A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Zadaxin Side Effects, and Drug Interactions - Thymalfasin
Zadaxin Side Effects, and Drug Interactions - Thymalfasin
DRUG INTERACTIONS
and
Incompatibilities
Interactions between ZADAXIN and other drugs have not been
fully evaluated. Caution should be exercised when administering ZADAXIN therapy
in combination with other immunomodulating drugs. ZADAXIN should not be mixed
with any other drug.
Carcinogenesis, Mutagenesis,
Impairment of Fertility
Long term studies with thymosin alpha 1 have not been done
to determine carcinogenicity. Mutagenicity studies with thymosin alpha 1 showed
no adverse findings.
Pregnancy Category C
Teratology studies in mice and rabbits have shown no difference
in fetal abnormalities in control animals and animals given thymosin alpha 1.
It is not known whether ZADAXIN can cause fetal harm when administered to a
pregnant woman or affect reproduction capacity. ZADAXIN should be given to a
pregnant woman only if the benefits clearly outweigh the risks.
Nursing mothers
It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when
ZADAXIN is administered to a nursing woman.
Pediatric Use
Safety and effectiveness have not been established in patients
below the age of 18 years.
SIDE EFFECTS
ZADAXIN is well tolerated. During clinical experience involving
over 2000 individuals with various diseases distributed over all age groups,
no clinically significant adverse reactions attributable to thymosin alpha 1
administration were reported (see table below).
|
Disease
|
Adverse Event Rate
|
|
Viral Infection
|
Chronic hepatitis B Chronic hepatitis C Human immunodeficiency
|
<1% drug related adverse events
for all indications
|
|
Cancer
|
Non-small cell lung cancer Melanoma
|
|
Vaccine adjuvant
|
Hepatitis B vaccine Influenza vaccine
|
|
Immune disorders
|
Autoimmune liver disease Primary immune deficiency
|
Adverse experiences have been infrequent and mild, consisting
primarily of local discomfort at the injection site, and rare instances of erythema,
transient muscle atrophy, polyarthralgia combined with hand edema, and rash.
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