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ABRAXANE
Overview
What is ABRAXANE?
ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) is paclitaxel formulated as albumin-bound nanoparticles with a mean particle size of approximately 130 nanometers. Paclitaxel exists in the particles in a non-crystalline, amorphous state. ABRAXANE is supplied as a white to yellow, sterile, lyophilized powder for reconstitution with 20 mL of 0.9% Sodium Chloride Injection, USP prior to intravenous infusion. Each single-use vial contains 100 mg of paclitaxel (bound to human albumin) and approximately 900 mg of human albumin (containing sodium caprylate and sodium acetyltryptophanate). Each milliliter (mL) of reconstituted suspension contains 5 mg paclitaxel formulated as albumin-bound particles. ABRAXANE is free of solvents.
The active agent in ABRAXANE is paclitaxel, a microtubule inhibitor. The chemical name for paclitaxel is 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2,3)--benzoyl-3-phenylisoserine.
Paclitaxel has the following structural formula:
Paclitaxel is a white to off-white crystalline powder with the empirical formula CHNO and a molecular weight of 853.91. It is highly lipophilic, insoluble in water, and melts at approximately 216°C to 217°C.
What does ABRAXANE look like?
What are the available doses of ABRAXANE?
For injectable suspension: lyophilized powder containing 100 mg of paclitaxel formulated as albumin-bound particles in single-use vial for reconstitution.
What should I talk to my health care provider before I take ABRAXANE?
How should I use ABRAXANE?
ABRAXANE 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.
After failure of combination chemotherapy for metastatic breast cancer or relapse within 6 months of adjuvant chemotherapy, the recommended regimen for ABRAXANE is 260 mg/m administered intravenously over 30 minutes every 3 weeks.
What interacts with ABRAXANE?
Sorry No Records found
What are the warnings of ABRAXANE?
Sorry No Records found
What are the precautions of ABRAXANE?
Sorry No Records found
What are the side effects of ABRAXANE?
Sorry No records found
What should I look out for while using ABRAXANE?
Neutrophil counts of < 1,500 cells/mm. ()
Severe hypersensitivity reaction to ABRAXANE. ()
What might happen if I take too much ABRAXANE?
There is no known antidote for ABRAXANE overdosage. The primary anticipated complications of overdosage would consist of bone marrow suppression, sensory neurotoxicity, and mucositis.
How should I store and handle ABRAXANE?
Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published . There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.Folic Acid Tablets, USP 1 mg are yellow, functionally scored, round, standard convex debossed with “B”, “-“ and “01” on one side and plain on the other side supplied in bottles of 100 and 1000. 100s NDC 58657-150-01 1000s NDC 58657-150-10 Dispense in well-closed container with child-resistant closure. Store 20°-25°C (68°-77°F). [See USP controlled room temperature.]Manufactured by: Zhongshan, Guangdong 528437 P.R. China Manufactured for: Method Pharmaceuticals, LLC Arlington, TX 76006 Rev Date: 2/15Folic Acid Tablets, USP 1 mg are yellow, functionally scored, round, standard convex debossed with “B”, “-“ and “01” on one side and plain on the other side supplied in bottles of 100 and 1000. 100s NDC 58657-150-01 1000s NDC 58657-150-10 Dispense in well-closed container with child-resistant closure. Store 20°-25°C (68°-77°F). [See USP controlled room temperature.]Manufactured by: Zhongshan, Guangdong 528437 P.R. China Manufactured for: Method Pharmaceuticals, LLC Arlington, TX 76006 Rev Date: 2/15Folic Acid Tablets, USP 1 mg are yellow, functionally scored, round, standard convex debossed with “B”, “-“ and “01” on one side and plain on the other side supplied in bottles of 100 and 1000. 100s NDC 58657-150-01 1000s NDC 58657-150-10 Dispense in well-closed container with child-resistant closure. Store 20°-25°C (68°-77°F). [See USP controlled room temperature.]Manufactured by: Zhongshan, Guangdong 528437 P.R. China Manufactured for: Method Pharmaceuticals, LLC Arlington, TX 76006 Rev Date: 2/15Folic Acid Tablets, USP 1 mg are yellow, functionally scored, round, standard convex debossed with “B”, “-“ and “01” on one side and plain on the other side supplied in bottles of 100 and 1000. 100s NDC 58657-150-01 1000s NDC 58657-150-10 Dispense in well-closed container with child-resistant closure. Store 20°-25°C (68°-77°F). [See USP controlled room temperature.]Manufactured by: Zhongshan, Guangdong 528437 P.R. China Manufactured for: Method Pharmaceuticals, LLC Arlington, TX 76006 Rev Date: 2/15Folic Acid Tablets, USP 1 mg are yellow, functionally scored, round, standard convex debossed with “B”, “-“ and “01” on one side and plain on the other side supplied in bottles of 100 and 1000. 100s NDC 58657-150-01 1000s NDC 58657-150-10 Dispense in well-closed container with child-resistant closure. Store 20°-25°C (68°-77°F). [See USP controlled room temperature.]Manufactured by: Zhongshan, Guangdong 528437 P.R. China Manufactured for: Method Pharmaceuticals, LLC Arlington, TX 76006 Rev Date: 2/15Folic Acid Tablets, USP 1 mg are yellow, functionally scored, round, standard convex debossed with “B”, “-“ and “01” on one side and plain on the other side supplied in bottles of 100 and 1000. 100s NDC 58657-150-01 1000s NDC 58657-150-10 Dispense in well-closed container with child-resistant closure. Store 20°-25°C (68°-77°F). [See USP controlled room temperature.]Manufactured by: Zhongshan, Guangdong 528437 P.R. China Manufactured for: Method Pharmaceuticals, LLC Arlington, TX 76006 Rev Date: 2/15Folic Acid Tablets, USP 1 mg are yellow, functionally scored, round, standard convex debossed with “B”, “-“ and “01” on one side and plain on the other side supplied in bottles of 100 and 1000. 100s NDC 58657-150-01 1000s NDC 58657-150-10 Dispense in well-closed container with child-resistant closure. Store 20°-25°C (68°-77°F). [See USP controlled room temperature.]Manufactured by: Zhongshan, Guangdong 528437 P.R. China Manufactured for: Method Pharmaceuticals, LLC Arlington, TX 76006 Rev Date: 2/15
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
ABRAXANE is a microtubule inhibitor that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. Paclitaxel induces abnormal arrays or “bundles” of microtubules throughout the cell cycle and multiple asters of
microtubules during mitosis.
