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Abraxane Generic Name & Formulations
Legal Class
Rx
General Description
Paclitaxel [bound to albumin (human)] 100mg/vial; pwd for IV infusion after reconstitution; solvent-free.
Pharmacological Class
Taxane antimicrotubule.
How Supplied
Single-use vial—1
Manufacturer
Generic Availability
YES
Mechanism of Action
Paclitaxel is a microtubule inhibitor that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. Paclitaxel induces abnormal arrays or bundles of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.
Abraxane Indications
Indications
Treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy (prior therapy should have included an anthracycline unless clinically contraindicated).
Abraxane Dosage and Administration
Adult
Do not treat if neutrophil count <1,500 cells/mm3 or platelets <100,000 cells/mm3. 260mg/m2 by IV infusion over 30mins every 3 weeks. If severe neutropenia (neutrophil <500 cells/mm3 for ≥1week) or severe sensory neuropathy occurs: reduce subsequent doses to 220mg/m2; reduce to 180mg/m2 if severe neutropenia or sensory neuropathy recurs. If grade 3 sensory neuropathy occurs, suspend use until resolution to grade 1 or 2; reduce subsequent doses. Hepatic impairment: see full labeling. Avoid extravasation.
Children
Not evaluated.
Administration
Closely monitor infusion site for possible infiltration during administration. Limit infusion to 30mins. Premedication may be needed in those with prior hypersensitvity reaction. Reconstituted suspension should be milky and homogenous.
Nursing Considerations
Closely monitor infusion site for possible infiltration during administration. Limit infusion to 30 minutes. Premedication may be needed in those with prior hypersensitvity reaction. Reconstituted suspension should be milky and homogenous.
Abraxane Contraindications
Contraindications
Baseline neutrophil count <1,500 cells/mm3. History of severe hypersensitivity reaction (do not rechallenge).
Abraxane Boxed Warnings
Boxed Warning
Severe myelosuppression.
Abraxane Warnings/Precautions
Warnings/Precautions
Severe myelosuppression (esp. neutropenia); monitor. Perform CBCs frequently, including prior to dosing. Do not substitute for, or with, other paclitaxel formulations. Monitor for sensory neuropathy, sepsis or pneumonitis. Risk for severe/fatal sepsis if biliary obstruction or biliary stent are present. Cross-hypersensitivity with other taxane products; monitor those with previous history. Hepatic impairment (total bilirubin >5×ULN or AST >10×ULN): not recommended. Severe renal impairment or ESRD (estimated CrCl <30mL/min). Contains human albumin; remote risk of viral transmission. Embryo-fetal toxicity. Advise to use effective contraception during and for ≥6 months (females) and ≥3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after the last dose).
Abraxane Pharmacokinetics
Elimination
Fecal, renal (minor). Half-life: 13–27 hours.
Abraxane Interactions
Interactions
Caution when concomitant with drugs known to inhibit or induce either CYP2C8 or CYP3A4.
Abraxane Adverse Reactions
Adverse Reactions
Bone marrow suppression, infections, alopecia, sensory neuropathy (may require dose reduction or interruption), peripheral neuropathy, nausea, diarrhea, pyrexia, mucositis, fatigue/asthenia, myalgia/arthralgia, decreased appetite, dehydration, abnormal ECG; alkaline phosphatase or AST elevation; dyspnea, edema, hypotension, rash (may be serious); rare: thrombotic events.
Abraxane Clinical Trials
See Literature
Abraxane Note
Not Applicable
Abraxane Patient Counseling
See Literature
Abraxane Generic Name & Formulations
Legal Class
Rx
General Description
Paclitaxel [bound to albumin (human)] 100mg/vial; pwd for IV infusion after reconstitution; solvent-free.
Pharmacological Class
Taxane antimicrotubule.
How Supplied
Single-use vial—1
Manufacturer
Generic Availability
YES
Mechanism of Action
Paclitaxel is a microtubule inhibitor that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. Paclitaxel induces abnormal arrays or bundles of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.
Abraxane Indications
Indications
First-line treatment of metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.
Abraxane Dosage and Administration
Adult
Do not treat if neutrophil count <1,500 cells/mm3 or platelets <100,000 cells/mm3. 125mg/m2 IV over 30–40mins on Days 1, 8, and 15 of each 28-day cycle. Moderate to severe hepatic impairment (total bilirubin >1.5×ULN and AST ≤10×ULN): not recommended. Dose reductions for hematologic and neurologic adverse reactions: see full labeling. Avoid extravasation.
Children
Not evaluated.
Administration
Closely monitor infusion site for possible infiltration during administration. Limit infusion to 30mins. Premedication may be needed in those with prior hypersensitvity reaction. Reconstituted suspension should be milky and homogenous.
Nursing Considerations
Closely monitor infusion site for possible infiltration during administration. Limit infusion to 30 minutes. Premedication may be needed in those with prior hypersensitvity reaction. Reconstituted suspension should be milky and homogenous.
