Trade Name: Docetaxel

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Manufacturer: Amneal Pharmaceuticals LLC

Presentation: INJECTION, HUMAN PRESCRIPTION DRUG

Strength: 80 mg/4mL

Storage and handling

DOCETAXEL ANHYDROUS Microtubule Inhibition [PE],Microtubule Inhibitor [EPC]

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  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
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  3. Read more
  • No data
  • Treatment-related mortality associated with docetaxel n- 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/mn n
  • Avoid the use of docetaxel in patients with bilirubin > upper limit of normal (ULN), or to patients with AST and/or ALT >1.5 u00d7 ULN concomitant with alkaline phosphatase >2.5 u00d7 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 u00d7 ULN also had a higher rate of febrile neutropenia. Measure bilirubin, AST or ALT, and alkaline phosphatase prior to each cycle of docetaxel .
  • Do not administer docetaxel to patients with neutrophil counts of <1500 cells/mm. Monitor blood counts frequently as neutropenia may be severe and result in infection.
  • Do not administer docetaxel to patients who have a history of severe hypersensitivity reactions to docetexel or to other drugs formulated with polysorbate 80 . 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 .
  • Severe fluid retention occurred in 6.5% (6/92) of patients despite use of u00a0dexamethasone 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) n
  • WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION
  • See full prescribing information for complete boxed warning.
  • Treatment-related mortality increases with abnormal liver function, at higher doses, and in patients with NSCLC and prior platinum-based therapy receiving docetaxel at 100 mg/m. ()
  • Avoid use of docetaxel if bilirubin > ULN, or if AST and/or ALT >1.5 u00d7 ULN concomitant with alkaline phosphatase >2.5 u00d7 ULN. LFT elevations increase risk of severe or life-threatening complications. Obtain LFTs before each treatment cycle. ()
  • Do not administer docetaxel to patients with neutrophil counts <1500 cells/mm. Obtain frequent blood counts to monitor for neutropenia. (, )
  • Severe hypersensitivity, including fatal anaphylaxis, has been reported in patients who received dexamethasone premedication. Severe reactions require immediate discontinuation of docetaxel and administration of appropriate therapy. ()
  • Contraindicated if history of severe hypersensitivity reactions to docetaxel or to drugs formulated with polysorbate 80. ()
  • Severe fluid retention may occur despite dexamethasone. ()n
  • Warnings and Precautions (5.7, 5.12)u00a0 u00a0 u00a006/2019
  • Warnings and Precautions (5.8)u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 12/2019
  • Warnings and Precautions (5.14)u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 05/2020
  • Docetaxel injection is a microtubule inhibitor indicated for:
  • Breast Cancer (BC):
  • Non-small Cell Lung Cancer (NSCLC):
  • Castration-Resistant Prostate Cancer (CRPC):
  • Gastric Adenocarcinoma (GC):
  • Squamous Cell Carcinoma of the Head and Neck (SCCHN):
  • For all indications, toxicities may warrant dosage adjustments .
  • 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 hr every 3 weeks. PVC equipment is not recommended. n
  • For all patients:
  • Arrayn- One-vial Docetaxel Injection, USP
  • Docetaxel Injection USP, 20 mg/mL n- 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 1.6u00a0 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.
  • Injection: One-vial docetaxel injection: 20 mg/mL Single-Dose Vial, 80 mg/4 mL (20 mg/mL) Single-Dose Vial and 160 mg/8 mL (20 mg/mL) Single-Dose Vial. ()
  • Docetaxel injection is contraindicated in patients with:
  • No data
  • Second primary malignancies: In patients treated with docetaxel-containing regimens, monitor for delayed AML, MDS, NHL, and renal cancer. n n
  • Cutaneous reactions: Reactions including erythema of the extremities with edema followed by desquamation may occur. Severe cutaneous adverse reactions have been reported. Severe skin toxicity may require dose adjustment or permanent treatment discontinuation. ()
  • Neurologic reactions: Reactions including paresthesia, dysesthesia, and pain may occur. Severe neurosensory symptoms require dose adjustment or discontinuation if persistent. n
  • Eye disorders: Cystoid macular edema (CME) has been reported and requires treatment discontinuation. n
  • Asthenia: Severe asthenia may occur and may require treatment discontinuation. n
  • Embryo-fetal toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. , , n n
  • Alcohol content: The alcohol content in a dose of docetaxel injection may affect the central nervous system. This may include impairment of a patientu2019s ability to drive or use machines immediately after infusion. n n
  • Tumor lysis syndrome: Tumor lysis syndrome has been reported. Patients at risk should be well hydrated and closely monitored during treatment.u00a0n
  • The most serious adverse reactions from docetaxel are:
  • 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.
  • 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. n n
  • To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or n
  • Docetaxel is a CYP3A4 substrate. 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.n
  • In vivo n- [seeu00a0n n- Array
  • Cytochrome P450 3A4 inducers, inhibitors, or substrates: May alter docetaxel metabolism. n n
  • No data
  • Lactation: Advise women not to breastfeed. n n
  • Females and Males of Reproductive Potential: Verify pregnancy status of females prior to initiation of docetaxel. n n
  • 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.u00a0
  • In two reports of overdose, one patient received 150 mg/m and the other received 200 mg/m 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 u2265154 mg/kg (about 4.5 times the human dose of 100 mg/m on a mg/m 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 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 on a mg/m 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, -[[(1,1-dimethylethoxy) carbonyl) amino]-u03b1-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-1-cyclodeca[3,4]benz[1,2-]oxet-9-yl ester. Docetaxel anhydrous has the following structural formula:
