Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 10mg/mL
- 20mg/mL
- 100mg/mL
intrathecal injection, liposomal (DepoCyt)
- 50mg/5mL
powder for injection
- 100mg/vial
- 500mg/vial
- 1g/vial
- 2g/vial
Acute Nonlymphocytic Leukemia
IV administration for remission induction
- 100-200 mg/sq.meter/day for 5-10 days; begin second course in 2-4 weeks after initial therapy if necessary OR
- 100 mg/sq.meter for 7 days OR
- 100 mg/sq.meter/dose q12hr for 7 days
IT administration for remission induction
- 5-75 mg/sq.meter q2-7Days until CNS findings normalize
IV administration for remission maintenance
- 70-200 mg/sq.meter/day for 2-5 days at monthly intervals
IM administration for remission maintenance
- 1-1.5 mg/kg single dose for maintenance at 1- 4 week intervals
Meningeal Leukemia
IT administration
Refractory Leukemia
IV administration
Lymphomatous Meningitis (DepoCyt)
IT liposomal administration
- IT by intraventricular or lumbar puncture
- Induction: 50 mg q14Days weeks 1 and 3 (2 doses total)
- Consolidation: 50 mg q14Days (weeks 5, 7, 9) and an additional dose on week 13
- Maintenance: 50 mg q28Days for 4 doses (weeks 17, 21, 25, and 29)
Gliomas (Orphan)
IT liposomal (DepoCyt) received orphan designation for gliomas
Orphan indication sponsor
- Bruce Frankel, MD; Medical University of South Carolina, 96 Jonathan Lucas Street, Suite 428 CSB; Charleston, SC 29425
Administration
Allopurinol & IV hydration recommended for patients at risk of tumor lysis syndrome
IT: Patient should lie flat for 1 hour after lumbar puncture
Liposomal: To reduce incidence of arachnoiditis, administer dexamethasone concurrently
Monitor
CBC, LFTs, renal function
Suspend prescription if platelets <50,000/cu.mm or PMNs <1000/cu.mm
Other Indications & Uses
Conventional: ALL, AML, NHL
Liposomal
Dosage Forms & Strengths
injectable solution
- 10mg/mL
- 20mg/mL
- 100mg/mL
powder for injection
- 100mg/vial
- 500mg/vial
- 1g/vial
- 2g/vial
Conventional
As in adults
Liposomal
Not recommended
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (6)
- adenovirus types 4 and 7 live, oral
cytarabine decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.
- cedazuridine
cedazuridine will increase the level or effect of cytarabine by decreasing metabolism. Avoid or Use Alternate Drug. Cedazuridine, a CDA inhibitor, is used with decitabine to increase systemic exposure of decitabine. Use with other drugs metabolized by CDA may increase levels and toxicities of those drugs.
- influenza virus vaccine quadrivalent, adjuvanted
cytarabine decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- influenza virus vaccine trivalent, adjuvanted
cytarabine decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- palifermin
palifermin increases toxicity of cytarabine by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.
- tofacitinib
cytarabine, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
Monitor Closely (19)
- acalabrutinib
acalabrutinib, cytarabine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.
- belatacept
belatacept and cytarabine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- cholera vaccine
cytarabine decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.
- dengue vaccine
cytarabine decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- denosumab
cytarabine, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- dichlorphenamide
dichlorphenamide and cytarabine both decrease serum potassium. Use Caution/Monitor.
- digoxin
cytarabine decreases levels of digoxin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Cytarabine may decrease digoxin absorption even several days after stopping chemotherapy. Digoxin capsules and digitoxin do not appear to be affected. .
- fingolimod
cytarabine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .
- hydroxyurea
cytarabine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- influenza A (H5N1) vaccine
cytarabine decreases effects of influenza A (H5N1) vaccine by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.
- influenza virus vaccine (H5N1), adjuvanted
cytarabine decreases effects of influenza virus vaccine (H5N1), adjuvanted by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.
- meningococcal group B vaccine
cytarabine decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.
- ofatumumab SC
ofatumumab SC, cytarabine. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.
- olaparib
cytarabine and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.
- siponimod
siponimod and cytarabine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- sipuleucel-T
cytarabine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.
- tobramycin inhaled
tobramycin inhaled and cytarabine both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- trastuzumab
trastuzumab, cytarabine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- trastuzumab deruxtecan
trastuzumab deruxtecan, cytarabine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
Minor (5)
- gentamicin
cytarabine decreases effects of gentamicin by unspecified interaction mechanism. Minor/Significance Unknown.
