Details About Generic Salt ::  Cytarabi

Main Medicine Class::    

(SITE-ah-rah-been)

Cytosar-U

Sterile powder for reconstitution

100 mg, 500 mg, 1 g, 2 g vials

Class: Pyrimidine antimetabolite

 Indications Acute lymphocytic leukemia, acute and chronic myelocytic leukemia, meningeal leukemia, erythroleukemia, non-Hodgkin lymphoma.

Hodgkin disease, bone marrow transplantation.

 Contraindications Standard considerations.

 Route/Dosage

Acute Leukemia Induction

ADULTS: Continuous IV infusion or rapid injection 100 to 200 mg/m²/day or 3 mg/kg/day as a continuous IV infusion over 24 hr or in divided doses by rapid injection for 5 to 10 days with the courses repeated » q 2 wk.

PEDIATRIC: Continuous IV infusion or rapid injection 100 to 200 mg/m²/day as a continuous IV infusion over 24 hr or in divided doses by rapid injection for 5 to 10 days with the courses repeated » q 2 wk.

Acute Leukemia Maintenance

ADULTS: SC 1 mg/kg/dose 1 or 2 times/wk.

PEDIATRIC: SC or IM 1 to 1.5 mg/kg/dose q 1 to 4 wk. Alternate maintenance regimen: 70 to 200 mg/m²/day IV for 2 to 5 days repeated q mo.

Acute Non-Lymphocytic Leukemia (Combination with Other Chemotherapeutic Drugs)

ADULTS: Continuous infusion 100 mg/m²/day on days 1 through 7, or 100 mg/m² q 12 hr for 7 days. Alternate regimen: Cytarabine 10 mg/m²/dose SC bid for 7 to 14 days in combination with other chemotherapeutic drugs.

PEDIATRIC: Continuous infusion 100 mg/m²/day on days 1 through 7, or 100 mg/m² q 12 hr for 7 days.

Refractory Acute Leukemia or Lymphomas

ADULTS: IV High-dose cytarabine: 2000 to 3000 mg/m² q 12 hr for 2 to 6 days. Suspend or modify the dose of cytarabine if ANC is < 1000/mm³ or the platelet count is < 50,000/mm³.

PEDIATRIC: IV High-dose cytarabine: 1000 to 3000 mg/m² q 12 hr for 2 to 6 days. Suspend or modify the dose of cytarabine if ANC is < 1000/mm³ or the platelet count is < 50,000/mm³.

Adjustment in Hepatic Insufficiency

ADULTS: May require dosage reduction; specific guidelines are not established.

PEDIATRIC: Follow dosage adjustment guidelines recommended for adults.

Meningeal Leukemia

ADULTS: Intrathecally 5 to 75 mg/m² at intervals ranging from once a day for 4 days to once q 4 days (range, 2 to 7 days).

PEDIATRIC: Intrathecally 5 to 75 mg/m² at intervals ranging from once a day for 4 days to once q 4 days (range, 2 to 7 days). Many clinicians recommend dosing intrathecal cytarabine by the child’s age.

Pretreatment Regimen

Prophylactic use of corticosteroid eye drops decreases the risk of conjunctivitis or keratitis. Begin prophylactic therapy prior to chemotherapy and continue for 48 hr after the last dose of cytarabine.

Interactions

L-asparaginase

Prior therapy with L-asparaginase may increase the risk of acute pancreatitis.

Digoxin

Oral absorption of digoxin may be decreased.

Gentamicin

Gentamicin effectiveness against K. pneumoniae strains may be decreased.

Quinolone antibiotics

Cytarabine may decrease the oral absorption of quinolone antibiotics.

Lab Test Interferences None well documented.

 Adverse Reactions

CNS: Headache, dizziness; seizures, cerebral or cerebellar dysfunction presenting as personality changes, somnolence, coma, ataxia, dysarthria, and nystagmus (high dose); sensory neuropathy (high dose); necrotizing leukoencephalopathy with intrathecal cytarabine and cranial radiation. DERMATOLOGIC: Rash; cellulitis; thrombophlebitis; palmar-plantar erythrodysesthesia; severe rash with desquamation (high dose). GI: Nausea; vomiting; anorexia; mucositis; diarrhea; transient elevation of LFTs; neutropenic colitis; severe GI ulceration (high dose). HEMATOLOGIC: Bone marrow suppression. RESPIRATORY: Pulmonary edema, diffuse interstitial pneumonitis (high dose). OTHER: Cytarabine syndrome; arthralgias; myalgias; chest pain; fever; general feeling of discomfort or weakness; reddened eyes; skin rash. SPECIALSENSES: Hemorrhagic conjunctivitis, corneal toxicity, photophobia (high dose).

