Docetaxel (Taxotere)

Trade Name : TAXOTERE

Sanofi-Aventis U.S. LLC

INJECTION, SOLUTION, CONCENTRATE

Strength 20 mg/mL

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

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Docetaxel (Taxotere) which is also known as TAXOTERE and Manufactured by Sanofi-Aventis U.S. LLC. It is available in strength of 20 mg/mL per ml. Read more

Docetaxel (Taxotere) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

Treatment-related mortality associated with TAXOTERE 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 TAXOTERE as a single agent at a dose of 100 mg/mn n- [see ].
Avoid the use of TAXOTERE 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 TAXOTERE n- [see ]n- .
Do not administer TAXOTERE to patients with neutrophil counts of <1500 cells/mm. Monitor blood counts frequently as neutropenia may be severe and result in infection. n- [see ]n- .
Do not administer TAXOTERE to patients who have a history of severe hypersensitivity reactions to TAXOTERE 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 TAXOTERE infusion and administration of appropriate therapy n- [see ]
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) n- [see ].
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 TAXOTERE at 100 mg/m ()
Avoid use of TAXOTERE 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 TAXOTERE 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 TAXOTERE and administration of appropriate therapy ()
Contraindicated if history of severe hypersensitivity reactions to TAXOTERE or to drugs formulated with polysorbate 80 ()
Severe fluid retention may occur despite dexamethasone ()

No data

TAXOTERE 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:

One-vial TAXOTERE (Injection)
TAXOTERE 20 mg/mL
TAXOTERE (docetaxel) Injection 20 mg/1 mL single-dose vial: 20 mg docetaxel in 1 mL in 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol.
TAXOTERE 80 mg/4 mL
TAXOTERE (docetaxel) Injection 80 mg/4 mL single-dose vial: 80 mg docetaxel in 4 mL 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol.

Injection: One-vial TAXOTERE: Single-dose vials 20 mg/mL and 80 mg/4 mL ()

TAXOTERE is contraindicated in patients with:

Hypersensitivity to docetaxel or polysorbate 80 ()
Neutrophil counts of <1500 cells/mm ()

No data

Second primary malignancies: In patients treated with TAXOTERE-containing regimens, monitor for delayed AML, MDS, NHL, and renal cancer. ()
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. ()
Eye disorders: Cystoid macular edema (CME) has been reported and requires treatment discontinuation. ()
Asthenia: Severe asthenia may occur and may require treatment discontinuation. ()
Embryo-fetal toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. (, , )
Alcohol content: The alcohol content in a dose of TAXOTERE Injection may affect the central nervous system. This may include impairment of a patient's ability to drive or use machines immediately after infusion. ()

The most serious adverse reactions from TAXOTERE are:
The most common adverse reactions across all TAXOTERE 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 TAXOTERE 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. ()
To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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.
In vivon- [see , ].

Cytochrome P450 3A4 inducers, inhibitors, or substrates: May alter docetaxel metabolism. ()

No data

Lactation: Advise women not to breastfeed. ()
Females and Males of Reproductive Potential: Verify pregnancy status of females prior to initiation of TAXOTERE. ()

There is no known antidote for TAXOTERE 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 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 is (2R,3S)-N-carboxy-3-phenylisoserine,N--butyl ester, 13-ester with 5u03b2-20-epoxy-1,2u03b1,4,7u03b2,10u03b2,13u03b1-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, trihydrate. Docetaxel has the following structural formula:
Docetaxel is a white to almost-white powder with an empirical formula of CHNOu22193HO, and a molecular weight of 861.9. It is highly lipophilic and practically insoluble in water.

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

No data

No data

Advise the patient to read the FDA-approved patient labeling (Patient Information).

No data

NDC 0075-8003-01
TAXOTEREn (docetaxel)Injection Concentrate20 mg/mL
READY TO ADD TO INFUSION SOLUTION
For Intravenous Infusion Only
Contains 1 mL
Rx ONLY
SANOFI

NDC 0075-8004-04
TAXOTEREn (docetaxel)Injection Concentrate80 mg/4 mL(20 mg/mL)
READY TO ADD TO INFUSION SOLUTION
For Intravenous Infusion Only
Contains 4 mL
Rx ONLY
SANOFI

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Docetaxel (Taxotere)

Trade Name : TAXOTERE

INJECTION, SOLUTION, CONCENTRATE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Docetaxel (Taxotere)

Trade Name : TAXOTERE

INJECTION, SOLUTION, CONCENTRATE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

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