Eribulin Mesylate Drug Information
Generic name: ERIBULIN MESYLATE
Uses of Eribulin Mesylate
Metastatic Breast Cancer
Eribulin mesylate injection is 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.
Liposarcoma
Eribulin mesylate injection is indicated for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.
Dosage & Administration of Eribulin Mesylate
Instructions for Preparation and Administration
Aseptically withdraw the required amount of eribulin mesylate injection from the single-dose vial and administer undiluted or diluted in 100 mL of 0.9% Sodium Chloride Injection, USP. Do not dilute in or administer through an intravenous line containing solutions with dextrose. Do not administer in the same intravenous line concurrent with the other medicinal products.
Store undiluted eribulin mesylate injection in the syringe for up to 4 hours at room temperature or for up to 24 hours under refrigeration at 4°C (40°F). Store diluted solutions of eribulin mesylate injection for up to 4 hours at room temperature or up to 24 hours under refrigeration at 4°C (40°F). Discard unused portions of the vial.
| Event Description | Recommended Eribulin Mesylate Injection Dose |
|---|---|
| Permanently reduce the 1.4 mg/m 2 eribulin mesylate injection dose for any of the following: | 1.1 mg/m 2 |
| ANC <500/mm 3 for >7 days | |
| ANC <1,000 /mm 3 with fever or infection | |
| Platelets <25,000/mm 3 | |
| Platelets <50,000/mm 3 requiring transfusion | |
| Non-hematologic Grade 3 or 4 toxicities | |
| Omission or delay of Day 8 eribulin mesylate injection dose in previous cycle for toxicity | |
| Occurrence of any event requiring permanent dose reduction while receiving 1.1 mg/m 2 | 0.7 mg/m 2 |
| Occurrence of any event requiring permanent dose reduction while receiving 0.7 mg/m 2 | Discontinue eribulin mesylate injection |
| ANC = absolute neutrophil count. Toxicities graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. | |
Side Effects of Eribulin Mesylate
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice. The following adverse reactions are discussed in detail in other sections of the labeling: Neutropenia Peripheral neuropathy QT prolongation In clinical trials, eribulin mesylate has been administered to 1,963 patients including 467 patients exposed to eribulin mesylate for 6 months or longer. Metastatic Breast Cancer The most common adverse reactions (≥25%) reported in patients receiving eribulin mesylate were neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, and constipation.
The most common serious adverse reactions reported in patients receiving eribulin mesylate were febrile neutropenia (4%) and neutropenia (2%). The most common adverse reaction resulting in discontinuation of eribulin mesylate was peripheral neuropathy (5%). The adverse reactions described in Table 2 were identified in 750 patients treated in Study 1.
A total of 503 patients received eribulin mesylate and 247 patients in the control group received therapy consisting of chemotherapy or hormonal therapy (3%). The median duration of exposure was 118 days for patients receiving eribulin mesylate and 63 days for patients receiving control therapy. Table 2 reports the most common adverse reactions occurring in at least 10% of patients in either group.
Febrile neutropenia occurred in 5% (23/503) of patients; two patients (0.4%) died from complications of febrile neutropenia. Dose reduction due to neutropenia was required in 12% (62/503) of patients and discontinuation was required in <1% of patients. The mean time to nadir was 13 days and the mean time to recovery from severe neutropenia (<500/mm 3 ) was 8 days.
Grade 3 or greater thrombocytopenia occurred in 1% (7/503) of patients. G-CSF (granulocyte colony-stimulating factor) or GM-CSF (granulocyte–macrophage colony-stimulating factor) was used in 19% of patients who received eribulin mesylate. Dose reduction due to peripheral neuropathy was required by 3% (14/503) of patients who received eribulin mesylate.
