Halevan Chemo - How Do You Know When You Go Toxic

What is HALAVEN and how is it used?

HALAVEN is a prescription medicine used to care for people with:

• Chest cancer
  • that has spread to other parts of the torso, and
  • who take already received sure types of anticancer medicines afterwards the cancer has spread
• Liposarcoma
  • that cannot be treated with surgery or has spread to other parts of the body, and
  • who take received handling with a certain type of anticancer medicine

Information technology is not known if HALAVEN is condom and effective in children under 18 years of age.

What are the possible side effects of HALAVEN?

HALAVEN may cause serious side effects, including:

• Run into "What is the most important data I should know almost HALAVEN?"
• HALAVEN can cause changes in your heartbeat (called QT prolongation). This can cause irregular heartbeats. Your healthcare provider may do heart monitoring (electrocardiogram or ECG) or blood tests during your treatment with HALAVEN to bank check for heart problems.

The most common side furnishings of HALAVEN in people with breast cancer include:

• low white blood prison cell count (neutropenia)
• low red claret cell count (anemia)
• weakness or tiredness
• pilus loss (alopecia)
• nausea
• constipation

The about mutual side effects of HALAVEN in people with liposarcoma include:

• tiredness
• nausea
• hair loss (alopecia)
• constipation
• stomach pain
• fever

Your healthcare provider will do blood tests before and during handling while you lot are taking HALAVEN. The most common changes to blood tests in people with liposarcoma include:

• low white blood cell count (neutropenia)
• decreased claret levels of potassium or calcium

Tell your healthcare provider about any side outcome that bothers you or that does not go abroad.

These are not all the possible side effects of HALAVEN. Call your doctor for medical advice most side effects. Y'all may written report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

HALAVEN contains eribulin mesylate, a microtubule dynamics inhibitor. Eribulin mesylate is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okadai. The chemical name for eribulin mesylate is 11,xv:18,21:24,28Triepoxy-seven,9-ethano-12,xv-methano-9H,15H-furo[three,2-i]furo[2',iii':5,6]pyrano[4,iii-b][1,4]dioxacyclopentacosin-5(4H)-i, ii-[(2S)-3amino-ii-hydroxypropyl]hexacosahydro-3-methoxy-26-methyl-twenty,27-bis(methylene)-, (2R,3R,3aS,7R,8aS,9S,10aR,11S,12R,13aR,13bS,15S,18S,21S,24S,26R,28R,29aS)-, methanesulfonate (table salt). It has a molecular weight of 826.0 (729.9 for complimentary base). The empirical formula is C₄₀H₅₉NO₁₁ •CH_fourO₃S. Eribulin mesylate has the post-obit structural formula:

HALAVEN is a clear, colorless, sterile solution for intravenous assistants. Each vial contains 1 mg of eribulin mesylate as a 0.5 mg/mL solution in ethanol: water (5:95).

INDICATIONS

Metastatic Chest Cancer

HALAVEN is indicated for the treatment of patients with metastatic breast cancer who take previously received at least ii chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should take included an anthracycline and a taxane in either the adjuvant or metastatic setting [see Clinical Studies].

Liposarcoma

HALAVEN is indicated for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen [see Clinical Studies].

DOSAGE AND Administration

Recommended Dose

The recommended dose of HALAVEN is ane.iv mg/m² administered intravenously over 2 to 5 minutes on Days 1 and viii of a 21-24-hour interval cycle.

The recommended dose of HALAVEN in patients with mild hepatic impairment (Child-Pugh A) is i.1 mg/grand² administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle [see Utilise In Specific Populations].

The recommended dose of HALAVEN in patients with moderate hepatic harm (Child-Pugh B) is 0.7 mg/k² administered intravenously over 2 to 5 minutes on Days i and eight of a 21-day cycle [meet Apply In Specific Populations].

The recommended dose of HALAVEN in patients with moderate or astringent renal impairment (creatinine clearance (CLcr) 15-49 mL/min) is 1.1 mg/m^two administered intravenously over 2 to 5 minutes on Days one and 8 of a 21-24-hour interval wheel [see Use In Specific Populations].

Dose Modification

Assess for peripheral neuropathy and obtain complete blood prison cell counts prior to each dose.

Recommended Dose Delays

• Do non administrate HALAVEN on Twenty-four hours ane or Twenty-four hour period viii for any of the post-obit:
  • ANC < 1,000/mm^three
  • Platelets < 75,000/mmⁱⁱⁱ
  • Class three or iv non-hematological toxicities.
• The Mean solar day 8 dose may be delayed for a maximum of 1 week.
  • If toxicities do not resolve or improve to ≤ Grade two severity past 24-hour interval fifteen, omit the dose.
  • If toxicities resolve or improve to ≤ Grade 2 severity past Day 15, administer HALAVEN at a reduced dose and initiate the next wheel no sooner than ii weeks later.

Recommended Dose Reductions

• If a dose has been delayed for toxicity and toxicities accept recovered to Grade 2 severity or less, resume HALAVEN at a reduced dose as set out in Tabular array 1.
• Do not re-escalate HALAVEN dose afterwards it has been reduced.

Table 1: Recommended Dose Reductions

Event Description	Recommended HALAVEN Dose
Permanently reduce the ane.iv mg/yard2 HALAVEN dose for any of the following:
ANC <500/mmiii for >seven days	1.1 mg/yard2
ANC <1,000 /mm3 with fever or infection
Platelets <25,000/mmiii
Platelets <50,000/mm3 requiring transfusion
Non-hematologic Course 3 or 4 toxicities
Omission or filibuster of Day viii HALAVEN dose in previous bicycle for toxicity
Occurrence of any event requiring permanent dose reduction while receiving one.1 mg/m2	0.7 mg/thousandii
Occurrence of any event requiring permanent dose reduction while receiving 0.vii mg/10002	Discontinue HALAVEN
ANC = absolute neutrophil count. Toxicities graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for Agin Events (CTCAE) version 3.0.

