Dolutegravir Lamivudine Tenofovir Disoproxil Fumarate Brand Name Dovato: Side effects, cost, use for HIV, dosage, and more

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Dolutegravir Lamivudine Tenofovir Disoproxil Fumarate Brand Name

Dovato can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Dovato. These lists don’t include all possible side effects.For more information about the possible side effects of Dovato, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Dovato, you can do so through MedWatch.Mild side effectsMild side effects* of Dovato can include:Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.* This is a partial list of mild side effects from Dovato. To learn about other mild side effects, talk with your doctor or pharmacist, or view Dovato’s Patient Information.Serious side effectsSerious side effects from Dovato aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.Serious side effects, explained in more detail below in “Side effect details,” can include:allergic reactionhepatitis B virus that’s resistant to certain drugs*worsening of hepatitis B*lactic acidosis (occurs when lactic acid in your body builds up too fast, and your body can’t remove it quickly enough)liver problems, such as increased liver enzyme levels, liver failure, and liver toxicityimmune reconstitution syndrome (a sudden increase of activity in your immune system that causes it to overwork)depression or thoughts of suicide* Dovato has boxed warnings for these side effects. A boxed warning is the strongest warning from the Food and Drug Administration (FDA). The warning alerts doctors and patients about drug effects that may be dangerous. These two side effects are grouped together in the section “Hepatitis B virus that’s resistant to certain drugs” below.Side effect detailsYou may wonder how often certain side effects occur with this drug. Here’s some detail on certain side effects this drug may cause.Allergic reactionAs with most drugs, some people can have an allergic reaction after taking Dovato. In clinical trials, fewer than 1% of people taking Dovato had an allergic reaction to one of the drugs in it: dolutegravir. It’s not known how many people taking a different medication to treat their HIV also may have had an allergic reaction.Symptoms of allergic reactions in the clinical trials included a rash and blistering of the skin or mouth. Other symptoms were eye swelling or redness, and liver injury.In general, symptoms of a mild allergic reaction can include:skin rashitchinessflushing (warmth, swelling, or redness in your skin)A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:swelling under your skin, typically in your eyelids, lips, hands, or feetswelling of your tongue, mouth, or throattrouble breathingCall your doctor right away if you have an allergic reaction to Dovato, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.Hepatitis B virus that’s resistant to certain drugsDovato has boxed warnings for hepatitis B virus that’s resistant to certain drugs and worsening of hepatitis B. A boxed warning is the most serious warning from the FDA. Boxed warnings help make sure healthcare professionals and patients are aware of the risk of the medication.Before or when you start taking Dovato, your doctor will test you for a liver infection caused by the hepatitis B virus. This infection is also known as hepatitis B. If you have hepatitis B and HIV, one of the active drugs in Dovato (lamivudine) could make the hepatitis B virus resistant to lamivudine. This means that hepatitis B is harder to treat than usual. Your doctor may recommend different treatments for hepatitis B or a medication other than Dovato to treat HIV.Dovato hasn’t been tested in people with both HIV and hepatitis B. Therefore, it isn’t known if the drug is safe or effective in this group of people. It’s also not known how many people, after starting Dovato treatment, may have developed hepatitis B virus that’s resistant to certain drugs.In some cases, hepatitis B worsened in people with HIV who stopped taking drugs, such as Dovato, that contain lamivudine. Symptoms of worsening hepatitis B can include:If you have both hepatitis B and HIV, and you stop taking Dovato, your doctor may monitor your blood levels more often than before. This is to check your liver function and how hepatitis B may be affecting you. Your doctor may also prescribe medication to treat hepatitis B.If you have hepatitis B and develop any symptoms of it worsening while taking Dovato, talk with your doctor. (See above for symptoms.) They can recommend the best treatment plan for you.Lactic acidosisDovato may cause a serious side effect called lactic acidosis. Lactic acidosis occurs when you have too much acid in your blood. In clinical trials, it’s not known how many people may have experienced lactic acidosis.In rare cases, lactic acidosis may occur along with swelling of the liver and steatosis (fat buildup in the liver). People