• Metastatic or locally advanced breast cancer resistant to a taxane and anthracycline or resistant to a taxane and with contraindication to further anthracycline therapy (in combination with capecitabine).
• Metastatic or locally advanced breast cancer after failure of an anthracycline, a taxane, and capecitabine (as monotherapy).

Contraindicated in:

• Previous hypersensitivity to any medications containing Cremophor EL or similar derivatives (polyoxyethylated castor oil)
• Neutrophils <1500 cells/m³ or platelets <100,000 cells/m³
• Severe hepatic impairment
• Use with capecitabine is contraindicated for hepatic impairment (AST or ALT >2.5× upper limit of normal [ULN] or bilirubin >1× ULN) due to ↑ risk of toxicity and death associated with neutropenia
• OB: Pregnancy
• Lactation: Lactation.

Use Cautiously in:

• Diluent contains dehydrated alcohol; consider possible CNS effects
• Diabetes or history of neuropathy (↑ risk of severe neuropathy)
• History of cardiac disease (may ↑ risk of myocardial ischemia or ventricular dysfunction)
• Rep: Women of reproductive potential and men with female partners of reproductive potential
• Pedi: Safety and effectiveness not established in children.

CV: chest pain, edema, left ventricular dysfunction, myocardial ischemia.

Derm: alopecia, hyperpigmentation, nail disorder, palmar-plantar erythrodysesthesia (combination therapy with capecitabine), exfoliation, hot flushes, pruritus, rash.

EENT: ↑ lacrimation.

GI: abdominal pain, anorexia, constipation, diarrhea, mucositis, nausea, stomatitis, vomiting, altered taste.

GU: ↓ fertility.

Hemat: myelosuppression.

MS: arthralgia, musculoskeletal pain, myalgia.

Neuro: fatigue, peripheral neuropathy, weakness, dizziness, headache, insomnia.

Resp: dyspnea.

Misc: hypersensitivity reactions.

Drug-Drug:

• Strong CYP3A4 inhibitors, including ketoconazole, itraconazole, voriconazole, clarithromycin, atazanavir, ritonavir, and nefazodone, ↑ blood levels and the risk of serious toxicities; concurrent use should be avoided if possible. If concurrent use is required, dose reduction of ixabepilone is recommended.
• Inducers of the CYP3A4 enzyme system including dexamathasone, phenytoin, carbamazepine, phenobarbital, rifampin, rifampicin, or rifabutin may ↓ levels and effectiveness, avoid if possible.

Drug-Natural Products:

• St. John's wort may ↓ blood levels and should be avoided.

Drug-Food:

• Grapefruit juice may ↑ blood levels and toxicity; avoid concurrent use.

• Powder for injection (requires specific diluent for initial reconstitution): 15-mg vial (contains 16 mg ixabepilone to allow for withdrawal losses) with 8 mL of diluent in a separate vial as a kit; 45-mg vial (contains 47 mg ixabepilone to allow for withdrawal losses) with 23.5 mL of diluent in a separate vial as a kit;

• IV (Adults): 40 mg/m² every 3 wk; not to exceed dose greater than that calculated for 2.2 m² (88 mg/dose).

Ixempra Kit

• Binds to -tubulin subunits on microtubules; this action blocks cells in mitosis, leading to cell death.
• Also has antiangiogenic activity.

• Decreased spread of breast cancer.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: epothilone B analogues

Absorption: IV administration results in complete bioavailablity.

Distribution: Unknown.

Metabolism/Excretion: Extensively metabolized by the liver, primarily by the CYP3A4 isoenzyme. Metabolites are not active and are excreted mainly by the kidneys.

Half-life: 52 hr.

(plasma concentrations)

• Explain purpose of ixabepilone to patient.
• Advise patient to avoid grapefruit juice during therapy; may lead to increased levels and side effects.
• Solution contains alcohol and may cause drowsiness or dizziness. Caution patient to avoid driving and other activities requiring alertness until response to medication is known.
• Instruct patient to notify health care professional promptly if fever >100.5°F; chills; cough; hoarseness; sore throat; signs of infection; lower back or side pain; burning, painful or difficult urination; bleeding gums; bruising; petechiae; blood in stools, urine, or emesis; increased fatigue; dyspnea; or orthostatic hypotension occurs. Caution patient to avoid crowds and persons with known infections. Instruct patients to use a soft toothbrush and electric razor and to avoid falls. Caution patient not to drink alcoholic beverages or take medication containing aspirin or NSAIDs; may precipitate bleeding.
• Instruct patient to notify health care professional promptly if signs and symptoms of hypersensitivity (hives, urticaria, pruritus, rash, flushing, swelling, dyspnea, chest tightness), peripheral neuropathy (numbness and tingling in hands and feet), or cardiac adverse reactions (chest pain, difficulty breathing, palpitations, unusual weight gain) occur.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other Rx, OTC, or herbal products, especially St. John's wort.
• Instruct patient not to receive any vaccinations without advice of health care professional.
• Discuss the possibility of hair loss with patient. Explore methods of coping. Regrowth usually occurs 2–3 mo after discontinuation of therapy.
• Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception during and for 7 mo after last dose of therapy and to avoid breastfeeding during and for 2 wks after last dose of therapy. Advise males with female partners of reproductive potential to use effective contraception during and for four mo after last dose. May impair female and male fertility.

icks-a-BEP-i-lone

NDC Code^*

• 70020- R-Pharm US Operating, LLC
  • 70020-1910- IXEMPRA
    • 70020-1910-1- 1 KIT in 1 PACKAGE, COMBINATION (70020-1910-1) * 15 mg in 1 VIAL, SINGLE-USE * 8 mL in 1 VIAL, SINGLE-USE

• 70020- R-Pharm US Operating, LLC
  • 70020-1911- IXEMPRA
    • 70020-1911-1- 1 KIT in 1 PACKAGE, COMBINATION (70020-1911-1) * 45 mg in 1 VIAL, SINGLE-USE * 23.5 mL in 1 VIAL, SINGLE-USE