othbrushes, dental floss, and toothpicks.
Intramuscular injections
Intramuscular injections should not be administered to patients with platelet counts < 50,000/mm3 who are receiving nelarabine. IM injections may cause bleeding, bruising, or hematomas due to nelarabine-induced thrombocytopenia.
Hyperkalemia, hyperphosphatemia, hyperuricemia, hypocalcemia
Hyperkalemia, hyperphosphatemia, hyperuricemia, hypocalcemia, and decreased urine output may be indicative of nelarabine-induced tumor lysis syndrome (TLS). Appropriate measures (e.g., aggressive hydration and allopurinol) must be taken to prevent severe electrolyte imbalances and renal toxicity during and following chemotherapy administration in patients with large chemosensitive tumors such as leukemia or lymphoma.
Hepatic disease
Nelarabine has not been studied in patients with hepatic disease. The risk of severe adverse reactions may be higher in patients with severe hepatic impairment (bilirubin > 3 mg/dl); these patients should be closely monitored during nelarabine therapy.
Renal failure, renal impairment
The clearance of the active metabolite of nelarabine, ARA-G, is decreased as renal function is decreased. Because the risk of adverse reactions is greater in patients with severe renal impairment or renal failure (creatinine clearance < 30 ml/minute), these patients should be closely monitored for toxicities when treated with nelarabine.
Pregnancy
Nelarabine is classified as FDA pregnancy risk category D and has been shown to produce toxic effects in fetal animal studies. There are no data concerning the effects in pregnant women. Therefore, nelarabine should be avoided during pregnancy, and women of childbearing potential should be instructed to avoid becoming pregnant during nelarabine therapy. If a women becomes pregnant while receiving this drug, she should be counseled of the potential harm to the fetus and the possibility of loss of pregnancy.
Breast-feeding
Adverse effects to the nursing infant are unknown. It also is unknown whether nelarabine or ARA-G are excreted into breast milk. According to the manufacturer, a decision should be made whether to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother.
Accidental exposure, ocular exposure
Use care to avoid accidental exposure to nelarabine during preparation, handling, and administration. The use of protective gowns, gloves and goggles is recommended. Avoid ocular exposure of nelarabine solutions. If exposure occurs, the eye should be rinsed immediately and thoroughly. Ocular exposure may result in irritation or corneal ulceration. Caution is recommended in the handling and administration of nelarabine solution to avoid skin. If exposed to nelarabine, skin should be thoroughly rinsed.
Vaccination
Vaccination during chemotherapy or radiation therapy should be avoided because the antibody response is suboptimal. When chemotherapy, such as nelarabine, is being planned, vaccination should precede the initiation of chemotherapy by >= 2 weeks. The administration of live vaccines to immunocompromised patients should be avoided. Those undergoing chemotherapy should not be exposed to others who have recently received the oral poliovirus vaccine (OPV). Measles-mumps-rubella (MMR) vaccination is not contraindicated for the close contacts, including health care professionals, of immunocompromised patien |