 Precautions

Pregnancy: Category D. Lactation: Undetermined. Children: Conventional cytarabine is indicated for use in children. Benzyl alcohol: Benzyl alcohol is contained in the diluent for some conventional cytarabine products. Benzyl alcohol has been reported to be associated with a fatal “gasping syndrome” in premature infants. Do not use conventinal cytarabine injection with benzyl alcohol intrathecally. Extravasation risk: May cause local irritation or phlebitis. Refer to your institution specific protocol. Hypersensitivity: Cases of anaphylaxis have occurred resulting in acute cardiopulmonary arrest which required resuscitation. This occurred immediately after IV administration. Infection: Viral, bacterial, fungal, parasitic, or saprophytic infections in any location in the body may be associated with the use of cytarabine alone or in combination with other immunosuppressive agents. Intrathecal use: If used intrathecally, do not use a diluent with benzyl alcohol. Myelosupression/Hematologic: Anemia, leukopenia, thrombocytopenia, megaloblastosis, and reduced reticulocytes can be expected. The severity of these reactions is dose- and schedule-dependent. Neuropathies: Peripheral motor and sensory neuropathies have occurred. Neurotoxicity: Enhanced neurotoxicity has been associated with concurrent use of intrathecal cytarabine and other cytotoxic agents administered intrathecally. Renal/Hepatic function impairment: Patients with renal or hepatic function impairment may have a higher likelihood of CNS toxicity after high-dose cytarabine. Use the drug with caution and possibly at reduced doses in patients with poor liver or kidney function.

PATIENT CARE CONSIDERATIONS

 Administration/Storage

• Store at room temperature.
• When reconstituted with Bacteriostatic Water for Injection (with benzyl alcohol), cytarabine is stable for 2 days at room temperature. Use preservative-free cytarabine solutions within 24 hr of reconstitution. Discard if solution appears hazy.
• Diluted cytarabine solutions (concentration 0.5 mg/mL) are stable for 8 days at room temperature when diluted with Sterile Water, 0.9% Sodium Chloride, or 5% Dextrose.
• Administer by SC/IM injection, IV injection or infusion, intrathecal.
• Rotate injection sites for SC/IM administration.

IV Infusion

• Reconstitute with Bacteriostatic Water for Injection (with 0.9% benzyl alcohol). May be further diluted with > 50 mL of 0.9% Sodium Chloride for IV infusion.
• Give by bolus injection over 1 to 3 min through a running IV line; infuse IV over 15 min in > 50 mL of 0.9% Sodium Chloride; continuous IV infusion over 5 days. Cytarabine doses are often infused over 30 min.

Intrathecal

• Dilute with an isotonic buffered diluent without preservative such as Lactated Ringer’s injection or 0.9% Sodium Chloride.

High Dose

• Dilute with preservative-free 0.9% Sodium Chloride.
• Give IV infusion over 1 to 3 hr.

SC/IM

• Smaller volumes of diluent can be used to prepare a 100 mg/mL solution for SC/IM injection.

 Assessment/Interventions

• Hyperuricemia may occur due to rapid cell lysis; monitor serum uric acid. Minimize effects of hyperuricemia with hydration, urinary alkalinization, and allopurinol.
• During induction therapy, perform leukocyte and platelet counts daily. Perform bone marrow examinations frequently after blasts have disappeared from the peripheral blood.
• Suspend or modify therapy when drug-induced marrow depression results in a platelet count < 50,000/mm³ or a polymorphonuclear granulocyte count < 1000/mm³.
• Perform periodic checks of bone marrow, liver, and kidney functions.
• Observe patients on high-dose cytarabine for neuropathy.

 Patient/Family Education

• Inform patients about the expected adverse events of headache, nausea, vomiting, and fever, and about the early signs and symptoms of neurotoxicity. Instruct patients to seek medical attention if signs or symptoms of neurotoxicity develop, or if oral dexamethasone is not well tolerated.

