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Do not take riociguat if you are pregnant or plan to become pregnant. Riociguat may harm the fetus. If you are sexually active and able to become pregnant, you should not begin taking riociguat until a pregnancy test has shown that you are not pregnant. You must use reliable methods of birth control during treatment and for one month after stopping riociguat. Do not have unprotected sex. Talk to your doctor about birth control methods that are effective and will work for you. Call your doctor immediately if you miss a menstrual period or think you may be pregnant while you are taking riociguat.
If you are a parent or guardian of a female who had not yet reached puberty, check your child regularly to see if she is developing any signs of puberty (breast buds, pubic hair )and let her doctor know about any changes. Your child may reach puberty before having her first menstrual period.
Because of the risk of birth defects, riociguat is available only through a special restricted distribution program. A program called Adempas Risk Evaluation and Mitigation Strategies (REMS) Program has been set up for all female patients to make sure that they are tested for pregnancy every month during treatment and for 1 month after stopping riociguat.Female patients can get riociguat only if they are registered with Adempas REMS Program. During enrollment you will choose a certified specialty pharmacy that will ship your medication to you. Ask your doctor if you have any questions about how you will receive your medication.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with riociguat and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.
Talk to your doctor about the risks of taking riociguat.