Taxotere Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Taxotere Indications
Indications
Taxotere Dosage and Administration
Adult
Children
Taxotere Contraindications
Contraindications
Taxotere Boxed Warnings
Boxed Warning
Taxotere Warnings/Precautions
Warnings/Precautions
Increased risk of mortality in those with abnormal liver function, receiving high doses, with NSCLC and a history of prior platinum-based chemotherapy. Hepatic impairment; bilirubin >ULN, AST and/or ALT >1.5×ULN concomitant with alkaline phosphatase >2.5×ULN: avoid. Obtain bilirubin, AST/ALT, and alkaline phosphatase prior to each cycle. Monitor peripheral blood counts frequently (esp. neutrophils, platelets). Patients with neutropenia: monitor closely for GI toxicity. Monitor for hypersensitivity reactions (esp. during 1st and 2nd infusions); discontinue if severe and do not rechallenge. Previous history of hypersensitivity to paclitaxel; monitor closely. Pre-existing effusions (monitor closely). Monitor for second primary malignancies (eg, AML, MDS, NHL, renal cancer). Monitor closely for severe cutaneous adverse reactions (eg, Stevens-Johnson syndrome [SJS], toxic epidermal necrolysis [TEN], acute generalized exanthematous pustulosis [AGEP]); consider permanent discontinuation if occur. Adjust dose if severe neurosensory symptoms (eg, paresthesia, dysesthesia, pain) occur; discontinue if symptoms persist. Monitor for eye disorders; discontinue if cystoid macular edema is diagnosed (consider alternative non-taxane chemotherapy). Risk of tumor lysis syndrome (esp. in renal impairment, hyperuricemia, bulky tumor): monitor closely. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for 2 months (females of reproductive potential) and for 4 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
Taxotere Pharmacokinetics
Distribution
Mean steady state volume of distribution was 113 L. Docetaxel is ~94% protein bound in vitro, mainly to α1-acid glycoprotein, albumin, and lipoproteins.
Elimination
Fecal (80%), renal. Mean terminal half-life: 116 hours.
Taxotere Interactions
Interactions
Taxotere Adverse Reactions
Adverse Reactions
Taxotere Clinical Trials
See Literature
Taxotere Note
Not Applicable
Taxotere Patient Counseling
See Literature
Taxotere Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Taxotere Indications
Indications
Taxotere Dosage and Administration
Adult
Children
Taxotere Contraindications
Contraindications
Taxotere Boxed Warnings
Boxed Warning
Taxotere Warnings/Precautions
Warnings/Precautions
Increased risk of mortality in those with abnormal liver function, receiving high doses, with NSCLC and a history of prior platinum-based chemotherapy. Hepatic impairment; bilirubin >ULN, AST and/or ALT >1.5×ULN concomitant with alkaline phosphatase >2.5×ULN: avoid. Obtain bilirubin, AST/ALT, and alkaline phosphatase prior to each cycle. Monitor peripheral blood counts frequently (esp. neutrophils, platelets). Patients with neutropenia: monitor closely for GI toxicity. Monitor for hypersensitivity reactions (esp. during 1st and 2nd infusions); discontinue if severe and do not rechallenge. Previous history of hypersensitivity to paclitaxel; monitor closely. Pre-existing effusions (monitor closely). Monitor for second primary malignancies (eg, AML, MDS, NHL, renal cancer). Monitor closely for severe cutaneous adverse reactions (eg, Stevens-Johnson syndrome [SJS], toxic epidermal necrolysis [TEN], acute generalized exanthematous pustulosis [AGEP]); consider permanent discontinuation if occur. Adjust dose if severe neurosensory symptoms (eg, paresthesia, dysesthesia, pain) occur; discontinue if symptoms persist. Monitor for eye disorders; discontinue if cystoid macular edema is diagnosed (consider alternative non-taxane chemotherapy). Risk of tumor lysis syndrome (esp. in renal impairment, hyperuricemia, bulky tumor): monitor closely. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for 2 months (females of reproductive potential) and for 4 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
Taxotere Pharmacokinetics
Distribution
Mean steady state volume of distribution was 113 L. Docetaxel is ~94% protein bound in vitro, mainly to α1-acid glycoprotein, albumin, and lipoproteins.
Elimination
Fecal (80%), renal. Mean terminal half-life: 116 hours.
Taxotere Interactions
Interactions
Taxotere Adverse Reactions
Adverse Reactions
Taxotere Clinical Trials
See Literature
Taxotere Note
Not Applicable
Taxotere Patient Counseling
See Literature
Taxotere Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Taxotere Indications
Indications
Taxotere Dosage and Administration
Adult
Children
Taxotere Contraindications
Contraindications
Taxotere Boxed Warnings
Boxed Warning
Taxotere Warnings/Precautions
Warnings/Precautions
Increased risk of mortality in those with abnormal liver function, receiving high doses, with NSCLC and a history of prior platinum-based chemotherapy. Hepatic impairment; bilirubin >ULN, AST and/or ALT >1.5×ULN concomitant with alkaline phosphatase >2.5×ULN: avoid. Obtain bilirubin, AST/ALT, and alkaline phosphatase prior to each cycle. Monitor peripheral blood counts frequently (esp. neutrophils, platelets). Patients with neutropenia: monitor closely for GI toxicity. Monitor for hypersensitivity reactions (esp. during 1st and 2nd infusions); discontinue if severe and do not rechallenge. Previous history of hypersensitivity to paclitaxel; monitor closely. Pre-existing effusions (monitor closely). Monitor for second primary malignancies (eg, AML, MDS, NHL, renal cancer). Monitor closely for severe cutaneous adverse reactions (eg, Stevens-Johnson syndrome [SJS], toxic epidermal necrolysis [TEN], acute generalized exanthematous pustulosis [AGEP]); consider permanent discontinuation if occur. Adjust dose if severe neurosensory symptoms (eg, paresthesia, dysesthesia, pain) occur; discontinue if symptoms persist. Monitor for eye disorders; discontinue if cystoid macular edema is diagnosed (consider alternative non-taxane chemotherapy). Risk of tumor lysis syndrome (esp. in renal impairment, hyperuricemia, bulky tumor): monitor closely. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for 2 months (females of reproductive potential) and for 4 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
Taxotere Pharmacokinetics
Distribution
Mean steady state volume of distribution was 113 L. Docetaxel is ~94% protein bound in vitro, mainly to α1-acid glycoprotein, albumin, and lipoproteins.