Instructions For Preparation And Administration

Aseptically withdraw the required amount of HALAVEN from the single-employ vial and administer undiluted or diluted in 100 mL of 0.9% Sodium Chloride Injection, USP.

Exercise non dilute in or administer through an intravenous line containing solutions with dextrose. Exercise not administer in the same intravenous line concurrent with the other medicinal products.

Store undiluted HALAVEN in the syringe for up to four hours at room temperature or for up to 24 hours under refrigeration (forty°F or 4°C). Store diluted solutions of HALAVEN for up to four hours at room temperature or up to 24 hours under refrigeration.

Discard unused portions of the vial.

HOW SUPPLIED

Dosage Forms And Strengths

Injection

1 mg/two mL (0.5 mg/mL).

Storage And Handling

NDC 62856-389-01

Injection

1 mg/ii mL, in a unmarried-apply vial. One vial per carton.

Store at 25°C (77°F); excursions permitted to 15° – thirty° C (59° - 86° F). Practise not freeze or refrigerate. Store the vials in their original cartons.

Distributed by: Eisai Inc. Woodcliff Lake, NJ 07677. Revised: February 2021

SLIDESHOW

Breast Cancer Awareness: Symptoms, Diagnosis, and Treatment See Slideshow

Side Effects & Drug Interactions

SIDE Effects

Clinical Trials Feel

Considering clinical trials are conducted under widely varying weather condition, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in other clinical trials and may non reverberate the rates observed in clinical practise.

The post-obit agin reactions are discussed in item in other sections of the labeling:

• Neutropenia [see WARNINGS AND PRECAUTIONS]
• Peripheral neuropathy [see WARNINGS AND PRECAUTIONS]
• QT prolongation [see WARNINGS AND PRECAUTIONS]

In clinical trials, HALAVEN has been administered to 1963 patients including 467 patients exposed to HALAVEN for half dozen months or longer. The majority of the 1963 patients were women (92%) with a median age of 55 years (range: 17 to 85 years). The racial and ethnic distribution was White (72%), Black (4%), Asian (ix%), and other (3%).

Metastatic Breast Cancer

The nearly common adverse reactions (≥25%) reported in patients receiving HALAVEN were neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, and constipation. The most mutual serious adverse reactions reported in patients receiving HALAVEN were delirious neutropenia (4%) and neutropenia (2%). The well-nigh common agin reaction resulting in discontinuation of HALAVEN was peripheral neuropathy (v%).

The agin reactions described in Table 2 were identified in 750 patients treated in Report i [see Clinical Studies]. In Study ane, patients were randomized (2:ane) to receive either HALAVEN (1.4 mg/mⁱⁱ on Days 1 and 8 of a 21-day cycle) or unmarried amanuensis treatment called by their physician (control grouping). A full of 503 patients received HALAVEN and 247 patients in the control group received therapy consisting of chemotherapy [total 97% (anthracyclines ten%, capecitabine 18%, gemcitabine 19%, taxanes 15%, vinorelbine 25%, other chemotherapies 10%)] or hormonal therapy (3%). The median elapsing of exposure was 118 days for patients receiving HALAVEN and 63 days for patients receiving control therapy. Table 2 reports the most common agin reactions occurring in at least x% of patients in either grouping.

Table 2: Adverse Reactions^a with a Per-Patient Incidence of at Least 10% in Study i

Adverse Reactions	HALAVEN n=503		Control Group northward=247
	All Grades	≥ Course 3	All Grades	≥ Grade 3
Claret and lymphatic system disordersb
Neutropenia	82%	57%	53%	23%
Anemia	58%	ii%	55%	4%
Nervous system disorders
Peripheral neuropathyc	35%	8%	16%	2%
Headache	19%	<1%	12%	<1%
General disorders
Asthenia/Fatigue	54%	10%	xl%	eleven%
Pyrexia	21%	<ane%	xiii%	<1%
Mucosal inflammation	9%	one%	10%	2%
Gastrointestinal disorders
Nausea	35%	1%	28%	3%
Constipation	25%	1%	21%	one%
Vomiting	eighteen%	1%	18%	ane%
Diarrhea	18%	0	xviii%	0
Musculoskeletal and connective tissue disorders
Arthralgia/Myalgia	22%	<1%	12%	1%
Back pain	16%	1%	seven%	ii%
Os pain	12%	2%	9%	2%
Hurting in extremity	eleven%	i%	10%	1%
Metabolism and nutrition disorders
Decreased weight	21%	1%	14%	<1%
Anorexia	20%	one%	13%	1%
Respiratory, thoracic, and mediastinal disorders
Dyspnea	sixteen%	4%	xiii%	four%
Cough	fourteen%	0	9%	0
Pare and subcutaneous tissue disorders
Alopecia	45%	NAd	10%	NAd
Infections
Urinary Tract Infection	10%	ane%	5%	0
a agin reactions were graded per National Cancer Establish Criteria for Adverse Events version iv.0. b based upon laboratory information. c includes peripheral neuropathy, peripheral sensorimotor neuropathy, peripheral motor neuropathy, polyneuropathy, peripheral sensory neuropathy, and paraesthesia. d not applicable; (grading system does not specify > Grade ii for alopecia).

Cytopenias

Form 3 neutropenia occurred in 28% (143/503) of patients who received HALAVEN in Study 1, and 29% (144/503) of patients experienced Grade 4 neutropenia. Febrile neutropenia occurred in 5% (23/503) of patients; 2 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 hateful fourth dimension to recovery from severe neutropenia (<500/mm³) was 8 days. Form iii or greater thrombocytopenia occurred in 1% (7/503) of patients. Chiliad-CSF (granulocyte colony-stimulating factor) or GM-CSF (granulocyte–macrophage colony-stimulating factor) was used in 19% of patients who received HALAVEN.

Peripheral Neuropathy

In Study 1, 17% of enrolled patients had Grade 1 peripheral neuropathy and iii% of patients had Grade 2 peripheral neuropathy at baseline. Dose reduction due to peripheral neuropathy was required by three% (14/503) of patients who received HALAVEN. Four per centum (20/503) of patients experienced peripheral motor neuropathy of whatsoever class and 2% (8/503) of patients developed Form 3 peripheral motor neuropathy.