- maitake
maitake increases effects of cytarabine by pharmacodynamic synergism. Minor/Significance Unknown. Maitake mushroom has anti-tumor effects (animal/in vitro research).
- taurine
cytarabine decreases levels of taurine by unspecified interaction mechanism. Minor/Significance Unknown.
- vitamin A
vitamin A, cytarabine. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Antioxidants such as vitamin A enhance the efficacy, and reduce toxicity, of antineoplastic drugs.
- vitamin E
vitamin E, cytarabine. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Antioxidants such as vitamin E enhance the efficacy, and reduce toxicity, of antineoplastic drugs.
Adverse Effects
1-10%
Anorexia
Nausea
Vomiting
Diarrhea
Oral/anal inflammation
Thrombophlebitis
Bleeding
Myelosuppression
Rash
Fever
Hepatic dysfunction
Frequency Not Defined
Headache
Neuropathy
Chest pain
Pericarditis
Pneumonia
Anemia
Bleeding
Leukopenia
Thrombocytopenia
Kidney disease
Infectious disease
Sepsis
"Cytarabine syndrome": fever, myalgia, bone pain, rash, conjunctivitis, malaise
Skin ulcers
Cellulitis
Urinary retention
Neuritis
Jaundice
Anaphylaxis
Warnings
Black Box Warnings
Conventional formulation
- Only physicians experienced in cancer chemotherapy should administer
- For induction therapy, administer in facility with lab and supportive resources sufficient to monitor drug tolerance and protect and maintain patient if compromised by drug toxicity
- Main toxic effect is bone marrow suppression with leukopenia, thrombocytopenia, and anemia
- Less serious toxicity includes nausea, vomiting, diarrhea, abdominal pain, oral ulceration, and hepatic dysfunction
Arachnoiditis with liposomal IT administration
- In all clinical studies, chemical arachnoiditis, a syndrome manifested primarily by nausea, vomiting, headache and fever, was a common adverse event
- If left untreated, chemical arachnoiditis may be fatal
- The incidence and severity of chemical arachnoiditis can be reduced by coadministration of dexamethasone
Contraindications
Hypersensitivity
Liposomal cytarabine: active meningeal infection
Cautions
Potent bone marrow suppression
Severe and at times fatal CNS, GI, and pulmonary toxicity
Cardiomyopathy with subsequent death reported following experimental high dose therapy with cytarabine in combination with cyclophosphamide when used for bone marrow transplant preparation
Do not use benzyl alcohol-containing solutions IT or in neonates
Avoid pregnancy
Liposomal IT administration
- CSF flow assessment should be considered before treatment is started Blockage to CSF flow may increase risk of neurotoxicity due to increased serum concentrations
- To reduce incidence of arachnoiditis, administer dexamethasone concurrently
- Hydrocephalus has also been reported, possibly precipitated by arachnoiditis
- Infectious meningitis may be associated with IT drug administration
- Following IT administration, CNS toxicity, including persistent extreme somnolence, hemiplegia, visual disturbances including blindness which may be total and permanent, deafness, cranial nerve palsies, and visual disturbances including blindness which may be total and permanent, have been reported
- Symptoms and signs of peripheral neuropathy (eg, pain, numbness, paresthesia, weakness, impaired bowel and bladder control) observed; in some cases, these signs and symptoms have been reported as Cauda Equina Syndrome
Pregnancy & Lactation
Pregnancy Category: D
Lactation: not known if excreted in breast milk, avoid
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Metabolite cytarabine-5'-triphosphate inhibits DNA polymerase during S phase
Absorption
Systemic Exposure after IT: negligible
Peak plasma time: 20-60 min
Peak CSF time (IT): 60 min
Peak CSF concentration (IT): 30-50 mcg/mL
Distribution
Protein bound: 13%
Metabolism
Metabolism: liver (major), kidneys (minor); neglible following IT administration
Metabolites: cytarabine-5'-triphosphate (ara-CTP)
Elimination
Half-life: 1-3 hr
Half-life (CSF after IT): 5.9-82.4 hr
CSF clearance rate: 0.24 mL/min
Excretion: urine
Administration
IV Incompatibilities
Additive: fluorouracil, gentamicin(?), heparin, hydrocortisone sodium succinate(?), insulin, methylprednisolone(?), nafcillin, oxacillin, penicillin G sodium
Y-site: allopurinol, amphotericin B cholesteryl SO4, ganciclovir
IV Compatibilities
Solution: compatible with most common IV fluids
Additive: corticotropin, daunorubicin/etoposide, hydroxyzine, lincomycin, methotrexate, mitoxantrone, ondansetron, KCl, NaHCO3, vincristine
Syringe: metoclopramide