Elimination
Fecal (80%), renal. Mean terminal half-life: 116 hours.
Taxotere Interactions
Interactions
Taxotere Adverse Reactions
Adverse Reactions
Taxotere Clinical Trials
See Literature
Taxotere Note
Not Applicable
Taxotere Patient Counseling
See Literature
Taxotere Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Taxotere Indications
Indications
Taxotere Dosage and Administration
Adult
Children
Taxotere Contraindications
Contraindications
Taxotere Boxed Warnings
Boxed Warning
Taxotere Warnings/Precautions
Warnings/Precautions
Increased risk of mortality in those with abnormal liver function, receiving high doses, with NSCLC and a history of prior platinum-based chemotherapy. Hepatic impairment; bilirubin >ULN, AST and/or ALT >1.5×ULN concomitant with alkaline phosphatase >2.5×ULN: avoid. Obtain bilirubin, AST/ALT, and alkaline phosphatase prior to each cycle. Monitor peripheral blood counts frequently (esp. neutrophils, platelets). Patients with neutropenia: monitor closely for GI toxicity. Monitor for hypersensitivity reactions (esp. during 1st and 2nd infusions); discontinue if severe and do not rechallenge. Previous history of hypersensitivity to paclitaxel; monitor closely. Pre-existing effusions (monitor closely). Monitor for second primary malignancies (eg, AML, MDS, NHL, renal cancer). Monitor closely for severe cutaneous adverse reactions (eg, Stevens-Johnson syndrome [SJS], toxic epidermal necrolysis [TEN], acute generalized exanthematous pustulosis [AGEP]); consider permanent discontinuation if occur. Adjust dose if severe neurosensory symptoms (eg, paresthesia, dysesthesia, pain) occur; discontinue if symptoms persist. Monitor for eye disorders; discontinue if cystoid macular edema is diagnosed (consider alternative non-taxane chemotherapy). Risk of tumor lysis syndrome (esp. in renal impairment, hyperuricemia, bulky tumor): monitor closely. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for 2 months (females of reproductive potential) and for 4 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
Taxotere Pharmacokinetics
Distribution
Mean steady state volume of distribution was 113 L. Docetaxel is ~94% protein bound in vitro, mainly to α1-acid glycoprotein, albumin, and lipoproteins.
Elimination
Fecal (80%), renal. Mean terminal half-life: 116 hours.
Taxotere Interactions
Interactions
Taxotere Adverse Reactions
Adverse Reactions
Taxotere Clinical Trials
See Literature
Taxotere Note
Not Applicable
Taxotere Patient Counseling
See Literature
Taxotere Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Taxotere Indications
Indications
Taxotere Dosage and Administration
Adult
Children
Taxotere Contraindications
Contraindications
Taxotere Boxed Warnings
Boxed Warning
Taxotere Warnings/Precautions
Warnings/Precautions
Increased risk of mortality in those with abnormal liver function, receiving high doses, with NSCLC and a history of prior platinum-based chemotherapy. Hepatic impairment; bilirubin >ULN, AST and/or ALT >1.5×ULN concomitant with alkaline phosphatase >2.5×ULN: avoid. Obtain bilirubin, AST/ALT, and alkaline phosphatase prior to each cycle. Monitor peripheral blood counts frequently (esp. neutrophils, platelets). Patients with neutropenia: monitor closely for GI toxicity. Monitor for hypersensitivity reactions (esp. during 1st and 2nd infusions); discontinue if severe and do not rechallenge. Previous history of hypersensitivity to paclitaxel; monitor closely. Pre-existing effusions (monitor closely). Monitor for second primary malignancies (eg, AML, MDS, NHL, renal cancer). Monitor closely for severe cutaneous adverse reactions (eg, Stevens-Johnson syndrome [SJS], toxic epidermal necrolysis [TEN], acute generalized exanthematous pustulosis [AGEP]); consider permanent discontinuation if occur. Adjust dose if severe neurosensory symptoms (eg, paresthesia, dysesthesia, pain) occur; discontinue if symptoms persist. Monitor for eye disorders; discontinue if cystoid macular edema is diagnosed (consider alternative non-taxane chemotherapy). Risk of tumor lysis syndrome (esp. in renal impairment, hyperuricemia, bulky tumor): monitor closely. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for 2 months (females of reproductive potential) and for 4 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
Taxotere Pharmacokinetics
Distribution
Mean steady state volume of distribution was 113 L. Docetaxel is ~94% protein bound in vitro, mainly to α1-acid glycoprotein, albumin, and lipoproteins.
Elimination
Fecal (80%), renal. Mean terminal half-life: 116 hours.
Taxotere Interactions
Interactions
Taxotere Adverse Reactions
Adverse Reactions
Taxotere Clinical Trials
See Literature
Taxotere Note
Not Applicable
Taxotere Patient Counseling
See Literature