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HALAVEN

HALAVEN. Eribulin Mesylate.

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HALAVEN

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  1. HALAVEN Eribulin Mesylate

  2. HALAVENis a microtubule inhibitor indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. Approved in November 2010, by Eisai company.

  3. Mechanism of Action: Halaven (eribulin mesylate) is a non-taxane microtubule dynamics inhibitor. It is a synthetic analogue of halichondrin B, a product isolated from the marine spongeHalichondria okadai.Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates.

  4. Eribulin exerts its effects via a tubulin-based antimitotic mechanism leading to G2/M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after prolonged mitotic blockage.

  5. DOSAGE AND ADMINISTRATION: -Intravenous administration,1 mg per 2 mL (0.5 mg per mL). -Administer 1.4 mg/m2 intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. -Reduce dose in patients with hepatic impairment and moderate renal impairment. -Do not mix with other drugs or administer with dextrose-containing solutions.

  6. Half-life of approximately 40 hours Eribulin is eliminated primarily in feces unchanged. After administration of eribulin to patients, approximately 82% of the dose was eliminated in feces and 9% in urine. Side effect: Neutropenia Anemia Asthenia/fatigue Alopecia Peripheral neuropathy Nausea Constipation

  7. WARNINGS AND PRECAUTIONS: 1- Neutropenia: Monitor peripheral blood cell counts and adjust dose as appropriate . 2- Peripheral Neuropathy: Monitor for signs of neuropathy. 3- In Pregnancy: Fetal harm can occur when administered to a pregnant woman.

  8. 4- QT Prolongation: Monitor for prolonged QT intervals in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities. Avoid in patients with congenital long QT syndrome.

  9. THANK YOU

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