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The safety information provided below is crucial for understanding the potential risks associated with the use of Tivicay (dolutegravir). It is important to review these details and consult your healthcare provider if you have any questions or concerns.

• Allergic Reactions: Although uncommon, Tivicay (dolutegravir) can cause serious and potentially life-threatening allergic reactions, particularly in individuals with a history of allergy to dolutegravir. Symptoms to watch for include severe rash accompanied by fever, general malaise, muscle or joint pain, mouth sores, blisters, facial swelling, or difficulty breathing. If you experience any of these symptoms, discontinue use immediately and seek medical attention.

• Liver Problems: There is a rare risk of significant liver issues in individuals taking dolutegravir, including those with hepatitis B or C, which may increase the likelihood of liver complications. It is important to discuss your medical history with your healthcare provider prior to starting Tivicay (dolutegravir). Regular blood tests are recommended during treatment to monitor liver health. Contact your healthcare provider if you notice symptoms indicative of liver damage, such as nausea, vomiting, fatigue, pain in the upper right abdomen, jaundice, or dark urine.

• Immune System Reactions: Combination antiretroviral therapy, including Tivicay (dolutegravir), can alter immune system activity, potentially leading to immune reconstitution syndrome. This condition occurs when the immune system becomes more active and begins to fight off infections that were previously overlooked. In rare cases, the immune system may also attack healthy cells (autoimmune response). Symptoms can emerge in the initial weeks or months of treatment. Report any new symptoms such as fever, pain, hair loss, bulging eyes, or excessive sweating to your healthcare provider without delay.

• Drug Interactions: Certain medications may affect the metabolism of Tivicay (dolutegravir), impacting its effectiveness and increasing the risk of side effects. It is essential to inform your healthcare provider of all medications you are currently taking.

• Pregnancy Risks: Use of Tivicay (dolutegravir) during early pregnancy may increase the risk of neural tube defects in the unborn child. If you are capable of becoming pregnant, a pregnancy test will be recommended to ensure the medication's safety. Discuss birth control options with your provider while being treated with Tivicay (dolutegravir). Its use in the second and third trimesters may be considered if the benefits outweigh the potential risks. Consult your healthcare provider if you are pregnant or planning to become pregnant to discuss appropriate HIV treatment options.

• Contraindications: Tivicay (dolutegravir) should not be used in conjunction with dofetilide (Tikosyn) due to the increased risk of serious side effects, such as irregular heartbeat. If this applies to you, consult your healthcare provider before commencing treatment with Tivicay (dolutegravir).

When taking this medication, some individuals may experience mild side effects such as headache, trouble sleeping, dizziness, nausea, diarrhea, rash, and fatigue. These are generally mild but if they persist or worsen, it is advisable to consult your healthcare provider. Elevated levels of lipase, blood sugar, and creatine kinase, as well as abnormal liver function tests, have also been noted in a small percentage of patients.

It is important to be aware of rare but serious side effects, which require immediate medical attention. These include severe allergic reactions characterized by rash, itching, swelling of the face, tongue, or throat, severe dizziness, and breathing difficulties. Serious liver issues may manifest as persistent nausea, vomiting, appetite loss, stomach pain, jaundice, and dark urine. Additionally, significant mental or mood changes such as depression or suicidal thoughts should be reported promptly.

In some cases, as your immune system strengthens, it might reactivate previous infections, leading to symptoms like unexplained weight loss, severe fatigue, persistent muscle aches, or headaches. Other serious conditions to watch for include signs of an overactive thyroid, such as irritability and irregular heartbeat, or symptoms indicative of Guillain-Barre syndrome, like unsteadiness and coordination loss. Always seek medical help if you notice these severe side effects.