Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3789
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Pegasys (Injection, Solution)
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There are no safety and efficacy data on treatment
of chronic hepatitis C or hepatitis B for longer than 48 weeks. For
patients with hepatitis C, consideration should be given to discontinuing
therapy after 12 to 24 weeks of therapy if the patient has failed
to demonstrate an early virologic response defined as undetectable
HCV RNA or at least a 2logreduction from baseline in
HCV RNA titer by 12 weeks of therapy . A patient should self-inject PEGASYS only
if the physician determines that it is appropriate and the patient
agrees to medical follow-up as necessary and training in proper injection
technique has been provided to him/her (see illustrated PEGASYS MEDICATION GUIDE for directions on injection
site preparation and injection instructions). PEGASYS should be inspected visually for particulate matter and discoloration
before administration, and not used if particulate matter is visible
or product is discolored. Vials and prefilled syringes with particulate
matter or discoloration should be returned to the pharmacist.<br/>Chronic Hepatitis C:<br/>PEGASYS Monotherapy: The recommended dose of PEGASYS monotherapy for
chronic hepatitis C is 180��g (1.0 mL vial or 0.5 mL prefilled
syringe) once weekly for 48 weeks by subcutaneous administration in
the abdomen or thigh.<br/>PEGASYS and COPEGUS Combination Therapy: The recommended dose of PEGASYS when used in combination
with ribavirin for chronic hepatitis C is 180��g (1.0 mL vial
or 0.5 mL prefilled syringe) once weekly. The recommended dose of
COPEGUS and duration for PEGASYS/COPEGUS therapy is based on viral
genotype (see Table 7). 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. Since COPEGUS absorption increases when administered with a meal,
patients are advised to take COPEGUS with food.<br/>CHC with HIV Coinfection:<br/>PEGASYS Monotherapy: The recommended dose of PEGASYS monotherapy for
chronic hepatitis C in patients coinfected with HIV is 180��g
(1.0 mL vial or 0.5 mL prefilled syringe) once weekly for 48 weeks
by subcutaneous administration in the abdomen or thigh.<br/>PEGASYS/COPEGUS Combination Therapy: The recommended dose when used in combination with
ribavirin is PEGASYS 180��g sc once weekly and COPEGUS 800 mg
po daily given in two divided doses for a total of 48 weeks, regardless
of genotype. Since COPEGUS absorption increases
when administered with a meal, patients are advised to take COPEGUS
with food.<br/>Chronic Hepatitis B:<br/>PEGASYS Monotherapy: The recommended dose of PEGASYS monotherapy for
hepatitis B is 180��g (1.0 mL vial or 0.5 mL prefilled syringe)
once weekly for 48 weeks by subcutaneous administration in the abdomen
or thigh.<br/>Dose Modifications: 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. If intolerance persists after dose
adjustment, COPEGUS/PEGASYS therapy should be discontinued.<br/>PEGASYS:<br/>General: When dose modification is required for moderate
to severe adverse reactions (clinical and/or laboratory), initial
dose reduction to 135��g (which is 0.75 mL for the vials or adjustment
to the corresponding graduation mark for the syringes) is generally
adequate. However, in some cases, dose reduction to 90��g (which
is 0.5 mL for the vials or adjustment to the corresponding graduation
mark for the syringes) may be needed. Following improvement of the
adverse reaction, re-escalation of the dose may be considered .<br/>Hematological:<br/>Psychiatric: Depression:<br/>Renal Function: In patients with end-stage renal disease requiring
hemodialysis, dose reduction to 135��g PEGASYS is recommended.
Signs and symptoms of interferon toxicity should be closely monitored.<br/>Liver Function: If ALT increases are progressive despite dose reduction
or accompanied by increased bilirubin or evidence of hepatic decompensation,
therapy should be immediately discontinued. In chronic hepatitis C patients with progressive ALT increases above
baseline values, the dose of PEGASYS should be reduced to 135��g
and more frequent monitoring of liver function should be performed.
