution should be exercised in initiating treatment in any patient with baseline risk of severe anemia (e.g., spherocytosis, history of gastrointestinal bleeding) [see Dosage and Administration (2.3)].

Fatal and nonfatal myocardial infarctions have been reported in patients with anemia caused by COPEGUS. Patients should be assessed for underlying cardiac disease before initiation of ribavirin therapy. Patients with pre-existing cardiac disease should have electrocardiograms administered before treatment, and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be suspended or discontinued [see Dosage and Administration (2.3)]. Because cardiac disease may be worsened by drug-induced anemia, patients with a history of significant or unstable cardiac disease should not use COPEGUS [see Boxed Warning and Dosage and Administration (2.3)].

Chronic hepatitis C (CHC) patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons, including PEGASYS. Cirrhotic CHC patients coinfected with HIV receiving highly active antiretroviral therapy (HAART) and interferon alfa-2a with or without ribavirin appear to be at increased risk for the development of hepatic decompensation compared to patients not receiving HAART. In Study NR15961 [see Clinical Studies (14.3)], among 129 CHC/HIV cirrhotic patients receiving HAART, 14 (11%) of these patients across all treatment arms developed hepatic decompensation resulting in 6 deaths. All 14 patients were on NRTIs, including stavudine, didanosine, abacavir, zidovudine, and lamivudine. These small numbers of patients do not permit discrimination between specific NRTIs or the associated risk. During treatment, patients' clinical status and hepatic function should be closely monitored for signs and symptoms of hepatic decompensation. Treatment with PEGASYS/COPEGUS should be discontinued immediately in patients with hepatic decompensation [see Contraindications (4)].

Severe acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, and anaphylaxis) have been observed during alpha interferon and ribavirin therapy. If such a reaction occurs, therapy with PEGASYS and COPEGUS should be discontinued immediately and appropriate medical therapy instituted. Serious skin reactions including vesiculobullous eruptions, reactions in the spectrum of Stevens-Johnson Syndrome (erythema multiforme major) with varying degrees of skin and mucosal involvement and exfoliative dermatitis (erythroderma) have been reported in patients receiving PEGASYS with and without ribavirin. Patients developing signs or symptoms of severe skin reactions must discontinue therapy [see Adverse Reactions (6.2)].

Dyspnea, pulmonary infiltrates, pneumonitis, pulmonary hypertension, and pneumonia have been reported during therapy with ribavirin and interferon. Occasional cases of fatal pneumonia have occurred. In addition, sarcoidosis or the exacerbation of sarcoidosis has been reported. If there is evidence of pulmonary infiltrates or pulmonary function impairment, patients should be closely monitored and, if appropriate, combination COPEGUS/PEGASYS treatment should be discontinued.

Pancytopenia (marked decreases in RBCs, neutrophils and platelets) and bone marrow suppression have been reported in the literature to occur within 3 to 7 weeks after the concomitant administration of pegylated interferon/ribavirin and azathioprine. In this limited number of patients (n=8), myelotoxicity was reversible within 4 to 6 weeks upon withdrawal of both HCV antiviral therapy and concomitant azathioprine and did not recur upon reintroduction of either treatment alone. PEGASYS, COPEGUS, and azathioprine should be discontinued for pancytopenia, and pegylated interferon/ribavirin should not be re-introduced with concomitant azathioprine [see Drug Interactions (7.3)].

COPEGUS and PEGASYS therapy should be suspended in patients with signs and symptoms of pancreatitis, and discontinued in patients with confirmed pancreatitis.

Pediatric subjects treated with PEGASYS plus COPEGUS combination therapy showed a delay in weight and height increases after 48 weeks of therapy compared with baseline. Both weight and height for age z-scores as well as the percentiles of the normative population for subject weight and height decreased during treatment. At the end of 2 years follow-up after treatment, most subjects had returned to baseline normative growth curve percentiles for weight and height (mean weight for age percentile was 64% at baseline and 60% at 2 years post-treatment; mean height percentile was 54% at baseline and 56% at 2 years post-treatment). At the end of treatment, 43% of subjects experienced a weight percentile decrease of 15 percentiles or more, and 25% experienced a height percentile decrease of 15 percentiles or more on the normative growth curves. At 2 years post-treatment, 16% of subjects remained 15 percentiles or more below their baseline weight curve and 11% remained 15 percentiles or more below their baseline height curve.

Before beginning PEGASYS/COPEGUS combination therapy, standard hematological and biochemical laboratory tests are recommended for all patients. Pregnancy screening for women of childbearing potential must be performed. Patients who have pre-existing cardiac abnormalities should have electrocardiograms administered before treatment with PEGASYS/COPEGUS.

