Abraxane

Instructions for Paclitaxel for Injection (Abraxane)

Common name: Paclitaxel for Injection

Trade name: Abraxane

Full names: Paclitaxel for Injection, Abraxane, Paclitaxel for Injection (Albumin Bound)

Indications:

Abraxane is a microscopic inhibitor suitable for the treatment of:

(1) Metastatic breast cancer, recurrence of metastatic disease or adjuvant chemotherapy within 6 months after combined chemotherapy failure. Prior therapy should include an anthracycline unless clinically contraindicated.

(2) For selected patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are not cured by surgery or radiotherapy, combined with carboplatin [carboplatin] as first-line treatment.

(3) Metastatic pancreatic cancer as first-line treatment combined with gemcitabine [gemcitabine].

Usage and dosage:

(1) Metastatic breast cancer: The recommended dose of Abraxane is 260mg/㎡ intravenously administered over 30 minutes, once every 3 weeks.

(2) Non-small cell lung cancer: The recommended dose of Abraxane is 100 mg/m2 intravenously over 30 minutes on days 1, 8, and 15 of every 21-day course of treatment; carboplatin should be given immediately after Abraxane on the first day of every 21-day course of treatment.

(3) Pancreatic cancer: The recommended dose of Abraxane is 125 mg/m2 intravenously over 30-40 minutes on days 1, 8 and 15 of every 28-day course of treatment; gemcitabine should be given immediately after Abraxane on days 1, 8 and 15 of every 28-day course of treatment.

Adverse reactions:

(1) The most common adverse reactions (≥20%) in metastatic breast cancer are alopecia, neutropenia, sensory neuropathy, abnormal ECG, fatigue/weakness, myalgia/arthralgia, increased AST, increased alkaline phosphatase, anemia, nausea, infection, and diarrhea.

(2) The most common adverse reactions (≥20%) in NSCLC are anemia, neutropenia, thrombocytopenia, flare, peripheral neuropathy, nausea, and fatigue.

(3) The most common (≥20%) adverse reactions of Abraxane in pancreatic cancer are neutropenia, fatigue, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea, pyrexia, vomiting, anorexia, rash, and dehydration.

Contraindications:

If the patient's peripheral blood neutrophil count is less than 1500/mm3 before treatment, this product should not be given.

This product is prohibited for patients allergic to paclitaxel or human albumin.

Precautions:

Hematology: Myelosuppression (primarily neutropenia) is dose-dependent and dose-limiting toxicity. If the patient's peripheral blood neutrophil count is less than 1500/mm3 before treatment, the drug should not be administered. To monitor patients for possible bone marrow toxicity during dosing, peripheral blood cell counts should be performed periodically. Administration can be continued when the patient's neutrophil count recovers to >1500/mm3 and platelet count >100,000/mm3. If severe neutropenia occurs during treatment (less than 500/mm3 for 7 days or longer), the dosage should be reduced during subsequent treatment.

Nervous system: Peripheral neurotoxicity may occur after using this product. Generally, no dosage adjustment is required for grade 1 or 2 peripheral neurotoxicity. If grade 3 peripheral neurotoxicity occurs, treatment needs to be stopped until recovery to grade 2 or less, and the dose needs to be reduced in subsequent treatment.

Abnormal liver function: Because the exposure and toxicity of paclitaxel can be increased by abnormal liver function, caution should be used when treating patients with abnormal liver function.

Patients with abnormal liver function may be at increased risk for toxicity, especially the development of myelosuppression; these patients should be monitored closely to prevent the development of severe myelosuppression. ABRAXANE is not recommended for patients with total bilirubin >5×ULN or AST >10×ULN.

Severe hypersensitivity reactions: Severe hypersensitivity reactions are rare, including very rare fatal anaphylaxis events. If a patient has experienced a severe hypersensitivity reaction while receiving this product, this product should not be used again.

Medication for male patients: If male patients receive this product, it is recommended that they take contraceptive measures during treatment.

Human serum albumin: This product contains serum albumin derived from human blood. However, due to strict screening of blood donors and strict quality control during the production process, the risk of contracting viral diseases through treatment with this product is extremely low, and the theoretical risk of contracting Creutzfeldt-Jakob syndrome (CJD) is also extremely low. No cases of viral infection or Creutzfeldt-Jakob disease have been reported so far.

Effects on ability to drive and operate machinery: Adverse events such as fatigue, drowsiness, and discomfort may affect driving and operation of machinery.

Storage:

Put the vial containing the medicine in the original box and store it away from light at room temperature (20~25℃).

Mechanism of action:

Paclitaxel (ABRAXANE suspension injection) is a microtubule inhibitor that can promote the assembly of microtubules in tubulin dimers and organize depolymerization to solidify microtubules. This solidification results in the inhibition of the normal dynamic reorganization of the microtubule network, which is important for interphase and mitotic processes. Paclitaxel induces abnormal arrangement of microtubules or the formation of microtubule bundles throughout the cell cycle, and the formation of multiple microbodies during mitosis.

Safety and Efficacy:

A randomized controlled phase II clinical trial of paclitaxel for injection (albumin-bound) and solvent-based paclitaxel conducted on Chinese patients with metastatic breast cancer showed that ABRAXANE paclitaxel for injection (albumin-bound) had a significantly higher total effective rate than solvent-based paclitaxel. This result is consistent with the results of global phase III clinical trials conducted on patients in Europe and the United States. Compared with solvent-based paclitaxel, ABRAXANE injection of paclitaxel (albumin-bound) nearly doubled the total effective rate, and the median time to tumor progression was also longer than that of solvent-based paclitaxel, reaching 7.6 months. ABRAXANE injection paclitaxel (albumin-bound) also improved progression-free survival by 26% compared with solvent-based paclitaxel. At the same time, the most common toxic effects of the two treatments were similar and acceptable, the incidence of serious adverse events was basically equivalent, and both treatments were well tolerated.

A phase II clinical trial conducted by Michael et al. in Houston, USA, showed that injectable paclitaxel (albumin-bound) is effective in treating platinum-sensitive recurrent ovarian cancer, peritoneal cancer or fallopian tube cancer and is well tolerated by patients. The study included 47 patients with histologically or cytologically confirmed ovarian, fallopian tube, or peritoneal epithelial cancer who were administered intravenous nab-paclitaxel 260 mg over 30 minutes on day 1 of a 21-day treatment cycle. mg/m2 treatment for a total of 6 cycles or until disease progression. The results showed that among 44 evaluable patients, the objective response rate (ORR) was 64%, the median time to remission was 1.3 months, and the median PFS was 8.5 months. The most common grade 3 to 4 treatment-related toxic reactions were neutropenia (24%) and neuropathy (9%).