Doxol

Doxol

docetaxel

Manufacturer:

Venus Remedies

Distributor:

Unimed
Concise Prescribing Info
Contents
Docetaxel
Indications/Uses
In combination w/ doxorubicin & cyclophosphamide for adjuvant treatment of patients w/ operable node +ve breast cancer. In combination w/ doxorubicin for locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy. In combination w/ capecitabine for locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Locally advanced or metastatic NSCLC after failure of platinum-based chemotherapy. In combination w/ cisplatin for unresectable, locally advanced or metastatic NSCLC in patients who have not previously received chemotherapy. In combination w/ carboplatin as treatment option to cisplatin-based therapy. Metastatic ovarian carcinoma after failure of 1st-line or subsequent chemotherapy. Monotherapy for recurrent &/or metastatic squamous cell head & neck carcinoma after failure of previous chemotherapy. In combination w/ prednisone or prednisolone for hormone refractory metastatic prostate cancer. In combination w/ cisplatin & 5-fluorouracil (5-FU) for metastatic gastric adenocarcinoma including gastroesophageal junction adenocarcinoma who have not received prior chemotherapy for metastatic disease. In combination w/ cisplatin & 5-FU for induction treatment of inoperable locally advanced squamous cell head & neck carcinoma.
Dosage/Direction for Use
Breast, NSCLC, gastric, head & neck cancers premed Oral corticosteroid eg, dexamethasone 16 mg daily for 3 days starting 1 day prior to docetaxel administration. Prostate cancer premed Oral dexamethasone 8 mg 12 hr, 3 hr & 1 hr before infusion. Adjuvant treatment of operable node +ve breast cancer 75 mg/m2 1 hr after doxorubicin 50 mg/m2 & cyclophosphamide 500 mg/m2 every 3 wk for 6 cycles. Locally advanced or metastatic breast cancer 100 mg/m2. 1st-line treatment: 75 mg/m2 in combination w/ doxorubicin 50 mg/m2. Combination w/ capecitabine: 75 mg/m2 every 3 wk w/ capecitabine 1,250 mg/m2 bd for 2 wk followed by 1-wk rest period. NSCLC 75 mg/m2 followed by cisplatin 75 mg/m2 over 30-60 min. Treatment after failure of prior platinum-based chemotherapy 75 mg/m2 as single agent. Prostate cancer 75 mg/m2 w/ continuous oral prednisone/prednisolone 5 mg bd. Gastric adenocarcinoma 75 mg/m2 as 1-hr infusion followed by cisplatin 75 mg/m2 as 1-3 hr infusion (both on day 1 only), followed by 5-FU 750 mg/m2 daily as 24-hr continuous infusion for 5 days starting at end of cisplatin infusion. Repeat regimen every 3 wk. Head & neck cancer Induction chemotherapy followed by RT: 75 mg/m2 as 1-hr infusion followed by cisplatin 75 mg/m2 over 1 hr on day 1, followed by 5-FU 750 mg/m2 daily as continuous infusion for 5 days. Repeat regimen every 3 wk for 4 cycles. Induction chemotherapy followed by chemoradiotherapy: 75 mg/m2 as 1-hr IV infusion on day 1 followed by cisplatin 100 mg/m2 as 30-min to 3-hr infusion, followed by 5-FU 1,000 mg/m2 daily as continuous infusion from day 1-4. Repeat regimen every 3 wk for 3 cycles. Ovarian cancer & squamous cell head & neck carcinoma 100 mg/m2 as 1-hr infusion every 3 wk. In combination: 75 mg/m2 as 1-hr infusion every 3 wk.
Contraindications
Hypersensitivity. Baseline neutrophil count <1,500 cells/mm3. Severe hepatic impairment. Pregnancy & lactation.
Special Precautions
Hypersensitivity reactions during 1st & 2nd infusions. Cutaneous toxicity; severe fluid retention; severe neurosensory symptoms. Complicated neutropenia; GI reactions; CHF; leukemia; patients w/ 4+ nodes. Monitor blood cell count frequently. Avoid concomitant use w/ CYP3A4 inhibitors. Hepatic impairment. Women of childbearing potential should use effective contraception during & at least 3 mth after therapy. Not to be used during pregnancy. Lactation. Childn 1-18 yr w/ nasopharyngeal carcinoma. Elderly ≥65 yr.
Adverse Reactions
Edema, vasodilatation; alopecia, nail disorder & changes, skin &/or subcutaneous tissue disorder, pruritus, rash; nausea, stomatitis, vomiting; anemia, leukopenia, neutropenia; asthenia, neuropathy; amenorrhea; fever, wt gain.
Drug Interactions
Affected exposure w/ strong CYP3A4 inhibitors eg, HIV PIs, azole antifungals. Increased risk of infection w/ rotavirus & live vaccines, chemotherapeutic agents. Increased risk of VTE w/ thalidomide. Cholestatic jaundice & pseudomembranous colitis w/ doxorubicin. Increased risk of toxicity w/ itraconazole, erythromycin, troleandomycin, indinavir, atazanavir, clarithromycin, ketoconazole, ritonavir, terfenadine, telithromycin, nefazodone, nelfinavir, cyclosporine, voriconazole, quinupristin/dalfopristin. Increased risk of neuropathy w/ cisplatin. Increased exposure & plasma conc w/ sorafenib. Increased doxorubicin exposure. Increased exposure w/ grapefruit juice.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01CD02 - docetaxel ; Belongs to the class of taxanes from plant alkaloids and other natural products. Used in the treatment of cancer.
Presentation/Packing
Form
Doxol infusion conc 20 mg/0.5 mL
Packing/Price
1's
Form
Doxol infusion conc 80 mg/2 mL
Packing/Price
1's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in