Docetaxel 10 mg/mL
docetaxel · INJECTION, SOLUTION · Baxter Healthcare Corporation
Docetaxel is a injection, solution containing docetaxel at 10 mg/mL, taken intravenous. Manufactured by Baxter Healthcare Corporation.
Key Facts
- Brand Name
- Docetaxel
- Generic Name
- docetaxel
- NDC Code (Product)
43066-010- Manufacturer
- Baxter Healthcare Corporation
- Strength
- 10 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA201525
- Marketing Start
- 02/19/2018
Recall History
Infusion Options, Inc.
Lack of Assurance of Sterility
Dr. Reddy's Laboratories, Inc.
Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Sanofi-Aventis U.S. LLC
Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
Sagent Pharmaceuticals
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Shilpa Medicare Limited
CGMP Deviations
Sagent Pharmaceuticals
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Dr. Reddy's Laboratories, Inc.
Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is removed when the cap is flipped off.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Docetaxel Injection is a microtubule inhibitor indicated for: • Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC ( 1.1 ) • Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC ( 1.2 ) • Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer ( 1.3 ) • Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction ( 1.4 ) • Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN ( 1.5 ) 1.1 Breast Cancer Docetaxel Injection is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. Docetaxel Injection in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patie…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For all indications, toxicities may warrant dosage adjustments [ see Dosage and Administration (2.7) ]. Administer in a facility equipped to manage possible complications (e.g., anaphylaxis). Administer in a facility equipped to manage possible complications (e.g., anaphylaxis). Administer intravenously (IV) over 1 hour every 3 weeks. PVC equipment is not recommended. Use only a 21 gauge needle to withdraw Docetaxel Injection from the vial. • BC locally advanced or metastatic: 60 mg/m 2 to 100 mg/m 2 single agent ( 2.1 ) • BC adjuvant: 75 mg/m 2 administered 1 hour after doxorubicin 50 mg/m 2 and cyclophosphamide 500 mg/m 2 every 3 weeks for 6 cycles ( 2.1 ) • NSCLC: after platinum therapy failure: 75 mg/m 2 single agent ( 2.2 ) • NSCLC: chemotherapy-naïve: 75 mg/m 2 followed by cisplatin 75 mg/m 2 ( 2.2 ) • CRPC: 75 mg/m 2 with 5 mg prednisone twice a day continuously ( 2.3 ) • GC: 75 mg/m 2 followed by cisplatin 75 mg/m 2 (both on day 1 only) followed by fluorouracil 750 mg/m 2 per day as a 24-hour IV (days 1–5), starting at end of cisplatin infusion ( 2.4 ) • SCCHN: 75 mg/m 2 followed by cisplatin 75 mg/m 2 IV (day 1), followed by fluorouracil 750 mg/…
Contraindications
4 CONTRAINDICATIONS Docetaxel Injection is contraindicated in patients with: • neutrophil counts of <1500 cells/mm 3 [ see Warnings and Precautions (5.3) ]. • a history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80. Severe reactions, including anaphylaxis, have occurred [ see Warnings and Precautions (5.5) ]. • Hypersensitivity to docetaxel or polysorbate 80 ( 4 ) • Neutrophil counts of <1500 cells/mm 3 ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Docetaxel is a CYP3A4 substrate. In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds that induce, inhibit, or are metabolized by cytochrome P450 3A4. In vivo studies showed that the exposure of docetaxel increased 2.2-fold when it was coadministered with ketoconazole, a potent inhibitor of CYP3A4. Protease inhibitors, particularly ritonavir, may increase the exposure of docetaxel. Concomitant use of Docetaxel Injection and drugs that inhibit CYP3A4 may increase exposure to docetaxel and should be avoided. In patients receiving treatment with Docetaxel Injection close monitoring for toxicity and a Docetaxel Injection dose reduction could be considered if systemic administration of a potent CYP3A4 inhibitor cannot be avoided [ see Dosage and Administration (2.7) , Clinical Pharmacology (12.3) ]. • Cytochrome P450 3A4 inducers, inhibitors, or substrates: May alter docetaxel metabolism. ( 7 )
Adverse Reactions
6 ADVERSE REACTIONS The most serious adverse reactions from docetaxel are: • Toxic Deaths [ see Boxed Warning , Warnings and Precautions (5.1) ] • Hepatic Impairment [ see Boxed Warning , Warnings and Precautions (5.2) ] • Hematologic Effects [ see Boxed Warning , Warnings and Precautions (5.3) ] • Enterocolitis and Neutropenic Colitis [ see Warnings and Precautions (5.4) ] • Hypersensitivity Reactions [ see Boxed Warning , Warnings and Precautions (5.5) ] • Fluid Retention [ see Boxed Warning , Warnings and Precautions (5.6) ] • Second Primary Malignancies [ see Warnings and Precautions (5.7) ] • Cutaneous Reactions [ see Warnings and Precautions (5.8) ] • Neurologic Reactions [ see Warnings and Precautions (5.9) ] • Eye Disorders [ see Warnings and Precautions (5.10) ] • Asthenia [ see Warnings and Precautions (5.11) ] • Alcohol Content [ see Warnings and Precautions (5.13) ] The most common adverse reactions across all docetaxel indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alop…
Frequently Asked Questions
What is Docetaxel used for?
Docetaxel contains docetaxel. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Docetaxel a controlled substance?
Docetaxel is not classified as a controlled substance by the DEA.
What is the generic name for Docetaxel?
The generic name for Docetaxel is docetaxel. There are 3 other brand versions of docetaxel.
What is the NDC code for Docetaxel 10 mg/mL?
The NDC (National Drug Code) for Docetaxel 10 mg/mL is 43066-010, listed by Baxter Healthcare Corporation.