One eribulin mesylate-treated patient without documented liver metastases had concomitant Grade 2 elevations in bilirubin and ALT; these abnormalities resolved and did not recur with re-exposure to eribulin mesylate. Less Common Adverse Reactions: The following additional adverse reactions were reported in ≥5% to <10% of the eribulin mesylate-treated group: Eye Disorders: increased lacrimation Gastrointestinal Disorders: dyspepsia, abdominal pain, stomatitis, dry mouth General Disorders and Administration Site Conditions: peripheral edema Infections and Infestations: upper respiratory tract infection Metabolism and Nutrition Disorders: hypokalemia Musculoskeletal and Connective Tissue Disorders: muscle spasms, muscular weakness Nervous System Disorders: dysgeusia, dizziness Psychiatric Disorders: insomnia, depression· Skin and Subcutaneous Tissue Disorders: rash Liposarcoma The safety of eribulin mesylate was evaluated in Study 2, an open-label, randomized, multicenter, active-controlled trial, in which patients were randomized (1:1) to receive either eribulin mesylate 1.4 mg/m 2 on Days 1 and 8 of a 21-day cycle or dacarbazine at doses of every 3 weeks. A total of 223 patients received eribulin mesylate and 221 patients received dacarbazine.
Patients were required to have received at least two prior systemic chemotherapy regimens. The trial excluded patients with pre-existing ≥ Grade 3 peripheral neuropathy, known central nervous system metastasis, elevated serum bilirubin or significant chronic liver disease, history of myocardial infarction within 6 months, history of New York Heart Association Class II or IV heart failure, or cardiac arrhythmia requiring treatment. The median duration of exposure was 2.3 months (range: 21 days to 26 months) for patients receiving eribulin mesylate.
The most common adverse reactions (≥25%) reported in patients receiving eribulin mesylate were fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia. The most common (≥5%) Grade 3 to 4 laboratory abnormalities reported in patients receiving eribulin mesylate were neutropenia, hypokalemia, and hypocalcemia. The most common serious adverse reactions reported in patients receiving eribulin mesylate were neutropenia (4.9%) and pyrexia (4.5%).
Permanent discontinuation of eribulin mesylate for adverse reactions occurred in 8% of patients. The most common adverse reactions resulting in discontinuation of eribulin mesylate were fatigue and thrombocytopenia (0.9% each). Twenty-six percent of patients required at least one dose reduction.
The most frequent adverse reactions that led to dose reduction were neutropenia (18%) and peripheral neuropathy (4.0%). Table 3 summarizes the incidence of adverse reactions occurring in at least 10% of patients in the eribulin mesylate-treated arm in Study 2. Other clinically important adverse reactions occurring in ≥10% of the eribulin mesylate-treated patients were: Gastrointestinal Disorders: nausea (4 ) Metabolism and Nutrition Disorders: decreased appetite (19%) Musculoskeletal and Connective Tissue Disorders: arthralgia/myalgia (16%); back pain (16%) Respiratory Disorders: cough (18%) Less Common Adverse Reactions: The following additional clinically important adverse reactions were reported in ≥5% to <10% of the eribulin mesylate-treated group: Blood and Lymphatic System Disorders: thrombocytopenia Eye Disorders: increased lacrimation Gastrointestinal Disorders: dyspepsia Metabolism and Nutrition Disorders: hyperglycemia Musculoskeletal and Connective Tissue Disorders: muscle spasms, musculoskeletal pain Nervous System Disorders: dizziness, dysgeusia Psychiatric Disorders: insomnia, anxiety Respiratory, Thoracic, and Mediastinal Disorders: oropharyngeal pain Vascular Disorders: hypotension
Postmarketing Experience
