Modigraf - tacrolimus

What is Modigraf?

Modigraf is a medicine containing the active substance tacrolimus. It is available as sachets (0.2 mg and 1 mg) containing granules for the preparation of an oral suspension.

What is Modigraf used for?

Modigraf is used in adults and children undergoing kidney, liver or heart transplants to prevent rejection (a phenomenon in which the immune system attacks the transplanted organ).

Modigraf can also be used to treat organ rejection if therapy with other immunosuppressive drugs is not effective.

The medicine can only be obtained with a prescription .

How is Modigraf used?

Modigraf therapy should only be prescribed by physicians with experience in treating transplant patients.

Modigraf is a long-term therapy. The dose is calculated based on the patient's weight. Your doctor should monitor the levels of tacrolimus in your blood to make sure they are within the predefined limits.

In the prevention of rejection, the Modigraf dose to be used depends on the type of transplant received.

For kidney transplant patients, the initial daily dose is 0.2-0.3 mg per kilogram of body weight in adults and 0.3 mg / kg in children. For patients undergoing liver transplantation, the initial daily dose is 0.1-0.2 mg / kg in adults and 0.3 mg / kg in children. For heart transplant patients, the initial daily dose is 0.075 mg / kg in adults and 0.3 mg / kg in children.

In anti-rejection therapy the same doses can be used as for kidney or liver transplants. For heart transplants, the dose is 0.15 mg / kg / day in adults and 0.2-0.3 mg / kg in children. Modigraf should be taken twice a day, preferably in the morning and in the evening.

How does Modigraf work?

The active substance in Modigraf, tacrolimus, is an immunosuppressive agent. This means that it reduces the activity of the immune system (the body's natural defenses). Tacrolimus acts on particular cells of the immune system, called T-lymphocytes, responsible for attacking the transplanted organ (organ rejection).

Tacrolimus has been available in the European Union (EU) for the prevention of organ rejection since the mid-1990s. Modigraf is similar to another medicine containing tacrolimus, Prograf or Prograft, available in capsules. Because Modigraf contains granules, it allows you to make minor dose adjustments and provides an alternative for small children and those who are unable to swallow capsules.

How has Modigraf been studied?

Since tacrolimus has been used for many years, the pharmaceutical company presented the results of studies

from the scientific literature on the efficacy of tacrolimus in organ transplantation.

Modigraft has been studied in two main studies in children undergoing liver transplantation. One study involved 28 children who took the medicine for up to one year. Modigraf has not been compared with other medicines. The main measure of effectiveness was based on the number of patients who had not had an organ rejection. The second study involved 185 children who had taken either Modigraf with corticosteroids (a group of immunosuppressive drugs) or a combination of other immunosuppressive drugs (ciclosporin, azathioprine and corticosteroids) for one year. In this study, the main measure of effectiveness was based on the number of patients who had not had organ rejection. The number of organ rejections in patients not responding to corticosteroids was also examined.

What benefits has Modigraf shown during the studies?

Modigraf has been shown to be effective in preventing organ rejection in children undergoing liver transplantation. In the first study, 79% of the patients taking Modigraf (22 out of 28) had not had an organ rejection. In the second study, the difference between the total number of discards for the combinations of the two drugs was not considered relevant. However, the Modigraf combination was more effective than the other combination in preventing organ rejections that could not be treated with corticosteroids.

What is the risk associated with Modigraf?

The most common side effects with Modigraf (seen in more than 1 patient in 10) are diabetes, hyperglycaemia (high blood glucose), hypokalemia (high blood potassium), insomnia, headache, tremor, hypertension ( high blood pressure), diarrhea, nausea, abnormal liver tests and kidney problems. For the full list of all side effects reported with Modigraf, see the Package Leaflet.

Modigraf should not be used in people who may be hypersensitive (allergic) to tacrolimus or any of the other substances or to other macrolides (medicines with a similar structure to tacrolimus).

Why has Modigraf been approved?

The Committee for Medicinal Products for Human Use (CHMP) believes that Modigraf is similar, in terms of efficacy and safety, to other tacrolimus-containing medicines available in capsules. Modigraf offers

moreover, the possibility of administering the doses with greater accuracy and could be easier to administer to small children. The CHMP determined that Modigraf's benefits outweigh the risks in the prophylaxis of transplant rejection in kidney, liver or heart transplant patients and in the treatment of rejection resistant to therapy with other immunosuppressive drugs. The committee recommended that Modigraf be given marketing authorization.