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Fetcroja

Sourced directly from the authorized manufacturer network to ensure authenticity and quality.

Ready to proceed? Start a request for Fetcroja on our secure patient portal to submit your prescription, upload documents and track your approval status.

Fetcroja

Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.

Medicine Name: Fetcroja
Generic Name (API): Cefiderocol
Dosage Form & Strength: 1g
Route: Intravenous
Drug Class: Siderophore cephalosporin antibiotic

Manufacturer / Innovator:

USA

Regulatory Approval:

  • EMA (Europe)
  • FDA (US) – as Fetroja
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  • Medicines sourced from authorized manufacturers with full batch traceability

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  • EU-GDP Compliant Warehousing for secure, quality-controlled global distribution.

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  • Temperature-Controlled Logistics for Safe and Timely Delivery

    Temperature-controlled logistics ensuring safe, reliable, and timely medicine delivery.

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Understanding Fetcroja (Cefiderocol) and Its Medical Uses

Fetcroja is an antibiotic kept for some of the hardest bacterial infections doctors see in hospital, the ones caused by Gram-negative bacteria that no longer respond to common antibiotics. It is not a cancer medicine. Its active ingredient is cefiderocol, and the same medicine is sold in the United States under the name Fetroja. Both are made by Shionogi.

What Fetcroja Is Approved For

In the European Union, Fetcroja is approved for adults with infections caused by aerobic Gram-negative bacteria when other treatment options are limited. The European Commission authorised it on 23 April 2020. In the United States, Fetroja is approved for adults aged 18 and over with two types of infection: complicated urinary tract infections, including kidney infection (pyelonephritis), and hospital-acquired or ventilator-associated bacterial pneumonia, when these are caused by susceptible bacteria such as E. coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Acinetobacter baumannii complex and Enterobacter cloacae complex. The U.S. FDA approved the urinary infection use on 14 November 2019 and the pneumonia use on 25 September 2020.

How Fetcroja Works

Gram-negative bacteria have a tough outer wall that keeps many antibiotics out. They also need iron to survive, so they actively pull iron into themselves. Cefiderocol binds to iron and gets carried inside along with it, slipping past the defences that block other drugs. Once inside, it stops the bacteria from building their cell wall, which kills them. It has no useful activity against most Gram-positive bacteria or anaerobic bacteria, so doctors may combine it with other antibiotics when those germs are also suspected.

What the Clinical Trials Showed

In a study of 448 adults in hospital with complicated urinary tract infections, 72.6% of patients treated with Fetroja had both their symptoms resolve and the bacteria cleared at the test-of-cure visit, compared with 54.6% of patients given imipenem/cilastatin. In a second study of 292 adults with hospital-acquired or ventilator-associated pneumonia, most of them in intensive care, the death rate at day 14 was 12.4% with Fetroja and 12.2% with meropenem, which showed that Fetroja was no worse than this standard treatment.

How Fetcroja Is Given

Fetcroja is given in hospital as a slow drip into a vein. For adults with normal kidney function (creatinine clearance 60 to 119 mL/min), the U.S. label recommends 2 grams every 8 hours, each dose infused over 3 hours, usually for 7 to 14 days. The dose is changed for people whose kidneys work less well, for those on dialysis, and for those whose kidneys clear the drug unusually fast (creatinine clearance of 120 mL/min or more). Your infectious disease or critical care doctor will decide the exact dose and how long treatment lasts.

How It Is Supplied

Fetcroja comes as a white to off-white powder in single-dose glass vials, each holding 1 gram of cefiderocol, packed 10 vials to a carton. The hospital pharmacy dissolves and dilutes it before the infusion.

This information is not a treatment plan. For personalised medical advice, talk to your doctor and read the full prescribing information. You can see other specialist medicines we help with on our other therapeutic areas page.

Warnings and Precautions for Fetcroja

Important Safety Information for Fetcroja: Fetcroja is meant for serious infections where the bacteria are proven or strongly suspected to be susceptible. Because it is one of the few antibiotics that still works against many resistant bacteria, using it when it isn't needed raises the risk that bacteria become resistant to it too.

Higher Death Rate in One Study of Very Sick Patients

In a study of critically ill patients with carbapenem-resistant infections, more patients died with cefiderocol than with the best available alternative antibiotics, which were mostly colistin-based. Deaths by day 28 were 24.8% versus 18.4%, and by day 49 they were 33.7% versus 20.4%. The difference was seen in patients treated for pneumonia, bloodstream infections and sepsis, and its cause has not been established. Doctors are advised to watch closely how patients respond to treatment.