Medicscientist Drug Facts

Drugs Class ::

Indications for Drugs ::

 Indications Acute lymphocytic leukemia, acute and chronic myelocytic leukemia, meningeal leukemia, erythroleukemia, non-Hodgkin lymphoma.

Hodgkin disease, bone marrow transplantation.

Drug Dose ::

 Route/Dosage

Acute Leukemia Induction

ADULTS: Continuous IV infusion or rapid injection 100 to 200 mg/m²/day or 3 mg/kg/day as a continuous IV infusion over 24 hr or in divided doses by rapid injection for 5 to 10 days with the courses repeated » q 2 wk.

PEDIATRIC: Continuous IV infusion or rapid injection 100 to 200 mg/m²/day as a continuous IV infusion over 24 hr or in divided doses by rapid injection for 5 to 10 days with the courses repeated » q 2 wk.

Acute Leukemia Maintenance

ADULTS: SC 1 mg/kg/dose 1 or 2 times/wk.

PEDIATRIC: SC or IM 1 to 1.5 mg/kg/dose q 1 to 4 wk. Alternate maintenance regimen: 70 to 200 mg/m²/day IV for 2 to 5 days repeated q mo.

Acute Non-Lymphocytic Leukemia (Combination with Other Chemotherapeutic Drugs)

ADULTS: Continuous infusion 100 mg/m²/day on days 1 through 7, or 100 mg/m² q 12 hr for 7 days. Alternate regimen: Cytarabine 10 mg/m²/dose SC bid for 7 to 14 days in combination with other chemotherapeutic drugs.

PEDIATRIC: Continuous infusion 100 mg/m²/day on days 1 through 7, or 100 mg/m² q 12 hr for 7 days.

Refractory Acute Leukemia or Lymphomas

ADULTS: IV High-dose cytarabine: 2000 to 3000 mg/m² q 12 hr for 2 to 6 days. Suspend or modify the dose of cytarabine if ANC is < 1000/mm³ or the platelet count is < 50,000/mm³.

PEDIATRIC: IV High-dose cytarabine: 1000 to 3000 mg/m² q 12 hr for 2 to 6 days. Suspend or modify the dose of cytarabine if ANC is < 1000/mm³ or the platelet count is < 50,000/mm³.

Adjustment in Hepatic Insufficiency

ADULTS: May require dosage reduction; specific guidelines are not established.

PEDIATRIC: Follow dosage adjustment guidelines recommended for adults.

Meningeal Leukemia

ADULTS: Intrathecally 5 to 75 mg/m² at intervals ranging from once a day for 4 days to once q 4 days (range, 2 to 7 days).

PEDIATRIC: Intrathecally 5 to 75 mg/m² at intervals ranging from once a day for 4 days to once q 4 days (range, 2 to 7 days). Many clinicians recommend dosing intrathecal cytarabine by the child’s age.

Pretreatment Regimen

Prophylactic use of corticosteroid eye drops decreases the risk of conjunctivitis or keratitis. Begin prophylactic therapy prior to chemotherapy and continue for 48 hr after the last dose of cytarabine.

Contraindication ::

 Contraindications Standard considerations.

Drug Precautions ::

 Precautions

Pregnancy: Category D. Lactation: Undetermined. Children: Conventional cytarabine is indicated for use in children. Benzyl alcohol: Benzyl alcohol is contained in the diluent for some conventional cytarabine products. Benzyl alcohol has been reported to be associated with a fatal “gasping syndrome” in premature infants. Do not use conventinal cytarabine injection with benzyl alcohol intrathecally. Extravasation risk: May cause local irritation or phlebitis. Refer to your institution specific protocol. Hypersensitivity: Cases of anaphylaxis have occurred resulting in acute cardiopulmonary arrest which required resuscitation. This occurred immediately after IV administration. Infection: Viral, bacterial, fungal, parasitic, or saprophytic infections in any location in the body may be associated with the use of cytarabine alone or in combination with other immunosuppressive agents. Intrathecal use: If used intrathecally, do not use a diluent with benzyl alcohol. Myelosupression/Hematologic: Anemia, leukopenia, thrombocytopenia, megaloblastosis, and reduced reticulocytes can be expected. The severity of these reactions is dose- and schedule-dependent. Neuropathies: Peripheral motor and sensory neuropathies have occurred. Neurotoxicity: Enhanced neurotoxicity has been associated with concurrent use of intrathecal cytarabine and other cytotoxic agents administered intrathecally. Renal/Hepatic function impairment: Patients with renal or hepatic function impairment may have a higher likelihood of CNS toxicity after high-dose cytarabine. Use the drug with caution and possibly at reduced doses in patients with poor liver or kidney function.

