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A Nurse's Guide to IXEMPRA® (Ixabepilone) Therapy

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A Nurse's Guide to IXEMPRA® (Ixabepilone) Therapy A nurse’s guide to IXEMPRA® (ixabepilone) therapy An overview of dosing, preparation, administration, and management of adverse reactions for IXEMPRA Indications Safety information1 IXEMPRA is indicated in combination with WARNING: toxicity in hepatic impairment capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant • IXEMPRA in combination with capecitabine is to treatment with an anthracycline and a taxane, or contraindicated in patients with AST or ALT whose cancer is taxane resistant and for whom >2.5 × ULN or bilirubin >1 × ULN due to increased further anthracycline therapy is contraindicated. risk of toxicity and neutropenia-related death • Anthracycline resistance is defined as progression • In combination with capecitabine, the overall while on therapy or within 6 months in the adjuvant frequency of grades 3/4 adverse reactions, setting or 3 months in the metastatic setting febrile neutropenia, serious adverse reactions, and toxicity-related deaths was greater in • Taxane resistance is defined as progression while patients with hepatic impairment on therapy or within 12 months in the adjuvant setting or 4 months in the metastatic setting • Caution should be used when using IXEMPRA as monotherapy in patients with AST or ALT IXEMPRA is indicated as monotherapy for >5 × ULN; use of IXEMPRA in patients with the treatment of metastatic or locally advanced AST or ALT >10 × ULN or bilirubin >3 × ULN breast cancer in patients whose tumors are is not recommended resistant or refractory to anthracyclines, taxanes, • With monotherapy, grade 4 neutropenia, febrile and capecitabine. neutropenia, and serious adverse reactions were more frequent in patients with hepatic impairment ALT, alanine aminotransferase; AST, aspartate aminotransferase; ULN, upper limit of normal. Please click here for Important Safety Information, including boxed WARNING regarding hepatic impairment, and click here for Full Prescribing Information. Therapy as strong as her spirit Determination in the face of resistance Please click here for Important Safety Information, including boxed WARNING regarding hepatic impairment, and click here 2 for Full Prescribing Information. Table of contents When to use IXEMPRA ........................................................................5 Resistance criteria ...............................................................................6 IXEMPRA Zone ......................................................................................7 Dosing....................................................... ..............................................8 Administration.....................................................................................14 Common adverse reactions............................................................ ..18 Talking with your patients ................................................................ 22 Resources ............................................................................................23 Important Safety Information ........................................................... 24 Access and support............................................................................27 Please click here for Important Safety Information, including boxed WARNING regarding hepatic impairment, and click here 3 for Full Prescribing Information. Please click here for Important Safety Information, including boxed WARNING regarding hepatic impairment, and click here 4 for Full Prescribing Information. When to use IXEMPRA® (ixabepilone) Indications 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 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. Safety information: contraindications1 IXEMPRA is contraindicated in patients: • With a known history of a severe (CTC grades 3/4) hypersensitivity reaction to agents containing Cremophor® EL or its derivatives, such as polyoxyethylated castor oil • Who have a baseline neutrophil count <1,500 cells/mm3 or a platelet count <100,000 cells/mm3 • In combination with capecitabine when AST or ALT is >2.5 × ULN or bilirubin is >1 × ULN due to increased risk of toxicity and neutropenia-related death ALT, alanine aminotransferase; AST, aspartate aminotransferase; CTC, common terminology criteria; ULN, upper limit of normal. Please click here for Important Safety Information, including boxed