#最小單位貼紙

慢性骨髓性白血病、頭及頸鱗狀細胞癌
Chronic myeloid leukemia (Resistant); Squamous cell carcinoma of head and neck (in combination with chemoradiation therapy)
#仿單變更2022

Antineoplastic Agent
Hydroxyurea is an antimetabolite that selectively inhibits ribonucleoside diphosphate reductase, preventing the conversion of ribonucleotides to deoxyribonucleotides, halting the cell cycle at the G1/S phase and therefore has radiation sensitizing activity by maintaining cells in the G1 phase and interfering with DNA repair. In sickle cell anemia, hydroxyurea increases red blood cell (RBC) hemoglobin F levels, RBC water content, deformability of sickled cells, and alters adhesion of RBCs to endothelium.

Absorption:
Tmax: 1 to 4 hours
Distribution:
1. Protein binding: 75-80%
2. Vd: Equal to total body water
Metabolism:
1. Liver: 60%
2. Elimination Half Life: 2 to 4.5 hours
Excretion:
1. Renal clearance: 1.8 to 2.1 L/hr/m2
2. Total body clearance: 4.3 to 5.5 L/hr/m2

Hypersensitivity to hydroxyurea or any component of the product.

D; Weigh the potential benefits of drug treatment against potential risks before prescribing this drug during pregnancy

Infant risk cannot be ruled out.

Common:
Decreased platelet count, Decreased reticulocyte count, Myelosuppression, Neutropenia
Serious:
Gangrenous disorder, Skin cancer, Skin ulcer, Ulcer of lower extremity, Genetic mutation, Parvovirus infection
Warnings:
1. Bone marrow suppression: Leukopenia and neutropenia commonly occur (thrombocytopenia and anemia are less common) and occur first.
2. Pulmonary toxicity: Interstitial lung disease, including pulmonary fibrosis, lung infiltration, pneumonitis, and alveolitis/allergic alveolitis (some cases fatal), have been reported.
3. Hemolytic anemia: Has been reported when used for the treatment of myeloproliferative diseases.<20220311>

Note: Dosing weight by actual or ideal weight, whichever is less

Chronic myeloid leukemia, Resistant:
Initial 40 mg/kg/day (reduce initial dose for thrombocytopenia); reduce dose to 20 mg/kg/day if WBC count <2,000/mm3
Squamous cell carcinoma of head and neck:
1,000 mg every 12 hours for 11 doses per cycle, in combination with continuous infusion fluorouracil and radiation therapy

1. CrCl ≥60 mL/min: No dosage adjustment (of initial dose) necessary
2. CrCl <60 mL/min: Reduce initial dose by 50% (to 7.5~10 mg/kg/day); titrate to response/avoidance of toxicity
3. End-stage renal disease (ESRD): Reduce initial dose by 50% (to 7.5~10 mg/kg/day); administer after dialysis on dialysis days

There are no dosage adjustments provided in the manufacturer's labeling; closely monitor for bone marrow toxicity.