Pretomanid FGK

The medicine can only be obtained with a prescription. Treatment should be started and monitored by a doctor experienced in managing multi-drug resistant (MDR) tuberculosis.

Pretomanid FGK is available as tablets (200 mg). The recommended dose is 1 tablet with food once daily for 6 months or longer if necessary. It must be taken in combination with bedaquiline and linezolid.

For more information about using Pretomanid FGK, see the package leaflet or contact your doctor or pharmacist.

The way the active substance in Pretomanid FGK works is not fully understood. It is thought to block the building of the cell walls of the bacteria that cause tuberculosis (Mycobacterium tuberculosis) by interfering with the production of one of the cell wall components. Pretomanid is also thought to trigger the production of substances that are toxic for the bacteria (reactive nitrogen species). These actions are expected to kill the bacteria.

A main study showed that Pretomanid FGK taken with bedaquiline and linezolid for 6 months is effective at clearing the bacteria causing tuberculosis in patients with either extensively drug-resistant tuberculosis or MDR tuberculosis when other treatments did not work or cause too many side effects.

In this study, 90% of patients with extensively drug-resistant tuberculosis (63 out of 70) and 95% of patients with MDR tuberculosis (35 out of 37) were cleared of the infection and did not get re-infected in the 6 months after the end of the treatment.

The most common side effects with Pretomanid FGK (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting and blood tests showing raised levels of liver enzymes (a sign of liver stress).

For the full list of side effects and restrictions of Pretomanid FGK, see the package leaflet.

Pretomanid FGK used with  bedaquiline and linezolid has been shown to be effective at treating difficult-to-treat tuberculosis. Although the number of patients included in the main study was small and the effects of the combination were not compared with those of other treatments, the European Medicines Agency considered that the high cure rate in the study, the shorter treatment duration and simplification of treatment compared to existing therapies are significant benefits. Treatment options are limited for these patients with difficult-to-treat, life-threatening infections.

The safety profile of the combination regimen is considered acceptable and the side effects manageable, provided that close monitoring and surveillance of the patients during and after treatment are in place.

The European Medicines Agency decided that Pretomanid FGK’s benefits are greater than its risks and it can be authorised for use in the EU.

Pretomanid FGK has been given ‘conditional authorisation’. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.

Since Pretomanid FGK has been given conditional authorisation, the company that markets Pretomanid FGK will provide the final results of ongoing studies looking at the safety and effectiveness of various doses and treatment durations.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pretomanid FGK have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Pretomanid FGK are continuously monitored. Side effects reported with Pretomanid FGK are carefully evaluated and any necessary action taken to protect patients.

Pretomanid FGK received a conditional marketing authorisation valid throughout the EU on 31-07-2020.