Docetaxel injection is contraindicated in patients with: neutrophil counts of < 1,500 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) ] .
Treatment-related mortality associated with docetaxel is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive docetaxel as a single agent at a dose of 100 mg/m 2 [see Warnings and Precautions (5.1) ]. Avoid the use of docetaxel in patients with bilirubin > upper limit of normal (ULN), or to patients with AST and/or ALT > 1.5 × ULN concomitant with alkaline phosphatase > 2.5 × ULN. Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of severe neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Patients with isolated elevations of transaminase > 1.5 × ULN also had a higher rate of febrile neutropenia. Measure bilirubin, AST or ALT, and alkaline phosphatase prior to each cycle of docetaxel [see Warnings and Precautions (5.2) ] . Do not administer docetaxel to patients with neutrophil counts of < 1,500 cells/mm 3 . Monitor blood counts frequently as neutropenia may be severe and result in infection [see Warnings and Precautions (5.3) ] . Do not administer docetaxel to patients who have a history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80 [see Contraindications (4) ] . Severe hypersensitivity reactions have been reported in patients despite dexamethasone premedication. Hypersensitivity reactions require immediate discontinuation of the docetaxel infusion and administration of appropriate therapy [see Warnings and Precautions (5.5) ] . Severe fluid retention occurred in 6.5% (6/92) of patients despite use of dexamethasone premedication. It was characterized by one or more of the following events: poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites) [see Warnings and Precautions (5.6) ].
Docetaxel injection is contraindicated in patients with: neutrophil counts of < 1,500 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) ] .
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).
One-vial Docetaxel Injection, USP Docetaxel Injection USP, 20 mg/mL Single-Dose Vial Docetaxel Injection USP, 20 mg/mL: 20 mg docetaxel anhydrous, USP and 0.4 mg citric acid anhydrous in 1 mL in 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol. Docetaxel Injection USP, 80 mg/4 mL (20 mg/mL) Single-Dose Vial Docetaxel Injection USP, 80 mg/4 mL: 80 mg docetaxel anhydrous, USP and 1.6 mg citric acid anhydrous in 4 mL 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol. Docetaxel Injection USP, 160 mg/8 mL (20 mg/mL) Single-Dose Vial Docetaxel Injection USP, 160 mg/8 mL: 160 mg docetaxel anhydrous, USP and 3.2 mg citric acid anhydrous in 8 mL in 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol.
There is no known antidote for docetaxel overdosage. In case of overdosage, the patient should be kept in a specialized unit where vital functions can be closely monitored. Anticipated complications of overdosage include: bone marrow suppression, peripheral neurotoxicity, and mucositis. Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose. Other appropriate symptomatic measures should be taken, as needed. In two reports of overdose, one patient received 150 mg/m 2 and the other received 200 mg/m 2 as 1-hour infusions. Both patients experienced severe neutropenia, mild asthenia, cutaneous reactions, and mild paresthesia, and recovered without incident. In mice, lethality was observed following single intravenous doses that were ≥ 154 mg/kg (about 4.5 times the human dose of 100 mg/m 2 on a mg/m 2 basis); neurotoxicity associated with paralysis, non-extension of hind limbs, and myelin degeneration was observed in mice at 48 mg/kg (about 1.5 times the human dose of 100 mg/m 2 basis). In male and female rats, lethality was observed at a dose of 20 mg/kg (comparable to the human dose of 100 mg/m 2 on a mg/m 2 basis) and was associated with abnormal mitosis and necrosis of multiple organs.