After PEGASYS dose reduction or withholding, therapy can be resumed
after ALT flares subside. In chronic hepatitis
B patients with elevations in ALT (>5��ULN), more frequent monitoring
of liver function should be performed and consideration should be
given to either reducing the dose of PEGASYS to 135��g or temporarily
discontinuing treatment. After PEGASYS dose reduction or withholding,
therapy can be resumed after ALT flares subside. In patients with persistent, severe (ALT>10 times above the upper
limit of normal) hepatitis B flares, consideration should be given
to discontinuation of treatment.<br/>COPEGUS: Once COPEGUS has been withheld due to a laboratory
abnormality or clinical manifestation, an attempt may be made to restart
COPEGUS at 600 mg daily and further increase the dose to 800 mg daily
depending upon the physician's judgment. However, it is not recommended
that COPEGUS be increased to the original dose (1000 mg or 1200 mg).<br/>Renal Impairment: COPEGUS should not be used in patients with creatinine
clearance<50 mL/min .
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PEGASYS, peginterferon alfa-2a, is a covalent conjugate
of recombinant alfa-2a interferon (approximate molecular weight [MW]
20,000 daltons) with a single branched bis-monomethoxy polyethylene
glycol (PEG) chain (approximate MW 40,000 daltons). The PEG moiety
is linked at a single site to the interferon alfa moiety via a stable
amide bond to lysine. Peginterferon alfa-2a has an approximate molecular
weight of 60,000 daltons. Interferon alfa-2a is produced using recombinant
DNA technology in which a cloned human leukocyte interferon gene is
inserted into and expressed in Escherichia
coli. PEGASYS is supplied as an injectable
solution in vials and prefilled syringes. 180��g/1.0 mL Vial: A vial contains approximately 1.2 mL of solution
to deliver 1.0 mL of drug product. Subcutaneous (sc) administration
of 1.0 mL delivers 180��g of drug product (expressed as the amount
of interferon alfa-2a), 8.0 mg sodium chloride, 0.05 mg polysorbate
80, 10.0 mg benzyl alcohol, 2.62 mg sodium acetate trihydrate, and
0.05 mg acetic acid. The solution is colorless to light yellow and
the pH is 6.0��0.5. 180��g/0.5 mL
Prefilled Syringe: Each syringe contains 0.6 mL of solution to deliver
0.5 mL of drug product. Subcutaneous (sc) administration of 0.5 mL
delivers 180��g of drug product (expressed as the amount of interferon
alfa-2a), 4.0 mg sodium chloride, 0.025 mg polysorbate 80, 5.0 mg
benzyl alcohol, 1.3085 mg sodium acetate trihydrate, and 0.0231 mg
acetic acid. The solution is colorless to light yellow and the pH
is 6.0��0.5.
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Pharmacodynamics: Interferons bind to specific receptors on the cell
surface initiating intracellular signaling via a complex cascade of
protein-protein interactions leading to rapid activation of gene transcription.