Liver Function Examination Abnormalities

Among patients with Grade 0 or one ALT levels at baseline, 18% of HALAVEN-treated patients experienced Grade ii or greater ALT elevation. One HALAVEN-treated patient without documented liver metastases had concomitant Grade 2 elevations in bilirubin and ALT; these abnormalities resolved and did non recur with re-exposure to HALAVEN.

Less Common Adverse Reactions

The following additional adverse reactions were reported in ≥5% to <ten% of the HALAVEN-treated grouping:

• Eye Disorders: increased lacrimation
• Gastrointestinal Disorders: dyspepsia, intestinal pain, stomatitis, dry mouth
• General Disorders and Administration Site Weather: peripheral edema
• Infections and Infestations: upper respiratory tract infection
• Metabolism and Diet Disorders: hypokalemia
• Musculoskeletal and Connective Tissue Disorders: muscle spasms, muscular weakness
• Nervous Organisation Disorders: dysgeusia, dizziness
• Psychiatric Disorders: insomnia, depression
• Skin and Subcutaneous Tissue Disorders: rash

Liposarcoma

The safety of HALAVEN was evaluated in Study 2, an open-characterization, randomized, multicenter, active-controlled trial, in which patients were randomized (one:i) to receive either HALAVEN 1.iv mg/mⁱⁱ on Days ane and 8 of a 21-mean solar day cycle or dacarbazine at doses of 850 mg/m² (20%), 1000 mg/g² (64%), or 1200 mg/mⁱⁱ (16%) every 3 weeks. A total of 223 patients received HALAVEN and 221 patients received dacarbazine. Patients were required to have received at least ii prior systemic chemotherapy regimens. The trial excluded patients with pre-existing ≥ Grade iii peripheral neuropathy, known central nervous system metastasis, elevated serum bilirubin or significant chronic liver affliction, history of myocardial infarction within 6 months, history of New York Heart Clan Course II or IV eye failure, or cardiac arrhythmia requiring handling. The median historic period of the safety population in Written report 2 was 56 years (range: 24 to 83 years); 67% female; 73% White, iii% Black or African American, 8% Asian/Pacific Islander, and 15% unknown; 99% received prior anthracycline-containing regimen; and 99% received ≥ 2 prior regimens. The median duration of exposure was two.3 months (range: 21 days to 26 months) for patients receiving HALAVEN [encounter Clinical Studies].

The most common agin reactions (≥25%) reported in patients receiving HALAVEN were fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia. The most common (≥5%) Course 3-4 laboratory abnormalities reported in patients receiving HALAVEN were neutropenia, hypokalemia, and hypocalcemia. The about common serious adverse reactions reported in patients receiving HALAVEN were neutropenia (four.9%) and pyrexia (4.5%). Permanent discontinuation of HALAVEN for adverse reactions occurred in 8% of patients. The nearly common adverse reactions resulting in discontinuation of HALAVEN were fatigue and thrombocytopenia (0.9% each). Twenty-six percent of patients required at least i dose reduction. The nearly frequent adverse reactions that led to dose reduction were neutropenia (xviii%) and peripheral neuropathy (4.0%).

Tabular array 3 summarizes the incidence of agin reactions occurring in at least 10% of patients in the HALAVEN-treated arm in Study two.

Table 3: Adverse Reactions^a Occurring in ≥10% (all Grades) of Patients Treated on the HALAVEN arm and at a Higher Incidence than in the Dacarbazine Arm (Between Arm Difference of ≥five% for All Grades or ≥2% for Grades iii and 4) (Study two)^b

Adverse Reaction	HALAVEN n=223		Dacarbazine n=221
	All Grades	Grades three-4	All Grades	Grades 3-iv
Nervous arrangement disorders
Peripheral Neuropathyc	29%	3.1%	8%	0.5%
Headache	18%	0%	ten%	0%
General disorders
Pyrexia	28%	0.9%	14%	0.5%
Gastrointestinal disorders
Constipation	32%	0.nine%	26%	0.5%
Intestinal paind	29%	1.viii%	23%	iv.1%
Stomatitis	14%	0.9%	5%	0.5%
Skin and subcutaneous tissue disorders
Alopecia	35%	NAe	2.7%	NAeast
Infections
Urinary tract infection	11%	2.2%	5%	0.five%
a Agin reactions were graded per National Cancer Constitute 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 intestinal hurting, lower abdominal hurting, intestinal discomfort. east Non applicable; (grading arrangement does not specify > Grade 2 for alopecia).

Other clinically important agin reactions occurring in ≥x% of the HALAVEN-treated patients were:

• Gastrointestinal Disorders: nausea (41%); vomiting (19%), diarrhea (17%)
• General Disorders: asthenia/fatigue (62%); peripheral edema (12%)
• Metabolism and Nutrition Disorders: decreased appetite (19%)
• Musculoskeletal and Connective Tissue Disorders: arthralgia/myalgia (16%); dorsum pain (sixteen%)
• Respiratory Disorders: cough (18%)

Less Common Adverse Reactions

The following additional clinically important agin reactions were reported in ≥5% to <10% of the HALAVEN-treated grouping:

• Blood and Lymphatic Organization Disorders: thrombocytopenia
• Heart Disorders: increased lacrimation
• Gastrointestinal Disorders: dyspepsia
• Metabolism and Diet Disorders: hyperglycemia
• Musculoskeletal and Connective Tissue Disorders: muscle spasms, musculoskeletal pain
• Nervous Arrangement Disorders: dizziness, dysgeusia
• Psychiatric Disorders: insomnia, feet
• Respiratory, Thoracic, and Mediastinal Disorders: oropharyngeal hurting
• Vascular Disorders: hypotension

Table 4: Laboratory Abnormalities Occurring in ≥10% (all Grades) of Patients Treated on the HALAVEN arm and at a Higher Incidence than in the Dacarbazine Arm (Betwixt Arm Deviation of ≥5% for All Grades or ≥2% for Grades three and 4)^a (Written report two)^†

Laboratory Abnormality	Halaven		Dacarbazine
	All Grades	Grades 3 - 4	All Grades	Grades 3 – 4
Hematology
Anemia	lxx%	4.1%	52%	half dozen%
Neutropenia	63%	32%	30%	8.9%
Chemical science
Increased alanine aminotransferase (ALT)	43%	ii.three%	28%	ii.3%
Increased aspartate aminotransferase (AST)	36%	0.9%	16%	0.5%
Hypokalemia	30%	5.4%	fourteen%	two.8%
Hypocalcemia	28%	5%	xviii%	1.4%
Hypophosphatemia	20%	three.2%	eleven%	ane.four%
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.Halaven group (range 221-222) and dacarbazine group (range 214-215) † Laboratory results were graded per NCI CTCAE v4.03.