The following adverse drug reactions have been identified during post-approval use of eribulin mesylate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and Lymphatic System Disorders: lymphopenia Gastrointestinal Disorders: pancreatitis Hepatobiliary Disorders: hepatotoxicity Immune System Disorders: drug hypersensitivity Infections and Infestations: pneumonia, sepsis/neutropenic sepsis Metabolism and Nutrition Disorders: hypomagnesemia, dehydration Respiratory, thoracic and mediastinal disorders: interstitial lung disease Skin and Subcutaneous Tissue Disorders: pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis
| Adverse Reactions | Eribulin Mesylate n=503 | Control Group n=247 | ||
|---|---|---|---|---|
| All Grades | ≥ Grade 3 | All Grades | ≥ Grade 3 | |
| Blood and lymphatic system disorders b | ||||
| Neutropenia | 82% | 57% | 53% | 23% |
| Anemia | 58% | 2% | 55% | 4% |
| Nervous system disorders | ||||
| Peripheral neuropathy c | 35% | 8% | 16% | 2% |
| Headache | 19% | <1% | 12% | <1% |
| General disorders | ||||
| Asthenia/Fatigue | 54% | 10% | 40% | 11% |
| Pyrexia | 21% | <1% | 13% | <1% |
| Mucosalinflammation | 9% | 1% | 10% | 2% |
| Gastrointestinal disorders | ||||
| Nausea | 35% | 1% | 28% | 3% |
| Constipation | 25% | 1% | 21% | 1% |
| Vomiting | 18% | 1% | 18% | 1% |
| Diarrhea | 18% | 0 | 18% | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia/Myalgia | 22% | <1% | 12% | 1% |
| Back pain | 16% | 1% | 7% | 2% |
| Bone pain | 12% | 2% | 9% | 2% |
| Pain in extremity | 11% | 1% | 10% | 1% |
| Metabolism and nutrition disorders | ||||
| Decreased weight | 21% | 1% | 14% | <1% |
| Anorexia | 20% | 1% | 13% | 1% |
| Respiratory, thoracic, and mediastinal disorders | ||||
| Dyspnea | 16% | 4% | 13% | 4% |
| Cough | 14% | 0 | 9% | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 45% | NA d | 10% | NA d |
| Infections | ||||
| Urinary Tract Infection | 10% | 1% | 5% | 0 |
| a. adverse reactions were graded per National Cancer Institute Criteria for Adverse Events version 4.0. b based upon laboratory data c includes peripheral neuropathy, peripheral sensorimotor neuropathy, peripheral motorneuropathy, polyneuropathy, peripheral sensory neuropathy, and paraesthesia. d not applicable; (grading system does not specify > Grade 2 for alopecia). | ||||
| Table 3: Adverse Reactions a Occurring in ≥10% (all Grades) of Patients Treated on the Eribulin Mesylate arm and at a Higher Incidence than in the Dacarbazine Arm (Between Arm Difference of ≥5% for All Grades or ≥2% for Grades 3 and 4) (Study 2) b | ||||
| Adverse Reaction | Eribulin Mesylate n=223 | Dacarbazine n=221 | ||
| All Grades | Grades 3 to 4 | All Grades | Grades 3 to 4 | |
| Nervous system disorders | ||||
| Peripheral Neuropathy c | 29% | 3.1% | 8% | 0.5% |
| Headache | 18% | 0% | 10% | 0% |
| General disorders | ||||
| Pyrexia | 28% | 0.9% | 14% | 0.5% |
| Gastrointestinal disorders | ||||
| Constipation | 32% | 0.9% | 26% | 0.5% |
| Abdominal pain d | 29% | 1.8% | 23% | 4.1% |
| Stomatitis | 14% | 0.9% | 5% | 0.5% |
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 35% | NA e | 2.7% | NA e |
| Infections | ||||
| Urinary tract infection | 11% | 2.2% | 5% | 0.5% |
| a Adverse reactions were graded per National Cancer Institute Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03). b Safety data from one study site enrolling six patients were excluded. c Includes peripheral neuropathy, peripheral sensorimotor neuropathy, peripheral motor neuropathy, polyneuropathy, peripheral sensory neuropathy, and paraesthesia. d Includes abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort. e Not applicable; (grading system does not specify > Grade 2 for alopecia). | ||||
| Table 4: Laboratory Abnormalities Occurring in ≥10% (all Grades) of Patients Treated on the Eribulin Mesylate arm and at a Higher Incidence than in the Dacarbazine Arm (Between Arm Difference of ≥5% for All Grades or ≥2% for Grades 3 and 4) a (Study 2) | ||||
