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Alvotere - Docetaxel

Drug Name : Alvotere - Docetaxel
Drug Category : AntineoPlastics
Pharmacological Category: تاکسان ها / Taxane
Brand Name : Alvotere
Drug Forms :
Injection, solution [concentrate]: 20 mg/0.5 mL, 80mg/ 4mL, 160mg/ 8mL

Overdose

Toxicity includes febrile neutropenia, neutrophils ≤500/mm 3 for >1 week, severe or cumulative cutaneous reactions; in nonsmall cell lung cancer, this may also include platelets <25,000/mm 3 and other grade 3/4 nonhematologic toxicities.

Breast cancer (single agent):

Patients dosed initially at 100 mg/m 2 ; reduce dose to 75 mg/m 2 ; Note: If the patient continues to experience these adverse reactions, the dosage should be reduced to 55 mg/m 2 or therapy should be discontinued; discontinue for peripheral neuropathy ≥ grade 3. Patients initiated at 60 mg/m 2 who do not develop toxicity may tolerate higher doses.

Breast cancer, adjuvant treatment (combination chemotherapy):

TAC regimen should be administered when neutrophils are ≥1500/mm 3 . Patients experiencing febrile neutropenia should receive G-CSF in all subsequent cycles. Patients with persistent febrile neutropenia (while on G-CSF), patients experiencing severe/cumulative cutaneous reactions, moderate neurosensory effects (signs/symptoms) or grade 3 or 4 stomatitis should receive a reduced dose (60 mg/m 2) of docetaxel. Discontinue therapy with persistent toxicities after dosage reduction.

Nonsmall cell lung cancer:

Monotherapy: Patients dosed initially at 75 mg/m 2 should have dose held until toxicity is resolved, then resume at 55 mg/m 2 ; discontinue for peripheral neuropathy ≥ grade 3.

Combination therapy (with cisplatin): Patients dosed initially at 75 mg/m 2 should have the docetaxel dosage reduced to 65 mg/m 2 in subsequent cycles; if further adjustment is required, dosage may be reduced to 50 mg/m 2

Prostate cancer: Reduce dose to 60 mg/m 2; discontinue therapy if toxicities persist at lower dose.

Gastric cancer, head and neck cancer: 

Note: Cisplatin may require dose reductions/therapy delays for peripheral neuropathy, ototoxicity, and/or nephrotoxicity. Patients experiencing febrile neutropenia, documented infection with neutropenia or neutropenia >7 days should receive G-CSF in all subsequent cycles. For neutropenic complications despite G-CSF use, further reduce dose to 60 mg/m 2 . Dosing with neutropenic complications in subsequent cycles should be further reduced to 45 mg/m 2 . Patients who experience grade 4 thrombocytopenia should receive a dose reduction from 75 mg/m 2 to 60 mg/m 2 . Discontinue therapy for persistent toxicities.

Gastrointestinal toxicity for docetaxel in combination with cisplatin and fluorouracil for treatment of gastric cancer or head and neck cancer:

Diarrhea, grade 3:

First episode: Reduce fluorouracil dose by 20%

Second episode: Reduce docetaxel dose by 20%

Diarrhea, grade 4:

First episode: Reduce fluorouracil and docetaxel doses by 20%

Second episode: Discontinue treatment

Stomatitis, grade 3:

First episode: Reduce fluorouracil dose by 20%

Second episode: Discontinue fluorouracil for all subsequent cycles

Third episode: Reduce docetaxel dose by 20%

Stomatitis, grade 4:

 

First episode: Discontinue fluorouracil for all subsequent cycles

Second episode : Reduce docetaxel dose by 20% 

 

Anticipated complications of overdosage include: bone marrow suppression, peripheralneurotoxicity, and mucositis.

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.

Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose. Other appropriate symptomatic measures should be taken, as needed.


FDA Approval

Head and Neck Cancer; On October 17, 2006

Gastric Cancer; On March 22, 2006

Breast Cancer; On August 18, 2004

Prostate Cancer; On May 19, 2004

Non-Small Cell Lung Cancer; On December 23, 1999