After initiation of therapy, hematological tests should be performed at 2 weeks and 4 weeks and biochemical tests should be performed at 4 weeks. Additional testing should be performed periodically during therapy. In adult clinical studies, the CBC (including hemoglobin level and white blood cell and platelet counts) and chemistries (including liver function tests and uric acid) were measured at 1, 2, 4, 6, and 8 weeks, and then every 4 to 6 weeks or more frequently if abnormalities were found. In the pediatric clinical trial, hematological and chemistry assessments were at 1, 3, 5, and 8 weeks, then every 4 weeks. Thyroid stimulating hormone (TSH) was measured every 12 weeks. Monthly pregnancy testing should be performed during combination therapy and for 6 months after discontinuing therapy.

The entrance criteria used for the clinical studies of COPEGUS and PEGASYS may be considered as a guideline to acceptable baseline values for initiation of treatment:

PEGASYS in combination with COPEGUS causes a broad variety of serious adverse reactions [see Boxed Warning and Warnings and Precautions (5)]. The most common serious or life-threatening adverse reactions induced or aggravated by COPEGUS/PEGASYS include depression, suicide, relapse of drug abuse/overdose, and bacterial infections each occurring at a frequency of less than 1%. Hepatic decompensation occurred in 2% (10/574) CHC/HIV patients [see Warnings and Precautions (5.3)].

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Adult Patients

In the pivotal registration trials NV15801 and NV15942, 886 patients received COPEGUS for 48 weeks at doses of 1000/1200 mg based on body weight. In these trials, one or more serious adverse reactions occurred in 10% of CHC monoinfected subjects and in 19% of CHC/HIV subjects receiving PEGASYS alone or in combination with COPEGUS. The most common serious adverse event (3% in CHC and 5% in CHC/HIV) was bacterial infection (e.g., sepsis, osteomyelitis, endocarditis, pyelonephritis, pneumonia).

Other serious adverse reactions occurred at a frequency of less than 1% and included: suicide, suicidal ideation, psychosis, aggression, anxiety, drug abuse and drug overdose, angina, hepatic dysfunction, fatty liver, cholangitis, arrhythmia, diabetes mellitus, autoimmune phenomena (e.g., hyperthyroidism, hypothyroidism, sarcoidosis, systemic lupus erythematosus, rheumatoid arthritis), peripheral neuropathy, aplastic anemia, peptic ulcer, gastrointestinal bleeding, pancreatitis, colitis, corneal ulcer, pulmonary embolism, coma, myositis, cerebral hemorrhage, thrombotic thrombocytopenic purpura, psychotic disorder, and hallucination.

The percentage of patients in clinical trials who experienced one or more adverse events was 98%. The most commonly reported adverse reactions were psychiatric reactions, including depression, insomnia, irritability, anxiety, and flu-like symptoms such as fatigue, pyrexia, myalgia, headache and rigors. Other common reactions were anorexia, nausea and vomiting, diarrhea, arthralgias, injection site reactions, alopecia, and pruritus. Table 5 shows rates of adverse events occurring in greater than or equal to 5% subjects receiving pegylated interferon and ribavirin combination therapy in the CHC Clinical Trial, NV15801.

Ten percent of CHC monoinfected patients receiving 48 weeks of therapy with PEGASYS in combination with COPEGUS discontinued therapy; 16% of CHC/HIV coinfected patients discontinued therapy. The most common reasons for discontinuation of therapy were psychiatric, flu-like syndrome (e.g., lethargy, fatigue, headache), dermatologic and gastrointestinal disorders, and laboratory abnormalities (thrombocytopenia, neutropenia, and anemia).

Overall 39% of patients with CHC or CHC/HIV required modification of PEGASYS and/or COPEGUS therapy. The most common reason for dose modification of PEGASYS in CHC and CHC/HIV patients was for laboratory abnormalities; neutropenia (20% and 27%, respectively) and thrombocytopenia (4% and 6%, respectively). The most common reason for dose modification of COPEGUS in CHC and CHC/HIV patients was anemia (22% and 16%, respectively).

PEGASYS dose was reduced in 12% of patients receiving 1000 mg to 1200 mg COPEGUS for 48 weeks and in 7% of patients receiving 800 mg COPEGUS for 24 weeks. COPEGUS dose was reduced in 21% of patients receiving 1000 mg to 1200 mg COPEGUS for 48 weeks and in 12% of patients receiving 800 mg COPEGUS for 24 weeks.

