Eribulin (Halaven) is a non-taxane microtubule inhibitor - a chemotherapeutic anti-cancer drug that has been approved for the treatment of advanced metastatic breast cancer.

Eribulin Uses:

• Breast cancer, metastatic:

  • Treatment of metastatic breast cancer in patients who were treated with a minimum of 2 chemotherapy regimens containing anthracycline and taxane.

• Liposarcoma, unresectable, or metastatic:

  • Treatment of inoperable or metastatic liposarcoma in patients who have been treated before with an anthracycline-containing regime.

Eribulin (Halaven) Dose in Adults

Note: International Considerations:

• Some products may have vial strength and dosing expressed as the base (instead of as the salt).
• Refer to prescribing information for specific dosing information.

Eribulin (Halaven) Dose in the treatment of metastatic Breast cancer:

• IV: Eribulin mesylate: 1.4 mg/m² on days 1 and 8 of a 21-day treatment cycle

Eribulin (Halaven) Dose in the treatment of unresectable or metastatic liposarcoma:

• IV: Eribulin mesylate: 1.4 mg/m² on days 1 and 8 of a 21-day treatment cycle.

Use in Children:

Not indicated

Eribulin Pregnancy Category: D

• Fetal harm is possible. After completing therapy, avoid pregnancy in female patients and male partners.

Use while breastfeeding

• The manufacturer does not recommend breastfeeding during eribulin treatment or for two weeks after the last dose.

Eribulin (Halaven) Dose in Kidney disease:

• CrCl ≥50 mL/minute:

  • No dose adjustment needed

• CrCl 15 to 49 mL/minute:

  • Reduce dose to eribulin mesylate 1.1 mg/m².
  • ESRD (Canadian labeling): Use is not recommended.

Eribulin (Halaven) Dose in Liver disease:

• Mild hepatic impairment (Child-Pugh class A):

  • Reduce dose to eribulin mesylate 1.1 mg/m².

• Moderate hepatic impairment (Child-Pugh class B):

  • Reduce dose to eribulin mesylate 0.7 mg/m².

• Severe hepatic impairment (Child-Pugh class C):

  • No data are available. No dose adjustment provided.

Common Side Effects of Eribulin (Halaven):

• Cardiovascular:

  • Peripheral Edema

• Central Nervous System:

  • Fatigue
  • Peripheral Neuropathy
  • Headache

• Dermatologic:

  • Alopecia

• Endocrine & Metabolic:

  • Hypokalemia
  • Hypocalcemia
  • Weight Loss
  • Hypophosphatemia

• Gastrointestinal:

  • Nausea
  • Constipation
  • Abdominal Pain
  • Anorexia
  • Decreased Appetite
  • Vomiting
  • Diarrhea
  • Stomatitis

• Genitourinary:

  • Urinary Tract Infection

• Hematologic & Oncologic:

  • Neutropenia
  • Anemia

• Hepatic:

  • Increased Serum ALT
  • Increased Serum AST

• Neuromuscular & Skeletal:

  • Weakness
  • Arthralgia
  • Myalgia
  • Back Pain
  • Ostealgia
  • Limb Pain

• Respiratory:

  • Cough
  • Dyspnea

• Miscellaneous:

  • Fever

Less Common Side Effects Of Eribulin (Halaven):

• Cardiovascular:

  • Hypotension

• Central Nervous System:

  • Anxiety
  • Depression
  • Dizziness
  • Insomnia
  • Myasthenia

• Dermatologic:

  • Skin Rash

• Endocrine & Metabolic:

  • Hyperglycemia

• Gastrointestinal:

  • Dysgeusia
  • Dyspepsia
  • Xerostomia
  • Mucosal Inflammation

• Hematologic & Oncologic:

  • Thrombocytopenia
  • Febrile Neutropenia

• Neuromuscular & Skeletal:

  • Muscle Spasm
  • Musculoskeletal Pain,

• Ophthalmic:

  • Increased Lacrimation

• Respiratory:

  • Oropharyngeal Pain
  • Upper Respiratory Tract Infection

Contraindications to Eribulin (Halaven):

The manufacturer's labeling does not list any contraindications. Canadian labeling (not US labeling). Hypersensitivity to eribulin, halichondrin B or its chemical derivatives.

Warnings and precautions

• Suppression of bone marrow

  • Hematologic toxicities include severe neutropenia, neutropenic fever and even neutropenic sepsis. Before each dose, obtain CBC. If toxic effects occur, discontinue or hold the treatment.

• Peripheral neuropathy

  • Peripheral neuropathy can be a common side effect. It can last for up to one year in some cases.
  • You may experience side effects for up to nine months. As needed, you can either stop or continue treatment.

• Extension of QT

  • On the 8th day, QT prolongation was noted.
  • Patients with heart failure or bradyarrhythmia should monitor their ECG.
  • Before treatment, correct electrolyte disturbances such as hypokalemia or hypomagnesemia.
  • Avoid congenital QT syndrome.

• Hepatic impairment

  • Patients with mild or moderate symptoms (Child-Pugh Class A or B) must have their dose adjusted.
  • Increased incidences of neutropenia grade 4 and neutropenic fever are associated with transaminase elevations.

• Renal impairment

  • If you have severe or moderate renal dysfunction, adjust the dose.

Monitoring parameters

• CBC with differential prior to each dose (increase frequency for grades 3/4 cytopenias).
• Tests of renal and liver function
• Serum potassium and magnesium
• Before each dose, assess peripheral neuropathy
• Patients with heart failure and bradyarrhythmia should monitor their ECG with a concomitant medication that prolongs the QT interval and electrolyte abnormalities such as hypokalemia or hypomagnesemia.

How to administer Eribulin (Halaven)?

• IV: Infuse over 2 to 5 minutes. Use IV line only for this medication.
• Especially avoid administering dextrose from the same line.  May be undiluted or diluted.

Mechanism of action of Eribulin (Halaven):

• Non-taxane microtubule inhibit, which is an analog to halichondrin B. 
• It inhibits mitotic spindle creation and arrests the cell cycle at G-2/M phase. However, it does not affect microtubule depolymerization.

Protein binding:

• 49% to 65%

Metabolism:

• Negligible

Half-life, elimination:

• ~40 hours

Excretion:

• Feces (~82%, predominantly as unchanged drug);
• urine (9%, primarily as unchanged drug)

International Brands of Eribulin:

• Halaven

Eribulin Brand Names in Pakistan:

No Brands Available in Pakistan.