Allergic Reactions

Serious, sometimes fatal allergic reactions can happen with this family of antibiotics (beta-lactams). Fetcroja must not be used in anyone who has had a severe allergic reaction to cefiderocol or to other beta-lactam antibiotics such as penicillins or cephalosporins. Tell your doctor about any past antibiotic allergy before treatment starts.

Diarrhoea Caused by C. difficile

Like nearly all antibiotics, Fetcroja can upset the normal bacteria in the gut and allow Clostridioides difficile to grow. This can cause anything from mild diarrhoea to serious inflammation of the bowel, sometimes weeks after the antibiotic has been stopped. Report watery or bloody diarrhoea promptly.

Seizures and Other Nervous System Effects

Cephalosporin antibiotics can occasionally trigger seizures, confusion or muscle twitching, mainly in people with kidney problems whose dose has not been adjusted, or in people with epilepsy. This is one reason kidney function is checked and the dose is matched to it.

Other Points to Know

  • Cefiderocol can give false-positive results on urine dipstick tests for protein, ketones or blood, so labs may need to confirm these with other tests.
  • Its safety and effectiveness have not been established in children and teenagers under 18.
  • In the urinary infection study, the side effects seen in at least 3% of patients were diarrhoea (4%), reactions at the infusion site (4%), constipation (3%) and rash (3%).

How to Access Fetcroja in India: A 6-Step Process

Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.

Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.

Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.

Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.

Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant, cold-chain conditions to maintain product integrity.

Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.

Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.

Documentation and Availability of Fetcroja

Fetcroja (cefiderocol) is manufactured by Shionogi. Fetcroja is the EU/international brand name; the same active ingredient is marketed in the United States as Fetroja.

Documentation Required

Import of Fetcroja through a Named Patient Program requires a valid prescription from the treating infectious disease specialist, confirmation of infection type and prior treatment history, and supporting clinical documentation as required by Indian regulatory authorities.

Sourcing

NPP sources Fetcroja directly from Shionogi's authorized supply chain to ensure product authenticity and regulatory compliance.

Sourcing and Delivery of Fetcroja

Fetcroja is sourced through verified, GDP-compliant, cold-chain channels from Shionogi's authorized supply chain to ensure authenticity and quality.

Storage Requirements

Fetcroja vials should be stored refrigerated at 2°C to 8°C, protected from light, and kept in the original carton until time of use.

Delivery Process

Once sourced, Fetcroja is packed and transported under continuous cold-chain conditions to preserve product integrity throughout the import process, with tracking and updates provided at each stage of delivery to the patient or treating hospital in India.

Availability of Fetcroja Across Major Cities in India

Patients across India can access Fetcroja through NPP's regulated import pathway, with infectious disease and critical care specialists in major cities supporting the treatment process.

Mumbai

Leading infectious disease centers in Mumbai support treatment coordination for Fetcroja access.

Delhi

Delhi's major hospitals assist patients with prescription support and documentation for Fetcroja.

Bangalore

Bangalore's specialist network offers access to Fetcroja for patients with limited treatment options.

Chennai

Chennai-based specialists coordinate Fetcroja access alongside comprehensive infection management.

Hyderabad

Hyderabad's care institutions support patients pursuing Fetcroja therapy.

Kolkata

Kolkata's specialist centers help coordinate documentation and treatment access for Fetcroja.

Pune

Pune-based specialists assist with treatment planning for Fetcroja.

Ahmedabad

Ahmedabad's specialty hospitals support the import and treatment process for Fetcroja.

Kochi

Kochi's specialist units assist patients with the documentation needed for Fetcroja access.

Chandigarh

Chandigarh's care centers support Fetcroja treatment coordination for patients from North India.

Jaipur

Jaipur's specialists help patients navigate the Fetcroja access process.

Lucknow

Lucknow-based centers assist patients pursuing Fetcroja therapy.

Bhubaneswar

Bhubaneswar's institutions support access to Fetcroja for eligible patients.

Guwahati

Guwahati's specialists help coordinate Fetcroja access for patients across the Northeast.

Patients in other cities across India can also access Fetcroja through NPP's nationwide coordination network.

Author Details

Nitin Goswami

Written By

Nitin Goswami

Deputy Manager – Content & Social Media, Ikris Pharma Network

Sources: FDA • CDSCO

Dr. Chirag C Shah

Medically Reviewed By

Dr. Chirag C Shah

MBBS

Last Updated: 14 October 2026

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