The government said it has ordered Novartis to add “hepatitis B reactivation” to the precautions for Simulect Inj., an immunosuppressive drug to prevent acute organ rejection in kidney transplantation, from July 11.

The Ministry of Food and Drug Safety said it gave the order after confirming the reactivation of hepatitis B in the reports of significant adverse drug reactions.

Simulect prevents acute organ rejection in renal transplantation.

For adults, the injection is used in combination with immunosuppressive therapies such as cyclosporine and corticosteroids. It can also be used in combination with three immunosuppressants such as cyclosporine, corticosteroids, and azathioprine or mycophenolate mofetil. For children, the injection is used with cyclosporine and corticosteroids.

In post-marketing surveillance on 683 kidney transplant patients, Simulect showed 3.51 percent incidence of adverse drug reaction with 24 patients showing 37 cases of reactions.

The treatment had 1.02 percent incidence of diabetes with seven patients reporting 7 cases of adverse reactions.

Less than 1 percent of adverse drug reactions include hypercholesterolemia, hyperlipidemia, hyperglycemia, abdominal pain, elevation of alanine aminotransferase, a rise of creatinine in blood, an increase of asparagine aminotransferase, abnormality of liver function, a rise of cholesterol in blood, urinary tract infection, parvovirus infection, transplant rejection, toxicity of various drugs, leukopenia, herpes zoster, aerodermectasia, cold sensation, and tachycardia.

The incidence of significant adverse reactions was 1.17 percent with eight patients reporting nine cases. They include two instances of cytomegalovirus infection, abdominal pain, increased creatinine in blood, urinary tract infection, transplant rejection, herpes zoster, and aerodermectasia.

Unexpected adverse drug reactions were 10 cases. They included three cases of alanine aminotransferase elevation, three of ascitic acid aminotransferase increase, abnormal liver function, the toxicity of various drugs, aerodermectasia, and cold sensation.

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