对Alpha干扰素的 警告

liver411

对alpha干扰素的警告, 看看大家谁有时间帮大家翻翻. 谢谢先!

[B]WARNING[/B]
Alpha interferons, including PEG-INTRON and INTRON A, cause or
aggravate fatal or life-threatening neuropsychiatric, autoimmune,
ischemic, and infectious disorders. Patients should be monitored
closely with periodic clinical and laboratory evaluations. Patients
with persistently severe or worsening signs or symptoms of these
conditions should be withdrawn from therapy. In many but not all cases
these disorders resolve after stopping PEG-INTRON or INTRON A therapy.
REBETOL monotherapy is not effective for the treatment of chronic
hepatitis C and should not be used alone for this indication.
Ribavirin causes hemolytic anemia. Anemia associated with REBETOL
therapy may exacerbate cardiac disease that has lead to fatal and
nonfatal myocardial infarctions. Patients with a history of
significant or unstable cardiac disease should not be treated with
REBETOL? It is advised that complete blood counts (CBC) be obtained
at baseline and at weeks 2 and 4 of therapy or more frequently if
clinically indicated. REBETOL and combination REBETOL/PEG-INTRON or
INTRON A therapy must not be used by women, or male partners of women, who are or may become pregnant during therapy and during the 6 months after stopping therapy. REBETOL and combination REBETOL/PEG-INTRON or INTRON A therapy should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Women of childbearing potential and men must use effective
contraception (at least two reliable forms) during treatment and
during the 6-month posttreatment follow-up period. Significant
teratogenic and/or embryocidal effects have been demonstrated for
ribavirin 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 REBETOL? If pregnancy occurs in a
patient or partner of a patient during treatment or during the 6
months after treatment stops, physicians are encouraged to report such
cases by calling (800) 727-7064. PEG-INTRON?There are no new adverse
events specific to PEG-INTRON?as compared to INTRON?A (Interferon
alfa-2b, recombinant) for Injection, however, the incidence of some
(eg, injection site reactions, fever, rigors, nausea) were higher. The
most common adverse events associated with PEG-INTRON?were "flu-like"
symptoms, occurring in approximately 50% of patients, which may
decrease in severity as treatment continues. Application site
disorders were common (47%), but all were mild (44%) or moderate (4%)
and no patient discontinued, and included injection site inflammation
and reaction (ie, bruise, itchiness, irritation). Injection site pain
was reported in 2% of patients receiving PEG-INTRON? Alopecia
(thinning of the hair) is also often associated with alpha interferons
including PEG-INTRON? Psychiatric adverse events, which include
insomnia, were common (57%) with PEG-INTRON? but similar to INTRON?A
(58%). Depression was most common at 29%. Suicidal behavior including
ideation, suicidal attempts, and completed suicides occurred in 1% of
patients during or shortly after completing treatment with
PEG-INTRON? PEG-INTRON?REBETOL?is contraindicated in patients with
autoimmune hepatitis, decompensated liver disease, and in patients
with hemoglobinopathies (eg, thalassemia major, sickle-cell anemia).
The following serious or clinically significant adverse events have
been reported at a frequency < 1% with PEG-INTRON?or interferon
alpha: Severe decreases in neutrophil or platelet counts,
hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and
hemorrhagic colitis, development or exacerbation of autoimmune
disorders including thyroiditis, RA, systemic lupus erythematosus,
psoriasis, pulmonary disorders (dyspnea, pulmonary infiltrates,
pneumonitis and pneumonia, some resulting in patient deaths),
urticaria, angioedema, bronchoconstriction, anaphylaxis, retinal
hemorrhages, and cotton wool spots. In the PEG-INTRON/REBETOL
combination trial the incidence of serious adverse events was 17% in
the PEG-INTRON/REBETOL groups compared to 14% in the INTRON A/REBETOL groups. The incidence of severe adverse events in the
PEG-INTRON/REBETOL combination therapy trial was 23% in the INTRON
A/REBETOL group and 31-34% in the PEG-INTRON/REBETOL groups. Dose
reductions due to adverse reactions occurred in 42% of patients
receiving PEG-INTRON?(1.5 礸/kg)/REBETOL?and in 34% of those
receiving INTRON?A/REBETOL? REBETOL?should not be used in patients
with creatinine clearance < 50 mL/min. REBETRON Combination Therapy
The most common adverse experiences associated with therapy are
"flu-like" symptoms, such as headache, fatigue, myalgia, and fever,
which appear to decrease in severity as treatment continues. Severe
psychiatric adverse events, including depression, psychoses,
aggressive behavior, hallucinations, violent behavior (suicidal
ideation, suicidal attempts, suicides), and rare instances of
homicidal ideation have occurred during combination REBETOL/INTRON A
therapy, both in patients with and without a previous psychiatric
disorder. INTRON?A All patients receiving INTRON A therapy
experienced mild-to-moderate side effects. Some patients experienced
more severe side effects, including neutropenia, fatigue, myalgia,
headache, fever, chills, and increased SGOT. Other frequently
occurring side effects were nausea, vomiting, depression, alopecia,
diarrhea, and thrombocytopenia. DEPRESSION AND SUICIDAL BEHAVIOR,
INCLUDING SUICIDAL IDEATION, SUICIDAL ATTEMPTS, AND COMPLETED
SUICIDES, HAVE BEEN REPORTED IN ASSOCIATION WITH TREATMENT WITH ALFA INTERFERONS, INCLUDING INTRON A THERAPY.
_________________________________________________________________

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References

1. http://www.beincharge.com/links/peg.htm
2. http://g.msn.com/1HM1ENUS/c144??PS=47575