1. Clinical & Scientific Overview
Cefiderocol (TIP-MED-000536, Reference Code [R-17]) is classified under
Reserve Antimicrobials (WHO AWaRe Reserve) as a Siderophore Cephalosporin ('Trojan Horse' Reserve Antibiotic).
Within the Indian regulatory and compendial framework, it is governed under Schedule H1 Reserve Antibiotic.
Fetroja (Shionogi / Restricted Hospital Access)
Powder for IV Infusion: 1 g vial
Statutory Restriction, High-Alert & Dispensing Safeguards
Indian Regulatory & Statutory Control Basis: Schedule H1 Reserve Antibiotic
High-Alert Clinical Risk, Dependence & Narrow Therapeutic Index Warnings: Monitor renal function closely: augmented renal clearance (CrCl >=120 mL/min) requires 2 g IV every 6 hours, whereas renal impairment requires dose reduction.
Mandatory Dispensing Register & Institutional Custody Protocol: Reconstitute and infuse over 3 hours every 8 hours (standard CrCl 60–119 mL/min); reserve for culture-documented XDR infections.
3. Mechanism of Action & Pharmacodynamics
Catechol moiety chelates ferric iron (Fe3+), enabling active transport across the Gram-negative outer membrane via bacterial iron-transport channels (PiuA, CirA, Fiu) and stability against Ambler Class A, B (NDM, VIM, IMP), C, and D beta-lactamases.
4. Therapeutic Indications & Evidence-Supported Uses
- Extensively drug-resistant (XDR) Gram-negative infections including NDM-producing Enterobacterales, Stenotrophomonas maltophilia, and MDR Pseudomonas aeruginosa
5. Educational Dosage Context, Formulations & Administration
Educational Dosing & Regimen Summary: Specialist-Supervised Educational Reference Summary: Dosing of Cefiderocol must be individualised by a qualified specialist according to clinical indication, organ function, and institutional protocol (Powder for IV Infusion: 1 g vial).
Administration & Meal Timing: Routes: Intravenous Infusion (over 3 hours). Reconstitute and infuse over 3 hours every 8 hours (standard CrCl 60–119 mL/min); reserve for culture-documented XDR infections.
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Exhibits siderophore cephalosporin ('trojan horse' reserve antibiotic) pharmacokinetic disposition; verify baseline renal and hepatic clearance and check for active or prolonged-half-life metabolites before repeat dosing.
Hepatic Phase I (CYP450) and/or Phase II conjugation or specific non-renal clearance as detailed in clinical warnings.
Verify eGFR / CrCl before initiation; see specific metabolite and renal clearance notes above.
Assess baseline Child-Pugh status and hepatic transaminases prior to therapy.
7. Contraindications, Precautions & High-Risk Warnings
- Known severe hypersensitivity to Cefiderocol or formulation excipients
- Unsupervised outpatient self-administration or dispensing without mandatory statutory prescription verification
- Specific clinical contraindications detailed under High-Alert Warnings & Statutory Restrictions
Key Clinical Precautions: Monitor renal function closely: augmented renal clearance (CrCl >=120 mL/min) requires 2 g IV every 6 hours, whereas renal impairment requires dose reduction.
8. Adverse Effects Profile
- Monitor renal function closely: augmented renal clearance (CrCl >=120 mL/min) requires 2 g IV every 6 hours, whereas renal impairment requires dose reduction.
- Dose-dependent target-organ pharmacodynamic effects requiring clinical observation
- Monitor renal function closely: augmented renal clearance (CrCl >=120 mL/min) requires 2 g IV every 6 hours, whereas renal impairment requires dose reduction.
- High-alert toxicity, dependence/diversion risk, or severe organ-specific adverse events if administered outside protocol
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- Monitor renal function closely: augmented renal clearance (CrCl >=120 mL/min) requires 2 g IV every 6 hours, whereas renal impairment requires dose reduction.
- Review all concomitant CNS depressants, QTc-prolonging agents, nephrotoxins, or CYP450 modulators prior to dispensing.
10. Clinical Monitoring, Patient Counselling & Storage
Clinical & Laboratory Monitoring: Reconstitute and infuse over 3 hours every 8 hours (standard CrCl 60–119 mL/min); reserve for culture-documented XDR infections.
Pharmacist Patient Counselling Points:
- Reconstitute and infuse over 3 hours every 8 hours (standard CrCl 60–119 mL/min); reserve for culture-documented XDR infections.
- Must be used strictly under direct medical supervision; never share prescription medicines or alter the prescribed dose.
Storage, Stability & Dispensing Safeguards: Reconstitute and infuse over 3 hours every 8 hours (standard CrCl 60–119 mL/min); reserve for culture-documented XDR infections.
11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)
12. Authoritative References, Regulatory Sources & Editorial Disclaimer
Primary Compendial & Guideline Reference: Drugs and Cosmetics Act, 1940 & Rules, 1945 (Schedule H / H1 / X); NDPS Act, 1985 & Essential Narcotic Drugs (END) Notification; Indian Pharmacopoeia (IP) & National Formulary of India (NFI).
Official Verification Portals: CDSCO — Drugs & Cosmetics Act and Rules (Schedules H, H1, X) • Department of Revenue — Narcotic Drugs and Psychotropic Substances (NDPS) Act • Indian Pharmacopoeia Commission (IPC) — National Formulary of India
Last Medically & Pharmaceutically Reviewed: 2026-11-10 • Verification Status: VERIFIED_EDUCATIONAL_CONTENT
Educational & Clinical Disclaimer: This reference profile is published solely for pharmacy education, academic study, and professional clinical reference. It does not substitute for patient-specific clinical judgement, qualified specialist oncology/medical supervision, or official CDSCO/IP prescribing information. Never self-medicate with prescription, Schedule H/H1/X, NDPS, or oncology medicines.