ABRAXANE IS ADMINISTERED WEEKLY OVER 30 MINUTES
GENERALLY WITHOUT THE NEED FOR STEROID PRETREATMENT
Premedication may be needed in patients who have had a prior hypersensitivity reaction to ABRAXANE
- Severe hypersensitivity reactions with fatal outcome have been reported with ABRAXANE. Do not re-challenge
- Severe hypersensitivity reactions with fatal outcome have been reported with ABRAXANE.
Do not re-challenge
Administer ABRAXANE intravenously at
a dose of 100 mg/m2
Administer ABRAXANE intravenously at a dose of
100 mg/m2
ILLUSTRATIVE PURPOSES ONLY
The recommended ABRAXANE schedule is weekly dosing
The recommended ABRAXANE schedule is weekly dosing
- Administer ABRAXANE on Days 1, 8, and 15 of each 21-day cycle
- Administer carboplatin on Day 1 of each 21-day cycle
ABRAXANE is administered
over 30 minutes
ABRAXANE is administered
over 30 minutes
Note: An albumin form of paclitaxel may substantially affect a drug’s functional properties relative to those of drug in solution. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS.
- Duration and Dosing in the Phase III TrialCLOSE THE TAB
MEDIAN NUMBER OF TREATMENT CYCLES IN THE PHASE III PIVOTAL TRIAL OF ABRAXANE + CARBOPLATIN
MEDIAN NUMBER OF TREATMENT CYCLES IN THE PHASE III PIVOTAL TRIAL OF ABRAXANE + CARBOPLATIN
Patients in the study were treated until disease progression or development of unacceptable toxicity.DOSE ADJUSTMENTS
OBSERVED IN THE PHASE III PIVOTAL TRIALDOSE ADJUSTMENTS
OBSERVED IN THE PHASE III PIVOTAL TRIALAdverse reactions were assessed in 514 patients treated with ABRAXANE + carboplatin
- Dose ModificationsPLEASE SELECT A DOSE MODIFICATION BELOW:
- Hepatic
START WITH THE RIGHT DOSE OF ABRAXANE IN PATIENTS
WITH HEPATIC IMPAIRMENTSTART WITH THE RIGHT DOSE OF ABRAXANE IN PATIENTS
WITH HEPATIC IMPAIRMENTRecommendations for starting dose in patients with hepatic impairmentSGOT (AST) LEVELS
<10 x ULNANDBILIRUBIN LEVELS
>1.5 TO ≤3 x ULNSGOT (AST) LEVELS
<10 x ULNANDBILIRUBIN LEVELS
>ULN TO ≤1.5 x ULNSGOT (AST) LEVELS <10 x ULNANDBILIRUBIN LEVELS >1.5 TO ≤3 x ULNSGOT (AST) LEVELS
<10 x ULNANDBILIRUBIN LEVELS
>1.5 TO ≤3 x ULNSGOT (AST) LEVELS <10 x ULNANDBILIRUBIN LEVELS >3 TO ≤5 x ULNSGOT (AST) LEVELS
<10 x ULNANDBILIRUBIN LEVELS
>3 TO ≤5 x ULNSGOT (AST) LEVELS
>10 x ULNANDBILIRUBIN LEVELS >5 x ULNSGOT (AST) LEVELS
>10 x ULNORBILIRUBIN LEVELS
>5 x ULNMild
- No dose adjustment is necessary for patients with mild hepatic impairment
- Do not administer ABRAXANE to patients with total bilirubin >5 x ULN or AST >10 x ULN
- Patients with bilirubin levels above the ULN were excluded from the clinical trial for lung cancer
- Dosage recommendations are for the first course of therapy. The need for further dose adjustments in subsequent courses should be based on individual tolerance
- Patients with bilirubin levels above the ULN were excluded from the clinical trial for lung cancer
- Dosage recommendations are for the first course of therapy. The need for further dose adjustments in subsequent courses should be based on individual tolerance
Moderate
- Do not administer ABRAXANE to patients with total bilirubin >5 x ULN or AST >10 x ULN
- Patients with bilirubin levels above the ULN were excluded from the clinical trial for lung cancer
- Dosage recommendations are for the first course of therapy. The need for further dose adjustments in subsequent courses should be based on individual tolerance
Severe
- Do not administer ABRAXANE to patients with total bilirubin >5 x ULN or AST >10 x ULN
- Patients with bilirubin levels above the ULN were excluded from the clinical trial for lung cancer
- Dosage recommendations are for the first course of therapy. The need for further dose adjustments in subsequent courses should be based on individual tolerance
Very Severe
- Do not administer ABRAXANE to patients with total bilirubin >5 x ULN or AST >10 x ULN
- Patients with bilirubin levels above the ULN were excluded from the clinical trial for lung cancer
ULN=upper limit of normal.ABRAXANE dose
ILLUSTRATIVE PURPOSES ONLY
- aA dose increase to 100 mg/m2 in subsequent courses should be considered if the patient tolerates the reduced dose for 2 cycles.
