rative treatment-related non-hematological adverse events reported
in patients treated with capecitabine alone included: peripheral sensory
neuropathy 16% (Grade 3/4: 0%), palmar-plantar erythrodysesthesia
(hand-foot syndrome) 63% (Grade 3/4: 17%), fatigue/asthenia 29% (Grade 3/4:
4%), nausea 40% (Grade 3/4: 2%), diarrhea 39% (Grade 3/4: 9%), vomiting 24%
(Grade 3/4: 2%), myalgia/arthralgia 5% (Grade 3/4: <1%), anorexia 15%
(Grade 3/4: 1%), stomatitis/mucositis 20% (Grade 3/4: 3%), alopecia 3%
(Grade 3/4: 0%), abdominal pain 14% (Grade 3/4: 1%), nail disorder 10%
(Grade 3/4: <1%), musculoskeletal pain 5% (Grade 3/4: 0%), and constipation
6% (Grade 3/4: <1%). Treatment-related hematological adverse events of
Grade 3/4 severity reported in patients treated with capecitabine alone
included: neutropenia 11% and leukopenia 6%.
IMPORTANT SAFETY INFORMATION
TOXICITY IN HEPATIC IMPAIRMENT
IXEMPRA (ixabepilone) in combination with capecitabine is
contraindicated in patients with AST or ALT >2.5 x ULN or bilirubin >1 x
ULN due to increased risk of toxicity and neutropenia-related death.
In combination with capecitabine, the overall frequency of Grade 3/4
adverse reactions, febrile neutropenia, serious adverse reactions, and
toxicity related deaths was greater in patients with hepatic impairment.
Caution should be used when using IXEMPRA as monotherapy in patients
with AST or ALT > 5 x ULN. Use of IXEMPRA in patients with AST or ALT > 10
x ULN or bilirubin >3 x ULN is not recommended.
With monotherapy, Grade 4 neutropenia, febrile neutropenia, and serious
adverse reactions were more frequent in patients with hepatic impairment.
IXEMPRA is contraindicated in patients:
* with a known history of a severe (CTC Grade 3/4) hypersensitivity
reaction to agents containing Cremophor(R) EL or its derivatives such as
polyoxyethylated castor oil.
* who have a baseline neutrophil count <1500 cells/
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