Taxotere Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Mechanism of Action
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. Plasma protein bound: ~94% (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
Mechanism of Action
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. Plasma protein bound: ~94% (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
Mechanism of Action
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. Plasma protein bound: ~94% (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
Mechanism of Action
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. Plasma protein bound: ~94% (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
Mechanism of Action
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. Plasma protein bound: ~94% (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