NDC 70121-1221-1 Docetaxel Injection, USP 20 mg/mL Rx only Amneal Pharmaceuticals LLC NDC 70121-1222-1 Docetaxel Injection, USP 80 mg/4 mL Rx only Amneal Pharmaceuticals LLC NDC 70121-1223-1 Docetaxel Injection, USP 160 mg/8 mL Rx only Amneal Pharmaceuticals LLC
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1861411 | DOCEtaxel 160 MG in 8 ML Injection | PSN | 14 |
| 1860480 | DOCEtaxel 20 MG in 1 ML Injection | PSN | 14 |
| 1860485 | DOCEtaxel 80 MG in 4 ML Injection | PSN | 14 |
| 1860480 | 1 ML docetaxel 20 MG/ML Injection | SCD | 14 |
| 1860485 | 4 ML docetaxel 20 MG/ML Injection | SCD | 14 |
| 1861411 | 8 ML docetaxel 20 MG/ML Injection | SCD | 14 |
| 1861411 | docetaxel 160 MG per 8 ML Injection | SY | 14 |
| 1860480 | docetaxel 20 MG per 1 ML Injection | SY | 14 |
| 1860485 | docetaxel 80 MG per 4 ML Injection | SY | 14 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DOCETAXEL ANHYDROUS Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| be52172d-e80b-4aac-aa81-254100bce67f | Product name | 9 | 20260304 |
| c4fcacbc-a699-410c-905b-642c4d134e72 | Product name | 1 | 20250616 |
| ad3381c5-7539-4a18-83b7-e7382b118d04 | Product name | 1 | 20231117 |
| 60a22813-7270-4733-af61-30636bce9f0f | Product name | 4 | 20180820 |
| 0179c4ba-fb03-4931-875d-b4f1ba528029 | Product name | 1 | 20160107 |
| 9ff92ef8-2da9-4645-bbf8-642e7eb0d754 | Product name | 1 | 20150812 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70121-1221-1 | Docetaxel | 1 in 1 CARTON | INJECTION | 1 | 14 | |
| 70121-1221-1 | Docetaxel | 1 mL in 1 VIAL, GLASS | INJECTION | 1 | 14 | |
| 70121-1222-1 | Docetaxel | 1 in 1 CARTON | INJECTION | 1 | 14 | |
| 70121-1222-1 | Docetaxel | 4 mL in 1 VIAL, GLASS | INJECTION | 4 | 14 | |
| 70121-1223-1 | Docetaxel | 8 mL in 1 VIAL, GLASS | INJECTION | 8 | 14 | |
| 70121-1223-1 | Docetaxel | 1 in 1 CARTON | INJECTION | 1 | 14 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70121-1221 | DOCETAXEL INJECTION [AMNEAL PHARMACEUTICALS LLC] | 14 | Current NDC, Legacy NDC, 2 package rows | 20241122_67508df6-b96f-46fa-a792-0afcdfa9810e.zip |
| 70121-1222 | DOCETAXEL INJECTION [AMNEAL PHARMACEUTICALS LLC] | 14 | Current NDC, Legacy NDC, 2 package rows | 20241122_67508df6-b96f-46fa-a792-0afcdfa9810e.zip |
| 70121-1223 | DOCETAXEL INJECTION [AMNEAL PHARMACEUTICALS LLC] | 14 | Current NDC, Legacy NDC, 2 package rows | 20241122_67508df6-b96f-46fa-a792-0afcdfa9810e.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70121-1221-1 | ML - Milliliter | 70121-1221 | 26eecbee-63b3-4cf8-9c51-62e702d43565 | 1 | 2024-06-10 |
| 70121-1222-1 | ML - Milliliter | 70121-1222 | a4b53fd6-1d81-4115-a584-d4402e43de99 | 1 | 2024-06-10 |
| 70121-1223-1 | ML - Milliliter | 70121-1223 | 1e969d39-74ba-4d0f-ac00-ad04e41667fa | 1 | 2024-06-10 |
| Product NDC | Package NDC |
|---|---|
| 70121-1221 | 70121-1221-1 |
| 70121-1222 | 70121-1222-1 |
| 70121-1223 | 70121-1223-1 |
| Name | UNII | Kind |
|---|---|---|
| DOCETAXEL ANHYDROUS | 699121PHCA | ACTIB |
| ALCOHOL | 3K9958V90M | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| DOCETAXEL ANHYDROUS | 699121PHCA | ACTIB |
| ALCOHOL | 3K9958V90M | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| DOCETAXEL ANHYDROUS | 699121PHCA | ACTIB |
| ALCOHOL | 3K9958V90M | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
Treatment-related mortality associated with docetaxel is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive docetaxel as a single agent at a dose of 100 mg/m 2 [see Warnings and Precautions (5.1) ]. Avoid the use of docetaxel in patients with bilirubin > upper limit of normal (ULN), or to patients with AST and/or ALT > 1.5 × ULN concomitant with alkaline phosphatase > 2.5 × ULN. Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of severe neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Patients with isolated elevations of transaminase > 1.5 × ULN also had a higher rate of febrile neutropenia. Measure bilirubin, AST or ALT, and alkaline phosphatase prior to each cycle of docetaxel [see Warnings and Precautions (5.2) ] . Do not administer docetaxel to patients with neutrophil counts of < 1,500 cells/mm 3 . Monitor blood counts frequently as neutropenia may be severe and result in infection [see Warnings and Precautions (5.3) ] . Do not administer docetaxel to patients who have a history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80 [see Contraindications (4) ] . Severe hypersensitivity reactions have been reported in patients despite dexamethasone premedication. Hypersensitivity reactions require immediate discontinuation of the docetaxel infusion and administration of appropriate therapy [see Warnings and Precautions (5.5) ] . Severe fluid retention occurred in 6.5% (6/92) of patients despite use of dexamethasone premedication. It was characterized by one or more of the following events: poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites) [see Warnings and Precautions (5.6) ].
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).
One-vial Docetaxel Injection, USP Docetaxel Injection USP, 20 mg/mL Single-Dose Vial Docetaxel Injection USP, 20 mg/mL: 20 mg docetaxel anhydrous, USP and 0.4 mg citric acid anhydrous in 1 mL in 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol. Docetaxel Injection USP, 80 mg/4 mL (20 mg/mL) Single-Dose Vial Docetaxel Injection USP, 80 mg/4 mL: 80 mg docetaxel anhydrous, USP and 1.6 mg citric acid anhydrous in 4 mL 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol. Docetaxel Injection USP, 160 mg/8 mL (20 mg/mL) Single-Dose Vial Docetaxel Injection USP, 160 mg/8 mL: 160 mg docetaxel anhydrous, USP and 3.2 mg citric acid anhydrous in 8 mL in 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol.
Docetaxel injection is contraindicated in patients with: neutrophil counts of < 1,500 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) ] .
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, alopecia, skin reactions, and myalgia. Incidence varies depending on the indication. Adverse reactions are described according to indication. 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. Responding patients may not experience an improvement in performance status on therapy and may experience worsening. The relationship between changes in performance status, response to therapy, and treatment-related side effects has not been established.
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 co-administered with ketoconazole, a potent inhibitor of CYP3A4. Protease inhibitors, particularly ritonavir, may increase the exposure of docetaxel. Concomitant use of docetaxel and drugs that inhibit CYP3A4 may increase exposure to docetaxel and should be avoided. In patients receiving treatment with docetaxel, close monitoring for toxicity and a docetaxel 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) ].
There is no known antidote for docetaxel overdosage. In case of overdosage, the patient should be kept in a specialized unit where vital functions can be closely monitored. Anticipated complications of overdosage include: bone marrow suppression, peripheral neurotoxicity, and mucositis. Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose. Other appropriate symptomatic measures should be taken, as needed. In two reports of overdose, one patient received 150 mg/m 2 and the other received 200 mg/m 2 as 1-hour infusions. Both patients experienced severe neutropenia, mild asthenia, cutaneous reactions, and mild paresthesia, and recovered without incident. In mice, lethality was observed following single intravenous doses that were ≥ 154 mg/kg (about 4.5 times the human dose of 100 mg/m 2 on a mg/m 2 basis); neurotoxicity associated with paralysis, non-extension of hind limbs, and myelin degeneration was observed in mice at 48 mg/kg (about 1.5 times the human dose of 100 mg/m 2 basis). In male and female rats, lethality was observed at a dose of 20 mg/kg (comparable to the human dose of 100 mg/m 2 on a mg/m 2 basis) and was associated with abnormal mitosis and necrosis of multiple organs.
Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel anhydrous is benzenepropanoic acid, β-[[(1,1-dimethylethoxy) carbonyl) amino]-α-hydroxy-, 12b- (acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,6,11-trihydroxy-4a,8,13,13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-yl ester. Docetaxel anhydrous has the following structural formula: Docetaxel anhydrous, USP is a white or almost white crystalline powder with an molecular formula of C 43 H 53 NO 14 , and a molecular weight of 807.88. It is practically insoluble in water, soluble in acetone and methanol. One-vial Docetaxel Injection, USP Docetaxel Injection, USP is a sterile, non-pyrogenic, pale yellow to brownish-yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel anhydrous USP, 0.4 mg citric acid anhydrous in 0.54 g polysorbate 80 and 0.395 g dehydrated alcohol (50% v/v) solution. Docetaxel Injection, USP is available in single-dose vials containing 20 mg (1 mL), 80 mg (4 mL) and 160 mg (8 mL) docetaxel anhydrous, USP. Docetaxel Injection, USP requires NO prior dilution with a diluent and is ready to add to the infusion solution.
1. “OSHA Hazardous Drugs.” http://www.osha.gov/SLTC/hazardousdrugs/index.html
Advise the patient to read the FDA-approved patient labeling (Patient Information). Bone Marrow Suppression Advise patients that periodic assessment of their blood count will be performed to detect neutropenia, thrombocytopenia, and/ or anemia [see Contraindications (4) , Warnings and Precautions (5.3) ] . Instruct patients to monitor their temperature frequently and immediately report any occurrence of fever. Enterocolitis and Neutropenic Colitis Advise patients of the symptoms of colitis, such as abdominal pain or tenderness, and/or diarrhea, with or without fever, and instruct patients to promptly contact their healthcare provider if they experience these symptoms [see Dosage and Administration (2.7) and Warnings and Precautions (5.4) ]. Hypersensitivity Reactions Ask patients whether they have previously received paclitaxel therapy, and if they have experienced a hypersensitivity reaction to paclitaxel. Instruct patients to immediately report to their healthcare provider signs of a hypersensitivity reaction [see Contraindications (4) , Warnings and Precautions (5.5) ] . Fluid Retention Advise patients to report signs of fluid retention such as peripheral edema in the lower extremities, weight gain, and dyspnea immediately to their healthcare provider [see Warnings and Precautions (5.6) ] . Second Primary Malignancies Advise patients on the risk of second primary malignancies during treatment with docetaxel [see Warnings and Precautions (5.7) ]. Cutaneous Reactions Advise patients that localized erythema of the extremities and severe skin toxicities may occur. Instruct patients to immediately report severe cutaneous reactions to their healthcare provider [see Dosage and Administration (2.7) and Warnings and Precautions (5.8) ]. Neurologic Reactions Advise patients that neurosensory symptoms or peripheral neuropathy may occur. Instruct patients to immediately report neurologic reactions to their healthcare provider [see Dosage and Administration (2.7) and Warnings and Precautions (5.9) ]. Eye Disorders Advise patients that vision disturbances and excessive tearing are associated with docetaxel administration. Instruct patients to immediately report any vision changes to their healthcare provider [see Warnings and Precautions (5.10) ]. Gastrointestinal Reactions Explain to patients that nausea, vomiting, diarrhea, and constipation are associated with docetaxel administration. Instruct patients to report any severe events to their healthcare provider [see Adverse Reactions (6) ]. Cardiac Disorders Advise patients to report any irregular and/or rapid heartbeat, severe shortness of breath, dizziness, and/or fainting immediately to their healthcare provider [see Adverse Reactions (6) ] . Other Common Adverse Reactions Advise patients that other common adverse reactions associated with docetaxel may include alopecia (cases of permanent hair loss have been reported), asthenia, anorexia, dysgeusia, mucositis, myalgia, nail disorders, or pain. Instruct patients to report these reactions to their healthcare provider if serious events occur [see Adverse Reactions (6) ]. Importance of Corticosteroids Explain the significance of oral corticosteroids such as dexamethasone administration to the patient to help facilitate compliance. Instruct patients to report to their healthcare provider if they were not compliant with the oral corticosteroid regimen [see Dosage and Administration (2.6) ] . Embryo-Fetal Toxicity Docetaxel can cause fetal harm. Advise patients to inform their healthcare provider of a known or suspected pregnancy. Advise patients to avoid becoming pregnant while receiving this drug. Advise female patients of reproductive potential to use effective contraceptives during treatment and for 2 months after the last dose of docetaxel. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose of docetaxel [see Warnings and Precautions (5.12) , and Use in Specific Populations (8.1 , 8.3) ]. Lactation Advise women not to breastfeed during docetaxel treatment and for 1 week after the last dose [see Use in Specific Populations (8.2) ] . Infertility Advise males of reproductive potential that docetaxel may impair fertility [see Nonclinical Toxicology (13.1) ] . Alcohol Content in Docetaxel Injection Explain to patients the possible effects of the alcohol content in docetaxel injection, including possible effects on the central nervous system [see Warnings and Precautions (5.13) ] . Tumor Lysis Syndrome Advise patients of the potential risk of tumor lysis syndrome and to immediately report any signs or symptoms associated with this event (nausea, vomiting, confusion, shortness of breath, seizure, irregular heartbeat, dark or cloudy urine, reduced amount of urine, unusual tiredness, muscle cramps) to their healthcare provider. Advise patients of the importance of keeping scheduled appointment for blood work or other laboratory tests and of drinking adequate fluids to avoid dehydration [see Warnings and Precautions (5.14) ] . Ability to Drive or Operate Machines Explain to patients that docetaxel injection may impair their ability to drive or operate machines due to its side effects [see Adverse Reactions (6) ] or due to the alcohol content of docetaxel injection [see Warnings and Precautions (5.13) ] . Advise them not to drive or use machines if they experience these side effects during treatment. Drug Interactions Inform patients about the risk of drug interactions and the importance of providing a list of prescription and non-prescription drugs to their healthcare provider [see Drug Interactions (7) ] . Manufactured by: Amneal Oncology Pvt. Ltd. Telangana 509301, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 08-2023-07
Docetaxel (doe” se tax’el) Injection, USP For Intravenous use What is the most important information I should know about docetaxel injection? Docetaxel injection can cause serious side effects, including death. The chance of death in people who receive docetaxel injection is higher if you: have liver problems receive high doses of docetaxel injection have non-small cell lung cancer and have been treated with chemotherapy medicines that contain platinum Docetaxel injection can affect your blood cells. Your healthcare provider should do routine blood tests during treatment with docetaxel injection. This will include regular checks of your white blood cell counts. If your white blood cells are too low, your healthcare provider may not treat you with docetaxel injection until you have enough white blood cells. People with low white blood cell counts can develop life-threatening infections. The earliest sign of infection may be fever. Follow your healthcare provider’s instructions for how often to take your temperature during treatment with docetaxel injection. Call your healthcare provider right away if you have a fever. Swelling (inflammation) of the small intestine and colon. This can happen at any time during treatment and could lead to death as early as the first day you get symptoms. Tell your healthcare provider right away if you develop new or worse symptoms of intestinal problems, including stomach (abdominal) pain or tenderness or diarrhea, with or without fever. Severe allergic reactions are medical emergencies that can happen in people who receive docetaxel injection and can lead to death. You may be at higher risk of developing a severe allergic reaction to docetaxel if you are allergic to paclitaxel. Your healthcare provider will monitor you closely for allergic reactions during your docetaxel injection infusion. Tell your healthcare provider right away if you have any of these signs of a severe allergic reaction: trouble breathing sudden swelling of your face, lips, tongue, throat, or trouble swallowing hives (raised bumps), rash, or redness all over your body Your body may hold too much fluid (severe fluid retention) during treatment with docetaxel injection. This can be life threatening. To decrease the chance of this happening, you must take another medicine, a corticosteroid, before each docetaxel injection treatment. You must take the corticosteroid exactly as your healthcare provider tells you. Tell your healthcare provider or nurse before your docetaxel injection treatment if you forgot to take your corticosteroid dose or do not take it as your healthcare provider tells you. Tell your healthcare provider right away if you have swelling in your legs or feet, weight gain or shortness of breath. Risk of new cancers. An increase in new (second) cancers has happened in people treated with docetaxel injection together with certain other anticancer treatments. This includes certain blood cancers, such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), non-Hodgkin’s