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captivating [1,000/mm:<75,000/mm 3 or grade 3 or 4 nonhematologic toxicity on day 1 or 8: Withhold dose; may delay day 8 dose up to 1 week. If toxicity resolves to grade 2 by day 15 administer a reduced dose and wait at least 2 weeks before beginning the next cycle. Omit dose if not resolved to grade 2 by day 15. Do not re-escalate dose after reduction. Permanently reduce dose from eribulin mesylate 1.4 mg/m 2 to 1.1 mg/m 2 for the following: ANC> <500/mm 3 for >7 days ANC> <1000/mm 3 with fever or infection Platelets> <25,000/mm 3 Platelets> <50,000/mm 3 requiring transfusion Nonhematologic toxicity of grade 3 or 4 Dose omission or delay due to toxicity on day 8 of prior cycle Permanently reduce dose from eribulin mesylate 1.1 mg/m 2 to 0.7 mg/m 2 for occurrence of any of the above events; discontinue treatment if the above toxicities occur at the 0.7 mg/m 2 dose level. Dosing: Obesity ASCO Guidelines for appropriate chemotherapy dosing in obese adults with cancer: Utilize patient s actual body weight (full weight) for calculation of body surface area- or weight-based dosing, particularly when the intent of therapy is curative; manage regimen-related toxicities in the same manner as for nonobese patients; if a dose reduction is utilized due to toxicity, consider resumption of full weight-based dosing with subsequent cycles, especially if cause of toxicity (eg, hepatic or renal impairment) is resolved (Griggs, 2012). Reconstitution No dilution required. May prepare by drawing into a syringe for administration or may dilute in 100 mL NS. Discard unused portion of vial. Administration IV: Infuse over 2 to 5 minutes. May be administered undiluted or diluted. Do not administer other medications through the same IV line, or through a line containing dextrose. Storage Store intact vials at 25 C (77 F); excursions permitted between 15 C and 30 C (59 F and 86 F); do not freeze. Store in original carton. Undiluted solutions in a syringe and solutions diluted in normal saline for infusion are stable for up to 4 hours at room temperature or up to 24 hours refrigerated at 4 C (40 F). Drug Interactions BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Avoid combination CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Monitor therapy Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Avoid combination Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Avoid combination Lenograstim: Antineoplastic Agents may diminish the therapeutic effect of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Consider therapy modification Lipegfilgrastim: Antineoplastic Agents may diminish the therapeutic effect of Lipegfilgrastim. Management: Avoid concomitant use of lipegfilgrastim and myelosuppressive cytotoxic chemotherapy. Lipegfilgrastim should be administered at least 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Consider therapy modification MiFEPRIStone: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying). Management: Though the drugs listed here have uncertain QT-prolonging effects, they all have some possible association with QT prolongation and should generally be avoided when possible. Consider therapy modification Palifermin: May enhance the adverse/toxic effect of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Consider therapy modification Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Monitor therapy QTc-Prolonging Agents (Highest Risk): QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification QTc-Prolonging Agents (Moderate Risk): QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). Monitor therapy Adverse Reactions >10%: Cardiovascular: Peripheral edema ( 5% to 12%) Central nervous system: Fatigue ( 62%), peripheral neuropathy (29% to 35%; grades 3/4: 3% to 8%), headache (18% to 19%) Dermatologic: Alopecia (35% to 45%) Endocrine & metabolic: Hypokalemia ( 5% to 30%), hypocalcemia (28%), weight loss (21%), hypophosphatemia (20%) Gastrointestinal: Nausea (35% to 41%), constipation (25% to 32%), abdominal pain ( 5% to 29%), anorexia (20%), decreased appetite (19%), vomiting (18% to 19%), diarrhea (17% to 18%), stomatitis ( 5% to 14%) Genitourinary: Urinary tract infection (10% to 11%) Hematologic & oncologic: Neutropenia (63% to 82%; grade 4: 29% grades 3/4: 12% to 57%; nadir: 13 days; recovery: 8 days), anemia (58% to 70%; grades 3/4: 2% to 4%) Hepatic: Increased serum ALT (18% to 43%), increased serum AST (36%) Neuromuscular & skeletal: Weakness ( 62%), arthralgia ( 22%), myalgia ( 22%), back pain (16%), ostealgia (12%), limb pain (11%) Respiratory: Cough (14% to 18%), dyspnea (16%) Miscellaneous: Fever (21% to 28%) 1% to 10%: Cardiovascular: Hypotension ( 5% to> <10%) Central nervous system: Anxiety ( 5% to> <10%), depression ( 5% to> <10%), dizziness ( 5% to> <10%), insomnia ( 5% to> <10%), myasthenia ( 5% to> <10%) Dermatologic: Skin rash ( 5% to> <10%) Endocrine & metabolic: Hyperglycemia ( 5% to> <10%) Gastrointestinal: Dysgeusia ( 5% to> <10%), dyspepsia ( 5% to> <10%), xerostomia ( 5% to> <10%), mucosal inflammation (9%) Hematologic & oncologic: Thrombocytopenia ( 5% to> <10%; grades 3: 1%), febrile neutropenia ( 5%) Neuromuscular & skeletal: Muscle spasm ( 5% to> <10%), musculoskeletal pain ( 5% to> <10%), Ophthalmic: Increased lacrimation ( 5% to> <10%) Respiratory: Oropharyngeal pain ( 5% to> <10%), upper respiratory tract infection ( 5% to> <10%)> <1% (Limited to important or life-threatening): Dehydration, drug-induced