Chronic hepatitis C monoinfected patients treated for 24 weeks with PEGASYS and 800 mg COPEGUS were observed to have lower incidence of serious adverse events (3% vs. 10%), hemoglobin less than 10 g/dL (3% vs. 15%), dose modification of PEGASYS (30% vs. 36%) and COPEGUS (19% vs. 38%), and of withdrawal from treatment (5% vs. 15%) compared to patients treated for 48 weeks with PEGASYS and 1000 mg or 1200 mg COPEGUS. On the other hand, the overall incidence of adverse events appeared to be similar in the two treatment groups.

Table 5 Adverse Reactions Occurring in greater than or equal to 5% of Patients in Chronic Hepatitis C Clinical Trials (Study NV15801)
CHC Combination Therapy
Study NV15801
Body System PEGASYS 180 mcg +
1000 mg or 1200 mg
COPEGUS
48 weeks
Intron A +
1000 mg or 1200 mg
Rebetol®
48 weeks
N=451 N=443
% %
Application Site Disorders
Injection site reaction 23 16
Endocrine Disorders
Hypothyroidism 4 5
Flu-like Symptoms and Signs
Fatigue/Asthenia 65 68
Pyrexia 41 55
Rigors 25 37
Pain 10 9
Gastrointestinal
Nausea/Vomiting 25 29
Diarrhea 11 10
Abdominal pain 8 9
Dry mouth 4 7
Dyspepsia 6 5
HematologicSevere hematologic abnormalities (lymphocyte less than 500 cells/mm3; hemoglobin less than 10 g/dL; neutrophil less than 750 cells/mm3; platelet less than 50,000 cells/mm3).
Lymphopenia 14 12
Anemia 11 11
Neutropenia 27 8
Thrombocytopenia 5 <1
Metabolic and Nutritional
Anorexia 24 26
Weight decrease 10 10
Musculoskeletal, Connective Tissue and Bone
Myalgia 40 49
Arthralgia 22 23
Back pain 5 5
Neurological
Headache 43 49
Dizziness (excluding vertigo) 14 14
Memory impairment 6 5
Psychiatric
Irritability/Anxiety/Nervousness 33 38
Insomnia 30 37
Depression 20 28
Concentration impairment 10 13
Mood alteration 5 6
Resistance Mechanism Disorders
Overall 12 10
Respiratory, Thoracic and Mediastinal
Dyspnea 13 14
Cough 10 7
Dyspnea exertional 4 7
Skin and Subcutaneous Tissue
Alopecia 28 33
Pruritus 19 18
Dermatitis 16 13
Dry skin 10 13
Rash 8 5
Sweating increased 6 5
Eczema 5 4
Visual Disorders
Vision blurred 5 2

Pediatric Subjects

In a clinical trial with 114 pediatric subjects (5 to 17 years of age) treated with PEGASYS alone or in combination with COPEGUS, dose modifications were required in approximately one-third of subjects, most commonly for neutropenia and anemia. In general, the safety profile observed in pediatric subjects was similar to that seen in adults. In the pediatric study, the most common adverse events in subjects treated with combination therapy PEGASYS and COPEGUS for up to 48 weeks were influenza-like illness (91%), upper respiratory tract infection (60%), headache (64%), gastrointestinal disorder (56%), skin disorder (47%), and injection-site reaction (45%). Seven subjects receiving combination PEGASYS and COPEGUS treatment for 48 weeks discontinued therapy for safety reasons (depression, psychiatric evaluation abnormal, transient blindness, retinal exudates, hyperglycemia, type 1 diabetes mellitus, and anemia). Severe adverse events were reported in 2 subjects in the PEGASYS plus COPEGUS combination therapy group (hyperglycemia and cholecystectomy).

Growth inhibition was observed in pediatric subjects. During combination therapy for up to 48 weeks with PEGASYS and COPEGUS, negative changes in weight for age z-score and height for age z-score after 48 weeks of therapy compared with baseline were observed [see Warnings and Precautions (5.8)].

In pediatric subjects randomized to combination therapy, the incidence of most adverse reactions were similar for the entire treatment period (up to 48 weeks plus 24 weeks follow-up) in comparison to the first 24 weeks, and increased only slightly for headache, gastrointestinal disorder, irritability and rash. The majority of adverse reactions occurred in the first 24 weeks of treatment.

