Ofev

Before taking this medicine

The FDA label lists no formal contraindications for Ofev. However, it is not recommended for people with moderate or severe liver impairment. Mild liver impairment requires additional care. Ofev can harm an unborn baby. Women who could become pregnant should use highly effective contraception. Vomiting or diarrhea may make oral hormonal contraceptives less reliable; alternative highly effective contraception is advised in these circumstances. Breastfeeding is not recommended during treatment. Conditions requiring caution include: - Liver problems: serious liver injury, including fatal cases, has been reported. Liver blood tests are needed before treatment, regularly during the first three months and periodically afterward. - Higher cardiovascular risk, including known coronary artery disease: blood clots in arteries have been reported. - A known bleeding risk: Ofev should be used only if the expected benefit outweighs the risk. - Recent abdominal surgery, a history of diverticular disease, or use of corticosteroids or NSAIDs: these require caution because a hole in the stomach or bowel wall has been reported. In people at known risk, treatment should be used only if the expected benefit outweighs that risk. - Severe kidney impairment or end-stage kidney disease: safety and effectiveness have not been studied. Diarrhea, nausea or vomiting require prompt management; treatment must be stopped if severe symptoms persist despite treatment for them. New or worsening protein in the urine may require a treatment interruption. Smoking reduces exposure to Ofev and may affect its effectiveness.