Nelarabine - Nelarabine injection

Nelarabine injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens.

• Adult Dose
  : 1500 mg/m
  ² administered intravenously over 2 hours on Days 1, 3, and 5 repeated every 21 days. (
  
  2.1 Recommended Dosage

  This product is for intravenous use only.

  Adult Dosage

  : The recommended adult dose of nelarabine injection is 1500 mg/m²administered intravenously over 2 hours on Days 1, 3, and 5 repeated every 21 days. Administer nelarabine injection undiluted.

  Pediatric Dosage

  : The recommended pediatric dose of nelarabine injection is 650 mg/m²administered intravenously over 1 hour daily for 5 consecutive days repeated every 21 days. Administer nelarabine injection undiluted.

  The recommended duration of treatment for adult and pediatric patients has not been clearly established. In clinical trials, treatment was generally continued until there was evidence of disease progression, the patient experienced unacceptable toxicity, the patient became a candidate for hematopoietic stem cell transplantation (HSCT), or the patient no longer continued to benefit from treatment.
  )
  
• Pediatric Dose
  : 650 mg/m
  ² administered intravenously over 1 hour daily for 5 consecutive days repeated every 21 days. (
  
  2.1 Recommended Dosage

  This product is for intravenous use only.

  Adult Dosage

  : The recommended adult dose of nelarabine injection is 1500 mg/m²administered intravenously over 2 hours on Days 1, 3, and 5 repeated every 21 days. Administer nelarabine injection undiluted.

  Pediatric Dosage

  : The recommended pediatric dose of nelarabine injection is 650 mg/m²administered intravenously over 1 hour daily for 5 consecutive days repeated every 21 days. Administer nelarabine injection undiluted.

  The recommended duration of treatment for adult and pediatric patients has not been clearly established. In clinical trials, treatment was generally continued until there was evidence of disease progression, the patient experienced unacceptable toxicity, the patient became a candidate for hematopoietic stem cell transplantation (HSCT), or the patient no longer continued to benefit from treatment.
  )
  
• Discontinue treatment for neurologic reactions greater than or equal to Grade 2. (
  
  2.2 Dosage Modification

  Discontinue nelarabine injection if the patient develops a neurologic adverse reaction of NCI CTCAE Grade 2 or greater. Dosage may be delayed for other toxicity, including hematologic toxicity

  [see Boxed Warning, Warnings and Precautions ].
  )
  
• Dosage may be delayed for hematologic reactions. (
  
  2.2 Dosage Modification

  Discontinue nelarabine injection if the patient develops a neurologic adverse reaction of NCI CTCAE Grade 2 or greater. Dosage may be delayed for other toxicity, including hematologic toxicity

  [see Boxed Warning, Warnings and Precautions ].
  )
  
• Take measures to prevent hyperuricemia. (
  
  2.4 Prevention of Hyperuricemia

  Take precautions against hyperuricemia (e.g., hydration, urine alkalinization, and prophylaxis with allopurinol)

  [see

  Warnings and Precautions (5.4)

  ].
  )
  

Injection: 250 mg/50 mL (5 mg/mL) single-dose vial

• Lactation
  :
  
  Advise not to breastfeed. (
  
  8.2 Lactation

  Risk Summary

  There are no data on the presence of nelarabine or ara-G in human or animal milk, the effect on the breastfed child, or the effect on milk production. Because of the potential for serious adverse reactions in the breastfed child from nelarabine injection, such as severe neurological reactions, advise women not to breastfeed during treatment with nelarabine injection.
  )
  
• Renal Impairment
  : Closely monitor patients with moderate or severe renal impairment for toxicities. (
  
  8.6 Renal Impairment

  Ara-G clearance decreased as renal function decreased

  [see

  Clinical Pharmacology (12.3)

  ]

  . Because the risk of adverse reactions to this drug may be greater in patients with moderate (CLCr 30 to 50 mL/min) or severe (CLCr less than 30 mL/min) renal impairment, these patients should be closely monitored for toxicities when treated with nelarabine injection

  [see

  Dosage and Administration (2.3)

  ].
  )
  
• Hepatic Impairment
  : Closely monitor patients with severe hepatic impairment for toxicities. (
  
  8.7 Hepatic Impairment

  The influence of hepatic impairment on the pharmacokinetics of nelarabine has not been evaluated. Because the risk of adverse reactions to this drug may be greater in patients with severe hepatic impairment (total bilirubin greater than 3 times upper limit of normal), these patients should be closely monitored for toxicities when treated with nelarabine injection.
  )