hypersensitivity, hepatotoxicity, hypomagnesemia, interstitial pulmonary disease, lymphocytopenia, pancreatitis, pneumonia, prolonged Q-T interval on ECG, pruritus, sepsis, Stevens-Johnson syndrome, toxic epidermal necrolysis Warnings/Precautions Concerns related to adverse effects: Bone marrow suppression: Hematologic toxicity, including severe neutropenia and neutropenic fever, has occurred. Neutropenic sepsis (fatal) has also been reported (case reports). May require treatment delay and dosage reduction. A higher incidence of grade 4 neutropenia and neutropenic fever occurred in patients with ALT or AST >3 x ULN or bilirubin >1.5 x ULN. Monitor complete blood counts prior to each dose; more frequently if severe cytopenias develop. Patients with baseline neutrophils> <1,500/mm 3 were not included in clinical studies. Peripheral neuropathy: Peripheral neuropathy commonly occurs. Peripheral neuropathy may be prolonged (>1 year in 5% of metastatic breast cancer patients and >60 days in close to 60% of liposarcoma patients); over 60% of liposarcoma patients with peripheral neuropathy had not recovered within a median follow-up of ~6 months in one clinical trial. The median time to the first occurrence of peripheral neuropathy (any severity) in liposarcoma patients was 5 months (range: 3.5 to 9 months). Monitor for signs of peripheral motor or sensory neuropathy. May require treatment delay or discontinuation. Some patients may have preexisting neuropathy due to prior chemotherapy; monitor closely for worsening neuropathy. QT prolongation: QT prolongation was observed on day 8 of eribulin therapy (in an uncontrolled study). Monitor ECG in patients with heart failure, bradyarrhythmia, with concomitant medication known to prolong the QT interval, or with electrolyte imbalance. Correct hypokalemia and hypomagnesemia prior to treatment; monitor electrolytes periodically during treatment. Avoid use in patients with congenital long QT syndrome. Disease-related concerns: Hepatic impairment: Dosage reduction required in patients with mild to moderate (Child-Pugh class A or B) hepatic impairment; use has not been studied in patients with severe hepatic impairment. Transaminase or bilirubin elevations are associated with a higher incidence of grade 4 neutropenia and neutropenic fever. Renal impairment: Dosage reduction required in patients with moderate or severe renal impairment (CrCl 15 to 49 mL/minute). Concurrent drug therapy issues: Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Other warnings/precautions: International issues: Some products available internationally may have vial strength and dosing expressed as the base (instead of as the salt). Refer to prescribing information for specific dosing information. Monitoring Parameters CBC with differential prior to each dose (increase frequency with grades 3/4 cytopenias); renal and liver function tests; serum electrolytes, including potassium and magnesium. Assess for peripheral neuropathy prior to each dose. Monitor ECG in patients with heart failure, bradyarrhythmia, with concomitant medication known to prolong the QT interval, and electrolyte abnormalities (eg, hypokalemia, hypomagnesemia). Pregnancy Considerations Adverse effects were observed in animal reproduction studies. Based on its mechanism of action, eribulin would be expected to cause fetal harm if administered during pregnancy. Women of reproductive potential should use effective contraception to avoid pregnancy during eribulin treatment and for at least 2 weeks following the last eribulin dose; males with female partners of reproductive potential should use effective contraception during eribulin treatment and for 3.5 months following the last dose. The Canadian labeling recommends effective contraception during and for at least 3 months after treatment in women of reproductive potential. Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience headache, hair loss, nausea, vomiting, constipation, diarrhea, mouth sores, lack of appetite, weight loss, joint pain, muscle pain, bone pain, abdominal pain, or back pain. Have patient report immediately to prescriber signs of infection, burning or numbness feeling, painful extremities, tachycardia, abnormal heartbeat, severe dizziness, passing out, shortness of breath, swelling of arms or legs, bruising, bleeding, or severe loss of strength and energy (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Next Interactions Print this page Add to My Med List More about eribulin Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En Español 8 Reviews Add your own review/rating Drug class: mitotic inhibitors Consumer resources Eribulin Eribulin Intravenous (Advanced Reading) Professional resources Eribulin Mesylate (AHFS Monograph) Other brands: Halaven Related treatment guides Breast Cancer Breast Cancer, Metastatic Liposarcoma> ]} Drug Status Rx Availability Prescription only D Pregnancy Category Positive evidence of risk N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Eribulin Rating 8 User Reviews 9.5 /10 8 User Reviews 9.5 Rate it! Drug Class Mitotic inhibitors Related Drugs mitotic inhibitors Taxol , Taxotere , paclitaxel , Abraxane , docetaxel , etoposide Liposarcoma Halaven , More... Breast Cancer, Metastatic anastrozole , tamoxifen , letrozole , Arimidex , Femara , Xeloda , Taxol , capecitabine , More... Breast Cancer methotrexate , anastrozole , tamoxifen , letrozole , Arimidex , Femara , exemestane , fluorouracil , More...} } you bought


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