Ixabepilone - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Ixabepilone. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
WARNING: TOXICITY IN PATIENTS WITH HEPATIC IMPAIRMENT IXEMPRA 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 [see Contraindications and Warnings and Precautions ]. WARNING: TOXICITY IN PATIENTS WITH HEPATIC IMPAIRMENT See full prescribing information for complete boxed warning. IXEMPRA ® 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. ( 4 , 5.3 )
5 WARNINGS AND PRECAUTIONS Peripheral Neuropathy: Monitor for symptoms of neuropathy (sensory and motor neuropathy).) Withhold, reduce, or discontinue IXEMPRA depending on severity. ( 2.3 , 5.1 ).
Myelosuppression: Neutropenia, febrile neutropenia, and infections have occurred.
Monitor blood cell counts before and during treatment with IXEMPRA.
Withhold, reduce, or discontinue IXEMPRA depending on severity ( 2.3 , 5.2 ).
Increased Toxicity in Patients with Hepatic Impairment: Grade 4 neutropenia, febrile neutropenia, and serious adverse reactions may occur in patients with hepatic impairment during treatment with IXEMPRA.
Reduce dose depending on severity. ( 2.3 , 5.3 , 6.1 ).
Hypersensitivity Reactions: Severe hypersensitivity reactions (including anaphylaxis) have occurred.
Premedicate all patients before treatment with IXEMPRA.
Withhold, reduce, or discontinue IXEMPRA depending on severity ( 2.1 , 2.3 , 5.4 ).
Cardiac Adverse Reactions: Myocardial ischemia and ventricular dysfunction have occurred.
Closely monitor patients with a history of cardiac disease during treatment with IXEMPRA.
Consider discontinuation of IXEMPRA in patients who develop cardiac ischemia or impaired cardiac function ( 2.3 , 5.5 ).
Embryo-Fetal Toxicity: Can cause fetal harm.
Advise patients of potential risk to a fetus and to use effective contraception ( 5.6 , 8.1 , 8.3) Alcohol Content: The alcohol content in a dose of IXEMPRA may affect the central nervous system.
This may include impairment of a patient's ability to drive or use machines immediately after infusion. .
5.2 Myelosuppression Severe, life-threatening, or fatal myelosuppression can occur in patients treated with IXEMPRA.
Myelosuppression is dose-dependent and primarily manifests as neutropenia.
In clinical studies, grade 4 neutropenia (<500 cells/mm 3 ) occurred in 36% of patients treated with IXEMPRA in combination with capecitabine and 23% of patients treated with single agent IXEMPRA monotherapy.
Febrile neutropenia and infection with neutropenia were reported in 5% and 6% of patients treated with IXEMPRA in combination with capecitabine, respectively, and 3% and 5% of patients treated with IXEMPRA as a single agent, respectively.
Neutropenia-related death occurred in 1.9% of 414 patients with normal hepatic function or mild hepatic impairment treated with IXEMPRA in combination with capecitabine.
The rate of neutropenia-related deaths was higher (29%, 5 out of 17) in patients with AST or ALT >2.5 x ULN or bilirubin >1.5 x ULN [see Boxed Warning, Contraindications , and Warnings and Precautions ] .
Neutropenia-related death occurred in 0.4% of 240 patients treated with IXEMPRA as a single agent.
No neutropenia-related deaths were reported in 24 patients with AST or ALT >2.5 x ULN or bilirubin >1.5 x ULN treated with IXEMPRA as a single agent.
IXEMPRA is contraindicated for use in patients with a neutrophil count of <1500 cells/mm 3 . [see Contraindications ] .
Monitor patients receiving IXEMPRA for myelosuppression with frequent peripheral blood cell counts.
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