| Laboratory Abnormality | Eribulin Mesylate | Dacarbazine | ||
| All Grades | Grades 3 to 4 | All Grades | Grades 3 to 4 | |
| Hematology | ||||
| Anemia | 70% | 4.1% | 52% | 6% |
| Neutropenia | 63% | 32% | 30% | 8.9% |
| Chemistry | ||||
| Increased alanine aminotransferase (ALT) | 43% | 2.3% | 28% | 2.3% |
| Increased aspartate aminotransferase (AST) | 36% | 0.9% | 16% | 0.5% |
| Hypokalemia | 30% | 5.4% | 14% | 2.8% |
| Hypocalcemia | 28% | 5% | 18% | 1.4% |
| Hypophosphatemia | 20% | 3.2% | 11% | 1.4% |
| a Each test incidence is based on the number of patients who had both baseline and at least one on-study measurement and at least 1 grade increase from baseline. Eribulin mesylate group (range221 to 222) and dacarbazine group (range 214 to 215). Laboratory results were graded per NCI CTCAE v4.03. | ||||
Warnings & Cautions for Eribulin Mesylate
Embryo-Fetal Toxicity Based on findings from an animal reproduction study and its mechanism of action, eribulin mesylate can cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies of eribulin mesylate in pregnant women. In animal reproduction studies, eribulin mesylate caused embryo-fetal toxicity when administered to pregnant rats during organogenesis at doses below the recommended human dose.
Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with eribulin mesylate injection and for at least 2 weeks following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with eribulin mesylate injection and for 3.5 months following the final dose.
QT Prolongation In an uncontrolled open-label
ECG study in 26 patients, QT prolongation was observed on Day 8, independent of eribulin concentration, with no QT prolongation observed on Day 1. ECG monitoring is recommended if therapy is initiated in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, including Class Ia and III antiarrhythmics, and electrolyte abnormalities. Correct hypokalemia or hypomagnesemia prior to initiating eribulin mesylate injection and monitor these electrolytes periodically during therapy.
Avoid eribulin mesylate injection in patients with congenital long QT syndrome.
Drug Interactions with Eribulin Mesylate
Effects of Other Drugs on Eribulin Mesylate
No drug-drug interactions are expected with CYP3A4 inhibitors, CYP3A4 inducers or P‑glycoprotein (P-gp) inhibitors. Clinically meaningful differences in exposure (AUC) were not observed in patients with advanced solid tumors when eribulin mesylate was administered with or without ketoconazole (a strong inhibitor of CYP3A4 and a P-gp inhibitor) and when eribulin mesylate was administered with or without rifampin (a CYP3A4 inducer).
Effects of Eribulin Mesylate on Other Drugs
Eribulin does not inhibit CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4 enzymes or induce CYP1A2, CYP2C9, CYP2C19 or CYP3A4 enzymes at relevant clinical concentrations. Eribulin is not expected to alter the plasma concentrations of drugs that are substrates of these enzymes.
Pregnancy Safety for Eribulin Mesylate
Pregnancy Risk Summary Based on findings from an animal reproduction study and its mechanism of action, eribulin mesylate, can cause fetal harm when administered to a pregnant woman. There are no available data on the use of eribulin mesylate during pregnancy. In an animal reproduction study, eribulin mesylate caused embryo-fetal toxicity when administered to pregnant rats during organogenesis at doses below the recommended human dose.
Advise pregnant women of the potential risk to a fetus. The estimated background risks of major birth defects and miscarriage for the indicated populations are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically-recognized pregnancies is respectively.
