TURALIO can cause serious side effects, including serious liver problems, which may be severe and can lead to death, including liver failure and a liver injury called vanishing bile duct syndrome (VBDS) that can cause the loss of bile ducts in the liver. Severe or life-threatening liver problems can happen with TURALIO even if your healthcare provider monitors liver blood tests during treatment and stops treatment with TURALIO. Your healthcare provider will do blood tests to check for liver problems before starting treatment with TURALIO, every week for the first 8 weeks during treatment, every 2 weeks for the next month, then every 3 months after that.

• If you develop liver problems during treatment with TURALIO, your healthcare provider may do blood tests more often to monitor you or refer you to a liver specialist (hepatologist). It is important to stay under the care of your healthcare provider during treatment with TURALIO. Stop taking TURALIO and call your healthcare provider right away if you develop yellowing of your skin and whites of your eyes or dark urine. Tell your healthcare provider right away if you have any of these symptoms of liver problems during treatment with TURALIO: lack or loss of appetite, right upper stomach-area (abdomen) pain or tenderness, feeling overly tired, nausea, vomiting, fever, rash, or itching.
• Because of the risk of serious liver problems, TURALIO is available only through a restricted program called the TURALIO REMS Program. Your healthcare provider must be enrolled in the program in order for you to be prescribed TURALIO. There is a registry that collects information about the effects of taking TURALIO over time. You must complete and sign an enrollment form for the TURALIO REMS Program and the registry. Ask your healthcare provider for more information.

Before you take TURALIO, tell your healthcare provider about all of your medical conditions, including if you have or had liver or kidney problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. TURALIO may harm your baby. Do not breastfeed during treatment with TURALIO and for at least 1 week after your final dose.

• If you are a female who is able to become pregnant, your healthcare provider will do a pregnancy test before you start treatment with TURALIO. You should use an effective non-hormonal method of birth control (contraception) during treatment with TURALIO and for 1 month after your final dose of TURALIO. Birth control pills (oral contraceptives) and other hormonal forms of birth control may not be effective if used during treatment with TURALIO. Talk with your healthcare provider about birth control methods you can use during this time. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with TURALIO.
• If you are a male with a female partner who is able to become pregnant, use effective birth control (contraception) during treatment and for 1 week after your final dose of TURALIO. Tell your healthcare provider right away if your female partner becomes pregnant or thinks she is pregnant during your treatment with TURALIO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements. Certain medicines may affect the way TURALIO works and TURALIO may affect how other medicines work. Taking TURALIO with certain medicines may increase the amount of TURALIO in your blood. This may make it more likely for you to have side effects and may cause more severe side effects. Avoid taking proton pump inhibitor medicines and St. John’s wort because they can affect how TURALIO works. If you take an antacid medicine, take TURALIO either 2 hours before or 2 hours after taking an antacid medicine. If you take an H2 receptor blocker medicine, take TURALIO at least 2 hours before or 10 hours after taking an H2 receptor blocker medicine.

Take TURALIO with a low-fat meal (about 11 to 14 grams of total fat). See “What should I avoid while taking TURALIO?” TURALIO capsules must be swallowed whole. Do not open, break, or chew TURALIO capsules.