GLAXO SMITH KLINE INC
GLAXO SMITH KLINE INC
Refer Glaxo Smith Kline
Nelarabine 250mg ( 5mg/ml in 50ml ) injection vials,
|250mg inj||0.00||50ml vials|
List of Related Indications:
- Leukemia /Lymphoma
List Of Drugs:
- Nelarabine - @ - DNA Demethylation Agents - Antineoplastic Agents
Indication Type Description:
Dosages/ Overdosage Etc
Pregnancy and lactation
Most common adverse reactions in children regardless of causuality were-
hematologic disorders eg anemia, leukopenia, neutropenia, thrombocytopenia.
Of the non-hematologic adverse reactions in children - most frequent are-
headache, increased transaminase levels, decreased potassium, decreased albumin,
increased blood bilirubin and vomiting
Most common advere reactions in adults-
GI disorders eg constipation, diarrhea, nausea, vomiting,
hemotologic disoders, eg.anemia neutropenia, thrombocytopenia,
respiratory disorders eg cough, dyspnea
nervous system disorders - eg somnolence, dizziness, and pyrexia
Most common in children
Hematologic - anemia 40% leucopenia 12% neutropenia 15% thrombocytopenia 25%
Hepatic - blood albumin decreased 4% blod bilirubin increased 5%
transaminase increased 3%
Most common in adults-
CNS - Fatigue 8%
Hematologic - anemia 16% febrile neutropenia 7% neutropenia 12%
Nelarabine is contraindicated in patients with a history of hypersensitivity to nelarabine
Special Precautions /Warnings
Neurologic effects - nelarabine is a potent antineoplastic agent with potentially significant
toxic side effects. Neutrotoxicity is the dose limiting toxicity to nelarabine.
Closely observe patients for signs and symptoms of neurologic toxicity.
IV hydration- patients receiving nelarabine should receive IV hydration.
Consider use of allopurinol inpatients at risk of hyperuricemia.
Immunocompromised patients - avoid administration of live vaccines to immunocompromised patients
Renal function impairment - closely monitor for toxicites when treated with nelarabine
Hepatic function impairment - closely monitor for toxicites when treated with nelarabine
Hazardous tasks - caution patients receiving nelarabine therapy about operating hazardous machinery , because they may experience somnolence
Pregnancy - advice women of child bearing age to avoid becoming pregnant while receiving treatment wih nelarabine
Lactation- discontinue breast feeding in women who are receiving nelarabine
Children- follow doctors advice
Elderly - decreased renal response are more common in the elderly
Monitoring- regularly monitor complete blood counts, including platelets
Dosages/ Overdosage Etc:
Adults- recommended adult dose of nelarabine is 1500mg/m2 administered IV over 2 hours on day 1 ,3, and 5 repeated every 21 days. Nelabarine is administered undiluted
Children - recommended pediatric dose of nelarabine is 650mg/m2 administrered IV over 2 hours for 5 consecutive days, repeated every 21 days. nelarabine is administered undiluted.
Supportive measures - appropiate measures eg hydration, urine alkalisation, must be taken to prevent hyperuricemia of tumor lysis syndrome.
Storage- store at 25C ( 77F ) ,excursions permitted to 15C to 30C ( 59 to 86F)
1. Because patients receiving nelarabine therapy may experience somnolence , caution, them about operating hazardous machinery.
1. Instruct patiients to contact their physician if they experience new or worsening of symptoms of peripheral neuropathy. including, tingling, or numbness of fingers, hands, toes, unsteadiness while walking, weakness arising from low chair, weakness while climbing chairs, increased tripping while walking over uneven surfaces.
3. Instruct patients that seizures have known to occur in patients receiving nelarabine. Report to your doctor, if seizure occurs
4. Patients who develop fever or signs of infection while on therapy , should notify their
5. Advice patients to use contraceptive measures to prevent pregnancy and to avoid
breast feeding during treatment, with nelarabine.
Pregnancy and lactation:
Advice women of child bearing age to avoid becoming pregnant while receiving
treatment wih nelarabine
Discontinue breast feeding in women who are receiving nelarabine
Follow doctors advice
Decreased renal response are more common in the elderly