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hydroxyurea (Rx)Brand and Other Names:Droxia, Hydrea, more...hydroxycarbamide

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsules

  • 200mg
  • 300mg
  • 400mg
  • 500mg
more...

Solid Tumors

Intermittent Therapy: 80 mg/kg PO q3day, OR 

Continuous Therapy: 20-30 mg/kg PO qDay

Head & Neck Tumors

Concomitant therapy with irradiation

  • 80 mg/kg PO q3days 
  • Begin 7 days prior to initiation of irradiation

Chronic Myelocytic Leukemia, Resistant

Continuous Therapy: 20-30 mg/kg PO qDay 

Sickle Cell Disease

Start: 15 mg/kg/day as single dose; monitor patient’s blood count every two weeks 

Titrate by 5 mg/kg/day q12wk

Dose is not increased if blood counts are between acceptable range and toxic

Not to exceed 35 mg/kg/day

Discontinue therapy until hematologic recovery if blood counts are considered toxic; may resume treatment after reducing dose by 2.5 mg/kg/day from dose associated with hematological toxicity

Thrombocythemia, Essential

15 mg/kg PO qDay 

Titrate to control platelets & maintain WBC count

HIV, Adjunct Treatment (Off-label)

500 mg PO BID

Use with antiretrovirals

Psoriasis (Off-label)

1000-1500 mg/day PO qDay-BID

Other Information

Monitor: CBC

Sickle Cell Disease (Orphan)

Siklos: Orphan designation for treatment of sickle cell disease in patients aged <18 yr

Pedroxa: Treatment of symptomatic sickle cell disease in children aged <17 yr

Sponsors

  • Siklos: addmedica Laboratories; 101 rue Saint Lazare; Paris75009 France
  • Pedroxa: Ebelle D'Ebelle Pharmaceuticals LLC; 5 Witherwood Drive; Hamburg, NJ 07419
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Interactions

Interaction Checker

hydroxyurea and

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse Effects

            Frequency Not Defined

            Nausea

            Vomiting

            Constipation

            Diarrhea

            Mucositis

            Acute pulmonary reactions (rare)

            Genetic mutation (long-term use)

            Myelosuppression

            Secondary leukemia (long-term use)

            Elevated BUN, Cr

            Hyperuricemia

            Renal failure

            Rash

            Hyperpigmentation

            Skin ulcer

            Gangrenous disorder

            Postmarketing Reports

            Tumor lysis syndrome

            Anemia

            Gastric irritation

            Platelet depression

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            Warnings

            Black Box Warnings

            Hydroxyurea therapy may be complicated by severe, sometimes life-threatening, adverse effects; because of this, it should be administered under the supervision of a physician experienced in the use of this medication

            Hydroxyurea is mutagenic and clastogenic, and causes cellular transformation to a tumorigenic phenotype, and is thus unequivocally genotoxic and a presumed transspecies carcinogen that implies a carcinogenic risk to humans; advise sun protection and monitor patients for malignancies

            Hydroxyurea may cause severe myelosuppression; do not administer if bone marrow function is markedly depressed; monitor blood counts at baseline and throughout treatment; interrupt treatment and reduce dose as necessary

            In patients receiving long-term hydroxyurea for myeloproliferative disorders, such as polycythemia vera and thrombocythemia, secondary leukemias have been reported

            It is unknown whether this leukemogenic effect is secondary to hydroxyurea or is associated with the patients' underlying disease

            The physician and patient must very carefully consider the potential benefits relative to the undefined risk of developing secondary malignancies

            Contraindications

            Hypersensitivity

            Severe anemia, bone marrow depression

            WBC <2500/mm³, platelets <100,000/mm³

            Pregnancy, lactation

            Cautions

            Caution in renal impairment, coadministration with myelosuppressive agents

            Leukopenia and neutropenia commonly occur; thrombocytopenia and anemia are less common; hematologic toxicity is reversible

            Do not change dose too frequently

            Not recommended in sickle cell anemia if neutrophils <2,000/mm³, platelets <80,000/mm³, hemoglobin <4 g/dL, or reticulocytes <80,000/mm³ when hemoglobin <9 g/dL

            Increased risk of hepatotoxicity, which may be fatal, may occur, particularly in combination with didanosine and stavudine

            Risk of cutaneous vasculitic toxicities in patients with myeloproliferative disorders, especially with history of or concurrent interferon therapy

            Discontinue if WBC <2500/mm³ and/or plateletes<100,000/mm³

            Erythrocyte abnormalities reported; self-limiting megaloblastic erythropoiesis reported early in treatment, unrelated to vitamin B12 or folic acid deficiency

            Hyperuricemia may occur; adequate hydration, dosage adjustment, or initiation of uricosuric agents may be necessary

            Interferes with analytical analyses of the enzymes (urease, uricase, and lactate dehydrogenase) used in the determination of urea, uric acid and lactic acid, rendering falsely elevated results

            Advise females of reproductive potential to use effective contraception during and after treatment for at least 6 months after therapy; advise males of reproductive potential to use effective contraception during and after treatment for at least 1 year after therapy

            Avoid use of live vaccine; concomitant use with a live virus vaccine may potentiate replication of virus and/or may increase adverse reaction of vaccine because normal defense mechanisms may be suppressed; may result in severe infection; antibody response to vaccine may be decreased

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: excreted in breast milk, do not nurse

            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.

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            Pharmacology

            Mechanism of Action

            The precise mechanism by which hydroxyurea produces its cytotoxic and cytoreductive effects is not known. However, various studies support the hypothesis that hydroxyurea causes an immediate inhibition of DNA synthesis by acting as a ribonucleotide reductase inhibitor, without interfering with the synthesis of ribonucleic acid or of protein.

            The mechanisms by which hydroxyurea produces its beneficial effects in patients with sickle cell anemia (SCA) are uncertain. Known pharmacologic effects of hydroxyurea that may contribute to its beneficial effects include increasing hemoglobin F levels in red blood cells (RBCs), decreasing neutrophils, increasing the water content of RBCs, increasing deformability of sickled cells, and altering the adhesion of RBCs to endothelium.

            Absorption

            Duration: up to 24 hr

            Peak Plasma Time: 1-4 hr

            Distribution

            Vd: 0.5 L/kg

            Protein binding: 75-80%

            Metabolism

            Metabolized (60%) by liver and GI tract

            Metabolites: CO2, urea

            Elimination

            Half-Life: 2-4 hr

            Excretion: Urine (40% of administered dose in sickle cell anemia patients)

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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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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