Paclitaxel Protein-bound Particles
Generic Name: paclitaxel protein-bound particles
Brand Names:
Paclitaxel Protein-bound Particles
11 DESCRIPTION Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is paclitaxel formulated as albumin-bound nanoparticles with a mean particle size of approximately 130 nanometers. Paclitaxel exists in the particles in a non‑crystalline, amorphous state. Paclitaxel is a microtubule inhibitor. The chemical name for paclitaxel is 5β,20-Epoxy- 1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2 R ,3 S )- N -benzoyl-3-phenylisoserine.
Overview
11 DESCRIPTION Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is paclitaxel formulated as albumin-bound nanoparticles with a mean particle size of approximately 130 nanometers. Paclitaxel exists in the particles in a non‑crystalline, amorphous state. Paclitaxel is a microtubule inhibitor. The chemical name for paclitaxel is 5β,20-Epoxy- 1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2 R ,3 S )- N -benzoyl-3-phenylisoserine.
Uses
1 INDICATIONS AND USAGE Paclitaxel is a microtubule inhibitor indicated for the treatment of: Metastatic 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. ( 1.1 ) Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. ( 1.2 ) Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.
Dosage
2 DOSAGE AND ADMINISTRATION Do not substitute paclitaxel protein-bound particles for injectable suspension (albumin-bound) for other paclitaxel products. (2.1) Extravasation : Closely monitor the infusion site for extravasation and infiltration. ( 2.1 ) Metastatic Breast Cancer (MBC): Recommended dosage of paclitaxel protein-bound particles for injectable suspension (albumin-bound) is 260 mg/m2 intravenously over 30 minutes every 3 weeks.
Side Effects
6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions (≥ 20%) with single-agent use of paclitaxel protein-bound particles for injectable suspension (albumin-bound) in metastatic breast cancer are alopecia, neutropenia, sensory neuropathy, abnormal ECG, fatigue/asthenia, myalgia/arthralgia, AST elevation, alkaline phosphatase elevation, anemia, nausea, infections, and diarrhea [see Adverse Reactions ( 6.1 )] .
Interactions
7 DRUG INTERACTIONS The metabolism of paclitaxel is catalyzed by CYP2C8 and CYP3A4. Caution should be exercised when administering paclitaxel protein-bound particles for injectable suspension (albumin-bound) concomitantly with medicines known to inhibit or induce either CYP2C8 or CYP3A4. Use caution when concomitantly administering paclitaxel protein-bound particles for injectable suspension (albumin-bound) with inhibitors or inducers of either CYP2C8 or CYP3A4. ( 7 )
Warnings
WARNING: SEVERE MYELOSUPPRESSION Do not administer paclitaxel protein-bound particles for injectable suspension (albumin-bound) therapy to patients who have baseline neutrophil counts of less than 1,500 cells/mm 3 . [see Contraindications ( 4 )]. Monitor for neutropenia, which may be severe and result in infection or sepsis, it is recommended that frequent [see Warnings and Precautions ( 5.1 , 5.3 )]. 5 WARNINGS AND PRECAUTIONS Sensory neuropathy occurs frequently and may require dose reduction or treatment interruption. ( 5.2 ) Sepsis occurred in patients with or without neutropenia who received paclitaxel protein-bound particles for injectable suspension (albumin-bound) in combination with gemcitabine; interrupt paclitaxel protein-bound particles for injectable suspension (albumin-bound) and gemcitabine until sepsis resolves, and if neutropenia, until neutrophils are at least 1500 cells/mm 3 , then resume treatment at reduced dose levels. 4 CONTRAINDICATIONS Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is contraindicated in patients with: Baseline neutrophil counts of < 1,500 cells/mm 3 [see Warnings and Precautions ( 5.1 )] A history of severe hypersensitivity reactions to paclitaxel protein-bound particles for injectable suspension (albumin-bound) [see Warnings and Precautions ( 5.5 )] .
Pregnancy
8.1 Pregnancy Risk Summary Based on its mechanism of action and findings in animals, paclitaxel protein-bound particles for injectable suspension (albumin-bound) can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is a white to yellow, sterile lyophilized cake or powder supplied as: NDC 69097-398-78 100 mg of paclitaxel in a single-dose vial, individually packaged in a carton. Store the vials in original cartons at 20ºC to 25ºC (68ºF to 77ºF).
Frequently Asked Questions
What is Paclitaxel Protein-bound Particles used for?▼
1 INDICATIONS AND USAGE Paclitaxel is a microtubule inhibitor indicated for the treatment of: Metastatic 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. ( 1.1 ) Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. ( 1.2 ) Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.
What are the side effects of Paclitaxel Protein-bound Particles?▼
6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions (≥ 20%) with single-agent use of paclitaxel protein-bound particles for injectable suspension (albumin-bound) in metastatic breast cancer are alopecia, neutropenia, sensory neuropathy, abnormal ECG, fatigue/asthenia, myalgia/arthralgia, AST elevation, alkaline phosphatase elevation, anemia, nausea, infections, and diarrhea [see Adverse Reactions ( 6.1 )] .
Can I take Paclitaxel Protein-bound Particles during pregnancy?▼
8.1 Pregnancy Risk Summary Based on its mechanism of action and findings in animals, paclitaxel protein-bound particles for injectable suspension (albumin-bound) can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] .
What are the important warnings for Paclitaxel Protein-bound Particles?▼
WARNING: SEVERE MYELOSUPPRESSION Do not administer paclitaxel protein-bound particles for injectable suspension (albumin-bound) therapy to patients who have baseline neutrophil counts of less than 1,500 cells/mm 3 . [see Contraindications ( 4 )]. Monitor for neutropenia, which may be severe and result in infection or sepsis, it is recommended that frequent [see Warnings and Precautions ( 5.1 , 5.3 )]. 5 WARNINGS AND PRECAUTIONS Sensory neuropathy occurs frequently and may require dose reduction or treatment interruption. ( 5.2 ) Sepsis occurred in patients with or without neutropenia who received paclitaxel protein-bound particles for injectable suspension (albumin-bound) in combination with gemcitabine; interrupt paclitaxel protein-bound particles for injectable suspension (albumin-bound) and gemcitabine until sepsis resolves, and if neutropenia, until neutrophils are at least 1500 cells/mm 3 , then resume treatment at reduced dose levels. 4 CONTRAINDICATIONS Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is contraindicated in patients with: Baseline neutrophil counts of < 1,500 cells/mm 3 [see Warnings and Precautions ( 5.1 )] A history of severe hypersensitivity reactions to paclitaxel protein-bound particles for injectable suspension (albumin-bound) [see Warnings and Precautions ( 5.5 )] .
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.