#高警訊藥品

睪丸癌
Testicular cancer: Treatment (third-line) of germ cell testicular cancer, in combination with other chemotherapy drugs and with concurrent mesna for prophylaxis of hemorrhagic cystitis

Antineoplastic Agent, Alkylating Agent
Ifosfamide causes cross-linking of strands of DNA by binding with nucleic acids and other intracellular structures, resulting in cell death; inhibits protein synthesis and DNA synthesis

1. Metabolism: Hepatic
2. Excretion: (Renal, low doses) 12 to 18%; (high doses) 70 to 86%; (unchanged) 61%
3. Renal clearance: 1.28 L/hr
4. Dialyzable: Yes
5. Elimination Half Life: 7 h

1. Hypersensitivity to ifosfamide.
2. Urinary outflow obstruction.
3. Severe leukopenia/thrombocytopenia; severe renal and/or hepatic impairment; cystitis; active infection; advanced cerebral arteriosclerosis

D

Infant risk cannot be ruled out.

Alopecia, nausea and vomiting, anemia, leukopenia, infectious disease, hematuria

Testicular cancer:
IV 1,200 mg/m²/day for 5 days every 3 weeks for 4 cycles
1. VIP regimen (in combination with etoposide, mesna, and cisplatin)
2. VeIP regimen (in combination with vinblastine, mesna, and cisplatin)
Administration:
1. Infusion over 30-120 minutes or continuous 24 hours (refer to specific protocol for infusion duration).
2. To prevent bladder toxicity, ifosfamide should be given with mesna and hydration.

Safety and effectiveness in children have not been established.

1. CrCl ≥50 mL/minute: No dosage adjustment necessary.
2. CrCl <50 mL/minute, Hemodialysis: Use is not recommended.

1. Bilirubin >3 mg/dL: Administer 25% of dose.
2. Mild or moderate impairment: No dosage adjustment necessary.
3. Severe impairment: Use is not recommended.

1. Reconstitution: Reconstitute powder with sterile water for injection to a final concentration of 50 mg/mL.
2. Dilution: may be diluted with D5W, NS, LR, or Sterile Water for Injection to a final concentration of 0.6 to 20 mg/mL.
3. Administration: slow IV infusion over at least 30 minutes.
4. Storage: Store unopened vials at controlled room temperature between 20 and 25°C (Protect from above 30°C); Refrigerate reconstituted or reconstituted and further diluted solutions and use within 24 hours.