Table 6 Percentage of Pediatric Subjects with Adverse ReactionsDisplayed adverse drug reactions include all grades of reported adverse clinical events considered possibly, probably, or definitely related to study drug. During First 24 Weeks of Treatment by Treatment Group and for 24 Weeks Post-treatment (in at Least 10% of Subjects)
Study NV17424
System Organ Class PEGASYS
180 mcg/1.73 m2 × BSA + COPEGUS
15 mg/kg (N=55)
PEGASYS
180 mcg/1.73 m2 × BSA + PlaceboSubjects in the PEGASYS plus placebo arm who did not achieve undetectable viral load at week 24 switched to combination treatment thereafter. Therefore, only the first 24 weeks are presented for the comparison of combination therapy with monotherapy. (N=59)
% %
General disorders and administration site conditions
  Influenza like illness 91 81
  Injection site reaction 44 42
  Fatigue 25 20
  Irritability 24 14
Gastrointestinal disorders
  Gastrointestinal disorder 49 44
Nervous system disorders
  Headache 51 39
Skin and subcutaneous tissue disorders
  Rash 15 10
  Pruritus 11 12
Musculoskeletal, connective tissue and bone disorders
  Musculoskeletal pain 35 29
Psychiatric disorders
  Insomnia 9 12
Metabolism and nutrition disorders
  Decreased appetite 11 14

Common Adverse Reactions in CHC with HIV Coinfection (Adults)

The adverse event profile of coinfected patients treated with PEGASYS/COPEGUS in Study NR15961 was generally similar to that shown for monoinfected patients in Study NV15801 ( Table 5 ). Events occurring more frequently in coinfected patients were neutropenia (40%), anemia (14%), thrombocytopenia (8%), weight decrease (16%), and mood alteration (9%).

Laboratory Test Abnormalities

Adult Patients

Anemia due to hemolysis is the most significant toxicity of ribavirin therapy. Anemia (hemoglobin less than 10 g/dL) was observed in 13% of all COPEGUS and PEGASYS combination-treated patients in clinical trials. The maximum drop in hemoglobin occurred during the first 8 weeks of initiation of ribavirin therapy [see Dosage

Manufacturer

Genentech, Inc.

Active Ingredients

Source

Drugs and Medications [3 Associated Drugs and Medications listed on BioPortfolio]

Pegasys [Genentech, Inc.]

These highlights do not include all the information needed to use PEGASYS safely and effectively. See full prescribing information for PEGASYS. PEGASYS® (peginterferon alfa-2a)Injection for Subcutan...

Rebetol [Schering Corporation]

These highlights do not include all the information needed to use REBETOL safely and effectively. See full prescribing information for REBETOL.REBETOL (ribavirin, USP) Capsules, Oral SolutionInitial U...

Pegintron [Schering Corporation]

These highlights do not include all the information needed to use PegIntron safely and effectively. See full prescribing information for PegIntron. PegIntron (Peginterferon alfa-2b) Injection, Powder ...

Clinical Trials [56 Associated Clinical Trials listed on BioPortfolio]

A Bioequivalence Study of an Oral Solution of Copegus (Ribavirin) Compared to Copegus Tablets

This four-period, single-center, open-label, single-dose, randomized, cross-over study will assess the bioequivalence and safety of an oral solution of Copegus (ribavirin) compared to a Co...

A Study of RO5024048 in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C, Genotype 1 or 4

This 6-arm study will assess the efficacy and safety of RO5024048 (R7128) in co mbination with the approved doses of Pegasys (180micrograms sc weekly) + Copegus (1000/1200mg po daily) (SO...

SYREN Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin) in Non-Responder Patients With Chronic Hepatitis C (CHC) Genotype 1.

This study will evaluate the efficacy and safety of 4 regimens of PEGASYS plus Copegus, in patients with chronic hepatitis C (CHC) genotype 1 who have failed to respond to previous treatme...

Pegasys and Copegus for Asian Patients With Treatment-naive Hepatitis C Genotypes 6, 7, 8, 9

The purpose of this research study is to test the safety, tolerability, and effectiveness of the drugs Pegasys and Copegus when used for hepatitis C genotypes 6, 7, 8, and 9. Patients are ...

A Study of Combination Treatment With PEGASYS (Peginterferon Alfa-2a (40KD) Plus COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C.

This 3 arm study will assess the safety and efficacy of combination treatment with PEGASYS + Copegus in patients with chronic hepatitis C. Three groups of patients will be studied; 1) tho...

PubMed Articles [0 Results]

None

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Gastroenterology
Astroesophageal Reflux Disease (GERD) Barrett's Esophagus Celiac Disease Cholesterol Crohn's Disease Gastroenterology Hepatitis Hepatology Irritable Bowel Syndrome (IBS) Pancreatitis Peptic Ulcer Disease...

Infectious-diseases
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...


Drugs and Medication Quicklinks


Searches Linking to this Drug Record