IXEMPRA® (ixabepilone)
The IXEMPRA program offers reimbursement support and helpful resources.
Various health insurers have different reimbursement procedures or requirements that need to be addressed prior to administration of a treatment or service. For assistance with reimbursement, based on your practice setting, click on the links below.
Indications
IXEMPRA is indicated as monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine.
IXEMPRA is indicated in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. Anthracycline resistance is defined as progression while on therapy or within 6 months in the adjuvant setting or 3 months in the metastatic setting. Taxane resistance is defined as progression while on therapy or within 12 months in the adjuvant setting or 4 months in the metastatic setting.
Important Safety Information
Toxicity in hepatic impairment
- IXEMPRA (ixabepilone) in combination with capecitabine is
contraindicated in patients with AST or ALT >2.5 × ULN or
bilirubin >1 × 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 × ULN. Use of IXEMPRA in patients
with AST or ALT >10 × ULN or bilirubin >3 × ULN is not
recommended
- With monotherapy, grade 4 neutropenia, febrile neutropenia, and
serious adverse reactions were more frequent in patients with
hepatic impairment
Contraindications
- IXEMPRA is contraindicated in patients:
- with a known history of a severe (CTC grade 3/4) hypersensitivity
reaction to agents containing Cremophor® EL or its derivatives such
as polyoxyethylated castor oil
- who have a baseline neutrophil count <1500 cells/mm3 or a
platelet count <100,000 cells/mm3
Peripheral neuropathy
- Peripheral neuropathy was common. 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
peripheral neuropathy may require changes in the dose or discontinuation of IXEMPRA
- Neuropathy was the most frequent cause of treatment discontinuation due to drug toxicity. Caution should be used when treating patients with diabetes mellitus or preexisting peripheral neuropathy.
Myelosuppression
- Myelosuppression is dose-dependent and primarily manifested as neutropenia
- Patients should be monitored for myelosuppression; frequent
peripheral blood cell counts are recommended for all patients
receiving IXEMPRA
- Patients who experience severe neutropenia or thrombocytopenia
should have their dose reduced. Neutropenia-related deaths occurred
in 1.9% of 414 patients with normal hepatic function or mild hepatic impairment treated with IXEMPRA in combination with capecitabine. Neutropenia-related death occurred in
0.4% of 240 patients with IXEMPRA as monotherapy
Hypersensitivity reaction
- Premedicate with an H1 and an H2 antagonist approximately 1 hour
before IXEMPRA infusion and observe for hypersensitivity
reactions (eg, flushing, rash, dyspnea, and bronchospasm)
- In case of severe hypersensitivity reactions, infusion of IXEMPRA
should be stopped and aggressive supportive treatment (eg,
epinephrine, corticosteroids) started
- Patients who experience a hypersensitivity reaction in one cycle of
IXEMPRA must be premedicated in subsequent cycles with a
corticosteroid in addition to the H1 and H2 antagonists, and
extension of the infusion time should be considered
Pregnancy
- Women should be advised not to become pregnant when taking
IXEMPRA. If this drug is used during pregnancy or the patient
becomes pregnant, the patient should be apprised of the potential
hazard to the fetus
Cardiac adverse reactions
- Caution should be exercised in patients with a history of cardiac
disease. Discontinuation of IXEMPRA should be considered in
patients who develop cardiac ischemia or impaired cardiac function
due to reports of cardiovascular adverse reactions (eg, myocardial
ischemia, supraventricular arrhythmia, and ventricular dysfunction).
The frequency of cardiac adverse reactions (myocardial ischemia
and ventricular dysfunction) was higher in the IXEMPRA in
combination with capecitabine (1.9%) than in the capecitabine alone
(0.3%) treatment group
Potential for cognitive impairment from excipients
- IXEMPRA contains dehydrated alcohol USP. Consideration should
be given to the possibility of central nervous system and other
effects of alcohol
Adverse reactions
- The most common adverse reactions (≥20%) reported by patients receiving IXEMPRA were peripheral sensory neuropathy,
fatigue/asthenia, myalgia/arthralgia, alopecia, nausea, vomiting,
stomatitis/mucositis, diarrhea, and musculoskeletal pain. The
following additional events occurred in ≥20% in combination
treatment: palmar-plantar erythrodysesthesia (hand-foot)
syndrome, anorexia, abdominal pain, nail disorder, and
constipation. Drug-associated hematologic abnormalities (>40%)
include neutropenia, leukopenia, anemia, and thrombocytopenia
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