- Neutropenia
DOSING FOR YOUR PATIENTS
WHO EXPERIENCE HEMATOLOGIC TOXICITIESDOSING FOR YOUR PATIENTS
WHO EXPERIENCE HEMATOLOGIC TOXICITIESRecommendations for permanent dose modification in NSCLC patients with neutropeniaMAKE A SELECTION:
- Do not administer ABRAXANE 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
- Nadir ANC <500 cells/mm3 with neutropenic fever >38OC
OR- Delay of next cycle due to persistent neutropenia* (nadir ANC <1500 cells/mm3)
OR- Nadir ANC <500 cells/mm3 for >1 week
- Do not administer ABRAXANE 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
- Nadir ANC <500 cells/mm3 with neutropenic fever >38OC
OR- Delay of next cycle due to persistent neutropenia*
(nadir ANC <1500 cells/mm3)
OR- Nadir ANC <500 cells/mm3 for >1 week
- Do not administer ABRAXANE 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
- Nadir ANC <500 cells/mm3 with neutropenic fever >38OC
OR- Delay of next cycle due to persistent neutropenia*
(nadir ANC <1500 cells/mm3)
OR- Nadir ANC <500 cells/mm3 for >1 week
ILLUSTRATIVE PURPOSES ONLY
- Prior to permanent dose reduction, withhold treatment until ANC recovery to ≥1500 cells/mm3 on Day 1 or ≥500 cells/mm3 on Day 8 or 15 of a cycle
- Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Days 1, 8, and 15
- In the phase III ABRAXANE NSCLC clinical trial, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grade 1-4 neutropenia; 47% experienced
Grade 3-4 neutropenia
- Prior to permanent dose reduction, withhold treatment until ANC recovery to ≥1500 cells/mm3 on Day 1 or ≥500 cells/mm3 on Day 8 or 15 of a cycle
- Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Days 1, 8, and 15
- In the phase III ABRAXANE NSCLC clinical trial, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grade 1-4 neutropenia; 47% experienced Grade 3-4 neutropenia
- Prior to permanent dose reduction, withhold treatment until ANC recovery to ≥1500 cells/mm3 on Day 1 or ≥500 cells/mm3 on Day 8 or 15 of a cycle
- Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Days 1, 8, and 15
- In the phase III ABRAXANE NSCLC clinical trial, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grade 1-4 neutropenia; 47% experienced
Grade 3-4 neutropenia
- Prior to permanent dose reduction, withhold treatment until ANC recovery to ≥1500 cells/mm3 on Day 1 or ≥500 cells/mm3 on Day 8 or 15 of a cycle
- Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Days 1, 8, and 15
- In the phase III ABRAXANE NSCLC clinical trial, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grade 1-4 neutropenia; 47% experienced Grade 3-4 neutropenia
- Prior to permanent dose reduction, withhold treatment until ANC recovery to ≥1500 cells/mm3 on Day 1 or ≥500 cells/mm3 on Day 8 or 15 of a cycle
- Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Days 1, 8, and 15
- In the phase III ABRAXANE NSCLC clinical trial, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grade 1-4 neutropenia; 47% experienced
Grade 3-4 neutropenia
- Prior to permanent dose reduction, withhold treatment until ANC recovery to ≥1500 cells/mm3 on Day 1 or ≥500 cells/mm3 on Day 8 or 15 of a cycle
- Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Days 1, 8, and 15
- In the phase III ABRAXANE NSCLC clinical trial, 85% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grade 1-4 neutropenia; 47% experienced Grade 3-4 neutropenia
- *Maximum of 7 days post-scheduled Day 1 dose of next cycle.
