Label Changes for:

Ixempra kit (ixabepilone) for intravenous infusion

October 2009

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 2010 and October 2009

ADVERSE REACTIONS

Postmarketing Experience
  • Radiation recall has been reported during postmarketing use of Ixempra. Because this reaction was reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

DRUG INTERACTIONS

Drugs That May Decrease Ixabepilone Plasma Concentrations
  • CYP3A4 Inducers: Ixempra is a CYP3A4 substrate. Co-administration of Ixempra with rifampin, a potent CYP3A4 inducer, decreased ixabepilone AUC by 43% compared to Ixempra treatment alone.

WARNINGS AND PRECAUTIONS

Monitor for symptoms of neuropathy, primarily sensory. Neuropathy is cumulative, generally reversible and should be managed by dose adjustment and delays.

Peripheral Neuropathy (ammendment to terminology)
  • Peripheral neuropathy was common (see Table 3). Patients treated with Ixempra should be monitored for symptoms of neuropathy, such as burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, or neuropathic pain. Neuropathy occurred early during treatment; ~75% of new onset or worsening neuropathy occurred during the first 3 cycles. Patients experiencing new or worsening symptoms may require a reduction or delay in the dose of Ixempra. In clinical studies, peripheral neuropathy was managed through dose reductions, dose delays, and treatment discontinuation. Neuropathy was the most frequent cause of treatment discontinuation due to drug toxicity.
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