Interferon-stimulated genes modulate many biological effects including
the inhibition of viral replication in infected cells, inhibition
of cell proliferation and immunomodulation. The clinical relevance
of these in vitro activities is not known. PEGASYS stimulates the production of effector proteins such as serum
neopterin and 2', 5'-oligoadenylate synthetase.<br/>Pharmacokinetics: Maximal serum concentrations (C) and
AUC increased in a nonlinear dose related manner following administration
of 90 to 270��g of PEGASYS. Maximal serum concentrations (C) occur between 72 to 96 hours post-dose. Week 48 mean trough concentrations (16 ng/mL; range 4 to 28) at 168
hours post-dose are approximately 2-fold higher than week 1 mean trough
concentrations (9 ng/mL; range 0 to 15). Steady-state serum levels
are reached within 5 to 8 weeks of once weekly dosing. The peak to
trough ratio at week 48 is approximately 2. The mean systemic clearance
in healthy subjects given PEGASYS was 94 mL/h, which is approximately
100-fold lower than that for interferon alfa-2a (ROFERON-A). The mean terminal half-life after sc dosing in patients with
chronic hepatitis C was 160 hours (range 84 to 353 hours) compared
to 5 hours (range 3.7 to 8.5 hours) for ROFERON-A.<br/>Special Populations:<br/>Gender and Age: PEGASYS administration yielded similar pharmacokinetics
in male and female healthy subjects. The AUC was increased from 1295
to 1663 ng���h/mL in subjects older than 62 years taking 180��g PEGASYS, but peak concentrations were similar (9 vs. 10 ng/mL)
in those older and younger than 62 years.<br/>Pediatric Patients: In a population pharmacokinetics study, 14 children
2 to 8 years of age with CHC received PEGASYS based on their body
surface area (BSA of the child��180��g/1.73m). The clearance of PEGASYS in children was nearly 4-fold lower compared
to the clearance reported in adults. Steady-state
trough levels in children with the BSA-adjusted dosing were similar
to trough levels observed in adults with 180��g fixed dosing.
Time to reach the steady state in children is approximately 12 weeks,
whereas in adults, steady state is reached within 5 to 8 weeks. In
these children receiving the BSA adjusted dose, the mean exposure
(AUC) during the dosing interval is predicted to be 25% to 70% higher
than that observed in adults receiving 180��g fixed dosing. The
safety and effectiveness of PEGASYS in patients below the age of 18
years have not been established .<br/>Renal Dysfunction: In patients with end stage renal disease undergoing
hemodialysis, there is a 25% to 45% reduction in PEGASYS clearance
. The pharmacokinetics of ribavirin
following administration of COPEGUS have not been studied in patients
with renal impairment and there are limited data from clinical trials
on administration of COPEGUS in patients with creatinine clearance<50 mL/min. Therefore, patients with creatinine clearance<50
mL/min should not be treated with COPEGUS .<br/>Effect of Food on Absorption of Ribavirin: Bioavailability of a single oral dose of ribavirin
was increased by co-administration with a high-fat meal. The absorption
was slowed (Twas doubled) and the AUCand Cincreased by 42% and 66%, respectively, when
COPEGUS was taken with a high-fat meal compared with fasting conditions
.<br/>Drug Interactions:<br/>Nucleoside Analogues: In vitro data indicate ribavirin reduces phosphorylation
of lamivudine, stavudine, and zidovudine. However, no pharmacokinetic
(e.g., plasma concentrations or intracellular triphosphorylated active
metabolite concentrations) or pharmacodynamic (e.g., loss of HIV/HCV
virologic suppression) interaction was observed when ribavirin and
lamivudine (n=18), stavudine (n=10), or zidovudine (n=6) were co-administered
as part of a multi-drug regimen to HCV/HIV coinfected patients (see PRECAUTIONS:
Drug Interactions). In
vitro, didanosine or its active metabolite (dideoxyadenosine 5'-triphosphate)
is increased when didanosine is co-administered with ribavirin (see PRECAUTIONS:
Drug Interactions).<br/>Drugs Metabolized by Cytochrome P450: There was no effect on the pharmacokinetics of representative
drugs metabolized by CYP 2C9, CYP 2C19, CYP 2D6 or CYP 3A4. Treatment with PEGASYS once weekly for 4 weeks in healthy
subjects was associated with an inhibition of P450 1A2 and a 25% increase
in theophylline AUC .<br/>Methadone: The pharmacokinetics of concomitant administration
of methadone and PEGASYS were evaluated in 24 PEGASYS naive chronic
hepatitis C (CHC) patients (15 male, 9 female) who received 180��g
PEGASYS subcutaneously weekly. All patients were on stable methadone
maintenance therapy (median dose 95 mg, range 30 mg to 150 mg) prior
to receiving PEGASYS. Mean methadone PK parameters were 10% to 15%
higher after 4 weeks of PEGASYS treatment as compared to baseline
. Methadone did not significantly alter the PK of PEGASYS
as compared to a PK study of 6 chronic hepatitis C patients not receiving
methadone.