taking lamivudine, one of the active drugs in Dovato, did have this side effect. But it’s not known how often it occurred with lamivudine, which wasn’t compared with a different drug or a placebo. (A placebo is a treatment with no active drug in it.)You may be at an increased risk for developing lactic acidosis and swelling of the liver if you’re female* or have obesity.While you’re taking Dovato, your doctor will likely monitor your blood for any changes in your liver function. If you develop symptoms of lactic acidosis or if your blood levels change, your doctor may have you stop taking Dovato.Symptoms of lactic acidosis include:stomach paindiarrheamuscle painfeeling very tiredfeeling dizzy or lightheadedfast or irregular heart ratetrouble breathingThese side effects can be very serious, and in rare cases, may lead to death. Lactic acidosis is a serious medical emergency. If you’re taking Dovato and have any mild symptoms of lactic acidosis, tell your doctor right away. Otherwise, call 911 or your local emergency number, or go to the nearest emergency room right away.* Use of the terms “female” or “male” within this article refers to a person’s gender assigned at birth.Liver problemsOne of the drugs in Dovato, dolutegravir, may cause liver side effects. In clinical trials, increased liver enzyme levels, liver failure, and liver toxicity were reported. Increased liver enzyme levels may indicate decreased function of your liver.* And liver toxicity refers to liver problems that may occur from exposure to medications or other substances.The trials included people taking either:dolutegravir (Tivicay) and lamivudine (Epivir)dolutegravir and emtricitabine/tenofovir disoproxil fumarate (Truvada)Dovato contains both dolutegravir and lamivudine.The trial results showed that increased levels of liver enzymes occurred in:between 1% and 4% of people taking Tivicay and Epivirbetween 1% and 4% of people taking Tivicay and TruvadaIt wasn’t reported how many people had liver failure or liver toxicity.Also, liver injury has been reported in people taking a called drug called abacavir/dolutegravir/lamivudine (Triumeq). This medication contains two of the active drugs, dolutegravir and lamivudine, that are in Dovato. Therefore, it’s possible that Dovato may also cause liver injury.Symptoms of liver problemsSymptoms of liver problems can include jaundice (yellowing of the skin or white of the eyes), belly pain, and nausea and vomiting.If you develop any symptoms of liver problems while using Dovato, be sure to talk with your doctor. They may give you blood tests to see if the drug is the cause.* If you have HIV and hepatitis, you may have worsening of your liver function while taking Dovato. (To learn more, see “Liver problems” in the “Dovato precautions” section below.)Immune reconstitution syndromeDuring Dovato treatment, changes may take place in the immune system. This is called immune reconstitution syndrome. It isn’t known how many people may have experienced this side effect in clinical trials.When you have HIV that isn’t being treated or if your treatment isn’t working, your immune system can become weaker. Once you start taking medication to treat your HIV, your immune system may become stronger again. Immune reconstitution syndrome occurs when your immune system gets stronger. It may begin to fight infections that it didn’t used to fight. This can cause swelling of your lymph nodes, fever, or trouble breathing.It’s also possible to develop other immune system conditions, such as Graves’ disease, which involves the thyroid. These conditions can occur because of an overactive immune system as well.If you develop symptoms of immune reconstitution syndrome while using Dovato, talk with your doctor. They may do some testing to see if your immune system is causing the symptoms.Depression or thoughts of suicideIt is possible, but rare, that people taking Dovato may develop depression or have thoughts of suicide. In clinical trials:fewer than 2% of people taking dolutegravir and lamivudine (the two active ingredients in Dovato) experienced depressionfewer than 2% of people had thoughts of suicideIt isn’t known how often these side effects occurred in people taking a different HIV medication or a placebo. (A placebo is a treatment with no active drug in it).Symptoms of depression include:loss of interest in activities that used to excite youfeeling sad or lonelyweight loss or weight gainsleeping too much or too littlePeople with suicidal thoughts may feel hopeless, ashamed, or preoccupied with death. However, they may keep these thoughts and feelings to themselves.If you develop symptoms of depression or have thoughts of suicide while taking Dovato, be sure to tell your doctor right away. They should be able to help you with your symptoms. Your doctor may also recommend that you stop taking Dovato and take a different medication to treat your HIV.

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