Non-Clinical Toxicology
Neutrophil counts of < 1,500 cells/mm. ()Severe hypersensitivity reaction to ABRAXANE. ()
There is evidence that the anticonvulsant action of phenytoin is antagonized by folic acid. A patient whose epilepsy is completely controlled by phenytoin may require increased doses to prevent convulsions if folic acid is given.
Folate deficiency may result from increased loss of folate, as in renal dialysis and/or interference with metabolism (e.g., folic acid antagonists such as methotrexate); the administration of anticonvulsants, such as diphenylhydantoin, primidone, and barbiturates; alcohol consumption and, especially, alcoholic cirrhosis; and the administration of pyrimethamine and nitrofurantoin.
False low serum and red cell folate levels may occur if the patient has been taking antibiotics, such as tetracycline, which suppress the growth of
Bone marrow suppression (primarily neutropenia) is dose-dependent and a dose-limiting toxicity of ABRAXANE. In clinical studies, Grade 3-4 neutropenia occurred in 34% of patients with metastatic breast cancer (MBC), 47% of patients with non-small cell lung cancer (NSCLC), and 38% of patients with pancreatic cancer.
Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Day 1 (for MBC) and Days 1, 8, and 15 (for NSCLC and for pancreatic cancer). Do not administer ABRAXANE to patients with baseline absolute neutrophil counts (ANC) of less than 1,500 cells/mm. In the case of severe neutropenia (<500 cells/mm for seven days or more) during a course of ABRAXANE therapy, reduce the dose of ABRAXANE in subsequent courses in patients with either MBC or NSCLC.
In patients with MBC, resume treatment with every-3-week cycles of ABRAXANE after ANC recovers to a level >1,500 cells/mm and platelets recover to a level >100,000 cells/mm.
In patients with NSCLC, resume treatment if recommended (see Dosage and Administration, ) at permanently reduced doses for both weekly ABRAXANE and every-3-week carboplatin after ANC recovers to at least 1500 cells/mm and platelet count of at least 100,000 cells/mm on Day 1 or to an ANC of at least 500 cells/mm and platelet count of at least 50,000 cells/mm on Days 8 or 15 of the cycle
In patients with adenocarcinoma of the pancreas, withhold ABRAXANE and gemcitabine if the ANC is less than 500 cells/mm or platelets are less than 50,000 cells/mm and delay initiation of the next cycle if the ANC is less than 1500 cells/mm or platelet count is less than 100,000 cells/mm on Day 1 of the cycle. Resume treatment with appropriate dose reduction if recommended .
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 ABRAXANE 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 .
The most common adverse reactions (≥ 20%) of ABRAXANE in combination with carboplatin for non-small cell lung cancer are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue The most common serious adverse reactions of ABRAXANE 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 ABRAXANE are neutropenia (3%), thrombocytopenia (3%), and peripheral neuropathy (1%). The most common adverse reactions resulting in dose reduction of ABRAXANE are neutropenia (24%), thrombocytopenia (13%), and anemia (6%). The most common adverse reactions leading to withholding or delay in ABRAXANE dosing are neutropenia (41%), thrombocytopenia (30%), and anemia (16%).
In a randomized open-label trial of ABRAXANE in combination with gemcitabine for pancreatic adenocarcinoma , the most common (≥ 20%) selected (with a ≥ 5% higher incidence) adverse reactions of ABRAXANE are neutropenia, fatigue, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea, pyrexia, vomiting, decreased appetite, rash, and dehydration. The most common serious adverse reactions of ABRAXANE (with a ≥ 1% higher incidence) are pyrexia (6%), dehydration (5%), pneumonia (4%) and vomiting (4%). The most common adverse reactions resulting in permanent discontinuation of ABRAXANE are peripheral neuropathy (8%), fatigue (4%) and thrombocytopenia (2%). The most common adverse reactions resulting in dose reduction of ABRAXANE are neutropenia (10%) and peripheral neuropathy (6%). The most common adverse reactions leading to withholding or delay in ABRAXANE dosing are neutropenia (16%), thrombocytopenia (12%), fatigue (8%), peripheral neuropathy (15%), anemia (5%) and diarrhea (5%).
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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