Data Animal Data In an embryo-fetal developmental toxicity study, pregnant rats received intravenous infusion of eribulin mesylate during organogenesis (Gestation Days 8, 10, and 12) at doses approximately times the recommended human dose, based on body surface area. Increased abortion and severe fetal external or soft tissue malformations, including the absence of a lower jaw and tongue, or stomach and spleen, were observed at doses 0.64 times the recommended human dose of 1.4 mg/m 2 based on body surface area. Increased embryo-fetal death/resorption, reduced fetal weights, and minor skeletal anomalies consistent with developmental delay were also reported at doses at or above a maternally toxic dose of approximately 0.43 times the recommended human dose.
Pediatric Use of Eribulin Mesylate
Pediatric Use The safety and effectiveness of eribulin mesylate injection in pediatric patients have not been established. Pediatric use information describing clinical studies in which efficacy was not demonstrated is approved for Eisai Inc’s HALAVEN ® (eribulin mesylate) injection. However, due to Eisai Inc’s marketing exclusivity rights, this drug product is not labeled with that information.
Overdosage Information for Eribulin Mesylate
Overdosage of eribulin mesylate has been reported at approximately 4 times the recommended dose, which resulted in Grade 3 neutropenia lasting seven days and a Grade 3 hypersensitivity reaction lasting one day. There is no known antidote for eribulin mesylate injection overdose.
Clinical Studies of Eribulin Mesylate
Metastatic Breast Cancer Study 1 was an open-label, randomized, multicenter trial of 762 patients with metastatic breast cancer who received at least two chemotherapeutic regimens for the treatment of metastatic disease and experienced disease progression within 6 months of their last chemotherapeutic regimen. Patients were required to receive prior anthracycline- and taxane-based chemotherapy for adjuvant or metastatic disease. Patients were randomized (2:1) to receive eribulin mesylate (n=508) or a single agent therapy selected prior to randomization (control arm, n=254).
Randomization was stratified by geographic region, HER2/neu status, and prior capecitabine exposure. Eribulin mesylate-treated patients received a median of 5 cycles (range: 1 to 23 cycles) of therapy. The main efficacy outcome was overall survival.
Patient demographic and baseline characteristics were comparable between the treatment arms. Sixty-four percent of patients were enrolled in North America/Western Europe/Australia, 25% in Eastern Europe/Russia, and 11% in Latin America/South Africa. Ninety-one percent of patients had a baseline ECOG performance status of 0 or 1.
Patients received a median of four prior chemotherapy regimens in both arms. In Study 1, a statistically significant improvement in overall survival was observed in patients randomized to the eribulin mesylate arm compared to the control arm (see Table 5). An updated, unplanned survival analysis, conducted when 77% of events had been observed (see Figure 1), was consistent with the primary analysis.
Eligible patients were required to have unresectable, locally advanced or metastatic liposarcoma or leiomyosarcoma, at least two prior systemic chemotherapies (one of which must have included an anthracycline), and disease progression within 6 months of the most recent chemotherapy regimen. Treatment continued until disease progression or unacceptable toxicity. Randomization was stratified by histology (liposarcoma or leiomyosarcoma), number of prior therapies (2 vs. > 2), and geographic region U.S. and Canada vs.
Western Europe, Australia, and Israel vs. Eastern Europe, Latin America, and Asia. The major efficacy outcome measure was overall survival (OS).
Additional efficacy outcome measures were progression-free survival (PFS) and confirmed objective response rate (ORR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Patients in the dacarbazine arm were not offered eribulin mesylate at the time of disease progression. A total of 446 patients were randomized, 225 to the eribulin mesylate arm and 221 to the dacarbazine arm.
The distribution of subtypes of liposarcoma, based on local histologic assessment, were 45% dedifferentiated, 37% myxoid/round cell, and 18% pleomorphic. Study 2 demonstrated a statistically significant improvement in OS in patients randomized to eribulin mesylate compared with dacarbazine (see Table 6). There was no significant difference in progression-free survival in the overall population.
