REMS
Paclitaxel:
- Advanced ovarian cancer (with cisplatin).
- Non-small cell lung cancer (NSCLC) when potentially curative surgery and/or radiation therapy is not an option.
- Metastatic breast cancer unresponsive to other therapy.
- Node-positive breast cancer when administered sequentially to standard combination chemotherapy that includes doxorubicin.
- Treatment of AIDS-related Kaposi’s sarcoma.
Paclitaxel (albumin-bound):
- Metastatic breast cancer after treatment failure or relapse where therapy included an anthracycline.
- Locally advanced or metastatic NSCLC when potentially curative surgery or radiation therapy is not an option (with carboplatin).
- Metastatic pancreatic adenocarcinoma (with gemcitabine)
Absorption: IV administration results in complete bioavailability.
Distribution: Cross the placenta.
Protein Binding: 89–98%.
Metabolism/Excretion: Highly metabolized by the liver (primarily by CYP2C8 and CYP3A4), <10% excreted unchanged in urine.
Half-life: Paclitaxel — 13–52 hr; Paclitaxel protein-bound particles (albumin-bound) — 27 hr.
CV: ECG changes, edema, hypotension, bradycardia.
Derm: STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, alopecia.
GI: diarrhea, ↑liver enzymes, mucositis, nausea, vomiting, pancreatitis.
Hemat: neutropenia, anemia, thrombocytopenia.
Local: injection site reactions.
MS: arthralgia, myalgia.
GU: renal failure.
Neuro: peripheral neuropathy , dizziness, headache, seizures.
Resp: PULMONARY EMBOLISM, PULMONARY FIBROSIS, cough, dyspnea, interstitial pneumonia.
Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), SEPSIS.
Many other regimens are used
Paclitaxel
Ovarian Cancer- IV (Adults): Previously untreated patients — 175 mg/m2 over 3 hr every 3 wk or 135 mg/m2 over 24 hr every 3 wk, followed by cisplatin; Previously treated patients — 135 mg/m2 or 175 mg/m2 over 3 hr every 3 wk.
Breast Cancer- IV (Adults): Adjuvant treatment of node-positive breast cancer — 175 mg/m2 over 3 hr every 3 wk for 4 courses administered sequentially to doxorubicin-containing combination chemotherapy; Failure of initial therapy for metastatic disease or relapse within 6 mo of adjuvant therapy — 175 mg/m2 over 3 hr every 3 wk.
NSCLC- IV (Adults): 135 mg/m2 over 24 hr every 3 wk, followed by cisplatin.
AIDS-Related Kaposi’s Sarcoma- IV (Adults): 135 mg/m2 over 3 hr every 3 wk or 100 mg/m2 over 3 hr every 2 wk (dose ↓/adjustment may be necessary in patients with advanced HIV infection).
Paclitaxel Protein-Bound Particles (albumin-bound)
Breast Cancer- IV (Adults): 260 mg/m2 over 30 min every 3 wk.
Hepatic Impairment
- IV (Adults): Moderate hepatic impairment (AST levels <10 × ULN and bilirubin levels 1.51–3 × ULN) — 200 mg/m2 over 30 min every 3 wk; dose may be ↑ to 260 mg/m2 for the 3rd course based on individual tolerance; Severe hepatic impairment (AST levels <10 × ULN and bilirubin levels 3.01–5× ULN) — 200 mg/m2 over 30 min every 3 wk; dose may be ↑ to 260 mg/m2 for the 3rd course based on individual tolerance; Severe hepatic impairment (AST levels >10 × ULN or bilirubin levels >5 × ULN) — Avoid use.
NSCLC- IV (Adults): 100 mg/m2 over 30 min on Days 1, 8, and 15 of each 21-day cycle.
Hepatic Impairment
- IV (Adults): Moderate hepatic impairment (AST levels <10 × ULN and bilirubin levels 1.51–3 × ULN) — 80 mg/m2 over 30 min on Days 1, 8, and 15 of each 21–day cycle; dose may be ↑ to 100 mg/m2 for the 3rd course based on individual tolerance; Severe hepatic impairment (AST levels <10 × ULN and bilirubin levels 3.01–5 × ULN) — 80 mg/m2 over 30 min on Days 1, 8, and 15 of each 21–day cycle; dose may be ↑ to 100 mg/m2 for the 3rd course based on individual tolerance; Severe hepatic impairment (AST levels >10 × ULN or bilirubin levels >5 × ULN) — Avoid use.
Pancreatic Adenocarcinoma- IV (Adults): 125 mg/m2 over 30–40 min on Days 1, 8, and 15 of each 28–day cycle.
Hepatic Impairment
- IV (Adults): Moderate or severe hepatic impairment — Avoid use.
Taxol
paclitaxel protein-bound particles (Albumin-Bound): Abraxane
Therapeutic Classification: antineoplastics
Pharmacologic Classification: taxoids
Paclitaxel
(generic available)
- Solution for injection: 6 mg/mL;
Paclitaxel Protein-Bound Particles (albumin-bound)
- Lyophilized powder for injection: 100 mg/vial;
1500/mm3 (for patients with ovarian, lung, breast, or pancreatic cancer) or 
Grade 3 sensory neuropathy occurs, withhold paclitaxel protein-bound (albumin-bound) until resolution to Grade 1 or 2 for metastatic breast cancer or until resolution to