Intaxel

Intaxel

paclitaxel

Manufacturer:

Fresenius Kabi

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Paclitaxel
Indications/Uses
In combination w/ cisplatin as 1st line treatment of advanced ovarian carcinoma. Adjuvant treatment of node +ve breast cancer. In combination w/ cisplatin for NSCLC patients who are not candidates for potentially curative surgery &/or RT. 2nd-line therapy for advanced metastatic ovarian carcinoma; metastatic disease or relapse w/in 6 mth of adjuvant chemotherapy including anthracycline after failure of anthracycline combination chemotherapy; AIDS-related Kaposi's sarcoma.
Dosage/Direction for Use
Premed: Dexamethasone 20 mg orally 12 & 6 hr prior to therapy & cimetidine 300 mg IV or ranitidine 50 mg IV & diphenhydramine 50 mg IV 30 min prior to therapy. Ovarian cancer & NSCLC Previously untreated patients Combination therapy: 175 mg/m2 IV over 3 hr followed by platinum compd every 3 wk. Alternatively, 135 mg/m2 over 24 hr followed by platinum compound every 3 wk. 2nd-line therapy for advanced metastatic ovarian carcinoma & metastatic disease or relapse w/in 6 mth of adjuvant chemotherapy Patients previously treated w/ chemotherapy Monotherapy: 175 mg/m2 IV over 3 hr every 3 wk. Breast cancer Adjuvant therapy: 175 mg/m2 IV over 3 hr every 3 wk for 4 courses. Kaposi's sarcoma 2nd-line therapy: 135 mg/m2 IV over 3 hr w/ 3-wk interval between courses or 100 mg/m2 IV over 3 hr w/ 2-wk interval between courses (dose intensity 45-50 mg/m2/wk).
Contraindications
History of hypersensitivity reaction to paclitaxel or other drugs formulated in polyoxyl 35 castor oil. Baseline neutrophil count <1,500 cells/mm3.
Special Precautions
Not to be re-challenged in patients who experience severe hypersensitivity reactions. Not to be administered in patients w/ baseline neutrophil counts of <1,500 cells/mm3. Not to be retreated w/ subsequent cycle until neutrophils recover to >1,500 cells/mm3 & platelets recover to >100,000 cells/mm3. Bone marrow suppression; severe conduction abnormalities. Pretreat w/ corticosteroids (eg, dexamethasone), diphenhydramine or promethazine HCl and H2 antagonists (eg, cimetidine or ranitidine) before therapy. Check cardiac functions before administration. Frequently monitor blood counts during treatment. Women of childbearing potential should avoid becoming pregnant during therapy. Pregnancy. Discontinue lactation when receiving therapy. Childn.
Adverse Reactions
Neutropenia, anemia; hypersensitivity reactions; infections including sepsis, pneumonia & peritonitis, UTI, URTI; transient asymptomatic bradycardia; neurotoxicity eg, sensory, motor & autonomic neuropathy, transient myalgia &/or arthalgia; GI toxic effects eg, anorexia, nausea, vomiting & diarrhea, elevated SGPT, SGOT, alkaline phosphatase & bilirubin; alopecia.
Drug Interactions
Possible inhibition of metabolism w/ ketoconazole.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01CD01 - paclitaxel ; Belongs to the class of taxanes from plant alkaloids and other natural products. Used in the treatment of cancer.
Presentation/Packing
Form
Intaxel inj 100 mg/17 mL
Packing/Price
1's
Form
Intaxel inj 260 mg/43.4 mL
Packing/Price
1's
Form
Intaxel inj 30 mg/5 mL
Packing/Price
1's
Form
Intaxel inj 300 mg/50 mL
Packing/Price
1's
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