Postmarketing Experience

The following agin drug reactions have been identified during postal service-approval of HALAVEN. Considering 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 Organisation 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

DRUG INTERACTIONS

Effects Of Other Drugs On HALAVEN

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 avant-garde solid tumors when HALAVEN was administered with or without ketoconazole (a potent inhibitor of CYP3A4 and a P-gp inhibitor) and when HALAVEN was administered with or without rifampin (a CYP3A4 inducer) [see CLINICAL PHARMACOLOGY].

Effects Of HALAVEN On Other Drugs

Eribulin does non 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 modify the plasma concentrations of drugs that are substrates of these enzymes [meet CLINICAL PHARMACOLOGY].

WARNINGS

Included equally part of the "PRECAUTIONS" Section

PRECAUTIONS

Neutropenia

In Study 1, severe neutropenia (ANC < 500/mm^three) lasting more than one week occurred in 12% (62/503) of patients with metastatic breast cancer, leading to discontinuation in <1% of patients. Febrile neutropenia (fever ≥38.5°C with Grade three or four neutropenia) occurred in 5% (23/503) of patients; two patients (0.4%) died from complications of delirious neutropenia [run into Adverse REACTIONS].

In Report 1, patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × ULN (upper limit of normal) experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal aminotransferase levels. Patients with bilirubin > ane.v × ULN also had a higher incidence of Grade 4 neutropenia and febrile neutropenia.

In Written report 2, severe neutropenia (ANC < 500/mm³) lasting more than ane calendar week occurred in 12% (26/222) of patients with liposarcoma or leiomyosarcoma. Delirious neutropenia occurred in 0.nine% of patients treated with HALAVEN and fatal neutropenic sepsis in 0.9% [encounter Agin REACTIONS].

Monitor consummate blood counts prior to each dose; increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration of HALAVEN and reduce subsequent doses in patients who feel febrile neutropenia or Grade 4 neutropenia lasting longer than vii days [see DOSAGE AND Assistants]. Clinical studies of HALAVEN did not include patients with baseline neutrophil counts below 1,500/mm³.

Peripheral Neuropathy

In Study i, Grade iii peripheral neuropathy occurred in eight% (40/503) of patients, and Grade 4 in 0.4% (2/503) of patients with metastatic breast cancer (MBC). Peripheral neuropathy was the well-nigh common toxicity leading to discontinuation of HALAVEN (5% of patients; 24/503) in Study 1. Neuropathy lasting more than one year occurred in five% (26/503) of patients. Twenty-2 percent (109/503) of patients developed a new or worsening neuropathy that had non recovered within a median follow-up duration of 269 days (range 25-662 days).

In Study 2, Grade three peripheral neuropathy occurred in 3.1% (vii/223) of HALAVEN-treated patients. Peripheral neuropathy led to discontinuation of HALAVEN in 0.9% of patients. The median time to first occurrence of peripheral neuropathy of whatever severity was v months (range: 3.5 months to ix months). Neuropathy lasting more than than 60 days occurred in 58% (38/65) of patients. Sixty three percent (41/65) had not recovered within a median follow-upwardly duration of vi.4 months (range: 27 days to 29 months).

Monitor patients closely for signs of peripheral motor and sensory neuropathy. Withhold HALAVEN in patients who experience Grade 3 or iv peripheral neuropathy, until resolution to Course 2 or less [run across DOSAGE AND ADMINISTRATION].

Embryo-Fetal Toxicity

Based on findings from an brute reproduction study and its machinery of activeness, HALAVEN can cause fetal harm when administered to a meaning woman. In that location are no adequate and well-controlled studies of HALAVEN in pregnant women. In creature reproduction studies, eribulin mesylate caused embryo-fetal toxicity when administered to meaning rats during organogenesis at doses beneath the recommended human dose. Suggest significant women of the potential run a risk to a fetus. Suggest females of reproductive potential to use constructive contraception during treatment with HALAVEN and for at to the lowest degree two weeks post-obit the terminal dose. Advise males with female partners of reproductive potential to use constructive contraception during treatment with HALAVEN and for 3.v months following the final dose [see Use In Specific Populations].

QT Prolongation

In an uncontrolled open-characterization ECG study in 26 patients, QT prolongation was observed on Day 8, independent of eribulin concentration, with no QT prolongation observed on Twenty-four hours 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 HALAVEN and monitor these electrolytes periodically during therapy. Avoid HALAVEN in patients with built long QT syndrome.

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (PATIENT Data).

Neutropenia

Advise patients to contact their health intendance provider for a fever of 100.5°F or greater or other signs or symptoms of infection such as chills, coughing, or burning or hurting on urination [see WARNINGS AND PRECAUTIONS].

Peripheral Neuropathy

Advise patients to inform their healthcare providers of new or worsening numbness, tingling and pain in their extremities [see WARNINGS AND PRECAUTIONS].

Embryo-Fetal Toxicity

• Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see WARNINGS AND PRECAUTIONS, Use In Specific Populations].
• Suggest females of reproductive potential to use effective contraception during treatment with HALAVEN and for at least 2 weeks later on the final dose [see Use In Specific Populations].
• Advise males with female partners of reproductive potential to use effective contraception during treatment with HALAVEN and for 3.five months following the terminal dose [meet Use In Specific Populations].

