Classifications: antineoplastic; antimetabolite; Therapeutic:antineoplastic; antimetabolite
Pregnancy Category: D
500 mg capsules
A cell-cycle-phase antineoplastic agent; hydroxyurea causes an immediate inhibition of DNA synthesis by acting as an RNA
reductase inhibitor, necessary for DNA synthesis but without interfering with the synthesis of RNA or protein.
Cytotoxic effect limited to tissues with high rates of cell proliferation. No cross resistance with other antineoplastics
has been demonstrated.
Palliative treatment of metastatic melanoma, chronic myelocytic leukemia; recurrent metastatic, or inoperable ovarian cancer.
Also used as adjunct to x-ray therapy for treatment of advanced primary squamous cell (epidermoid) carcinoma of head (excluding
lip), neck, lungs.
Psoriasis; combination therapy with radiation of lung carcinoma; sickle cell anemia.
Pregnancy (category D), lactation, children, myelosuppression.
Recent use of other cytotoxic drugs or irradiation; bone marrow depression; renal dysfunction; older adults; history of
Route & Dosage
Adult: PO 80 mg/kg q3d or 2030 mg/kg/d
Sickle Cell Anemia
Adult: PO 15 mg/kg/d, may increase by 5 mg/kg/d (max: of 35 mg/kg/d or until toxicity develops)
Clcr 1050 mL/min: administer 50% of dose; <10 mL/min: administer 20% of dose
Hemodialysis: Administer dose after hemodialysis; no supplemental dose needed
- Open, mix with water, and give immediately when patient has difficulty swallowing capsule.
- Store in tightly covered container at 15°30° C (59°86° F) unless otherwise directed.
Adverse Effects (≥1%)CNS:
Rare: Headache, dizziness, hallucinations, convulsions. GI:
Stomatitis, anorexia, nausea, vomiting, diarrhea, constipation
. Hematologic: Bone marrow suppression
anemia, thrombocytopenia), megaloblastic erythropoiesis. Skin:
Maculopapular rash, facial erythema, postirradiation erythema. Urogenital:
Renal tubular dysfunction, elevated BUN, serum, creatinine levels, hyperuricemia. Body as a Whole:
Fever, chills, malaise.
No clinically significant interactions established.
Readily absorbed from GI tract. Peak:
2 h. Distribution:
Crosses bloodbrain barrier. Metabolism:
In liver. Elimination:
As respiratory CO2
and as urea in urine.
Assessment & Drug Effects
- Lab tests: Determine status of kidney, liver, and bone marrow function before and periodically during therapy; monitor hemoglobin,
WBC, platelet counts at least once weekly.
- Interrupt therapy if WBC drops to 2500/mm3 or platelets to 100,000/mm3.
- Monitor I&O. Advise patients with high serum uric acid levels to drink at least 1012 240 mL (8 oz) glasses of fluid
daily to prevent uric acid nephropathy.
- Note: Patients with marked renal dysfunction may rapidly develop visual and auditory hallucinations and hematologic toxicity.
Patient & Family Education
- Note: Incidence of toxicity is as high as 66% with doses of 40 mg/kg body weight.
- Notify physician of fever, chills, sore throat, nausea, vomiting, diarrhea, loss of appetite, and unusual bruising or bleeding.
- Use barrier contraceptive during therapy. Drug is teratogenic.