Treatment effects of eribulin mesylate were limited to patients with liposarcoma based on pre-planned, exploratory subgroup analyses of OS and PFS (see Tables 6 and 7 and Figure 2). There was no evidence of efficacy of eribulin mesylate in patients with advanced or metastatic leiomyosarcoma in Study 2 (see Table 7). Table 6: Efficacy Results for the a Efficacy data from one study site enrolling six patients were excluded. *All patients = liposarcoma and leiomyosarcoma. N/A = not applicable Figure 2: Kaplan-Meier Curves of Overall Survival in the Liposarcoma Stratum in Study 2 Table 7: Efficacy Results for the 5.2 7.4 a Efficacy data from one study site enrolling six patients were excluded.
| Overall Survival | Eribulin Mesylate (n=508) | Control Arm (n=254) |
|---|---|---|
| Primary survival analysis | ||
| Number of deaths | 274 | 148 |
| Median, months (95% CI) | 13.1 (11.8, 14.3) | 10.6 (9.3, 12.5) |
| Hazard Ratio (95% CI) a | 0.81 (0.66, 0.99) | |
| P value b | 0.041 | |
| Updated survival analysis | ||
| Number of deaths | 386 | 203 |
| Median, months (95% CI) | 13.2 (12.1, 14.4) | 10.6 (9.2, 12.0) |
| CI = confidence interval a Based on Cox proportional hazards model stratified by geographic region, HER2 status,and prior capecitabine therapy. b Based on a log-rank test stratified by geographic region, HER2 status, and prior capecitabine therapy. | ||
| Liposarcoma Stratum | All Patients* | ||||
|---|---|---|---|---|---|
| Eribulin Mesylate (n=71) | Dacarbazine (n=72) | Eribulin Mesylate (n=225) | Dacarbazine (n=221) | ||
| Overall survival | |||||
| Deaths, n (%) | 52 (73) | 63 (88) | 173 (77) | 179 (81) | |
| Median, months (95% CI) | 15.6 (10.2, 18.6) | 8.4 (5.2, 10.1) | 13.5 (11.1, 16.5) | 11.3 (9.5, 12.6) | |
| Hazard ratio (HR)(95% CI) | 0.51 (0.35, 0.75) | 0.75 (0.61, 0.94) | |||
| Stratified log-rank p value | N/A | 0.011 | |||
| Progression-free survival | |||||
| Events, n (%) | 57 (80) | 59 (82) | 194 (86) | 185 (84) | |
| Disease progression | 53 | 52 | 180 | 170 | |
| Death | 4 | 7 | 14 | 15 | |
| Median, months (95% CI) | 2.9 (2.6, 4.8) | 1.7 (1.4, 2.6) | 2.6 (2.0, 2.8) | 2.6 (1.7, 2.7) | |
| HR(95% CI) | 0.52(0.35, 0.78) | 0.86 (0.69, 1.06) | |||
| Objective response rate | |||||
| Objective response rate (%)(95% CI) | 1.4 (0, 7.6) | 0 (0, 4.2) | 4.0 (1.8, 7.5) | 5.0 (2.5, 8.7) | |
| Leiomyosarcoma Stratum | ||
| Eribulin Mesylate (n=154) | Dacarbazine (n=149) | |
| Overall survival | ||
| Deaths, n (%) | 121 (79) | 116 (78) |
| Median, months (95%CI) | 12.8 (10.3, 14.8) | 12.3 (11.0, 15.1) |
| HR (95% CI) | 0.90 (0.69, 1.18) | |
| Progression-free survival | ||
| Events, n (%) | 137 (89) | 126 (85) |
| Disease progression | 127 | 118 |
| Death | 10 | 8 |
| Median, months (95% CI) | 2.2 (1.5, 2.7) | 2.6 (2.2, 2.9) |
| HR (95% CI) | 1.05 (0.81, 1.35) | |
| Objective response rate (%)(95% CI) | 5.2 (2.3, 10) | 7.4 (3.7, 12.8) |
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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