Lactation

Advise women non to breastfeed during treatment with HALAVEN and for 2 weeks after the final dose [meet Employ In Specific Populations].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Carcinogenicity studies have not been conducted with eribulin mesylate. Eribulin mesylate was not mutagenic in in vitro bacterial reverse mutation assays (Ames test). Eribulin mesylate was positive in mouse lymphoma mutagenesis assays, and was clastogenic in an in vivo rat bone marrow micronucleus assay.

Fertility studies accept not been conducted with eribulin mesylate in humans or animals; however, nonclinical findings in repeat-dose dog and rat toxicology studies propose that male fertility may be compromised by treatment with eribulin mesylate. Rats exhibited testicular toxicity (hypocellularity of seminiferous epithelium with hypospermia/aspermia) following dosing with eribulin mesylate at or in a higher place 0.43 times the recommended human dose (based on body surface area) given in one case weekly for three weeks, or at or above 0.21 times the recommended human dose (based on trunk surface surface area) given in one case weekly for 3 out of five weeks, repeated for 6 cycles. Testicular toxicity was also observed in dogs given 0.64 times the recommended human dose (based on body expanse) weekly for 3 out of 5 weeks, repeated for 6 cycles.

Employ In Specific Populations

Pregnancy

Gamble Summary

Based on findings from an animal reproduction written report and its mechanism of action, HALAVEN can crusade fetal harm when administered to a pregnant woman [see CLINICAL PHARMACOLOGY]. There are no available data on the employ of HALAVEN during pregnancy. In an animal reproduction study, eribulin mesylate acquired embryo-fetal toxicity when administered to pregnant rats during organogenesis at doses below the recommended man dose [see Data]. Propose 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. full general population, the estimated background risk of major birth defects and miscarriage in clinically-recognized pregnancies is 2% to four% and 15% to twenty%, 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 0.04, 0.13, 0.43 and 0.64 times the recommended human dose, based on trunk expanse. Increased abortion and severe fetal external or soft tissue malformations, including the absenteeism of a lower jaw and natural language, or stomach and spleen, were observed at doses 0.64 times the recommended human dose of 1.4 mg/m² based on torso surface area. Increased embryo-fetal decease/resorption, reduced fetal weights, and minor skeletal anomalies consequent with developmental delay were also reported at doses at or above a maternally toxic dose of approximately 0.43 times the recommended human being dose.

Lactation

Gamble Summary

There is no information regarding the presence of eribulin mesylate or its metabolites in man milk, the effects on the breastfed infant, or the effects on milk production. No lactation studies in animals were conducted. Because of the potential for serious agin reactions in breastfed infants from eribulin mesylate, advise women non to breastfeed during treatment with HALAVEN and for ii weeks later on the concluding dose.

Females And Males Of Reproductive Potential

Contraception

Females

Based on findings from an creature reproduction study and its mechanism of action, HALAVEN can cause fetal damage when administered to a significant woman [see Pregnancy]. Advise females of reproductive potential to use effective contraception during treatment with HALAVEN and for at least 2 weeks post-obit the final dose.

Males

Based on its mechanism of action, propose males with female person partners of reproductive potential to use constructive contraception during treatment with HALAVEN and for 3.5 months following the terminal dose.

Infertility

Males

Based on animal information, HALAVEN may result in damage to male reproductive tissues leading to impaired fertility of unknown duration [come across Nonclinical Toxicology].

Pediatric Use

The safety and effectiveness of HALAVEN in pediatric patients below the age of eighteen years have not been established.

Geriatric Use

Study i did not include sufficient numbers of subjects with metastatic breast cancer aged 65 years and older to decide whether they respond differently from younger subjects. Of the 827 subjects who received the recommended dose and schedule of HALAVEN in clinical studies with advanced breast cancer, 15% (121/827) were 65 and older, and ii% (17/827) patients were 75 and older. No overall differences in safety were observed between these subjects and younger subjects.

Clinical studies of HALAVEN did not include a sufficient number of subjects in Study 2 aged 65 years and older to determine whether they respond differently from younger subjects.

Hepatic Damage

Assistants of HALAVEN at a dose of 1.1 mg/m^two to patients with mild hepatic impairment and 0.7 mg/k^two to patients with moderate hepatic impairment resulted in like exposure to eribulin as a dose of i.4 mg/g² to patients with normal hepatic office. Therefore, a lower starting dose of 1.1 mg/mⁱⁱ is recommended for patients with mild hepatic impairment (Child-Pugh A) and of 0.7 mg/chiliad² is recommended for patients with moderate hepatic impairment (Child-Pugh B). HALAVEN was not studied in patients with astringent hepatic impairment (Child-Pugh C) [come across DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY].

Renal Impairment

For patients with moderate or severe renal impairment (CLcr xv-49 mL/min), reduce the starting dose to ane.1 mg/mⁱⁱ [run into DOSAGE AND Assistants, CLINICAL PHARMACOLOGY].

Overdosage & Contraindications

OVERDOSE

Overdosage of HALAVEN 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 HALAVEN overdose.

CONTRAINDICATIONS

None.

CLINICAL PHARMACOLOGY

Mechanism Of Action

Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates. Eribulin exerts its effects via a tubulin-based antimitotic mechanism leading to Yard₂/Chiliad jail cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after prolonged mitotic blockage.

In addition, eribulin treatment of human being chest cancer cells caused changes in morphology and gene expression also equally decreased migration and invasiveness in vitro. In mouse xenograft models of homo breast cancer, eribulin treatment was associated with increased vascular perfusion and permeability in the tumor cores, resulting in reduced tumor hypoxia, and changes in the expression of genes in tumor specimens associated with a change in phenotype.

Pharmacodynamics

Cardiac Electrophysiology

The consequence of HALAVEN on the QTc interval was assessed in an open-label, uncontrolled, multicenter, single-arm defended QT trial. A total of 26 patients with solid tumors received 1.4 mg/thou² of HALAVEN on Days 1 and 8 of a 21-day cycle. A delayed QTc prolongation was observed on Day eight, with no prolongation observed on 24-hour interval 1. The maximum mean QTcF modify from baseline (95% upper confidence interval) was 11.4 (nineteen.five) ms.

