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(doe-seh-TAX-ehl)

Taxotere

Solution for injection

40 mg/mL

Class: Mitotic inhibitor

 Actions Docetaxel acts by disrupting cells’ microtubular network that is essential for mitotic and interphase cellular functions. Docetaxel binds to free tubulin and promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly. Mean value for steady-state volume of distribution is 113 L. Docetaxel is » 94% protein bound, mainly to a₁-acid glycoprotein, albumin, and lipoproteins. Docetaxel is metabolized by the CYP3A4 isoenzyme, and exhibits a 3-compartment pharmacokinetic model, with half lives for the a, b, and u phases of 4 min, 36 min, and 11.1 hr, respectively. Mean value for total body clearance was 21 L/hr/m². In patients with mild to moderate liver function impairment, total body clearance was lowered by » 27%, resulting in a 38% increase in AUC.

 Indications Locally advanced or metastatic breast cancer; locally advanced or metastatic non-small cell lung cancer.

Ovarian cancer.

 Contraindications History of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80; neutrophil counts of < 1500 cells/mm³.

 Route/Dosage

Locally Advanced or Metastatic Breast Cancer

ADULTS: IV 60 to 100 mg/m² administered over 1 hr q 3 wk.

Dosage Adjustment for Breast Cancer

ADULTS: Initial dose (100 mg/m²): Adjust dose to 75 mg/m² in patients who experience febrile neutropenia, neutrophils < 500 cells/mm³ for > 1 wk, severe or cumulative cutaneous reactions, or severe peripheral neuropathy.

If reactions continue, decrease the dosage to 55 mg/m² or discontinue treatment.

Initial dose (60 mg/m²): Patients who do not experience these symptoms may tolerate higher doses.

Discontinue docetaxel treatment entirely if patients develop at least grade 3 peripheral neuropathy.

Locally Advanced or Metastatic Non-Small Cell Lung Cancer

ADULTS: IV 70 mg/m² administered over 1 hr q 3 wk.

Dosage Adjustments for Non-Small Cell Lung Cancer

ADULTS: Initial dose (75 mg/m²): Withhold treatment in patients who experience febrile neuropenia, neutrophils < 500 cells/mm³ for > 1 wk, severe or cumulative cutaneous reactions, or other grade 3 and 4 non-hematological toxicities during treatment until resolution of the toxicity, and then resume at 55 mg/m².

Discontinue docetaxel treatment entirely if patients develop at least grade 3 peripheral neuropathy.

Dosage Adjustments in Hepatic Dysfunction

ADULTS: IV Avoid use in patients with bilirubin above the upper limit of normal, AST or ALT > 1.5 times the upper limit of normal concomitant with alkaline phosphatase > 2.5 times the upper limit of normal.

Pretreatment Regimen

To reduce the severity of hypersensitivity reactions and fluid retention, premedicate with 8 mg dexamethasone orally twice daily for 3 days starting the day before docetaxel administration.

Interactions

CYP450

Docetaxel is metabolized by cytochrome P450 3A. Potential exists for significant drug interactions between docetaxel and agents that inhibit or induce cytochrome P450 enzymes (eg, rifampin, phenobarbital, erythromycin, ketoconazole).

Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Edema; weight gain; pleural effusion; pericardial effusion or ascites; hypotension. CNS: Peripheral neuropathies. DERMATOLOGIC: Alopecia; localized edema; desquamation of extremities; rash with pruritus; hypo- or hyperpigmentation of nails, onycholysis, pain of nails. GI: Nausea; vomiting; diarrhea; stomatitis; elevated LFTs. HEMATOLOGIC: Bone marrow suppression. HYPERSENSITIVITY: Hypotension; bronchospasm; generalized rash; erythema; flushing; rash with or without pruritus; chest tightness; back pain; dyspnea; drug fever; chills. MUSCULOSKELETAL: Arthralgia, myalgia.

