IXABEPILONE

Other

Brand names: IXEMPRA

Intravenous

Mechanism of Action

12.1 Mechanism of Action Ixabepilone is a semi-synthetic analog of epothilone B. Ixabepilone binds directly to β-tubulin subunits on microtubules, leading to suppression of microtubule dynamics. Ixabepilone suppresses the dynamic instability of αβ-II and αβ-III microtubules. Ixabepilone possesses low in vitro susceptibility to multiple tumor resistance mechanisms including efflux transporters, such as MRP-1 and P-glycoprotein (P-gp). Ixabepilone blocks cells in the mitotic phase of the cell division cycle, leading to cell death.

Indications

taxanes

a taxane

and capecitabine. ( 1 ).

Contraindications

• 4 CONTRAINDICATIONS IXEMPRA is contraindicated in patients who have: a neutrophil count <1500 cells/mm 3 or a platelet count <100
• 000 cells/mm 3 [see Warnings and Precautions ( 5.2 )]. a history of severe hypersensitivity to agents containing Cremophor ® EL or its derivatives (e.g.

FDA Warnings

5 WARNINGS AND PRECAUTIONS Peripheral Neuropathy: Monitor for symptoms of neuropathy (sensory and motor neuropathy)
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
Advise patients of potential risk to a fetus and to use effective contraception ( 5
2 Myelosuppression Severe, life-threatening, or fatal myelosuppression can occur in patients treated with IXEMPRA

Known Side Effects

5 documented side effects by frequency

Vomiting

1-10%

Nausea

1-10%

Fatigue

1-10%

Diarrhea

1-10%

Shortness of Breath

1-10%

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Formulations

Dosage Forms

Tablet

Route

Intravenous