What are possible side effects of DOVATO?

DOVATO can cause serious side effects, including:

• Those in the “What is the most important information I should know about DOVATO?” section.

• Allergic reactions. Call your healthcare provider right away if you develop a rash with DOVATO. Stop taking DOVATO and get medical help right away if you develop a rash with any of the following signs or symptoms: fever; generally ill feeling; tiredness; muscle or joint aches; blisters or sores in mouth; blisters or peeling of the skin; redness or swelling of the eyes; swelling of the mouth, face, lips, or tongue; problems breathing.

• Liver problems. People with a history of hepatitis B or C virus may have an increased risk of developing new or worsening changes in certain liver tests during treatment with DOVATO. Liver problems, including liver failure, have also happened in people without a history of liver disease or other risk factors. Your healthcare provider may do blood tests to check your liver.

Tell your healthcare provider right away if you get any of the following signs or symptoms of liver problems: your skin or the white part of your eyes turns yellow (jaundice); dark or “tea-colored” urine; light-colored stools (bowel movements); nausea or vomiting; loss of appetite; and/or pain, aching, or tenderness on the right side of your stomach area.

• Too much lactic acid in your blood (lactic acidosis). Lactic acidosis is a serious medical emergency that can lead to death. Tell your healthcare provider right away if you get any of the following symptoms that could be signs of lactic acidosis: feel very weak or tired; unusual (not normal) muscle pain; trouble breathing; stomach pain with nausea and vomiting; feel cold, especially in your arms and legs; feel dizzy or lightheaded; and/or a fast or irregular heartbeat.

• Lactic acidosis can also lead to severe liver problems, which can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Tell your healthcare provider right away if you get any of the signs or symptoms of liver problems which are listed above under “Liver problems.” You may be more likely to get lactic acidosis or severe liver problems if you are female or very overweight (obese).

• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after you start taking DOVATO.