AIFA wishes to provide information on the current state of shortage of cefodizime-based drugs.
The medicines in question are:
- Diezime, temporarily shortage due to production problems, due to difficulties in procuring the raw material. The Marketing Authorization Holder
(AIC) is Recordati Industria Chimica e Farmaceutica SpA and the packages concerned are those of a 1 g vial and a 4 ml solvent vial for solution for injection for intramuscular use (AIC n. 027940030) and those from a 1g vial and a 4ml solvent ampoule for solution for injection (AIC n. 027940042); - Modivid, no longer available due to the decision of the marketing authorization holder to cease marketing it permanently. The pack sizes concerned are those of a 1 g vial and a 4 ml solvent ampoule for solution for injection for intramuscular use (AIC n. 027951045) and those from a 1 g vial and a 4 ml solvent ampoule for solution for injection (AIC n. 027951033) and the marketing authorization holder is Sanofi SpA;
- Timecef, no longer available due to the marketing authorization holder's choice to cease marketing it permanently. The pack sizes concerned are those of a 1 g vial and a 4 ml solvent ampoule for solution for injection for intramuscular use (AIC n. 027939038) and the MA holder is Sanofi SpA
Therapeutic indications and classification
The drugs, containing the active ingredient cefodizime, belong to the class of antibacterials called cephalosporins and their use is elective and specific in serious bacterial infections of proven or presumed origin from difficult Gram-negatives or from mixed flora with the presence of Gram-negatives resistant to more common antibiotics, particularly in debilitated and/or immunocompromised patients.
What AIFA does to manage the shortage
The Agency has initiated constant dialogue with Recordati Industria Chimica e Farmaceutica SpA and with Sanofi SpA to verify the reasons for the unavailability of cefodizime-based drugs. In order to reduce the 
inconvenience for patients, in consideration of the fact that drugs with the same active ingredient are not authorized in Italy and that other cefodizime-based medicines are not on the market in the EU, AIFA has ordered every possible action in regulatory terms that could be support to marketing authorization holders in the actions to be taken to avoid, or minimize in terms of time, the shortage.
Any further update on the shortage status of cefodizime-based drugs will be promptly made available on the AIFA website, in the "AIFA communications on deficient drugs”.
Information for healthcare professionals
In this phase, the support of healthcare professionals is considered essential to ensure patients a careful evaluation of therapeutic alternatives. In this regard, Sanofi SpA will send - in agreement with AIFA - an information note to all healthcare professionals. It should also be remembered that, for patients not being treated with these drugs, it is important not to start new therapeutic cycles and that due to the method of administration, the other injectable methoximenic cephalosporins (ceftriaxone, ceftazidime, cefotaxime) can be considered alternatives to cefodizime.
Information for patients
The packs of Diezime (AIC n. 027940042) and Modivid (AIC n. 027951033) are used exclusively in hospital settings. The packages of Diezime (AIC n. 027940030), Modivid (AIC n. 027951045) and Timecef (AIC n. 027939038) are classified in level A and distributed through pharmacies open to the public upon presentation of a medical prescription. If you are currently on any of these drugs, talk to your doctor and follow any directions they give you.
For reports and requests for information, the e-mail box is active farmacicarenti@aifa.gov.it.
Contact details of the pharmaceutical company
For requests for information to be addressed to pharmaceutical companies, you can contact Sanofi SpA on 800.536389 and Recordati Industria Chimica e Farmaceutica SpA on 02.48787475.
Published on: 17 December 2019 by AIFA
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