Pacli 6 mg/ml (IV Infusion)

Indications

• First line therapy for advanced carcinoma of the ovary
• Treatment of breast cancer after failure of combination chemotherapy
• Treatment of non-small cell lung cancer
• Treatment of AIDS related Kaposi's Sarcoma
• Adjuvant treatment of node-positive breast cancer
• Treatment of metastatic cancer of the breast
• Treatment of Gastric Carcinoma
• Treatment of patients with unresectable locally recurrent or metastatic breast cancer
• Treatment in patients with tumors that over-express HER2
• First line and subsequent therapy for advanced carcinoma of the ovary

Pharmacology

• Promotes the assembly of microtubules
• Stabilizes microtubules
• Prevents depolymerization of microtubules
• Induces abnormal arrays of microtubules
• Results in inhibition of normal cellular functions
• Induces abnormal arrays of microtubules
• Decline of paclitaxel plasma concentrations in a biphasic manner
• Efflux of paclitaxel from the peripheral compartment

Dosage & Administration

• Pre-medication to prevent severe hypersensitivity reactions
• Recommended dosages for first-line and second-line treatment of ovarian cancer
• Recommended dosages for adjuvant chemotherapy in breast carcinoma
• Recommended dosages for first-line chemotherapy of breast carcinoma
• Recommended dosages for second-line chemotherapy of breast carcinoma
• Recommended dosages for non-small-cell lung cancer
• Recommended dosages for the treatment of AIDS-related KS
• Dose adjustment based on individual patient tolerance

Interaction

• No effect on clearance by cimetidine premedication
• Greater myelosuppression with cisplatin
• Decreased paclitaxel clearance with cisplatin
• Interaction with doxorubicin
• Metabolism by cytochrome P450 isoenzymes
• Caution when administering with medicines known to inhibit or induce CYP enzymes

Contraindications

• Severe hypersensitivity reactions to paclitaxel
• Contraindicated during lactation
• Baseline neutrophils and platelets count
• Severe hepatic impairment
• Concurrent, serious, uncontrolled infections

Side Effects

• Low blood counts
• Increased risk for infection
• Anemia and/or bleeding
• Hair loss
• Arthralgias and myalgias
• Peripheral neuropathy
• Nausea and vomiting
• Diarrhea
• Mouth sores
• Hypersensitivity reaction
• Fever
• Facial flushing
• Chills
• Shortness of breath
• Hives
• Swelling of the feet or ankles
• Liver problems
• Low blood pressure
• Darkening of the skin

Pregnancy & Lactation

• Pregnancy Category D
• Contraindicated during lactation

Precautions & Warnings

• Administration under the supervision of an experienced physician
• Premedication for hypersensitivity reactions
• Close monitoring for possible infusion site infiltration
• Bone marrow suppression and neutropenia
• Severe cardiac conduction abnormalities

Use in Special Populations

• Dose reduction for severe neutropenia or peripheral neuropathy
• Caution in patients with hepatic impairment
• Not recommended for use in pediatric patients

Overdose Effects

• No known antidote for paclitaxel overdose
• Closely monitor for bone marrow suppression, peripheral neurotoxicity, and mucositis
• Association with acute ethanol toxicity in pediatric patients

Reconstitution

• Dilution prior to infusion
• Stability of solutions for up to 27 hours
• Visual inspection prior to administration

Storage Conditions

• Keep in a dry place
• Store below 30°C
• Protect from light
• Use only freshly prepared solution

Related Brands

• Taxopac 6 mg/ml (IV Infusion) - renata-limited
• Paclitaxel 6 mg/ml (IV Infusion) - seacross-pharmaceuticals-ltd
• Aritax 6 mg/ml (IV Infusion) - aristopharma-ltd