Protein

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. …

• Do not substitute paclitaxel protein-bound particles for injectable suspension (albumin-bound) for other paclitaxel products
• Extravasation : Closely monitor the infusion site for extravasation and infiltration
• 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
• Non-Small Cell Lung Cancer (NSCLC): Recommended dosage of paclitaxel protein-bound particles for injectable suspension (albumin-bound) is 100 mg/m2 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)
• Adenocarcinoma of the Pancreas: Recommended dosage of paclitaxel protein-bound particles for injectable suspension (albumin-bound) is 125 mg/m2 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 injectable suspension (albumin-bound)
• Use in Patients with Hepatic Impairment: Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is not recommended for use in patients with AST > 10 x ULN; or bilirubin > 5 x ULN or with metastatic adenocarcinoma of the pancreas who have moderate to severe hepatic impairment
• For MBC or NSCLC, reduce starting dose in patients with moderate to severe hepatic impairment. …

For injectable suspension, for intravenous use: white to yellow, sterile lyophilized cake or powder containing 100 mg of paclitaxel formulated as albumin-bound particles in single-dose vial for reconstitution. …

• Safety and effectiveness
• In pediatric patients have not been established
• Pharmacokinetics, safety, and antitumor activity of paclitaxel protein-bound particles for injectable suspension (albumin-bound) were assessed in an open-label, dose escalation, dose expansion study (NCT01962103) in 96
• Pediatric patients aged 1.4 to < 17 years with recurrent or refractory pediatric solid tumors
• The maximum tolerated dose (MTD) normalized for body surface area (BSA) was lower
• In pediatric patients compared to adults
• No new safety signals were observed
• In pediatric patients across these studies. …

Of the 229 patients in the randomized study who received paclitaxel protein-bound particles for injectable suspension (albumin-bound) for the treatment of metastatic breast cancer, 13% were at least 65 years of age and < 2% were 75 years or older. …

• Advise the patient to read the approved patient labeling (Patient Information)
• Severe Myelosuppression Patients must be informed of the risk of low blood cell counts and severe and life-threatening infections and instructed to contact their healthcare provider immediately for fever or evidence of infection [see Warnings and Precautions , ]
• Severe Neuropathy Patients must be informed that sensory neuropathy occurs frequently with paclitaxel protein-bound particles for injectable suspension (albumin-bound) and patients should advise their healthcare providers of numbness, tingling, pain, or weakness involving the extremities [see Warnings and Precautions ]. …

• 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 ] A history of severe hypersensitivity reactions to paclitaxel protein-bound particles for injectable suspension (albumin-bound) [see Warnings and Precautions ]
• Neutrophil counts of < 1,500 cells/mm 3
• Severe hypersensitivity reactions to paclitaxel

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 )

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. …

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 )] . …

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 )] . …

There is no known antidote for paclitaxel protein-bound particles for injectable suspension (albumin-bound) overdosage. The primary anticipated complications of overdosage would consist of bone marrow suppression, sensory neurotoxicity, and mucositis.

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