#高警訊藥品

Advanced ovarian cancer (in combination with other established chemotherapy agents)

Antineoplastic Agent, Alkylating Agent; Platinum Analog
Carboplatin is a platinum compound alkylating agent which covalently binds to DNA; interferes with the function of DNA by producing interstrand DNA cross-links. Carboplatin is apparently not cell-cycle specific.

Distribution:
1. Vd: 16 L (based on a dose of 300 to 500 mg/m2); into liver, kidney, skin, and tumor tissue
2. Protein binding: (Carboplatin) 0%; (Platinum, from carboplatin): Irreversibly binds to plasma proteins
Metabolism:
1. Minimally hepatic to aquated and hydroxylated compounds
2. Half-life elimination, in patients CrCl >60 mL/minute: (Carboplatin) 2.6 to 5.9 hours; (Platinum ,from carboplatin): ≥5 days
Excretion:
Urine (~70% as carboplatin within 24 hours; 3% to 5% as platinum within 1 to 4 days)

1. Severe allergic reactions to cisplatin, platinum-containing compounds, or mannitol (certain preparations contain mannitol)
2. Severe bone marrow depression
3. Significant bleeding

D

Infant risk cannot be ruled out.

Common
1. Dermatologic: Alopecia
2. Endocrine metabolic: Hypocalcemia, Hypokalemia, Hypomagnesemia, Hyponatremia
3. Gastrointestinal: Abdominal pain, Diarrhea, Nausea, Vomiting
4. Hematologic: Anemia, Leukopenia, Neutropenia, Thrombocytopenia
5. Hepatic: Alkaline phosphatase raised, AST/SGOT level raised
6. Renal: Blood urea abnormal, Serum creatinine raised
7. Other: Pain
Serious
1. Hematologic: Myelosuppression
2. Immunologic: Hypersensitivity reaction
3. Ophthalmic: Unexplained visual loss, Visual disturbance

As a single agent:
1. IV 360 mg/m2 every 4 weeks
2. Dose adjustment (For single agnet Carboplatin):

Platelet	Neutrophil	Dose adjustment (compared to prior treatment dose)
>100,000	>2,000	125%
50~100,000	500~2,000	No adjustment
<50,0000	<500	75%

In combination with cyclophosphamide:
1. IV Carboplatin: 300 mg/m2 every 4 weeks for 6 cycles
2. IV Cyclophosphamide: 600 mg/m2 every 4 weeks for 6 cycles

Safety and effectiveness in pediatric patients have not been established

For single-agent therapy, by CrCl:
1. Baseline CrCl 41 to 59 mL/minute: Initiate at 250 mg/m2 and adjust subsequent doses based on bone marrow toxicity.
2. Baseline CrCl 16 to 40 mL/minute: Initiate at 200 mg/m2 and adjust subsequent doses based on bone marrow toxicity.
3. Baseline CrCl 15 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling.
By GFR:
1. GFR >50 mL/minute: No dosage adjustment is necessary.
2. GFR 10 to 50 mL/minute: Administer 50% of the usual dose.
3. GFR <10 mL/minute, CAPD: Administer 25% of the usual dose.
4. Hemodialysis: Administer 50% of the usual dose.
5. CRRT: 200 mg/m2

There are no dosage adjustments provided in the manufacturer's labeling; however, carboplatin undergoes minimal hepatic metabolism therefore dosage adjustment may not be needed.

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