注射用紫杉醇混悬液Abraxane

【Function and indications】:
Abraxane is a microinhibitor indicated for the treatment of:
(1) Metastatic breast cancer, recurrence within 6 months of metastatic disease or adjuvant chemotherapy after failure of combined chemotherapy. Previous treatment should include an anthracycline unless clinically contraindicated.
(2) For patients who are not selected for curative surgery or radiotherapy, locally advanced or metastatic non-small cell lung cancer (NSCLC), combined with carboplatin as first-line treatment.
(3) Metastatic pancreatic adenocarcinoma as first-line treatment in combination with gemcitabine.

【Model and specification】:
Injectable suspension: Single-use vial of lyophilized powder for reconstitution contains 100 mg of paclitaxel.

【Usage and dosage】:
(1) Metastatic breast cancer: The recommended dose of Abraxane is 260 mg/m2 intravenously over 30 minutes every 3 weeks.
(2) Non-small cell lung cancer: The recommended dose of Abraxane is 100 mg/m2 intravenously injected over 30 minutes on days 1, 8, and 15 of each 21-day cycle; carboplatin is administered immediately after Abraxane on day 1 of each 21-day cycle.
(3) Pancreatic adenocarcinoma: The recommended dose of Abraxane is 125 mg/m2 intravenously injected over 30-40 minutes on days 1, 8, and 15 of each 28-day cycle; gemcitabine is administered immediately after Abraxane on days 1, 8, and 15 of each 28-day cycle.
(4) No dose adjustment is required for patients with mild hepatic impairment. Withhold Abraxane if AST>10×ULN or bilirubin>5×ULN. Reduce the starting dose for patients with moderate to severe hepatic impairment.
(5) Dose reduction: Dose reduction or discontinuation may be required based on severe hematological, neurological, skin, or gastrointestinal toxicity.
(6) Use with caution when administering cytotoxic drugs. Closely monitor the infusion site for extravasation and infiltration. No premedication is required before administration.

[Clinical Research]:
A phase III study of Abraxane (paclitaxel protein-bound particle injection suspension) combined with gemcitabine in patients with untreated advanced pancreatic cancer reached the primary endpoint: overall survival. The study showed that the overall survival of the Abraxane combined with gemcitabine group was better than that of the gemcitabine monotherapy group, and the difference was statistically significant.

The MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study was an open, randomized, international study in which 861 patients with metastatic pancreatic cancer were randomly assigned to receive albumin-bound paclitaxel (125 mg/m2) combined with gemcitabine (1000 mg/m2) for 3 weeks and 1 week off or gemcitabine alone (1000 mg/m2, weekly treatment for 7 consecutive weeks, 1 week off; then weekly treatment for 3 consecutive weeks, 1 week off).

The primary endpoint of the study was improvement in overall survival. Secondary endpoints included progression-free survival, objective tumor response, and safety and tolerability of the combination therapy in this patient population. The safety profile observed with the combination of Abraxane and gemcitabine was similar to that observed in other clinical trials of Abraxane in pancreatic cancer.

【Precautions】:
(1) Abraxane causes bone marrow suppression. Monitor CBC and maintain and/or reduce dose as needed.
(2) Sensory neuropathy occurs frequently and may require dose reduction or treatment interruption.
(3) Sepsis with or without neutropenia occurs in patients receiving Abraxane and gemcitabine; interrupt Abraxane and gemcitabine until sepsis resolves, and if neutropenia occurs, until neutrophils are at least 1500 cells/mm3, then resume treatment at a reduced dose level.
(4) Pneumonitis occurs with the use of Abraxane and gemcitabine; permanently discontinue treatment with Abraxane and gemcitabine.
(5) Severe hypersensitivity reactions with fatal outcomes have been reported. Do not use this drug again.
(6) Paclitaxel exposure and toxicity may be increased in patients with liver damage; therefore, administer with caution.
(7) Abraxane contains albumin from human serum, which has a theoretical risk of viral transmission.
(8) Fetal harm may occur when administered to pregnant women. Women of childbearing potential are advised to avoid becoming pregnant while taking Abraxane.
(9) It is recommended not to become a father while taking Abraxane.

[Adverse Reactions and Contraindications]:
(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, seizures, peripheral neuropathy, nausea, and fatigue.
(3) The most common (≥ 20%) adverse reactions of Abraxane in pancreatic adenocarcinoma are neutropenia, fatigue, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea, fever, vomiting, anorexia, rash, and dehydration.

[Use in Pregnant Women]: Administration to pregnant women may cause fetal harm. Women of childbearing potential are advised to avoid becoming pregnant while receiving Abraxane.

[Drug Interactions]: Use with caution when Abraxane is administered concurrently with either CYP2C8 or CYP3A4 inhibitors or inducers

[Manufacturer]: United States