#高警訊藥品

乳癌、非小細胞肺癌、卵巢癌、卡波西氏肉瘤
Breast cancer:
1. Adjuvant treatment of node-positive breast cancer (as sequential therapy following anthracycline-containing combination chemotherapy)
2. treatment of metastatic breast cancer after failure of combination chemotherapy (for metastatic disease) or relapse within 6 months of adjuvant chemotherapy (prior therapy should have included an anthracycline unless contraindicated)
Non-small cell lung cancer:
First-line treatment of NSCLC (in combination with cisplatin) in patients who are not candidates for potentially curative surgery and/or radiation therapy
Ovarian cancer:
1. Subsequent therapy for treatment of advanced ovarian cancer
2. First-line therapy of ovarian cancer (in combination with cisplatin)
Kaposi sarcoma (AIDS-related):
Second-line treatment of AIDS-related Kaposi sarcoma

Antineoplastic Agent, Antimicrotubular; 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.

1. Distribution: Vd: 227 to 688 L/m2
2. Metabolism: (Hepatic) via CYP2C8 and CYP3A4 pathways
3. Excretion: (Renal) 1.3% to 12.6%
4. Elimination Half Life: 5.3 to 17.4h

1. Hypersensitivity to paclitaxel, polyoxyl 35/polyoxyethylated castor oil (Cremophor EL), or any component of the formulation
2. Treatment of solid tumors in patients with baseline neutrophil counts <1,500/mm3
3. Treatment of Kaposi sarcoma in patients with baseline neutrophil counts <1,000/mm3

1. Use of paclitaxel may be appropriate for the treatment of breast cancer and some gynecologic cancers during pregnancy .
2. In general, if chemotherapy is indicated, it should be avoided in the first trimester and there should be a 3-week time period between the last chemotherapy dose and anticipated delivery, and chemotherapy should not be administered beyond week 33 of gestation.

Due to the potential for serious adverse reactions in a breastfeeding infant, breastfeeding is not recommended by the manufacturer.

Common:
1. Dermatologic: Alopecia
2. Gastrointestinal: Diarrhea, Inflammatory disease of mucous membrane, Nausea and vomiting
3. Hematologic: Anemia, Leukopenia, Neutropenia, Thrombocytopenia
4. Immunologic: Hypersensitivity reaction
5. Musculoskeletal: Arthralgia, Myalgia
6. Neurologic: Peripheral neuropathy
Serious:
1. Cardiovascular: Atrial fibrillation, Cardiac dysrhythmia, Cardiotoxicity, Congestive heart failure, Myocardial infarction, Supraventricular tachycardia
2. Dermatologic: SJS, TEN
3. Gastrointestinal: Gastrointestinal perforation, Nausea and vomiting
4. Hematologic: Anemia, Deep venous thrombosis, Febrile neutropenia, Neutropenia, Thrombocytopenia
5. Immunologic: Anaphylaxis, Opportunistic infection, Sepsis
6. Neurologic: Peripheral neuropathy, Seizure, Tonic-clonic seizure
7. Respiratory: Pulmonary embolism, Respiratory failure

Breast cancer, adjuvant treatment: IV
175 mg/m2 over 3 hours every 3 weeks for 4 cycles (administer sequentially following an anthracycline-containing regimen)
Non-small cell lung cancer: IV
135 mg/m2 over 24 hours every 3 weeks (in combination with cisplatin)
Ovarian cancer, advanced: IV
1. Previously treated: 135 or 175 mg/m2 over 3 hours every 3 weeks
2. Previously untreated: 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)
Kaposi sarcoma, AIDS related: IV
135 mg/m2 over 3 hours every 3 weeks or 100 mg/m2 over 3 hours every 2 weeks (due to dose-related toxicity, the 100 mg/m2 dose should be used for patients with a lower performance status)
Note: Reduce the dexamethasone premedication dose to 10 mg

The safety and effectiveness of paclitaxel in pediatric patients have not been established.

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment is likely not necessary.

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.