Adult Dosing
Cancer of ovary (Taxol, paclitaxel (generic))
Previously untreated patients
- 175 mg/m2 IV over 3 hrs followed by 75 mg/m2 cisplatin dose OR 135 mg/m2 IV over 24 hrs q3 wks followed by cisplatin 75 mg/m2
Previously treated patients
- 175 mg/m2 or 135 mg/m2 IV over 3 hrs q3 weeks
Breast carcinoma, metastatic or relapsed
paclitaxel (generic), Taxol
- Initial: 175 mg/m2 IV over 3 hrs q3 wks for four courses administered sequentially to doxorubicin-containing combination chemotherapy
- After failure of initial chemotherapy: 175 mg/m2 IV over 3 hrs q3 weeks
Abraxane
- 260 mg/m2 IV q3 wks after failure of combination chemotherapy or relapse within 6 months of adjuvant chemotherapy
Non-small cell lung carcinoma
Taxol, paclitaxel (generic)
- 135 mg/m2 IV over 24 hrs q3 wks followed by cisplatin 75 mg/m2
Abraxane
- 100 mg/m² IV infused over 30 minutes on days 1, 8, and 15 of each 21-day cycle + Carboplatin AUC 6 mg•min/mL IV on Day 1 of each 21 day cycle immediately after paclitaxel protein bound infusion
AIDS-related Kaposi's sarcoma
Taxol, paclitaxel (generic)
- 135 mg/m2 IV over 3 hrs q3 wks; Alt: 100 mg/m2 IV over 3 hrs q2 wks
Note: Dosage modifications are based on hematologic and peripheral neuropathy toxicities
Pancreatic cancer
Abraxane
- 125 mg/m² IV infused over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle. Administer gemcitabine 1000 mg/m2 IV infused over 30-40 minutes immediately after paclitaxel protein bound on Days 1, 8 and 15 of each 28-day cycle
Pediatric Dosing
- Safety and effectiveness of paclitaxel in pediatric patients have not been established
[Outline]
Renal Dose Adjustment
- Renal impairment: Dose adjustment not defined
Hepatic Dose Adjustment
Taxol, paclitaxel (generic)
- If usual dose 135 mg/m2: Reduce dose of first course of therapy as follows (24-hour infusion)
- If transaminase levels <2 x ULN and bilirubin
1.5 mg/dL: 135 mg/m2 - If transaminase levels 2 - <10 x ULN and bilirubin 1.5 mg/dL: 100 mg/m2
- If transaminase levels <10 x ULN and bilirubin 1.6-7.5 mg/dL: 50 mg/m2
- If transaminase levels >10 x ULN and bilirubin > 7.5 mg/dL: Avoid use
- Adjust further doses based on tolerance
- Dose adjustments for kaposi's sarcoma not defined
- If usual dose 135 mg/m2: Reduce dose of first course of therapy as follows (3-hour infusion)
- If transaminase levels <10 x ULN and bilirubin 1.25 x ULN: 175 mg/m2
- If transaminase levels <10 x ULN and bilirubin 1.26-2 x ULN: 135 mg/m2
- If transaminase levels <10 x ULN and bilirubin 2.01-5 x ULN: 90 mg/m2
- If transaminase levels >10 x ULN and bilirubin >5 x ULN: Avoid use
- Adjust further doses based on tolerance
- Dose adjustments for kaposi's sarcoma not defined
Breast cancer
Abraxane
- Mild (AST <10 x ULN; bilirubin >ULN-1.25 X ULN): 260 mg/m2
- Moderate (AST <10 x ULN; bilirubin 1.26-2 x ULN): Reduce starting dose to 200 mg/m2
- Severe: (AST <10 x ULN; bilirubin 2.01-5 x ULN): Reduce starting dose to 130 mg/m2, AST >10 x ULN or bilirubin >5 X ULN: Not recommended
Non-small cell lung carcinoma
Abraxane
- Mild (AST <10 x ULN; bilirubin >ULN to 1.25 X ULN): 100 mg/m2
- Moderate (AST <10 x ULN; bilirubin 1.26-2 x ULN): 75 mg/m2
- Severe: (AST <10 x ULN; bilirubin 2.01-5 x ULN): 50 mg/m2, AST >10 x ULN or bilirubin >5 X ULN: Do not administer paclitaxel protein bound
Pancreatic cancer
Abraxane
- Mild (AST <10 x ULN; bilirubin >ULN to 1.25 X ULN): 125 mg/m2
- Moderate-to-severe (AST <10 x ULN; bilirubin 1.26-5 x ULN): Not recommended, AST >10 x ULN or bilirubin >5 X ULN: Do not administer paclitaxel protein bound
- Therapy should be administered only under supervision of a physician experienced in cancer chemotherapy in an adequate medical facility to manage complications [US Black Box Warning]
- Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, generalized urticaria have been reported in 2-4% of patients. Pretreat all patient with corticosteroids, diphenhydramine, and H2 antagonists. Fatal reactions have occurred despite premedication; do not rechallenge after severe hypersensitivity reactions [US Black Box Warning]
- Monitor CBC regularly. Myelosuppression, primarily neutropenia, may be severe and may result in infection, avoid if baseline neutrophil count < 1500 cells/mm3 (solid tumors) or if < 1000 cells/mm3 (AIDS-related Kaposi's sarcoma) [US Black Box Warning]
- May cause bone marrow suppression (primarily neutropenia) in a dose dependent manner. Monitor CBC frequently while on therapy
- Severe conduction abnormalities have been documented in fewer than 1% of patients during therapy, sometimes requiring a pacemaker
- For solid tumors, do not retreat with subsequent cycles until neutrophils recover to > 1500/mm3 and platelets recover to > 100,000/mm3
- Paclitaxel (albumin form) should not be substituted for or with other paclitaxel forms
- Closely monitor infusion site for possible infiltration during administration
- Monitor LFTs, CBC with differential, and platelet count at baseline, then frequently. Monitor vital signs frequently during 1st hr of infusion
Cautions: use cautiously in
- Hepatic impairment
- Concomitant chemotherapy
- Active infection
- Myelosuppression
- Geriatric patients
Pregnancy Category:D
Breastfeeding: Unsafe. Due to the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of nursing or discontinuation of drug, taking into account the importance of the drug to the mother.
US Trade Name(s)
US Availability
paclitaxel (generic)
- PWDR for INJ: 6 mg/mL (5, 16.7, 50 mL vials)
Abraxane (paclitaxel albumin bound)
- PWDR for INJ: 100 mg/vial
Taxol
Canadian Trade Name(s)
Canadian Availability
paclitaxel (generic)
Abraxane
- PWDR for INJ: 5 mg/mL (20 mL vial)
Taxol
UK Trade Name(s)
UK Availability
paclitaxel (generic)
- PWDR for INJ: 6 mg/mL (5, 16.7, 50 mL vials)
Abraxane
- PWDR for INJ: 5 mg/mL (20 mL vial)
Australian Trade Name(s)
Australian Availability
paclitaxel (generic)
- PWDR for INJ: 6 mg/mL (5, 16.7, 50 mL vials)
Abraxane
- PWDR for INJ: 100 mg/vial
Anzatax
- INJ: 30 mg/5 mL
- INJ: 100 mg/16.7 mL
- INJ: 150 mg/25 mL
Taxol
- INJ: 30 mg/5 mL
- INJ: 100 mg/16.7 mL
- INJ: 150 mg/25 mL
- INJ: 300 mg/50 mL
[Outline]