- Thrombocytopenia
CLOSE THE TABDOSING FOR YOUR PATIENTS
WHO EXPERIENCE HEMATOLOGIC TOXICITIESDOSING FOR YOUR PATIENTS
WHO EXPERIENCE HEMATOLOGIC TOXICITIESRecommendations for permanent dose modification in NSCLC patients with thrombocytopeniaMAKE A SELECTION:
- Do not administer ABRAXANE 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
- Prior to permanent dose reduction, withhold treatment until platelet count recovery to ≥100,000 cells/mm3 on Day 1 or ≥50,000 cells/mm3 on Days 8 or 15 of the cycle
- Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Days 1, 8, and 15
- In the phase III ABRAXANE NSCLC clinical trial, 68% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grade 1-4 thrombocytopenia; 18% experienced Grade 3-4 thrombocytopenia
- Do not administer ABRAXANE 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
- Prior to permanent dose reduction, withhold treatment until platelet count recovery to ≥100,000 cells/mm3 on Day 1 or ≥50,000 cells/mm3 on Days 8 or 15 of the cycle
- Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Days 1, 8, and 15
- In the phase III ABRAXANE NSCLC clinical trial, 68% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grade 1-4 thrombocytopenia; 18% experienced Grade 3-4 thrombocytopenia
Nadir platelets <50,000 cells/mm3
ILLUSTRATIVE PURPOSES ONLY
- Neurologic
DOSING FOR YOUR PATIENTS
WHO EXPERIENCE NEUROLOGIC TOXICITIESDOSING FOR YOUR PATIENTS
WHO EXPERIENCE NEUROLOGIC TOXICITIESRecommendations for permanent dose modification in NSCLC patients with neurologic toxicityMAKE A SELECTION:
- For Grade 3-4 peripheral neuropathy, withhold treatment until resolution to ≤Grade 1
- Treatment may be resumed at the next lower dose level in subsequent cycles according to the dose reduction guidelines for neurologic toxicity
- In the phase III ABRAXANE NSCLC clinical trial, 48% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grade 1-4 peripheral neuropathy; 3% experienced Grade 3-4 peripheral neuropathy; no Grade 4 peripheral neuropathy was seen in the ABRAXANE + carboplatin arm
- For Grade 3-4 peripheral neuropathy, withhold treatment until resolution to ≤Grade 1
- Treatment may be resumed at the next lower dose level in subsequent cycles according to the dose reduction guidelines for neurologic toxicity
- In the phase III ABRAXANE NSCLC clinical trial, 48% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grade 1-4 peripheral neuropathy; 3% experienced Grade 3-4 peripheral neuropathy; no Grade 4 peripheral neuropathy was seen in the ABRAXANE + carboplatin arm
- For Grade 3-4 peripheral neuropathy, withhold treatment until resolution to ≤Grade 1
- Treatment may be resumed at the next lower dose level in subsequent cycles according to the dose reduction guidelines for neurologic toxicity
- In the phase III ABRAXANE NSCLC clinical trial, 48% of patients treated with ABRAXANE (100 mg/m2 weekly) + carboplatin experienced Grade 1-4 peripheral neuropathy; 3% experienced Grade 3-4 peripheral neuropathy; no Grade 4 peripheral neuropathy was seen in the ABRAXANE + carboplatin arm
Severe sensory neuropathy
(Grade 3 or 4)
ILLUSTRATIVE PURPOSES ONLY
- Hepatic
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Additional Information for Readers Provided by Celgene Corporation
The clinical trial described in this article served as the
basis for the approval for ABRXANE for Injectable Suspension.
The analyses contained in the article may differ from those in the package insert for ABRAXANE.
Please see Important Safety Information and Prescribing Information, including Boxed WARNING.
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Additional Information for Readers Provided by Celgene Corporation
The clinical trial described in this article served as the
basis for the approval for ABRXANE for Injectable Suspension.
The analyses contained in the article may differ from those in the package insert for ABRAXANE.
Please see Important Safety Information and Prescribing Information, including Boxed WARNING.
Click “OK” to proceed or “CANCEL” to return to
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