cytarabine (Rx)

Brand and Other Names:Cytosar U, DepoCyt
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Dosing & Uses

AdultPediatric

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
more...

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

  • 30 mg/sq.meter intrathecal (IT) q4Days until CSF findings normal plus one additional dose 

Refractory Leukemia

IV administration

  • 3 g/sq.meter IV (infusion over 1-3 hours) q12hr x 4-12 doses 
  • Repeat q2-3Weeks

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
more...

Conventional

As in adults

Liposomal

Not recommended

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Interactions

Interaction Checker

and cytarabine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            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

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            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 pulmonoary 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
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            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.

            more...
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            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

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            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

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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