Hydrea

— THERAPEUTIC CATEGORIES —
  • Head and neck cancer
  • Leukemias, lymphomas, and other hematologic cancers
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Hydrea Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Hydroxyurea 500mg; caps.

    Pharmacological Class

    Antimetabolite.

    How Supplied

    Caps—100

    Manufacturer

    Bristol Myers Squibb

    Generic Availability

    YES

    Mechanism of Action

    The precise mechanism by which hydroxyurea produces its antineoplastic effects cannot, at present, be described. However, the reports of various studies in tissue culture in rats and humans lend support to 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.

    Hydrea Indications

    Indications

    Locally advanced squamous cell carcinomas of the head and neck (excluding the lip), in combination with concurrent chemoradiation.

    Hydrea Dosage and Administration

    Adult

    Base dose on ideal or actual weight, whichever is less. Individualize. Initially 15mg/kg/day. Renal impairment (CrCl <60mL/min or ESRD): initially 7.5mg/kg/day; give dose following dialysis (monitor). Dose modifications: see full labeling.

    Children

    Not established.

    Hydrea Contraindications

    Not Applicable

    Hydrea Boxed Warnings

    Not Applicable

    Hydrea Warnings/Precautions

    Warnings/Precautions

    Risk of severe myelosuppression. Markedly depressed bone marrow function: do not initiate. Monitor CBCs prior to and during therapy; interrupt, reduce dose, or discontinue as needed. Discontinue if confirmed diagnosis of hemolytic anemia. Monitor for secondary malignancies (eg, leukemia, skin cancer). Avoid sun exposure. Previous irradiation therapy; monitor for skin erythema. Macrocytosis may mask folic acid deficiency; prophylactic folic acid is recommended. Pulmonary toxicity (monitor). Myeloproliferative disorders; discontinue if cutaneous vasculitic ulcerations occur. Renal or hepatic impairment. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for ≥6 months (females of reproductive potential) or ≥1 year (males) after therapy. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended.

    Hydrea Pharmacokinetics

    Absorption

    Peak plasma concentrations are reached in 1–4 hours.

    Distribution

    Distributed throughout the body with a volume of distribution approximating total body water.

    Metabolism

    Hepatic.

    Elimination

    Renal (40%). 

    Hydrea Interactions

    Interactions

    Avoid concomitant didanosine, with or without stavudine, or other antiretrovirals (may cause pancreatitis [monitor], fatal hepatotoxicity, peripheral neuropathy). Avoid live vaccines. Increased risk of vasculitic toxicities with interferon therapy. May cause falsely elevated results in urea, uric acid, and lactic acid assays. May falsely elevate sensor glucose results from certain continuous glucose monitoring (CGM) systems leading to hypoglycemia, if results are relied upon to dose insulin.

    Hydrea Adverse Reactions

    Adverse Reactions

    Leukopenia, thrombocytopenia, anemia, GI upset, anorexia; secondary malignancies, macrocytosis, interstitial lung disease.

    Hydrea Clinical Trials

    See Literature

    Hydrea Note

    Notes

    Wear disposable gloves when handling caps or bottle.

    Hydrea Patient Counseling

    See Literature

    Hydrea Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Hydroxyurea 500mg; caps.

    Pharmacological Class

    Antimetabolite.

    How Supplied

    Caps—100

    Manufacturer

    Bristol Myers Squibb

    Generic Availability

    YES

    Mechanism of Action

    The precise mechanism by which hydroxyurea produces its antineoplastic effects cannot, at present, be described. However, the reports of various studies in tissue culture in rats and humans lend support to 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.

    Hydrea Indications

    Indications

    Resistant chronic myeloid leukemia.

    Hydrea Dosage and Administration

    Adult

    Base dose on ideal or actual weight, whichever is less. Individualize. Initially 15mg/kg/day. Renal impairment (CrCl <60mL/min or ESRD): initially 7.5mg/kg/day; give dose following dialysis (monitor). Dose modifications: see full labeling.

    Children

    Not established.

    Hydrea Contraindications

    Not Applicable

    Hydrea Boxed Warnings

    Not Applicable

    Hydrea Warnings/Precautions

    Warnings/Precautions

    Risk of severe myelosuppression. Markedly depressed bone marrow function: do not initiate. Monitor CBCs prior to and during therapy; interrupt, reduce dose, or discontinue as needed. Discontinue if confirmed diagnosis of hemolytic anemia. Monitor for secondary malignancies (eg, leukemia, skin cancer). Avoid sun exposure. Previous irradiation therapy; monitor for skin erythema. Macrocytosis may mask folic acid deficiency; prophylactic folic acid is recommended. Pulmonary toxicity (monitor). Myeloproliferative disorders; discontinue if cutaneous vasculitic ulcerations occur. Renal or hepatic impairment. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for ≥6 months (females of reproductive potential) or ≥1 year (males) after therapy. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended.

    Hydrea Pharmacokinetics

    Absorption

    Peak plasma concentrations are reached in 1–4 hours.

    Distribution

    Distributed throughout the body with a volume of distribution approximating total body water.

    Metabolism

    Hepatic.

    Elimination

    Renal (40%). 

    Hydrea Interactions

    Interactions

    Avoid concomitant didanosine, with or without stavudine, or other antiretrovirals (may cause pancreatitis [monitor], fatal hepatotoxicity, peripheral neuropathy). Avoid live vaccines. Increased risk of vasculitic toxicities with interferon therapy. May cause falsely elevated results in urea, uric acid, and lactic acid assays. May falsely elevate sensor glucose results from certain continuous glucose monitoring (CGM) systems leading to hypoglycemia, if results are relied upon to dose insulin.

    Hydrea Adverse Reactions

    Adverse Reactions

    Leukopenia, thrombocytopenia, anemia, GI upset, anorexia; secondary malignancies, macrocytosis, interstitial lung disease.

    Hydrea Clinical Trials

    See Literature

    Hydrea Note

    Notes

    Wear disposable gloves when handling caps or bottle.

    Hydrea Patient Counseling

    See Literature

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