Drug Side Effects ::

 Adverse Reactions

CNS: Headache, dizziness; seizures, cerebral or cerebellar dysfunction presenting as personality changes, somnolence, coma, ataxia, dysarthria, and nystagmus (high dose); sensory neuropathy (high dose); necrotizing leukoencephalopathy with intrathecal cytarabine and cranial radiation. DERMATOLOGIC: Rash; cellulitis; thrombophlebitis; palmar-plantar erythrodysesthesia; severe rash with desquamation (high dose). GI: Nausea; vomiting; anorexia; mucositis; diarrhea; transient elevation of LFTs; neutropenic colitis; severe GI ulceration (high dose). HEMATOLOGIC: Bone marrow suppression. RESPIRATORY: Pulmonary edema, diffuse interstitial pneumonitis (high dose). OTHER: Cytarabine syndrome; arthralgias; myalgias; chest pain; fever; general feeling of discomfort or weakness; reddened eyes; skin rash. SPECIALSENSES: Hemorrhagic conjunctivitis, corneal toxicity, photophobia (high dose).

Drug Mode of Action ::  

Drug Interactions ::

Interactions

L-asparaginase

Prior therapy with L-asparaginase may increase the risk of acute pancreatitis.

Digoxin

Oral absorption of digoxin may be decreased.

Gentamicin

Gentamicin effectiveness against K. pneumoniae strains may be decreased.

Quinolone antibiotics

Cytarabine may decrease the oral absorption of quinolone antibiotics.

Drug Assesment ::

 Assessment/Interventions

• Hyperuricemia may occur due to rapid cell lysis; monitor serum uric acid. Minimize effects of hyperuricemia with hydration, urinary alkalinization, and allopurinol.
• During induction therapy, perform leukocyte and platelet counts daily. Perform bone marrow examinations frequently after blasts have disappeared from the peripheral blood.
• Suspend or modify therapy when drug-induced marrow depression results in a platelet count < 50,000/mm³ or a polymorphonuclear granulocyte count < 1000/mm³.
• Perform periodic checks of bone marrow, liver, and kidney functions.
• Observe patients on high-dose cytarabine for neuropathy.

Drug Storage/Management ::

 Administration/Storage

• Store at room temperature.
• When reconstituted with Bacteriostatic Water for Injection (with benzyl alcohol), cytarabine is stable for 2 days at room temperature. Use preservative-free cytarabine solutions within 24 hr of reconstitution. Discard if solution appears hazy.
• Diluted cytarabine solutions (concentration 0.5 mg/mL) are stable for 8 days at room temperature when diluted with Sterile Water, 0.9% Sodium Chloride, or 5% Dextrose.
• Administer by SC/IM injection, IV injection or infusion, intrathecal.
• Rotate injection sites for SC/IM administration.

IV Infusion

• Reconstitute with Bacteriostatic Water for Injection (with 0.9% benzyl alcohol). May be further diluted with > 50 mL of 0.9% Sodium Chloride for IV infusion.
• Give by bolus injection over 1 to 3 min through a running IV line; infuse IV over 15 min in > 50 mL of 0.9% Sodium Chloride; continuous IV infusion over 5 days. Cytarabine doses are often infused over 30 min.

Intrathecal

• Dilute with an isotonic buffered diluent without preservative such as Lactated Ringer’s injection or 0.9% Sodium Chloride.

High Dose

• Dilute with preservative-free 0.9% Sodium Chloride.
• Give IV infusion over 1 to 3 hr.

SC/IM

• Smaller volumes of diluent can be used to prepare a 100 mg/mL solution for SC/IM injection.

Drug Notes ::

 Patient/Family Education

• Inform patients about the expected adverse events of headache, nausea, vomiting, and fever, and about the early signs and symptoms of neurotoxicity. Instruct patients to seek medical attention if signs or symptoms of neurotoxicity develop, or if oral dexamethasone is not well tolerated.

Medicscientist Drug Facts

Disclaimer ::

The Information available on this site is for only Informational Purpose , before any use of this information please consult your Doctor .Price of the drugs indicated above may not match to real price due to many possible reasons may , including local taxes etc.. These are only approximate indicative prices of the drug.