#高警訊藥品

治療乳癌、晚期卵巢癌、非小細胞肺癌、卡波西氏肉瘤
Breast cancer:
1. Adjuvant therapy for node-positive disease, administered sequentially to standard doxorubicin-containing regimen.
2. After failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.
Ovarian cancer, Advanced:
First-line therapy in combination with cisplatin; or in patients previously treated with chemotherapy
Non-small cell lung cancer:
First-line therapy in combination with cisplatin in patients who are not candidates for surgery and/or radiation
AIDS-related Kaposi's sarcoma:
Second line treatment

Antineoplastic Agent, Taxane Derivative
Paclitaxel promotes microtubule assembly by enhancing the action of tubulin dimers, stabilizing existing microtubules, and inhibiting their disassembly, interfering with the late G2 mitotic phase, and inhibiting cell replication. In addition, the drug can distort mitotic spindles, resulting in the breakage of chromosomes. Paclitaxel may also suppress cell proliferation and modulate immune response.

Distribution:
Vd: 227 to 688 L/m²
Metabolism:
Hepatic: via CYP2C8 and CYP3A4 pathways
Excretion:
Biliary; Renal: 1.3% to 12.6%
Elimination Half Life:
5.3to 17.4h

1. Baseline neutrophil counts of less than 1500 cells/mm³ in patients with solid tumors or less than 1000 cells/mm³ in patients with AIDS-related Kaposi's sarcoma .
2. Hypersensitivity to paclitaxel or to other drugs formulated in polyoxyl 35 castor oil.

D (FDA) (AUS)

Infant risk cannot be ruled out.(MDX)

Cardiovascular: Flushing, ECG abnormality, edema, hypotension
Central nervous system: Peripheral neuropathy
Dermatologic: Alopecia, skin rash
Gastrointestinal: Nausea, vomiting, diarrhea, mucositis, stomatitis, abdominal pain
Hematologic & oncologic: Neutropenia, leukopenia, anemia, thrombocytopenia, hemorrhage
Hepatic: Increased serum alkaline phosphatase, increased serum AST
Hypersensitivity: Hypersensitivity reaction
Infection: Infection
Local: Injection site reaction
Neuromuscular & skeletal: Arthralgia, myalgia, weakness
Renal: Increased serum creatinine

Breast cancer:
1. Metastatic or relapsed: 175 mg/m² over 3 hours every 3 weeks
2. Adjuvant treatment: 175 mg/m² over 3 hours every 3 weeks for 4 cycles (administer sequentially following an anthracycline-containing regimen)
Ovarian cancer, advanced:
175 mg/m² over 3 hours every 3 weeks (in combination with cisplatin) or 135 mg/m² over 24 hours administered every 3 weeks (in combination with cisplatin)
Non-small cell lung cancer:
135 mg/m² over 24 hours every 3 weeks (in combination with cisplatin)
Kaposi sarcoma, AIDS related:
135 mg/m² over 3 hours every 3 weeks or 100 mg/m² over 3 hours every 2 weeks

Safety and effectiveness not established in pediatric patients.

1. There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment is likely not necessary.
2. Paclitaxel is not dialyzable, it may be used either before or after hemodialysis.

24-hour infusion:
1. Transaminases <2 times upper limit of normal (ULN) and bilirubin level ≤1.5 mg/dL: 135 mg/m²
2. Transaminases 2 to <10 times ULN and bilirubin level ≤1.5 mg/dL: 100 mg/m²
3. Transaminases <10 times ULN and bilirubin level 1.6 to 7.5 mg/dL: 50 mg/m²
4. Transaminases ≥10 times ULN or bilirubin level >7.5 mg/dL: Avoid use
3-hour infusion:
1. Transaminases <10 times ULN and bilirubin level ≤1.25 times ULN: 175 mg/m²
2. Transaminases <10 times ULN and bilirubin level 1.26 to 2 times ULN: 135 mg/m²
3. Transaminases <10 times ULN and bilirubin level 2.01 to 5 times ULN: 90 mg/m²
4. Transaminases ≥10 times ULN or bilirubin level >5 times ULN: Avoid use