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  • Vesanoid ( tretinoin ) -Roche Laboratories

    Vesanoid: Black Box Warnings

    Appropriate Use
    weigh benefit vs. known adverse effects; admin. only by physician experienced in acute leukemia tx in adequate medical facility to manage complications
    Retinoic Acid-APL Syndrome
    occurs in 1st month of tx, possible after 1st dose; occurs in 25% of pts; incl. fever, dyspnea, acute resp. distress, weight gain, pulmonary infiltrates on x-ray, pleural and pericardial effusion, edema, and hepatic, renal, and multi-organ failure; may also incl. impaired myocardial contractility, episodic hypotension, and leukocytosis; at 1st signs give dexamethasone 10mg IV q12h x3 days or until sx resolve; cont. tretinoin tx in most pts, but may hold tx if mod-severe retinoic acid-APL syndrome
    Leukocytosis
    rapidly evolving leukocytosis assoc. w/ high risk of life-threatening complications occurs in 40% of pts, incr. risk if baseline WBC >5 x10^9/L; start high dose steroids immediately if retinoic acid-APL syndrome signs/sx also present; addition of chemotx can decr. incidence of retinoic acid-APL syndrome if baseline WBC >5 x10^9/L or baseline leukopenia w/ rapid incr. in WBC count on tretinoin tx; see pkg insert for chemo timing based on WBC count
    Teratogen
    high risk of severe fetal deformities; fully inform pregnant women or those of child-bearing potential of fetal risk, contraception failure risk, must use 2 reliable forms of contraception during and x1 month after D/C tx; must have neg. pregnancy test <1wk prior to tx start, or if unable to delay may start tx w/ 2 reliable forms of contraception; cont. pregnancy testing and contraception counseling qmo during tx

    Vesanoid: Adult Dosing

    Dosage forms: 10
    chemotherapy
    uses, dosing may vary
    Info: for all uses, refer to institution protocols and pkg insert prior to prescribing; see pkg insert for toxicity-related dose adjustments
    APL, remission induction
    45 mg/m^2/day PO div bid
    Max: duration 90 days; Info: D/C 30 days after remission; for FAB class M3 (incl. M3 variant) APL refractory to or relapsed from anthracycline tx or if anthracyclines contraindicated
    renal dosing
    not defined
    hepatic dosing
    not defined

    Vesanoid: Peds Dosing

    Dosage forms: 10
    chemotherapy
    uses, dosing may vary
    Info: for all uses, refer to institution protocols and pkg insert prior to prescribing; see pkg insert for toxicity-related dose adjustments
    APL, remission induction
    >1 yo
    Dose: 45 mg/m^2/day PO div bid; Max: duration 90 days; Info: D/C 30 days after remission; for FAB class M3 (incl. M3 variant) APL refractory to or relapsed from anthracycline tx or if anthracyclines contraindicated
    renal dosing
    not defined
    hepatic dosing
    not defined

    Vesanoid: Contraindications/Cautions

    • hypersens. to drug/class/compon.
    • hypersens. to retinoids
    • hypersens. to parabens
    • caution in pediatric pts

    Vesanoid: Adverse Reactions

    Serious Reactions
    • leukocytosis, rapidly evolving
    • RA-APL syndrome
    • hemorrhage
    • GI bleed
    • DIC
    • arrhythmia
    • pneumonia
    • renal insufficiency
    • cerebral hemorrhage
    • hepatosplenomegaly
    • pseudotumor cerebri
    • cardiac failure
    • cardiomyopathy
    • cerebellar edema
    • CNS depression
    • convulsions
    • encephalopathy
    • facial paralysis
    • GI ulceration
    • hemiplegia
    • hepatitis
    • MI
    • myocarditis/pericarditis
    • pulmonary HTN
    • renal failure
    • renal tubular necrosis
    • stroke
    • sepsis
    • thrombocytosis (rare)
    • thrombosis, venous/arterial
    • vasculitis (rare)
    • others: see pkg insert
    Common Reactions
    • headache
    • fever
    • weakness
    • skin/mucous membrane dryness
    • bone pain
    • malaise
    • shivering
    • hemorrhage
    • hypercholesterolemia
    • hypertriglyceridemia
    • infection
    • nausea/vomiting
    • rash
    • peripheral edema
    • elevated LFTs
    • leukocytosis, rapidly evolving
    • pain
    • GI bleeding
    • chest discomfort
    • abdominal pain
    • edema
    • DIC
    • GI disorders
    • mucositis
    • RA-APL syndrome
    • arrhythmias
    • diarrhea
    • earache/ear fullness
    • flushing
    • weight changes
    • dizziness
    • incr. sweating
    • pruritus
    • visual disturbance
    • others: see pkg insert

    Vesanoid: Safety Monitoring

    Pregnancy: D
    Lactation: Unsafe
    Monitoring Parameters: pregnancy test <1wk prior to tx start, then qmo; CBC, lipid panel, LFTs, PT/INR frequently

    Vesanoid: Pharmacology

    Metabolism: liver; CYP450: specific isozymes not defined
    Excretion: urine (63%), feces (31%); half-life: 0.5-2h
    Class: Other Oncologics
    Mechanism Of Action
    exact mechanism of action unknown; induces differentiation and decr. proliferation of APL cells (retinoid)

    Vesanoid: Manufacturer/Pricing

     
    Manufacturer: Roche Laboratories
    DEA/FDA: Rx

    Vesanoid: Patient Education

    Patient education material for this drug is not currently available.

    Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides.

    The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

    Vesanoid: Pill Pictures

    This information is currently unavailable or not applicable for this drug.

     


    Copyright 1996-2006 Cerner Multum, Inc. Version: 5.05. Revision Date: 10/09/2007
    Last Updated: 10/09/2007


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