  • u00a0n
  • Docetaxel anhydrous, USP is a white or almost-white crystalline powder with an empirical formula of CHNO, and a molecular weight of 807.88. It is u00a0practically insoluble in water, soluble in acetone and methanol.
  • Arrayn- 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 grams polysorbate 80 and 0.395 grams dehydrated alcohol 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.
  • No data
  • Carcinogenicity studies with docetaxel have not been performed.
  • Docetaxel was clastogenic in the chromosome aberration test in CHO-K cells and in the micronucleus test in mice administered doses of 0.39 to 1.56 mg/kg (about 1/60 to 1/15 the recommended human dose on a mg/m basis). Docetaxel was not mutagenic in the Ames test or the CHO/HGPRT gene mutation assays.
  • Docetaxel did not reduce fertility in rats when administered in multiple intravenous doses of up to 0.3 mg/kg (about 1/50 the recommended human dose on a mg/m basis), but decreased testicular weights were reported. This correlates with findings of a 10-cycle toxicity study (dosing once every 21 days for 6 months) in rats and dogs in which testicular atrophy or degeneration was observed at intravenous doses of 5 mg/kg in rats and 0.375 mg/kg in dogs (about 1/3 and 1/15 the recommended human dose on a mg/m basis, respectively). An increased frequency of dosing in rats produced similar effects at lower dose levels.
  • No data
  • 1. u201cOSHA Hazardous Drugs.u201d http://www.osha.gov/SLTC/hazardousdrugs/index.html
  • No data
  • 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 . 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 andn
  • 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 .
  • 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 .
  • Second Primary Malignancies
  • Advise patients on the risk of second primary malignancies during treatment with docetaxel n
  • 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 andn
  • Neurologic Reactions
  • Advise patients that neurosensory symptoms or peripheral neuropathy may occur. Instruct patients to immediately report neurologic reactions to their healthcare provider andn
  • 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 n
  • 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 n
  • 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 .
  • 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 n
  • 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 .
  • 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 6 months after the last dose of docetaxel. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of docetaxel and n
  • Lactation
  • Advise women not to breastfeed during docetaxel treatment and for 1 week after the last dose .
  • Infertility
  • Advise males of reproductive potential that docetaxel may impair fertility .
  • 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 .
  • 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. .
  • 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 or due to the alcohol content of docetaxel injection . 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 .
  • Manufactured by:n Telangana 509301, INDIA
  • Distributed by:n n Bridgewater, NJ 08807
  • Rev. 06-2020-04
  • Docetaxel (doeu201d se taxu2019el) Injection
  • For Intravenous use
  • What is the most important information I should know about n- docetaxel injection?
  • Docetaxel injection can cause serious side effects, including death.
  • Tell your healthcare provider right away if you have any of these signs of a severe allergic reaction:
  • Tell your healthcare provider right away if you have any of these signs of a severe skin reaction:
  • What isn- docetaxel injection?
  • Docetaxel injection is a prescription anti-cancer medicine used to treat certain people with:
  • It is not known if docetaxel injection is effective in children.
  • Do not receive docetaxel injection if you:
  • See 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 yourn- healthcare provider about all of your medical conditions, including if you:
  • Females who are able to become pregnant:
  • Males
  • Talk to your healthcare provider if you have questions about birth control options that are right for you.
  • Tell your healthcare provider about all the medicines you take,
  • 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 n- docetaxel injection?
  • What are the possible side effects of n- docetaxel injection?
  • Docetaxel injection may cause serious side effects including death.
  • The most common side effects of docetaxel injection include:
  • Tell your healthcare provider if you have a fast or irregular heartbeat, severe shortness of breath, dizziness or fainting during your infusion. If any of these events occurs after your infusion, get medical help right away.
  • Docetaxel injection may affect fertility in males. Talk to your healthcare provider if this is a concern for you.
  • These are not all the possible side effects of docetaxel injection. For more information, ask your healthcare provider or pharmacist.
  • Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • General information about the safe and effective use ofn- docetaxel injection.
  • Medicines are sometimes prescribed for purposes other than those listed in this Patient Information. You can ask your pharmacist or healthcare provider for information about docetaxel injection that is written for health professionals.
  • What are the ingredients inn- docetaxel injection?
  • Active ingredient:
  • Inactive ingredients:
  • For more information, go to www.amneal.com or call toll-free 1-877-835-5472.
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Manufactured by:n Telangana 509301, INDIA
  • Distributed by:
  • Amneal n- Pharmaceuticals LLC
  • Rev. 06-2020-04
  • u00a0NDC: 70121-1221-1
  • Name: Docetaxel Injection, USP
  • Strength: 20 mg/mL
  • Rx Only
  • Amneal Pharmaceuticals LLCn
  • Arrayn- Array
  • Arrayn- Arrayn- Array
  • NDC: 70121-1222-1
  • Name: Docetaxel Injection, USP
  • Strength: 80 mg/4 mL
  • Rx Only
  • Amneal Pharmaceuticals LLCn
  • Arrayn- Array
  • Arrayn- Array
  • NDC: 70121-1223-1
  • Name: Docetaxel Injection, USP
  • Strength: 160 mg/8 mL
  • Rx Only
  • Amneal Pharmaceuticals LLCn
  • Arrayn- Array

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