Abraxane Contraindications
Contraindications
Baseline neutrophil count <1,500 cells/mm3. History of severe hypersensitivity reaction (do not rechallenge).
Abraxane Boxed Warnings
Boxed Warning
Severe myelosuppression.
Abraxane Warnings/Precautions
Warnings/Precautions
Severe myelosuppression (esp. neutropenia); monitor. Perform CBCs frequently, including prior to dosing. Do not substitute for, or with, other paclitaxel formulations. Monitor for sensory neuropathy, sepsis or pneumonitis. Risk for severe/fatal sepsis if biliary obstruction or biliary stent are present. Cross-hypersensitivity with other taxane products; monitor those with previous history. Hepatic impairment (total bilirubin >5×ULN or AST >10×ULN): not recommended. Severe renal impairment or ESRD (estimated CrCl <30mL/min). Contains human albumin; remote risk of viral transmission. Embryo-fetal toxicity. Advise to use effective contraception during and for ≥6 months (females) and ≥3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after the last dose).
Abraxane Pharmacokinetics
Elimination
Fecal, renal (minor). Half-life: 13–27 hours.
Abraxane Interactions
Interactions
Caution when concomitant with drugs known to inhibit or induce either CYP2C8 or CYP3A4.
Abraxane Adverse Reactions
Adverse Reactions
Bone marrow suppression, infections, alopecia, sensory neuropathy (may require dose reduction or interruption), peripheral neuropathy, nausea, diarrhea, pyrexia, mucositis, fatigue/asthenia, myalgia/arthralgia, decreased appetite, dehydration, abnormal ECG; alkaline phosphatase or AST elevation; dyspnea, edema, hypotension, rash (may be serious); rare: thrombotic events.
Abraxane Clinical Trials
See Literature
Abraxane Note
Not Applicable
Abraxane Patient Counseling
See Literature
Abraxane Generic Name & Formulations
Legal Class
Rx
General Description
Paclitaxel [bound to albumin (human)] 100mg/vial; pwd for IV infusion after reconstitution; solvent-free.
Pharmacological Class
Taxane antimicrotubule.
How Supplied
Single-use vial—1
Manufacturer
Generic Availability
YES
Mechanism of Action
Paclitaxel is a microtubule inhibitor that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. Paclitaxel induces abnormal arrays or bundles of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.
Abraxane Indications
Indications
First-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
Abraxane Dosage and Administration
Adult
Do not treat if neutrophil count <1,500 cells/mm3 or platelets <100,000 cells/mm3. In combination with carboplatin: 100mg/m2 IV over 30mins on Days 1, 8, and 15 of each 21-day cycle. Dose reductions for hematologic and neurologic adverse reactions, hepatic impairment: see full labeling. Avoid extravasation.
Children
Not evaluated.
Administration
Closely monitor infusion site for possible infiltration during administration. Limit infusion to 30mins. Premedication may be needed in those with prior hypersensitvity reaction. Reconstituted suspension should be milky and homogenous.
Nursing Considerations
Closely monitor infusion site for possible infiltration during administration. Limit infusion to 30 minutes. Premedication may be needed in those with prior hypersensitvity reaction. Reconstituted suspension should be milky and homogenous.
Abraxane Contraindications
Contraindications
Baseline neutrophil count <1,500 cells/mm3. History of severe hypersensitivity reaction (do not rechallenge).
Abraxane Boxed Warnings
Boxed Warning
Severe myelosuppression.
Abraxane Warnings/Precautions
Warnings/Precautions
Severe myelosuppression (esp. neutropenia); monitor. Perform CBCs frequently, including prior to dosing. Do not substitute for, or with, other paclitaxel formulations. Monitor for sensory neuropathy, sepsis or pneumonitis. Risk for severe/fatal sepsis if biliary obstruction or biliary stent are present. Cross-hypersensitivity with other taxane products; monitor those with previous history. Hepatic impairment (total bilirubin >5×ULN or AST >10×ULN): not recommended. Severe renal impairment or ESRD (estimated CrCl <30mL/min). Contains human albumin; remote risk of viral transmission. Embryo-fetal toxicity. Advise to use effective contraception during and for ≥6 months (females) and ≥3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after the last dose).
Abraxane Pharmacokinetics
Elimination
Fecal, renal (minor). Half-life: 13–27 hours.
Abraxane Interactions
Interactions
Caution when concomitant with drugs known to inhibit or induce either CYP2C8 or CYP3A4.
Abraxane Adverse Reactions
Adverse Reactions
Bone marrow suppression, infections, alopecia, sensory neuropathy (may require dose reduction or interruption), peripheral neuropathy, nausea, diarrhea, pyrexia, mucositis, fatigue/asthenia, myalgia/arthralgia, decreased appetite, dehydration, abnormal ECG; alkaline phosphatase or AST elevation; dyspnea, edema, hypotension, rash (may be serious); rare: thrombotic events.
Abraxane Clinical Trials
See Literature
Abraxane Note
Not Applicable
Abraxane Patient Counseling
See Literature