Pharmacokinetics

The pharmacokinetics (PK) of eribulin is linear with a mean elimination half-life of approximately 40 hours, a hateful volume of distribution of 43 L/m² to 114 L/yard² and mean clearance of 1.16 Fifty/60 minutes/yard² to ii.42 50/hr/m² over the dose range of 0.25 mg/1000² to iv.0 mg/m^two. The human plasma protein bounden of eribulin at concentrations of 100 ng/mL to 1,000 ng/mL ranges from 49% to 65%. Eribulin exposure later multiple dosing is comparable to that post-obit a unmarried dose. No accumulation of eribulin is observed with weekly administration.

Elimination

Metabolism

Unchanged eribulin was the major circulating species in plasma following administration of ¹⁴C-eribulin to patients. Metabolite concentrations represented <0.half dozen% of parent compound, confirming that there are no major human metabolites of eribulin. Cytochrome P450 3A4 (CYP3A4) negligibly metabolizes eribulin in vitro.

Excretion

Eribulin is eliminated primarily in feces unchanged. After administration of ¹⁴C-eribulin to patients, approximately 82% of the dose was eliminated in feces and 9% in urine. Unchanged eribulin accounted for approximately 88% and 91% of total eribulin in feces and urine, respectively.

Specific Populations

Age, Sex activity, And Race/Ethnicity

Based on a population pharmacokinetic assay with information nerveless from 340 patients, sexual activity, race, and age do not have a clinically meaningful effect on the exposure of eribulin.

Hepatic Damage

In a report evaluating the effect of hepatic impairment on the PK of eribulin, eribulin exposures increased by 1.eight-fold in patients with mild hepatic impairment (Child-Pugh A; n=vii) and by 2.5-fold in patients with moderate (Child-Pugh B; n=5) hepatic impairment as compared to patients with normal hepatic function (n=6). Administration of HALAVEN at a dose of i.1 mg/g² to patients with mild hepatic impairment and 0.vii mg/m² to patients with moderate hepatic damage resulted in similar exposure to eribulin at a dose of i.four mg/m² to patients with normal hepatic role [encounter DOSAGE AND ADMINISTRATION, Apply In Specific Populations].

Renal Impairment

In a study evaluating the effect of renal harm on the PK of eribulin, patients with moderate (CLcr 30-49 mL/min; n=seven) and severe renal impairment (CLcr 15-29 mL/min; n=half-dozen) had 1.five-fold higher eribulin dose-normalized exposures compared to that in patients with normal renal function (CLcr ≥ eighty mL/min; n=6). In that location were no clinically meaningful changes in patients with mild renal impairment (CLcr l-79 mL/min; n=27) [run across DOSAGE AND ADMINISTRATION, Utilise In Specific Populations].

Drug Interaction Studies

Effect Of Potent Inhibitors Or Inducers Of CYP3A4 On Eribulin

The consequence of a strong CYP3A4 inhibitor and a P-gp inhibitor, ketoconazole, on the PK of eribulin was studied in a crossover trial of 12 patients with avant-garde solid tumors. No clinically relevant PK interaction was observed when HALAVEN was administered with or without ketoconazole (the geometric mean ratio of the AUC: 0.97; 90% CI: 0.83, 1.12).

The effect of a CYP3A4 inducer, rifampin, on the PK of eribulin was studied in a crossover trial of 14 patients with advanced solid tumors. No clinically relevant PK interaction was observed when HALAVEN was administered with or without rifampin (the geometric mean ratio of the AUC: ane.10; ninety CI%: 0.91, 1.34).

Issue Of Eribulin On CYP Substrates

Eribulin shows no induction potential for CYP1A, CYP2B6, CYP2C9, CYP2C19, and CYP3A in main homo hepatocytes. Eribulin inhibits CYP3A4 activity in human liver microsomes, but it is unlikely that eribulin will substantially increase the plasma levels of CYP3A4 substrates. No meaning inhibition of CYP1A2, CYP2C9, CYP2C19, CYP2D6, or CYP2E1 was detected with eribulin concentrations upwards to 5 μM in pooled human liver microsomes. In vitro drug interaction studies indicate that eribulin does not inhibit drugs that are substrates of these enzymes and it is unlikely that eribulin will bear upon plasma levels of drugs that are substrates of CYP enzymes.

Effect Of Transporters On Eribulin

In vitro data advise that eribulin at clinically relevant concentrations is a substrate of P-gp, but is not a substrate of chest cancer resistance protein (BCRP), multidrug resistance proteins (MRP2, MRP4), bile salt extrusion pump (BSEP), organic anion transporting polypeptides (OATP1B1, OATP1B3), organic anion transporters (OAT1, OAT3), organic cation transporters (OCT1, OCT2), or multidrug and toxin extrusion 1 (MATE1).

Result Of Eribulin On Transporters

In vitro data propose that eribulin at clinically relevant concentrations may inhibit P-gp, but does not inhibit BCRP, OATP1B1, OCT1, OAT1, OAT3, or MATE1.

Clinical Studies

Metastatic Breast Cancer

Study 1 was an open up-label, randomized, multicenter trial of 762 patients with metastatic breast cancer who received at least ii chemotherapeutic regimens for the treatment of metastatic illness and experienced disease progression inside 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 (ii:1) to receive HALAVEN (n=508) or a unmarried agent therapy selected prior to randomization (control arm, northward=254). Randomization was stratified by geographic region, HER2/neu condition, and prior capecitabine exposure. HALAVEN was administered at a dose of i.four mg/m² on Days 1 and 8 of a 21-solar day bicycle. HALAVEN-treated patients received a median of five cycles (range: 1 to 23 cycles) of therapy. Control arm therapy consisted of 97% chemotherapy (26% vinorelbine, xviii% gemcitabine, 18% capecitabine, 16% taxane, nine% anthracycline, ten% other chemotherapy), and 3% hormonal therapy. The main efficacy outcome was overall survival.

