Halaven

Instructions for Preparation and Administration (

HALAVEN is a microtubule inhibitor indicated for the treatment of patients with:

• Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. (
  1.1

  Me

  tastatic Breast Cancer

  HALAVEN 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

  [see

  Clinical Studies (14.1)

  ]

  .
  )
  
  
• Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. (
  1.2

  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 (14.2)

  ]

  .
  )

• Administer 1.4 mg/m2 intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. (
  2.1

  Recommended Dose

  The recommended dose of HALAVEN is 1.4 mg/m²administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.

  The recommended dose of HALAVEN in patients with mild hepatic impairment (Child-Pugh A) is 1.1 mg/m²administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle

  [

  see

  Use in Specific Populations (8.6)

  ]

  .

  The recommended dose of HALAVEN in patients with moderate hepatic impairment (Child-Pugh B) is 0.7 mg/m²administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle

  [

  see

  Use in Specific Populations (8.6)

  ]

  .

  The recommended dose of HALAVEN in patients with moderate or severe renal impairment (creatinine clearance (CLcr) 15-49 mL/min) is 1.1 mg/m²administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle

  [

  see

  Use in Specific Populations (8.7)

  ]

  .
  )
  
  
• Reduce dose in patients with hepatic impairment or with moderate or severe renal impairment. (
  2.1

  Recommended Dose

  The recommended dose of HALAVEN is 1.4 mg/m²administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.

  The recommended dose of HALAVEN in patients with mild hepatic impairment (Child-Pugh A) is 1.1 mg/m²administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle

  [

  see

  Use in Specific Populations (8.6)

  ]

  .

  The recommended dose of HALAVEN in patients with moderate hepatic impairment (Child-Pugh B) is 0.7 mg/m²administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle

  [

  see

  Use in Specific Populations (8.6)

  ]

  .

  The recommended dose of HALAVEN in patients with moderate or severe renal impairment (creatinine clearance (CLcr) 15-49 mL/min) is 1.1 mg/m²administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle

  [

  see

  Use in Specific Populations (8.7)

  ]

  .
  )
  
  
• Do not mix with other drugs or administer with dextrose-containing solutions. (
  2.3

  Instructions for Preparation and Administration

  Aseptically withdraw the required amount of HALAVEN 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 HALAVEN 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 HALAVEN 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.
  )

Injection:  1 mg/2 mL (0.5 mg/mL) eribulin mesylate is a clear, colorless, sterile solution in a single-dose vial. 

• Lactation:  Do not breastfeed. (
  8.2

  Lactation

  Risk Summary

  There is no information regarding the presence of eribulin mesylate or its metabolites in human 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 adverse reactions in breastfed infants from eribulin mesylate, advise women not to breastfeed during treatment with HALAVEN and for 2 weeks after the final dose.
  )
  
  
• Hepatic Impairment:  A lower starting dose is recommended for patients with mild (Child-Pugh A) and moderate (Child-Pugh B) hepatic impairment. Patients with severe hepatic impairment (Child-Pugh C) were not studied. (
  8.6

  Hepatic Impairment

  Administration of HALAVEN at a dose of 1.1 mg/m²to patients with mild hepatic impairment and 0.7 mg/m²to patients with moderate hepatic impairment resulted in similar exposure to eribulin as a dose of 1.4 mg/m²to patients with normal hepatic function. Therefore, a lower starting dose of 1.1 mg/m²is recommended for patients with mild hepatic impairment (Child-Pugh A) and of 0.7 mg/m²is recommended for patients with moderate hepatic impairment (Child-Pugh B). HALAVEN was not studied in patients with severe hepatic impairment (Child-Pugh C)

  [see

  Dosage and Administration (2.1)

  ,

  Clinical Pharmacology (12.3)

  ]

  .
  )
  
  
• Renal Impairment: A lower starting dose is recommended for patients with moderate (CLcr 30-49 mL/min) or severe (CLcr 15-29 mL/min) renal impairment. (
  8.7

  Renal Impairment

  For patients with moderate or severe renal impairment (CLcr 15-49 mL/min), reduce the starting dose to 1.1 mg/m²

  [see

  Dosage and Administration (2.1)

  ,

  Clinical Pharmacology (12.3)

  ]

  .
  )