 Precautions

Pregnancy: Category D. Lactation: Undetermined. Children: Safety and efficacy not established. Special risk: In general, do not give docetaxel to patients with bilirubin greater than the upper limit of normal (ULN) or to patients with AST or ALT > 1.5 × ULN concomitant with alkaline phosphatase (AP) > 2.5 × ULN. These patients are at increased risk for the development of grade 4 neutorpenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Asthenia: Severe asthenia has been reported in 14.9% of metastatic breast cancer patients. Dermatologic: Reversible cutaneous reactions characterized by a rash including localized eruptions, mainly on the feet or hands, but also on the arms, face, or thorax, usually associated with pruritus, have been observed. Localized erythema of the extremities with edema followed by desquamation has been observed. Severe nail disorders have been reported also. Extravasation risk: Local irritation or phlebitis may occur. Refer to your institution specific protocol. Fluid retention: Severe fluid retention has occurred. Hypersensitivity reactions: Severe hypersensitivity reactions may be characterized by hypotension or bronchospasm, or generalized rash/erythema. May occur within a few minutes following initiation of infusion. Neurologic: Severe neurosensory symptoms (eg, paresthesia, dysesthesia, pain) were observed in 5.5% of metastatic breast cancer patients. Dosage must be adjusted. If symptoms persist, discontinue treatment. Neutropenia: Neutropenia (< 2000 neutrophils/mm³) occurs in virtually all patients given 60 to 100 mg/m² of docetaxel, and grade 4 neutropenia (< 500 cells/mm³) occurs in 85% of patients given 100 mg/m² and 75% of patients given 60 mg/m². Do not administer to patients with neutrophils < 1500 cells/mm³.

PATIENT CARE CONSIDERATIONS

 Administration/Storage

• Refrigerate and protect from light. Reconstituted 10 mg/mL solution is stable for 8 hr at room temperature or stored in the refrigerator. Diluted 0.3 to 0.9 mg/mL solution is stable at room temperature for 4 hr under normal room lighting.
• Allow to stand at room temperature for 5 min before reconstitution.
• Withdraw diluent and add to the docetaxel vial. This results in a 10 To reduce the severity of hypersensitivity reactions and fluid retention, premedicate with 8 mg dexamethasone orally twice daily for 3 days starting the day before docetaxel administration mg/mL solution. Gently rotate vial for 15 sec to mix.
• After reconstitution, dilute with 0.9% Sodium Chloride or 5% Dextrose to a final docetaxel concentration of 0.3 to 0.74 mg/mL.
• Diluted solutions may leach DEHP from polyvinyl chloride (PVC) infusion sets or bags. Use glass, polypropylene, or polyolefin containers and polyethylene-lined administration sets.
• Administer by IV infusion over 1 hr.

 Assessment/Interventions

• Monitor CBC at baseline and throughout therapy. Docetaxel is also contraindicated in patients with neutrophil counts < 1500/mm³.
• Closely monitor patients with preexisting effusions from the first dose for the possible exacerbation of the effusions.
• Observe patients closely for hypersensitivity reactions, especially during the first and second infusions.
• Obtain bilirubin, AST, or ALT, and alkaline phosphatase values prior to each cycle of docetaxel therapy.

OVERDOSAGE: SIGNS & SYMPTOMS   Bone marrow suppression, peripheral neurotoxicity, mucositis

 Patient/Family Education

• Advise patients that if they have a fever over 100°F to call health care provider immediately. Tell doctor about symptoms of infection, such as a sore throat or cough or a burning sensation while urinating.
• Advise patients to tell health care provider if they feel a warm sensation, difficulty in breathing, itching, flushing or rash during or shortly after treatment.
• Advise patients to tell health care provider if they have any signs of fluid retention, shortness of breath, swelling of feet or hands, or unexplained weight gain.
• Advise patient to notify health care provider if muscle or joint pain occur.

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