📋 Indications & Clinical Dosage
*Metastatic ovarian cancer when first-line or subsequent treatment has failed, Treatment of recurrent carcinoma of the cervix after radiotherapy and for patients with stage IV B disease (in combination with cisplatin):*
BY IV INF: Adults: 1-5mg/m2 daily by IV INF over 30 min for 5 consecutive days. Repeat every 3 week for minimum of 4 courses.
*Relapsed small-cell lung cancer when retreatment with the first-line regimen is considered inappropriate:*
BY IV INF: Adult: (consult product literature or local protocols).
💊 Mode of Administration
Administer IVP Bolus over 30 min or by 24 hours continuous infusion. Reconstitute vials with 4 ml SWFI, D5W or NS: may be further diluted in 50-100ml D5w or NS for infusion.
⛔ Contraindications
Severe myelosuppression.
⚠️ Precautions & Warnings
Renal or hepatic impairment, mild to moderate renal impairment. Ensure baseline neutrophils as necessary prior to treatment. Monitor blood regularly.
⚠️ Adverse Reactions / Side Effects
Alopecia, anorexia, asthenia, bone marrow suppression, extravasation, GI effects, hyperuricaemia, myelosuppression (dose limiting), nausea, oral mucositis, thromboembolism, tumourlysis syndrome, vomiting.
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Contraindicated in pregnancy.
Lactation / Breastfeeding:
Contraindicated. Discontinue breast-feeding
🧪 Compatibility & Storage Stability
Stability & Storage: Store intact vials at 20 C-25-C (68 F- 77 F), protect vials from direct sunlight. Single-used vials should be discarded after initial vial entry. Solution for infusion is stable
for 24 hours at room temperature or up to 7 days under refrigeration after dilution in at least 50 ml D5W or NS.
📚 Official Regulatory & Clinical References
- Drug Regulatory Authority of Pakistan (DRAP): Drug Registration, S.R.O. Price Gazettes & National Essential Medicines List (NEML).
- World Health Organization (WHO): Collaborating Centre for Drug Statistics Methodology (ATC/DDD Index).
- Formulary Standards: British National Formulary (BNF) & Pakistan National Formulary (PNF) guidelines.