FETCROJA Powder for concentrate for solution for infusion Ref.[27921] Active ingredients: Cefiderocol

It is recommended that Fetcroja should be used to treat patients that have limited treatment options only after consultation with a physician with appropriate experience in the management of infectious diseases.

Posology

Table 1. Recommended dose of Fetcroja¹ for patients with a creatinine clearance (CrCL) ≥90 mL/min²:

¹ To be used in combination with antibacterial agents active against anaerobic pathogens and/or Gram-positive pathogens when these are known or suspected to be contributing to the infectious process.
² As calculated using the Cockcroft-Gault formula.
³ e.g. for complicated urinary tract infections including pyelonephritis and complicated intra-abdominal infections the recommended treatment duration is 5 to 10 days. For hospital-acquired pneumonia including ventilator-associated pneumonia the recommended treatment duration is 7 to 14 days. Treatment up to 21 days may be required.

Special populations

Renal impairment

Table 2. Recommended dose of Fetcroja for patients with a CrCl <90 ml/min¹:

¹ As calculated using the Cockcroft-Gault formula.
² As cefiderocol is removed by haemodialysis, administer cefiderocol at the earliest possible time after completion of haemodialysis on haemodialysis days.

Hepatic impairment

No dose adjustment is required in patients with hepatic impairment (see section 5.2).

Elderly population

No dosage adjustment is required (see section 5.2).

Paediatric population

The safety and efficacy of Fetcroja in children below 18 years of age has not yet been established. No data are available.

Method of administration

Intravenous use.

Fetcroja is administered by intravenous infusion over 3 hours.

For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.

If treatment with a combination of another medicinal product and Fetcroja is unavoidable, administration should not occur in the same syringe or in the same infusion solution. It is recommended to adequately flush intravenous lines between administration of different medicinal products.

There is no information on clinical signs and symptoms associated with an overdose of cefiderocol.

In the event of overdose, patients should be monitored and treatment discontinuation and general supportive treatment should be considered.

Approximately 60% of cefiderocol is removed by a 3- to 4-hour haemodialysis session.

Powder:

3 years.

Stability of reconstituted solution in the vial:

Chemical and physical in-use stability after reconstitution has been demonstrated for 1 hour at 25°C.

From a microbiological point of view, unless the method of opening/reconstitution precludes the risk of microbial contamination, the reconstituted product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and should not be more than 1 hour at 25°C.

Stability of the diluted solution in the infusion bag:

Chemical, microbiological and physical in-use stability after dilution has been demonstrated for 6 hours at 25°C and for 24 hours at 2 to 8°C protected from light, followed by 6 hours at 25°C.

From a microbiological point of view, diluted products should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 6 hours at 25°C or 24 hours at 2 to 8°C protected from light, followed by 6 hours at 25°C, unless dilution has taken place in controlled and validated aseptic conditions. The 6-hour period at 25°C should be inclusive of the product administration period of 3 hours (see section 4.2). If storing the infusion solution in the refrigerator, the infusion bag should be removed and allowed to reach room temperature prior to use.

For preparation of solution for administration, see Section 6.6.

Store in a refrigerator (2°C-8°C)

Store in the original carton in order to protect from light.

For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.

14 mL vial (Type I clear glass vial), chlorobutyl elastomeric stopper, and aluminum seal with a plastic flip-off cap. The vials are packed in a cardboard carton.

Pack size of 10 vials.

Each vial is for single use only.

The powder should be reconstituted with 10 mL of either sodium chloride 9 mg/ml (0.9%) solution for injection or 5% dextrose injection taken from the 100 mL bags that will be used to prepare the final infusion solution and should be gently shaken to dissolve. The vial(s) should be allowed to stand until the foaming generated on the surface has disappeared (typically within 2 minutes). The final volume of the reconstituted solution in the vial will be approximately 11.2 mL (caution: the reconstituted solution is not for direct injection).

To prepare the required doses, the appropriate volume of reconstituted solution should be withdrawn from the vial according to Table 4. Add the withdrawn volume to the infusion bag containing the remainder of the 100 mL of sodium chloride 9 mg/ml (0.9%) solution for injection, or 5% dextrose injection, inspect the resulting diluted drug product solution in the infusion bag visually for particulate matter and discoloration prior to use. Do not use discoloured solutions or solutions with visible particles.

Table 4. Preparation of cefiderocol doses:

Standard aseptic techniques should be used for solution preparation and administration.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.