Lymphoma (NHL), and kidney cancer. Changes in blood counts due to leukemia and other blood disorders may occur years after treatment with docetaxel injection. Your healthcare provider will check you for new cancers during and after your treatment with docetaxel injection. Severe skin problems. Tell your healthcare provider right away if you have any of these signs of a severe skin reaction: redness and swelling of your arms and legs. blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash. You may also have flu-like symptoms such as fever, chills, or muscle aches. red, scaly rash all over your body with blisters, small red or white bumps under the skin that contain pus (pustules) and fever. What is docetaxel injection? Docetaxel injection is a prescription anti-cancer medicine used to treat certain people with: breast cancer non-small cell lung cancer prostate cancer stomach cancer head and neck cancer It is not known if docetaxel injection is effective in children. Do not receive docetaxel injection if you: have a low white blood cell count. have had a severe allergic reaction to: docetaxel, the active ingredient in docetaxel injection, or any other medicines that contain polysorbate 80. Ask your healthcare provider or pharmacist if you are not sure. See “What is the most important information I should know about docetaxel injection?” for the signs and symptoms of a severe allergic reaction. See the end of this Patient Information for a complete list of the ingredients in docetaxel injection. Before you receive docetaxel injection, tell your healthcare provider about all of your medical conditions, including if you: are allergic to any medicines, including paclitaxel. See “ Do not receive docetaxel injection if you ”. have liver problems have kidney problems are pregnant or plan to become pregnant. Docetaxel injection can harm your unborn baby. You should not become pregnant during treatment with docetaxel injection. Tell your healthcare provider if you become pregnant or you think you may be pregnant during treatment with docetaxel injection. Females who are able to become pregnant: Your healthcare provider will check to see if you are pregnant before you start treatment with docetaxel injection. You should use effective birth control (contraception) during treatment with docetaxel injection and for 2 months after the last dose. Males with female partners who are able to become pregnant should use effective birth control during treatment with docetaxel injection and for 4 months after the last dose. Talk to your healthcare provider if you have questions about birth control options that are right for you. are breastfeeding or plan to breastfeed. It is not known if docetaxel passes into your breast milk. Do not breastfeed during treatment with docetaxel injection and for 1 week after the last dose. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Docetaxel injection may affect the way other medicines work, and other medicines may affect the way docetaxel injection works. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How will I receive docetaxel injection? Docetaxel injection will be given to you as an intravenous (IV) injection into your vein, usually over 1 hour. Docetaxel injection is usually given every 3 weeks. Your healthcare provider will decide how long you will receive treatment with docetaxel injection. Your healthcare provider will check your blood cell counts and other blood tests during your treatment with docetaxel injection to check for side effects of docetaxel injection. Your healthcare provider may stop your treatment, change the timing of your treatment, or change the dose of your treatment if you have certain side effects while receiving docetaxel injection. What are the possible side effects of docetaxel injection? Docetaxel injection may cause serious side effects including death. See “What is the most important information I should know about docetaxel injection ?” Neurologic problems. Neurologic symptoms are common in people who receive docetaxel injection but can be severe. Tell your healthcare provider right away if you have numbness, tingling, or burning in your hands or feet (peripheral neuropathy) or weakness of your legs, feet, arms, or hands (motor weakness). Vision problems including blurred vision or loss of vision. Tell your healthcare provider right away if you have any vision changes. Docetaxel injection contains alcohol. The alcohol content in docetaxel injection may impair your ability to drive or use machinery right after receiving docetaxel injection. Consider whether you should drive, operate machinery or do other dangerous activities right after you re...
NDC 70121-1221-1 Docetaxel Injection, USP 20 mg/mL Rx only Amneal Pharmaceuticals LLC NDC 70121-1222-1 Docetaxel Injection, USP 80 mg/4 mL Rx only Amneal Pharmaceuticals LLC NDC 70121-1223-1 Docetaxel Injection, USP 160 mg/8 mL Rx only Amneal Pharmaceuticals LLC