Patient demographic and baseline characteristics were comparable between the treatment artillery. The median age was 55 (range: 27 to 85 years) and 92% were White. 60-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 functioning status of 0 or 1. Tumor prognostic characteristics, including estrogen receptor status (positive: 67%, negative: 28%), progesterone receptor status (positive: 49%, negative: 39%), HER2/neu receptor status (positive: 16%, negative: 74%), triple negative status (ER-, PR-, HER2/neu-: 19%), presence of visceral affliction (82%, including lx% liver and 38% lung) and bone affliction (61%), and number of sites of metastases (greater than two: 50%), were also similar in the HALAVEN and command arms. Patients received a median of four prior chemotherapy regimens in both arms.

In Written report 1, a statistically meaning improvement in overall survival was observed in patients randomized to the HALAVEN arm compared to the control arm (see Table 5). An updated, unplanned survival analysis, conducted when 77% of events had been observed (come across Effigy ane), was consistent with the master assay. In patients randomized to HALAVEN, the objective response rate by the RECIST criteria was 11% (95% CI: eight.6%, fourteen.3%) and the median response elapsing was four.2 months (95% CI: 3.8, five.0 months).

Table 5: Comparison of Overall Survival in HALAVEN and Control Arm - Study ane

Overall Survival	HALAVEN (n=508)	Control Arm (north=254)
Primary survival analysis
Number of deaths	274	148
Median, months (95% CI)	thirteen.ane (11.8, xiv.3)	10.6 (9.3, 12.5)
Take chances Ratio (95% CI)a	0.81 (0.66, 0.99)
P valueb	0.041
Updated survival analysis
Number of deaths	386	203
Median, months (95% CI)	13.2 (12.1, 14.4)	10.6 (ix.2, 12.0)
CI = confidence interval a Based on Cox proportional hazards model stratified past geographic region, HER2 condition, and prior capecitabine therapy. b Based on a log-rank test stratified by geographic region, HER2 status, and prior capecitabine therapy.

Figure i: Updated Overall Survival Analysis for Written report 1

Liposarcoma

The efficacy and safe of HALAVEN were evaluated in Written report 2, an open-label, randomized (1:1), multicenter, active-controlled trial. Eligible patients were required to accept unresectable, locally avant-garde or metastatic liposarcoma or leiomyosarcoma, at least ii prior systemic chemotherapies (ane of which must have included an anthracycline), and affliction progression within six months of the most recent chemotherapy regimen. Patients were randomized to HALAVEN 1.4 mg/m² administered intravenously on Days 1 and eight of a 21-solar day wheel or to dacarbazine at a dose of 850 mg/yard^two, m mg/kⁱⁱ, or 1200 mg/1000² administered intravenously every 21 days (dacarbazine dose was selected by the investigator prior to randomization). Treatment continued until disease progression or unacceptable toxicity. Randomization was stratified by histology (liposarcoma or leiomyosarcoma), number of prior therapies (two vs. > two), and geographic region (U.South. and Canada vs. Western Europe, Commonwealth of australia, and Israel vs. Eastern Europe, Latin America, and Asia). The major efficacy outcome measure was overall survival (OS). Boosted efficacy outcome measures were progression-complimentary survival (PFS) and confirmed objective response rate (ORR) as assessed past the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST v1.one). Patients in the dacarbazine arm were not offered HALAVEN at the time of illness progression.

A total of 446 patients were randomized, 225 to the HALAVEN arm and 221 to the dacarbazine arm. The median age was 56 years (range: 24 to 83); 33% were male; 73% were White; 44% had ECOG performance status (PS) 0 and 53% had ECOG PS i; 68% had leiomyosarcoma and 32% had liposarcoma; 39% were enrolled in U.S. and Canada (Region 1) and 46% were enrolled in Western Europe, Commonwealth of australia, and Israel (Region 2); and 47% received more than 2 prior systemic chemotherapies. The most mutual (>40%) prior systemic chemotherapies were doxorubicin (90%), ifosfamide (62%), gemcitabine (59%), trabectedin (50%), and docetaxel (48%).

Of the 143 patients with liposarcoma, the median historic period was 55 years (range: 32 to 83); 62% were male, 72% were White; 41% had ECOG PS of 0 and 53% had ECOG PS of i; 35% were enrolled in Region 1 and 51% were enrolled in Region 2; and 44% received more than two prior systemic chemotherapies. The distribution of subtypes of liposarcoma, based on local histologic assessment, were 45% dedifferentiated, 37% myxoid/round cell, and eighteen% pleomorphic.

Report 2 demonstrated a statistically significant improvement in Os in patients randomized to HALAVEN compared with dacarbazine (see Tabular array 6). There was no pregnant divergence in progression-free survival in the overall population. Treatment furnishings of HALAVEN were limited to patients with liposarcoma based on pre-planned, exploratory subgroup analyses of OS and PFS (see Tables half-dozen and 7 and Figure 2). There was no evidence of efficacy of HALAVEN in patients with advanced or metastatic leiomyosarcoma in Written report 2 (meet Table 7).

