PXJ 6 mg/ml (IV Infusion)

Indications

• First line therapy for advanced carcinoma of the ovary
• Subsequent therapy for advanced carcinoma of the ovary
• Adjuvant treatment of node-positive breast cancer
• Treatment of breast cancer after failure of combination chemotherapy
• Treatment of metastatic cancer of the breast
• First line treatment of non-small cell lung cancer
• Second line treatment of AIDS related Kaposi's Sarcoma
• Treatment of Gastric Carcinoma

Pharmacology

• Promotes assembly of microtubules from tubulin dimers
• Stabilizes microtubules by preventing depolymerization
• Induces abnormal arrays or 'bundles' of microtubules
• Inhibition of normal dynamic reorganization of the microtubule network

Dosage & Administration

• Premedication required prior to administration
• Different dosages recommended based on the treatment type
• Repetition of therapy at 3-week intervals
• Dose adjustments based on individual patient tolerance
• Administration under the supervision of a physician experienced in chemotherapy

Interaction

• Cimetidine premedication does not affect clearance
• Interaction with cisplatin leading to greater myelosuppression
• Sequence effects observed with combination use of doxorubicin
• Caution required when administering concomitantly with CYP2C8 or CYP3A4 inhibitors or inducers

Contraindications

• Severe hypersensitivity reactions to paclitaxel
• Use during lactation
• Baseline neutrophils and platelets below specified levels
• Severe hepatic impairment
• Concurrent, serious, uncontrolled infections in KS

Side Effects

• Low blood counts leading to increased risk for infection, anemia, or bleeding
• Hair loss
• Arthralgias and myalgias
• Peripheral neuropathy
• Nausea and vomiting
• Hypersensitivity reaction
• Swelling of the feet or ankles (edema)
• Liver problems (rare)

Pregnancy & Lactation

• Pregnancy Category D
• Contraindicated during lactation

Precautions & Warnings

• Significant hypersensitivity reactions may occur
• Extravasation monitoring advisable
• Bone marrow suppression is the dose-limiting toxicity
• Severe cardiac conduction abnormalities reported rarely
• Continuous cardiac monitoring recommended

Use in Special Populations

• Dose reduction for patients with severe neutropenia or peripheral neuropathy
• Data insufficient to recommend dosage alterations in patients with hepatic impairment
• Not recommended for use in children below 18 years

Overdose Effects

• No known antidote
• Closely monitor the patient
• Treatment directed at the primary anticipated toxicities

Reconstitution

• Dilution required prior to infusion
• Physically and chemically stable for up to 27 hours
• Visual inspection for particulate matter and discoloration prior to administration

Storage Conditions

• Store below 30°C
• Protect from light
• Use only freshly prepared solution

Related Brands

• Paclitex 6 mg/ml (IV Infusion) - techno-drugs-ltd
• Paclitaxel Sandoz 6 mg/ml (IV Infusion) - sandoz-a-novartis-division