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Single Dose Vial: Each PEGASYS (peginterferon alfa-2a) 180��g
single use, clear glass vial provides 1.0 mL containing 180��g
peginterferon alfa-2a for sc injection. Each package contains 1 vial
(NDC 0004-0350-09).<br/>Vials Monthly Convenience Pack: Four vials of PEGASYS (peginterferon alfa-2a), 180��g single use, clear glass vials, in a box with 4 syringes and
8 alcohol swabs (NDC 0004-0350-39). Each syringe is a 1 mL (1 cc)
volume syringe supplied with a 27-gauge,��-inch needle with needle-stick
protection device.<br/>Prefilled Syringes Monthly Convenience Pack: Four prefilled syringes of PEGASYS (peginterferon
alfa-2a), 180��g single use, graduated, clear glass prefilled
syringes, in a box with 4 needles and 4 alcohol swabs (NDC 0004-0352-39).
Each syringe is a 0.5 mL (��cc) volume syringe supplied with
a 27-gauge,��-inch needle with needle-stick protection device.<br/>Storage: Store in the refrigerator at 2��C to 8��C
(36��F to 46��F). Do not freeze or shake. Protect from light.
Vials and prefilled syringes are for single use only. Discard any
unused portion. REBETRON,
REBETROL, and INTRON are registered
trademarks of Schering Corporation.
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Alpha interferons, including
PEGASYS (peginterferon alfa-2a), may cause or aggravate fatal or life-threatening
neuropsychiatric, autoimmune, ischemic, and infectious disorders.
Patients should be monitored closely with periodic clinical and laboratory
evaluations. Therapy should be withdrawn in patients with persistently
severe or worsening signs or symptoms of these conditions. In many,
but not all cases, these disorders resolve after stopping PEGASYS
therapy . Use with Ribavirin. Ribavirin, including
COPEGUS, may cause birth defects and/or death of
the fetus. Extreme care must be taken to avoid pregnancy in female
patients and in female partners of male patients. Ribavirin causes
hemolytic anemia. The anemia associated with ribavirin therapy may
result in a worsening of cardiac disease. Ribavirin is genotoxic andmutagenic and should be considered a potential carcinogen (see COPEGUS
Package Insert for additional information and other WARNINGS).
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There is limited experience with overdosage. The
maximum dose received by any patient was 7 times the intended dose
of PEGASYS (180��g/day for 7 days). There were no serious reactions
attributed to overdosages. Weekly doses of up to 630��g have
been administered to patients with cancer. Dose-limiting toxicities
were fatigue, elevated liver enzymes, neutropenia, and thrombocytopenia.
There is no specific antidote for PEGASYS. Hemodialysis and peritoneal
dialysis are not effective.
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peginterferon alfa-2a
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Pegasys (Injection, Solution)
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PEGASYS alone or in combination with COPEGUS causes
a broad variety of serious adverse reactions . The most common life-threatening
or fatal events induced or aggravated by PEGASYS and COPEGUS were
depression, suicide, relapse of drug abuse/overdose, and bacterial
infections, each occurring at a frequency of<1%. Hepatic decompensation
occurred in 2% (10/574) of CHC/HIV patients (see WARNINGS: Hepatic
Failure and Hepatitis Exacerbations). In all hepatitis C studies, one or more serious adverse
reactions occurred in 10% of CHC monoinfected patients and in 19%
of CHC/HIV patients 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 SAEs occurred at a frequency of<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. Nearly all patients in clinical
trials experienced one or more adverse events. For hepatitis C patients,
the most commonly reported adverse reactions were psychiatric reactions,
including depression, insomnia, irritability, anxiety, and flu-like
symptoms such as fatigue, pyrexia, myalgia, headache, andrigors.