Table vi: Efficacy Results for the Liposarcoma Stratum and All Patients* in Study 2^a

	Liposarcoma Stratum		All Patients*
	Halaven (n=71)	Dacarbazine (northward=72)	Halaven (northward=225)	Dacarbazine (n=221)
Overall survival
Deaths, northward (%)	52 (73)	63 (88)	173 (77)	179 (81)
Median, months (95% CI)	xv.6 (ten.2, 18.vi)	8.four (5.ii, 10.1)	13.five (xi.1, 16.v)	11.three (nine.5, 12.half dozen)
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	xiv	xv
Median, months (95% CI)	2.9 (2.6, 4.viii)	1.seven (1.four, 2.6)	two.6 (2.0, 2.8)	2.half dozen (1.7, 2.7)
HR (95% CI)	0.52 (0.35, 0.78)		0.86 (0.69, i.06)
Objective response rate
Objective response rate (%) (95% CI)	1.iv (0, 7.six)	0 (0, 4.ii)	four.0 (i.viii, seven.5)	5.0 (2.5, 8.7)
a Efficacy data from one report site enrolling six patients were excluded. *All patients = liposarcoma and leiomyosarcoma. † North/A = not applicable

Figure 2: Kaplan-Meier Curves of Overall Survival in the Liposarcoma Stratum in Study 2

Table 7: Efficacy Results for the Leiomyosarcoma Stratum in Study ii^a

	Leiomyosarcoma Stratum
	Halaven (northward=154)	Dacarbazine (north=149)
Overall survival
Deaths, north (%)	121 (79)	116 (78)
Median, months (95% CI)	12.8 (10.3, 14.eight)	12.3 (11.0, fifteen.1)
Hour (95% CI)	0.90 (0.69, 1.eighteen)
Progression-gratis survival
Events, n (%)	137 (89)	126 (85)
Disease progression	127	118
Death	10	8
Median, months (95% CI)	two.two (1.5, 2.7)	ii.half dozen (2.2, 2.nine)
HR (95% CI)	1.05 (0.81, one.35)
Objective response rate (%) (95% CI)	five.two (2.iii, 10)	vii.iv (3.vii, 12.viii)
a Efficacy data from i report site enrolling half-dozen patients were excluded.

PATIENT INFORMATION

HALAVEN^®
(HAL-ih-ven)
(eribulin mesylate) injection, for intravenous use

What is the virtually important data I should know about HALAVEN?

HALAVEN can cause serious side furnishings, including:

• Depression white blood cell count (neutropenia). This can lead to serious infections that could atomic number 82 to death. Your healthcare provider will cheque your blood jail cell counts before you lot receive each dose of HALAVEN and during treatment. Call your healthcare provider right away if yous develop any of these symptoms of infection:
  • fever (temperature to a higher place 100.v°F)
  • chills
  • cough
  • burning or pain when you urinate
• Numbness, tingling, or hurting in your hands or feet (peripheral neuropathy). Peripheral neuropathy is common with HALAVEN and sometimes can be severe. Tell your healthcare provider if y'all have new or worsening symptoms of peripheral neuropathy.
• Your healthcare provider may delay, subtract your dose, or cease treatment with HALAVEN if yous take side furnishings.

See "What are possible side effects of HALAVEN?" for more information about side effects.

What is HALAVEN?

HALAVEN is a prescription medicine used to treat people with:

• Breast cancer
  • that has spread to other parts of the body, and
  • who have already received certain types of anticancer medicines after the cancer has spread
• Liposarcoma
  • that cannot be treated with surgery or has spread to other parts of the body, and
  • who have received treatment with a sure type of anticancer medicine

It is not known if HALAVEN is safe and effective in children under 18 years of age.

Earlier you receive HALAVEN, tell your healthcare provider about all of your medical conditions, including if you:

• take liver or kidney problems
• have heart problems, including a trouble chosen congenital long QT syndrome
• accept low potassium or low magnesium in your blood
• are meaning or plan to become pregnant. HALAVEN tin can harm your unborn baby. Tell your healthcare provider right away if you lot become pregnant or think you lot are pregnant during handling with HALAVEN.
  • Females who are able to go significant should employ an constructive birth control during treatment with HALAVEN and for at to the lowest degree 2 weeks afterward the final dose of HALAVEN.
  • Males should use an effective form of nascency control when having sex with female partners who are able to get significant during treatment with HALAVEN and for 3 1/two months (xiv weeks) later the terminal dose of HALAVEN.
• are breastfeeding or plan to breastfeed. It is not known if HALAVEN passes into your breast milk. Exercise not breastfeed during treatment with HALAVEN and for 2 weeks after the concluding dose of HALAVEN.

Tell your healthcare provider well-nigh all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive HALAVEN?

• HALAVEN is given by intravenous (IV) injection in your vein.
• HALAVEN is given in "cycles" of treatment, with each cycle lasting 21 days.
• HALAVEN is usually given on day 1 and 24-hour interval 8 of a treatment cycle.

What are the possible side effects of HALAVEN?

HALAVEN may cause serious side effects, including:

• Run into "What is the near important data I should know most HALAVEN?"
• HALAVEN tin cause changes in your heartbeat (called QT prolongation). This can cause irregular heartbeats. Your healthcare provider may do heart monitoring (electrocardiogram or ECG) or blood tests during your treatment with HALAVEN to check for heart problems.

The most common side furnishings of HALAVEN in people with breast cancer include:

• low white blood jail cell count (neutropenia)
• depression crimson blood prison cell count (anemia)
• weakness or tiredness
• pilus loss (alopecia)
• nausea
• constipation

The almost common side furnishings of HALAVEN in people with liposarcoma include:

• tiredness
• nausea
• hair loss (baldness)
• constipation
• stomach pain
• fever

Your healthcare provider volition practice blood tests before and during treatment while yous are taking HALAVEN. The nearly mutual changes to blood tests in people with liposarcoma include:

• low white claret cell count (neutropenia)
• decreased claret levels of potassium or calcium

Tell your healthcare provider about any side outcome that bothers you or that does non get away.

These are not all the possible side furnishings of HALAVEN. Call your doc for medical advice about side effects. You may written report side furnishings to FDA at one-800-FDA-1088.

General information about HALAVEN

Medicines are sometimes prescribed for purposes other than those listed in a Patient Data leaflet. You can inquire your chemist or healthcare provider for information nearly HALAVEN that is written for health professionals.

What are the ingredients in HALAVEN?

Active Ingredient: eribulin mesylate

Inactive Ingredients: dehydrated alcohol, water for injection, and sodium hydroxide or muriatic acid may exist used for pH adjustment.

This Patient Data has been approved by the U.Southward. Food and Drug Administration.

From

Report Issues to the Food and Drug Assistants

You are encouraged to written report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or telephone call 1-800-FDA-1088.

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Source: https://www.rxlist.com/halaven-drug.htm

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