Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1635
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
ZIAGEN (Tablet)
|
| dailymed-instance:activeIng... | |
| dailymed-instance:boxedWarn... |
WARNING: RISK OF HYPERSENSITIVITY REACTIONS, LACTIC ACIDOSIS,
AND SEVERE HEPATOMEGALY: Serious and sometimes
fatal hypersensitivity reactions have been associated with ZIAGEN
(abacavir sulfate). Hypersensitivity to abacavir is a multi-organ clinical
syndrome usually characterized by a sign or symptom in 2 or more of
the following groups: (1) fever, (2) rash, (3) gastrointestinal (including
nausea, vomiting, diarrhea, or abdominal pain), (4) constitutional
(including generalized malaise, fatigue, or achiness), and (5) respiratory
(including dyspnea, cough, or pharyngitis). Discontinue ZIAGEN as
soon as a hypersensitivity reaction is suspected. Patients who carry the HLA-B*5701
allele are at high risk for experiencing a hypersensitivity reaction
to abacavir. Prior to initiating therapy with abacavir, screening
for the HLA-B*5701 allele is recommended; this approach has been found
to decrease the risk of hypersensitivity reaction. Screening is also
recommended prior to reinitiation of abacavir in patients of unknown
HLA-B*5701 status who have previously tolerated abacavir. HLA-B*5701-negative
patients may develop a suspected hypersensitivity reaction to abacavir;
however, this occurs significantly less frequently than in HLA-B*5701-positive
patients. Regardless of HLA-B*5701 status, permanently discontinue ZIAGEN if
hypersensitivity cannot be ruled out, even when other diagnoses are
possible. Following a hypersensitivity reaction to abacavir, NEVER restart
ZIAGEN or any other abacavir-containing product because more severe
symptoms can occur within hours and may include life-threatening hypotension
and death. Reintroduction of ZIAGEN or any other abacavir-containing product,
even in patients who have no identified history or unrecognized symptoms
of hypersensitivity to abacavir therapy, can result in serious or
fatal hypersensitivity reactions. Such reactions can occur within
hours [see Warnings and Precautions (5.1)]. Lactic
acidosis and severe hepatomegaly with steatosis, including fatal cases,
have been reported with the use of nucleoside analogues alone or in
combination, including ZIAGEN and other antiretrovirals [see Warnings and Precautions (5.2)].
|
| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... |
dailymed-ingredient:colloidal_silicon_dioxide,
dailymed-ingredient:hypromellose,
dailymed-ingredient:magnesium_stearate,
dailymed-ingredient:microcrystalline_cellulose,
dailymed-ingredient:polysorbate_80,
dailymed-ingredient:sodium_starch_glycolate,
dailymed-ingredient:titanium_dioxide,
dailymed-ingredient:triacetin,
dailymed-ingredient:yellow_iron_oxide
|
| dailymed-instance:genericMe... |
abacavir sulfate
|
| dailymed-instance:fullName |
ZIAGEN (Tablet)
|
| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
ZIAGEN
|