๐ Indications & Clinical Dosage
*Hodgkins disease, Lymphocytic lymphoma, Histiocytic lymphoma, Advanced mycosis fungoides, Advanced testicular cancer, Kaposis sarcoma, LettererSiwe disease, Resistant choriocarcinoma, Unresponsive breast cancer:*
BY IV INJ OR INF: Adults: At weekly intervals:1st dose=3.7 mg/m2, 2nd dose=5.5 mg/m2, 3rd dose=7.4 mg/m2, 4th dose=9.25 mg/m2, 5th dose= 11.1 mg/m2, increase to a max 18.5 mg/m2. Children: At weekly intervals: 1st dose=2.5 mg/ rn2, 2nd dose=3.75 mg/m2, 3rd dose=5 mg/m2, 4th dose=6.25 mg/m2, 5th dose= 7.5 mg/m2, increase to a max 12.5 mg/m2.
๐ Mode of Administration
For IV administration only, usually as a slow (2-3 min) push, or a bolus (5-15 min) infusion. It is occasionally given as a 24-hour continuous infusion. Reconstitute to a cone of 1 mg/ml with bacteriostatic water, bacteriostatic NS, SWFI, NS, or D5W; for infusion, may be diluted with 50-1000 ml NS or D5W.
โ Contraindications
Bone marrow suppression.
โ ๏ธ Precautions & Warnings
Intrathecal administration can cause severe neurotoxicity which may result in death.
๐ Drug Interactions
Mitomycin C, CYP3A4 enzyme inhibitors.
โ ๏ธ Adverse Reactions / Side Effects
Alopecia, autonomic neuropathy, hyperuricaemia, loss of deep tendon reflexes, motor weakness, myelosuppression(dose-limiting), nausea neurotoxicity, oral mucositis, ototoxicity, peripheral neuropathy, peripheral paraesthesia, severe bronchospasm following administration, severe local irritation, thromboembolism, tumourlysis syndrome, vomiting
๐คฐ Pregnancy & Lactation Safety
Pregnancy Risk:
Positive evidence of risk: Avoid
Lactation / Breastfeeding:
Contraindicated. Discontinue breast-feeding
๐งช Compatibility & Storage Stability
Compatibility: Stable in D5W, LR, NS, bacteriostatic water.
๐ 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.