WARNING regarding hepatic impairment, and click here 5 for Full Prescribing Information. Defined resistance criteria used in IXEMPRA® (ixabepilone) registrational studies1 Neoadjuvant/adjuvant setting Study 046: Study 081: IXEMPRA + capecitabine IXEMPRA monotherapy Recurrence within 6 months Recurrence within 6 months of the last dose (only for of anthracycline therapy anthracyclines and taxanes) and or Recurrence within 12 months Recurrence within 6 months of taxane therapy of last taxane dose when or further anthracycline therapy is contraindicated* Recurrence within 12 months of taxane therapy when HER2-positive patients must further anthracycline therapy also have progressed during is contraindicated* or after discontinuation of trastuzumab Metastatic setting Study 046: Study 081: IXEMPRA + capecitabine IXEMPRA monotherapy Progression while on therapy Progression or within 8 weeks of last dose within 3 months of of anthracycline, taxane, last anthracycline dose and capecitabine therapy and or Progression within Progression on a taxane 4 months of last taxane dose and capecitabine when or further anthracycline therapy is contraindicated* Progression within 4 months of last taxane dose HER2-positive patients must when further anthracycline also have progressed during therapy is contraindicated* or after discontinuation of trastuzumab HER2, human epidermal growth factor receptor 2. * For anthracyclines, patients who received a minimum cumulative dose of 240 mg/m2 of doxorubicin or 360 mg/m2 of epirubicin were also eligible. Please click here for Important Safety Information, including boxed WARNING regarding hepatic impairment, and click here 6 for Full Prescribing Information. Think IXEMPRA® (ixabepilone) when resistance emerges in mBC For patients with metastatic or locally advanced breast cancer resistant or refractory to an anthracycline, a taxane, and capecitabine1 Adjuvant 1L metastatic ≥2L metastatic RESISTANCE IXEMPRA anthracycline + taxane + capecitabine RESISTANCE RESISTANCE anthracycline + taxane capecitabine IXEMPRA RESISTANCE IXEMPRA anthracycline + taxane + capecitabine 1L, first-line; 2L, second-line; mBC, metastatic breast cancer. IXEMPRA Zone* * Reflects approved indications for IXEMPRA. When resistance emerges in the adjuvant setting1 • Consider IXEMPRA + capecitabine in patients resistant to an anthracycline (progressing while on therapy or within 6 months) and a taxane (progressing while on therapy or within 12 months) or in patients whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated When resistance emerges in the metastatic setting1 • Consider IXEMPRA + capecitabine in patients who are resistant to an anthracycline (progressing within 3 months) or in whom further anthracycline use is contraindicated and who progress within 4 months of taxane therapy • Consider IXEMPRA as monotherapy in patients resistant or refractory to an anthracycline, a taxane, and capecitabine IXEMPRA, in combination with capecitabine, is the only FDA-approved, non-taxane microtubule-targeting agent indicated as first-line therapy for the treatment of patients with metastatic or locally advanced breast cancer resistant to an anthracycline and a taxane1,2 Safety information: peripheral neuropathy1 Monitor for symptoms of neuropathy, primarily sensory. Neuropathy is cumulative, is generally reversible, and should be managed by dose adjustment and delays. Please see pages 18-20 for more information. Please click here for Important Safety Information, including boxed WARNING regarding hepatic impairment, and click here 7 for Full Prescribing Information. IXEMPRA® (ixabepilone) dosing1 The recommended dosage of IXEMPRA is 40 mg/m2 administered intravenously over 3 hours every 3 weeks • Doses for patients with body surface area greater than 2.2 m2 should be calculated based on 2.2 m2 • The dose of IXEMPRA is the same for monotherapy and combination therapy with capecitabine • For certain toxicities, an initial 20% dose reduction should be made, followed by an additional 20% dose reduction if toxicities recur Recommended dosage 40 mg/m2 IV over 3 hours every 3 weeks Initial 20% dose reduction in the presence of toxicities 32 mg/m2 IV over 3 hours every 3 weeks Additional 20% dose reduction if toxicities recur 25 mg/m2 IV over 3 hours every 3 weeks Please click here for Important Safety Information, including boxed WARNING regarding hepatic impairment, and click here 8 for Full Prescribing Information. For certain toxicities,
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