Y-site: amifostine, amsacrine, aztreonam, cefepime, chlorpromazine, cimetidine, cladribine, dexamethasone, diphenhydramine, doxorubicin liposomal, droperidol, etoposide PO4, famotidine, filgrastim, fludarabine, furosemide, gatifloxacin, gemcitabine, gentamicin, granisetron, heparin, hydrocortisone, hydromorphone, idarubicin, linezolid, lorazepam, melphalan, methotrexate, methylprednisolone, metoclopramide, morphine SO4, ondansetron, paclitaxel, piperacillin/tazobactam, prochlorperazine, promethazine, propofol, ranitidine, sargramostim, Na Bicarb, teniposide, thiotepa, vinorelbine
IV Preparation
Reconstitute vials in BWI containing benzyl alcohol 0.945% as follows (CAUTION: Do not use benzyl alcohol for intrathecal inj)
100 mg vial: add 5 mL diluent to 20 mg/mL
500 mg vial: add 10 mL diluent to 50 mg/mL
1 g vial: add 10 mL diluent to 100 mg/mL
2 g vial: add 20 mL diluent to 100 mg/mL
IV Administration
Rapid IV, infusion over 1-3 hr, or SC intrathecal
Has been administered by IM & continuous SC infusion
Storage
Store intact vials at controlled room temp
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| cytarabine injection - | 20 mg/mL vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
cytarabine injection
CYTARABINE - INJECTION
(sye-TAIR-uh-bean)
COMMON BRAND NAME(S): Cytosar-U, Tarabine PFS
WARNING: This medication may cause serious (rarely fatal) blood disorders (bone marrow suppression leading to anemia, low number of white blood cells and platelets). Liver problems may also occur. Your doctor will monitor you closely for these side effects.Tell your doctor right away if you develop any signs of infection (e.g., fever, chills, persistent sore throat), unusual fatigue, easy bruising or bleeding, nausea, vomiting, diarrhea, stomach/abdominal pain, dark urine, yellowing eyes/skin, or mouth sores.
USES: Cytarabine is used to treat various types of cancer. It is a chemotherapy drug that works by slowing or stopping cancer cell growth.
HOW TO USE: This medication is usually given by injection into a vein by a health care professional. It may also be given by other methods of injection depending upon your medical condition. The dosage is based on your medical condition, body size, and response to therapy.Unless your doctor instructs you otherwise, drink plenty of fluids while using this medication. This helps your kidneys remove the drug from your body and may help you avoid some of the side effects.
SIDE EFFECTS: See also the Warning section.Nausea, vomiting, loss of appetite, diarrhea, headache, dizziness, and pain/swelling/redness at the injection site may occur. Nausea and vomiting can be severe. In some cases, drug therapy may be needed to prevent or relieve nausea and vomiting. Not eating before your treatment may help relieve vomiting. Changes in diet such as eating several small meals or limiting activity may help lessen some of these effects. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Temporary hair loss may occur. Normal hair growth should return after treatment has ended.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: fever with body aches, muscle/bone pain, chest pain, eye redness/itching/pain, painful/difficult swallowing, anal sores, signs of kidney problems (such as change in the amount of urine), painful/difficult urination, joint/side/back pain, pain/redness/swelling of the arms/legs/feet, numbness or tingling of hands/feet, freckling, big toe pain, trouble breathing, black/bloody stools, blood in the urine, vomit that looks like coffee grounds, vision problems (including blindness), mental/mood changes (e.g., confusion), unexplained drowsiness, unconsciousness, enlarged abdomen, trouble walking, muscle weakness, loss of coordination, inability to move (paralysis), seizures.This medication can lower the body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills, unusual cough, or persistent sore throat.A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using cytarabine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: decreased bone marrow function/blood cell disorders (e.g., anemia, leukopenia, thrombocytopenia), liver disease, kidney disease, gout.Cytarabine can make you more likely to get infections or may worsen any current infections. Wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).This medication is not recommended for use during pregnancy. It may harm an unborn baby, especially in the first 3 months of pregnancy. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor.It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: digoxin, flucytosine, gentamicin.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include confusion, mental/mood changes.
NOTES: Laboratory and/or medical tests (such as complete blood counts, liver/kidney function, uric acid levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.
STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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