Other common reactions were anorexia, nausea and vomiting, diarrhea,
arthralgias, injection site reactions, alopecia, and pruritus. Overall 11% of CHC monoinfected patients receiving 48
weeks of therapy with PEGASYS either alone or 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%), Hgb<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. Because clinical trials are conducted under widely varying and controlled
conditions, adverse reaction rates observed in clinical trials of
a drug cannot be directly compared to rates in the clinical trials
of another drug. Also, the adverse event rates listed here may not
predict the rates observed in a broader patient population in clinical
practice.<br/>CHC With HIV Coinfection: The adverse event profile of coinfected patients
treated with PEGASYS and COPEGUS in Study 6 was generally similar
to that shown for monoinfected patients in Study 4 (Table 6). Events
occurring more frequently in coinfected patients were neutropenia
(40%), anemia (14%), thrombocytopenia (8%), weight decrease (16%),
and mood alteration (9%).<br/>Chronic Hepatitis B: In clinical trials of 48 week treatment duration,
the adverse event profile of PEGASYS in chronic hepatitis B was similar
to that seen in chronic hepatitis C PEGASYS monotherapy use, except
for exacerbations of hepatitis . Six percent of PEGASYS treated patients in the hepatitis
B studies experienced one or more serious adverse events. The most common or important serious adverse events in
the hepatitis B studies were infections (sepsis, appendicitis, tuberculosis,
influenza), hepatitis B flares, anaphylactic shock, thrombotic thrombocytopenic
purpura. The most commonly observed adverse
reactions were pyrexia (54% vs. 4%), headache (27% vs. 9%), fatigue
(24% vs. 10%), myalgia (26% vs. 4%), alopecia (18% vs. 2%), and anorexia
(16% vs. 3%) in the PEGASYS and lamivudine groups respectively. Overall 5% of hepatitis B patients discontinued PEGASYS
therapy and 40% of patients required modification of PEGASYS dose.
The most common reason for dose modification in patients receiving
PEGASYS therapy was for laboratory abnormalities including neutropenia
(20%), thrombocytopenia (13%), and ALT disorders (11%).<br/>Laboratory Test Values: The laboratory test values observed in the hepatitis
B trials (except where noted below) were similar to those seen in
the PEGASYS monotherapy hepatitis C trials.<br/>Neutrophils: In the hepatitis C studies, decreases in neutrophil
count below normal were observed in 95% of all patients treated with
PEGASYS either alone or in combination with COPEGUS. Severe potentially
life-threatening neutropenia (ANC<0.5��10/L)
occurred in 5% of CHC patients and 12% of CHC/HIV patients receiving
PEGASYS either alone or in combination with COPEGUS. Modification
of PEGASYS dose for neutropenia occurred in 17% of patients receiving
PEGASYS monotherapy and 22% of patients receiving PEGASYS/COPEGUS
combination therapy. In the CHC/HIV patients 27% required modification
of interferon dosage for neutropenia. Two percent of patients with
CHC and 10% of patients with CHC/HIV required permanent reductions
of PEGASYS dosage and<1% required permanent discontinuation. Median
neutrophil counts return to pre-treatment levels 4 weeks after cessation
of therapy (see DOSAGE AND ADMINISTRATION: Dose
Modifications).<br/>Lymphocytes: Decreases in lymphocyte count are induced by interferon
alpha therapy. PEGASYS plus COPEGUS combination therapy induced decreases
in median total lymphocyte counts (56% in CHC and 40% in CHC/HIV,
with median decrease of 1170 cells/mmin CHC and 800 cells/mmin CHC/HIV). In the hepatitis C studies, lymphopenia was
observed during both monotherapy (81%) and combination therapy with
PEGASYS and COPEGUS (91%). Severe lymphopenia (<0.5��10/L) occurred in approximately 5% of all monotherapy patients
and 14% of all combination PEGASYS and COPEGUS therapy recipients.
