Paclitaxel Protein-Bound Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Breast Cancer

260 mg/m2 administered intravenously over 30 minutes every 3 weeks

Usual Adult Dose for Non-Small Cell Lung Cancer

100 mg/m2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. The recommended dose of carboplatin is target AUC of 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of paclitaxel protein-bound administration.

The Calvert Formula for calculating carboplatin dosing is: Total carboplatin dose (mg) = (target AUC) x (GFR + 25) with GFR capped at 125 mL/min. For carboplatin target AUC of 6 mg*min/mL the resulting maximum carboplatin dose is 900 mg.

Usual Adult Dose for Pancreatic Cancer

125 mg/m2 administered as an intravenous infusion over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle.

Administer gemcitabine immediately after paclitaxel protein-bound on Days 1, 8 and 15 of each 28-day cycle.

Approved indication: Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.

Renal Dose Adjustments

The effects of renal dysfunction on paclitaxel protein-bound particles has not been formally investigated.

Liver Dose Adjustments

No dose adjustment is necessary for patients with mild hepatic impairment. If AST is greater than 10 times ULN or bilirubin is greater than 5 times ULN, withhold paclitaxel protein-bound. For moderate hepatic impairment (AST less than 10 times ULN and bilirubin 1.26 to 2 times ULN) and severe hepatic impairment (AST less than 10 times ULN and bilirubin 2.01 to 5 times ULN) the dose should be reduced to 200 mg/m2 and 130 mg/m2 respectively for MBC and 75 mg/m2 and 50 mg/m2 respectively for NSCLC. For MBC, the dose may be increased from 130 mg/m2 up to 200 mg/m2 in patients with severe hepatic impairment in subsequent cycles based on individual tolerance. For NSCLC, the dose may be increased from 50 mg/m2 up to 75 mg/m2 as tolerated.

For pancreatic adenocarcinoma, no dosage adjustment is needed for mild hepatic impairment, and use is not recommended for moderate or severe hepatic impairment.

Dose Adjustments

MBC:
Patients who experience severe neutropenia (neutrophils less than 500 cells/mm3 for a week or longer) or severe sensory neuropathy during therapy should have dosage reduced to 220 mg/m2 for subsequent courses. For recurrence of severe neutropenia or severe sensory neuropathy, additional dose reduction should be made to 180 mg/m2. For Grade 3 sensory neuropathy hold treatment until resolution to Grade 1 or 2, followed by a dose reduction for all subsequent courses.

NSCLC:
Do not administer on Day 1 of a cycle until absolute neutrophil count (ANC) is at least 1500 cells/mm3 and platelet count is at least 100,000 cells/mm3.

In patients who develop severe neutropenia or thrombocytopenia withhold treatment until counts recover to an absolute neutrophil count of at least 1500 cells/mm3 and platelet count of at least 100,000 cells/mm3 on Day 1 or to an absolute neutrophil count of at least 500 cells/mm3 and platelet count of at least 50,000 cells/mm3 on Days 8 or 15 of the cycle. Upon resumption of dosing, permanently reduce paclitaxel protein-bound and carboplatin doses as follows:
For the first occurrence of neutropenic fever (ANC less than 500/mm3 with fever greater than 38 degrees Centigrade) or ANC less than 500/mm3 or delay of next cycle by more than 7 days due to ANC less than 1500/mm3, reduce paclitaxel protein-bound dose to 75 mg/m2 and carboplatin dose to AUC of 4.5 mg*min/mL. For a second occurrence, reduce the dose to 50 mg/m2 and AUC of 3 mg*min/mL and for a third occurrence, discontinue treatment.

For the first occurrence of platelet count less than 50,000/mm3, reduce the paclitaxel protein-bound dose to 75 mg/m2 and carboplatin dose to AUC of 4.5 mg*min/mL and for the second occurrence, discontinue treatment.

Withhold paclitaxel protein-bound for Grade 3 to 4 peripheral neuropathy. Resume paclitaxel protein-bound and carboplatin at reduced doses when peripheral neuropathy improves to Grade 1 or completely resolves. For the first occurrence, reduce paclitaxel protein-bound dose to 75 mg/m2 and carboplatin dose to AUC of 4.5 mg*min/mL), for a second occurrence, reduce doses to 50 mg/m2 and AUC of 3 mg*min/mL respectively, and for a third occurrence, discontinue treatment.

Pancreatic adenocarcinoma:

Full dose: 125 mg/m2 paclitaxel protein-bound; 1000 mg/m2 gemcitabine
First dose reduction: 100 mg/m2; 800 mg/m2 gemcitabine
Second dose reduction: 75 mg/m2; 600 mg/m2 gemcitabine
If further dose reductions are required, discontinue therapy.

Adjustments for neutropenia/thrombocytopenia in patients with pancreatic adenocarcinoma:
Day 1:
ANC less than 1500 or platelets less than 100,000: Delay doses until recovery.
Day 8:
ANC 500 to less than 1000 or platelets 50,000 to less than 75,000: Reduce one dose level
ANC less than 500 or platelets less than 50,000: Withhold doses
Day 15:
If day 8 doses were reduced or given without modification:
ANC 500 to less than 1000 or platelets 50,000 to less than 75,000: Reduce one dose level from Day 8
ANC less than 500 or platelets less than 50,000: Withhold doses
If day 8 doses were withheld:
ANC 1000 or greater or platelets 75,000 or greater: Reduce one dose level from Day 1
ANC 500 to less than 1000 or platelets 50,000 to less than 75,000: Reduce two dose levels from Day 1
ANC less than 500 or platelets less than 50,000: Withhold doses

Dose modifications for other adverse drug reactions in patients with pancreatic adenocarcinoma:
Febrile Neutropenia:
Grade 3 or 4: Withhold until fever resolves and ANC is 1500 or greater; resume at next lower dose level.
Peripheral Neuropathy:
Grade 3 or 4: Withhold paclitaxel protein-bound until improves to Grade 1 or better and resume treatment at next lower dose level. No dose reduction is required for gemcitabine.
Cutaneous Toxicity:
Grade 2 or 3: Reduce to next lower dose level and discontinue treatment if toxicity persists.
Gastrointestinal Toxicity:
Grade 3 mucositis or diarrhea: Withhold until improvement to Grade 1 or better and resume treatment at next lower dose level.

Precautions

Because of the possibility of extravasation, close monitoring of the infusion site for possible infiltration during drug administration is recommended.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

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