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This document outlines crucial safety information regarding the use of Juluca (dolutegravir / rilpivirine). Please read thoroughly and discuss any questions or concerns with your healthcare provider.

• Severe Allergic Reactions: Juluca may occasionally cause serious allergic reactions that could be life-threatening, affecting various organs. If you experience symptoms such as a high fever, widespread blistering rash, facial swelling, or difficulty breathing, discontinue use immediately and seek medical attention.

• Liver Health: Individuals taking Juluca may see changes in liver function tests, particularly those with pre-existing liver conditions or hepatitis B/C infections. Your healthcare provider will assess your liver function before and during treatment with regular blood tests.

• Pregnancy Risks: Dolutegravir, a component of Juluca, may elevate the risk of neural tube defects if taken during the first trimester. If you are pregnant or planning to become pregnant, consult your healthcare provider for safer alternatives. Those taking Juluca who wish to avoid pregnancy should discuss birth control options with their provider.

• Mental Health Concerns: Rilpivirine can be associated with mood changes, including depression and suicidal thoughts. Notify your provider immediately if you notice mood alterations or have thoughts of self-harm.

• Drug Interactions: Inform your healthcare team of all medications, including OTC products and supplements, as many drugs can interact with Juluca, potentially causing side effects or reducing its effectiveness. Your provider may adjust your medication regimen accordingly.

Contraindications

Juluca should not be used under certain conditions due to potential serious health risks. Consult your healthcare provider if any of the following apply to you:

• Concurrent use with dofetilide (Tikosyn).
• Use with drugs that reduce rilpivirine levels, such as proton pump inhibitors, rifampin, or specific antiseizure medications.

When using this medication, some common side effects may include headache and diarrhea. These are typically mild, but if they persist or worsen, it's important to consult your healthcare provider. Some individuals may also experience nausea, stomach pain, low appetite, fatigue, or dizziness. Although these effects are generally not severe, monitoring them is important.

In some cases, more serious side effects may occur. These include unexplained weight loss, severe tiredness, persistent muscle aches or weakness, severe headaches, joint pain, numbness or tingling in the extremities, vision changes, and signs of infection such as a persistent sore throat, fever, or chills. If you notice any of these symptoms, contact your healthcare provider promptly.

Additionally, changes in body fat distribution may be observed, particularly increased fat in the upper back and stomach areas or decreased fat in the arms and legs. While the cause and long-term implications are not fully understood, discussing these changes with your healthcare provider is advisable.

While rare, this medication can lead to serious allergic reactions. Symptoms may include rash, itching or swelling, especially of the face, tongue, or throat, severe dizziness, and trouble breathing. Immediate medical attention is necessary if these occur. Similarly, mood changes such as depression or thoughts of suicide are serious and require prompt consultation with a healthcare provider.

Lastly, the drug can sometimes cause a rash that is not serious, but distinguishing it from a severe rash can be difficult. Seeking medical help if any rash develops is recommended. Always stay informed about any additional side effects you may experience and reach out to your healthcare provider if you have concerns.