The government said it would order Jeil Pharmaceutical and Myungmoon Pharm to add Hepatitis B recurrence to the precautions of their three anticancer drugs – Jeil’s TS-1 Cap. and Myungmoon’s two versions of Tego Cap.
The drugs treat gastric cancer and head and neck cancer, containing three ingredients, tegafur, gimeracil and oteracil potassium.
The Ministry of Food and Drug Safety said on Monday it would change approval conditions for the three products, TS-1 Cap., Tego Cap. 20 and Tego Cap. 25, to amend the precautions. If the drugmakers have any other opinions, they can submit them with reasons to the ministry by March 27.
The change in approval conditions is a follow-up measure after the European Commission added hepatitis B recurrence to the safety information of the three ingredients.
The warnings section under the precautions will have to state, “When this drug is administered to Hepatitis B virus carriers and those with a history of the hepatitis B infection (HBs antigen negative, HBc antibody positive, or HBs antibody positive), they may develop hepatitis by reactivating the hepatitis B virus. Thus, the presence of hepatitis virus should be checked before the administration of this drug.”
The new warnings will also include the following statement, “Hepatitis B virus carriers and those who were infected with the virus in the past should be aware of signs and symptoms of reactivation of the hepatitis B virus, by continuously checking liver functions and monitoring hepatitis virus markers during the period of administration of this drug.”
Last year, the three remedies’ warnings added that “unexplained adverse reactions such as corneal limbal stem cell deficiency may occur.”
The three medicines use tegafur, gimeracil, and oteracil potassium as major ingredients. The three agents generate “triple anti-cancer effect” together. Tegafur is an antitumor agent, and gimeracil is known to increase an antitumor effect, and oteracil has antitumor effect and gastrointestinal toxicity reduction effect.
The indications of the three drugs include progressive, metastatic or recurrent gastric cancer, postoperative adjuvant chemotherapy, progressive and recurrent head and neck cancer, and locally advanced or metastatic pancreatic cancer.