Bio-Milk

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
• 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
• Pediatric patients compared to
• Adults
• No new safety signals were observed
• 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.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.