Pfizer Korea’s renal cancer treatments Sutene Cap. (ingredient: sunitinib malate) and Inlyta Tab. (axitinib) will add precautions for pregnant and nursing women, the government said.
The Ministry of Food and Drug Safety on Thursday said it would order the company to change the two drugs’ caution labels based on the latest safety information from Canada, and receive the company’s opinions by July 5.
According to Health Canada’s safety information on Sutene capsules, the drug’s exposure to a fetus could cause central nervous system disorders such as Moebius syndrome and amniotic band syndrome in the fetus.
The ministry will reflect the information from Canada on locally authorized Sutene Cap. The precautions will state that a pregnant woman user should be aware of the drug’s teratogenic risk and that the fetus’ limbs and head require additional monitoring.
Pfizer’s other renal cancer drug Inlyta Tab. had aneurysm rupture cases reported to the U.S. Food and Drug Administration and the European Commission. The examples included current aneurysm events, and some of the cases were fatal.
The drugmaker will add a precaution of Inlyta Tab. that before treating a patient with a history of aneurysm, a physician should carefully consider the drug’s risk of aneurysm rupture.
The precaution will also include a recommendation for fertile women to use contraception during the medication and until the first week after the last administration.
Sutente is indicated for gastrointestinal tract tumors that failed imatinib mesylate therapy due to drug resistance and intolerance, advanced renal cell carcinoma, and unresectable and highly differentiated advanced and/or metastatic pancreatic endocrine tumors.
Inlyta Tab. is used in advanced renal cell cancer that has previously failed in one systemic therapy.
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