Paclitaxel Protein-Bound Particles For Injectable Suspension (Albumin-Bound)
PACLITAXEL PROTEIN-BOUND PARTICLES FOR INJECTABLE SUSPENSION (ALBUMIN-BOUND)- paclitaxel injection, powder, lyophilized, for suspension
TWi Pharmaceuticals, Inc.
Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound)
WARNING: SEVERE MYELOSUPPRESSION
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- Do not administer Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm3 [see Contraindications (4)].
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- Monitor for neutropenia, which may be severe and result in infection or sepsis [see Warnings and Precautions (5.1, 5.3)].
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- Perform frequent complete blood cell counts on all patients receiving Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) [see Warnings and Precautions (5.1, 5.3)].
1 INDICATIONS AND USAGE
1.1 Metastatic Breast Cancer
Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is indicated for the 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.
1.2 Non-Small Cell Lung Cancer
Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
1.3 Adenocarcinoma of the Pancreas
Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS. Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) has different dosage and administration instructions from other paclitaxel products.
Closely monitor the infusion site for extravasation or drug infiltration during administration. Limiting the infusion of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) to 30 minutes may reduce the risk of infusion-related reactions [see Adverse Reactions (6.2)].
Consider premedication in patients who have had prior hypersensitivity reactions to Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound). Do not re-challenge patients who experience a severe hypersensitivity reaction to Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) [see Contraindications (4) and Warnings and Precautions (5.5)].
2.2 Recommended Dosage for Metastatic Breast Cancer
After failure of combination chemotherapy for metastatic breast cancer or relapse within 6 months of adjuvant chemotherapy, the recommended regimen for Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is 260 mg/m2 administered intravenously over 30 minutes every 3 weeks.
2.3 Recommended Dosage for Non-Small Cell Lung Cancer
The recommended dose of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is 100 mg/m2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Administer carboplatin on Day 1 of each 21-day cycle immediately after Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) [see Clinical Studies (14.2)].
2.4 Recommended Dosage for Adenocarcinoma of the Pancreas
The recommended dose of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is 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 Particles for Injectable Suspension (Albumin-Bound) on Days 1, 8, and 15 of each 28-day cycle [see Clinical Studies (14.3)].
2.5 Dosage Modifications for Hepatic Impairment
For patients with moderate or severe hepatic impairment, reduce the starting dose of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) as shown in Table 1.
| AST = Aspartate Aminotransferase; MBC = Metastatic Breast Cancer; NSCLC = Non-Small Cell Lung Cancer; ULN = Upper limit of normal.a Dosage recommendations are for the first course of therapy. The need for further dose adjustments in subsequent courses should be based on individual tolerance.b A dose increase to 260 mg/m2 for patients with metastatic breast cancer or 100 mg/m2 for patients with non-small cell lung cancer in subsequent courses should be considered if the patient tolerates the reduced dose for two cycles.c Patients with bilirubin levels above the upper limit of normal were excluded from clinical trials for pancreatic or lung cancer. | ||||||
| AST Levels | Bilirubin Levels | Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) Dosea | ||||
| MBC | NSCLC c | Adenocarcinoma of Pancreasc | ||||
| Moderate | < 10 x ULN | AND | > 1.5 to ≤ 3 x ULN | 200 mg/m2 b | 80 mg/m2 b | not recommended |
| Severe | < 10 x ULN | AND | > 3 to ≤ 5 x ULN | 200 mg/m2 b | 80 mg/m2 b | not recommended |
| > 10 x ULN | OR | > 5 x ULN | not recommended | not recommended | not recommended | |
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