PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND 100 mg/20mL

Paclitaxel · INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION · American Regent, Inc.

No Recall History

Plain English

PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND is a injection, powder, lyophilized, for suspension containing paclitaxel at 100 mg/20mL, taken intravenous. Manufactured by American Regent, Inc..

Key Facts

Brand Name: PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND
Generic Name: Paclitaxel
NDC Code (Product): 0517-4300
Manufacturer: American Regent, Inc.
Strength: 100 mg/20mL
Dosage Form: INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route: INTRAVENOUS
Marketing Status
Application #: NDA211875
Drug Class: Microtubule Inhibitor [EPC]
Marketing Start: 05/02/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea4,519 reports

nausea4,519 reports

neutropenia4,401 reports

off label use4,278 reports

diarrhoea4,184 reports

anaemia3,855 reports

malignant neoplasm progression3,606 reports

disease progression3,337 reports

fatigue3,306 reports

neuropathy peripheral3,179 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) 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. ( 1.3 ) 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…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Do not substitute Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) for other non-protein-bound 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/m 2 intravenously over 30 minutes every 3 weeks. ( 2.2 ) Non-Small Cell Lung Cancer (NSCLC) : Recommended dosage of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is 100 mg/m 2 intravenously 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). ( 2.2 ) Adenocarcinoma of the Pancreas : Recommended dosage of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is 125 mg/m 2 intravenously over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle; administer gemcitabine on Days 1, 8 and 15 of each 28-day cycle immediately after Paclitaxel Protein-Bound Particles for Injec…

Contraindications

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 )] Neutrophil counts of < 1,500 cells/mm 3 . ( 4 ) Severe hypersensitivity reactions to Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound). ( 4 )

Drug 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 )

Adverse Reactions

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 protein bound paclitaxel 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 )] . The most common adverse reactions (≥ 20%) of protein bound paclitaxel in combination with carboplatin for non-small cell lung cancer are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue [see Adverse Reactions ( 6.1 )]. The most common serious adverse reactions of protein bound paclitaxel in combination with carboplatin for non-small cell lung cancer are anemia (4%) and pneumonia (3%). The most common adverse reactions resulting in permanent discontinuation of protein bound paclitaxel are neutropenia (3%), thrombocytopenia (3%)…

Frequently Asked Questions

What is PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND used for?

PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND contains Paclitaxel. It is a injection, powder, lyophilized, for suspension taken intravenous. Consult your doctor for specific uses.

Is PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND a controlled substance?

PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND is not classified as a controlled substance by the DEA.

What is the generic name for PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND?

The generic name for PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND is Paclitaxel. There are 11 other brand versions of Paclitaxel.

What is the NDC code for PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND 100 mg/20mL?

The NDC (National Drug Code) for PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND 100 mg/20mL is 0517-4300, listed by American Regent, Inc..

Product NDC

0517-4300

Package NDC

0517-4300-01

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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