Dose adjustments were not required by protocol. The clinical significance
of the lymphopenia is not known. In CHC with
HIV coinfection, CD4 counts decreased by 29% from baseline (median
decrease of 137 cells/mm) and CD8 counts decreased by
44% from baseline (median decrease of 389 cells/mm) in
the PEGASYS plus COPEGUS combination therapy arm. Median lymphocyte
CD4 and CD8 counts return to pre-treatment levels after 4 to 12 weeks
of the cessation of therapy. CD4% did not decrease during treatment.<br/>Platelets: In the hepatitis C studies, platelet counts decreased
in 52% of CHC patients and 51% of CHC/HIV patients treated with PEGASYS
alone (respectively median decrease of 41% and 35% from baseline),
and in 33% of CHC patients and 47% of CHC/HIV patients receiving combination
therapy with COPEGUS (median decrease of 30% from baseline). Moderate
to severe thrombocytopenia (<50,000/mm) was observed
in 4% of CHC and 8% of CHC/HIV patients. Median platelet counts return
to pre-treatment levels 4 weeks after the cessation of therapy.<br/>Hemoglobin: In the hepatitis C studies, the hemoglobin concentration
decreased below 12 g/dL in 17% (median Hgb reduction of 2.2 g/dL)
of monotherapy and 52% (median Hgb reduction of 3.7 g/dL) of combination
therapy patients. Severe anemia (Hgb<10 g/dL) was encountered
in 13% of all patients receiving combination therapy and in 2% of
CHC patients and 8% of CHC/HIV patients receiving PEGASYS monotherapy.
Dose modification for anemia in COPEGUS recipients treated for 48
weeks occurred in 22% of CHC patients and 16% of CHC/HIV patients
(see DOSAGE AND ADMINISTRATION: Dose
Modifications).<br/>Triglycerides: Triglyceride levels are elevated in patients receiving
alfa interferon therapy and were elevated in the majority of patients
participating in clinical studies receiving either PEGASYS alone or
in combination with COPEGUS. Random levels���400 mg/dL were
observed in about 20% of CHC patients. Severe elevations of triglycerides
(>1000 mg/dL) occurred in 2% of CHC monoinfected patients. In HCV/HIV coinfected patients, fasting levels���400
mg/dL were observed in up to 36% of patients receiving either PEGASYS
alone or in combination with COPEGUS. Severe elevations of triglycerides
(>1000 mg/dL) occurred in 7% of coinfected patients.<br/>ALT Elevations:<br/>Thyroid Function: PEGASYS alone or in combination with COPEGUS was
associated with the development of abnormalities in thyroid laboratory
values, some with associated clinical manifestations. In the hepatitis
C studies, hypothyroidism or hyperthyroidism requiring treatment,
dose modification or discontinuation occurred in 4% and 1% of PEGASYS
treated patients and 4% and 2% of PEGASYS and COPEGUS treated patients,
respectively. Approximately half of the patients, who developed thyroid
abnormalities during PEGASYS treatment, still had abnormalities during
the follow-up period .<br/>Immunogenicity:<br/>Postmarketing Experience: The following adverse reactions have been identified
and reported during post-approval use of PEGASYS therapy: hearing
impairment, hearing loss, and serious skin reactions . 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. Decisions to include these reactions in labeling are typically
based on one or more of the following factors: (1) seriousness of
the reaction, (2) frequency of reporting or (3) strength of causal
connection to PEGASYS.
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PEGASYS, peginterferon alfa-2a, alone or in combination
with COPEGUS, is indicated for the treatment of adults with chronic
hepatitis C virus infection who have compensated liver disease and
have not been previously treated with interferon alpha. Patients in
whom efficacy was demonstrated included patients with compensated
liver disease and histological evidence of cirrhosis (Child-Pugh class
A) and patients with HIV disease that is clinically stable (e.g.,
antiretroviral therapy not required or receiving stable antiretroviral
therapy). PEGASYS is indicated for the treatment
of adult patients with HBeAg positive and HBeAg negative chronic hepatitis
B who have compensated liver disease and evidence of viral replication
and liver inflammation.
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Pegasys
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