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Here is essential safety and warning information regarding the use of this medication. Please read carefully and discuss any concerns with your healthcare provider.

• Serious Allergic Reactions: Cabenuva (cabotegravir / rilpivirine) may cause severe allergic responses, especially if the injection is administered too rapidly. While most reactions are mild and resolve quickly, healthcare providers will monitor you post-injection. Some rilpivirine-containing HIV treatments can cause serious allergic reactions. To assess tolerance, your provider may recommend starting with a tablet form before transitioning to the injection. Be vigilant for symptoms such as rash, difficulty breathing, fever, fatigue, dizziness, mouth sores, conjunctivitis, dark urine, or facial swelling and seek immediate medical assistance if these occur.

• Liver Problems: There is a risk of severe liver issues, particularly for those with a history of liver problems. Discuss your medical history with your provider before beginning treatment, as regular blood tests will be necessary to monitor liver health. Seek prompt medical advice if you experience symptoms like drowsiness, pain in the upper right abdomen, jaundice, or dark urine.

• Depression and Suicidal Thoughts: Some individuals may experience mood changes, including depression or suicidal thoughts, while on Cabenuva (cabotegravir / rilpivirine). Contact your healthcare provider immediately if you detect any mood alterations to determine if they are medication-related and to evaluate the continued safety of using this medication.

• Worsening of HIV Infection: Adhering to the prescribed injection schedule is crucial. Missing doses can lead to viral mutations, reducing the efficacy of Cabenuva (cabotegravir / rilpivirine) and potentially worsening your HIV infection. Inform your provider promptly if you miss or anticipate missing a scheduled injection to discuss alternative arrangements.

• Interactions with Other Medications: Some drugs may alter the metabolism of Cabenuva (cabotegravir / rilpivirine), affecting its effectiveness and increasing the likelihood of side effects. Consult your healthcare provider about any other medications you are taking.

• Contraindications: Do not use this medication if you are on treatments that significantly reduce cabotegravir or rilpivirine levels, such as certain seizure medications (e.g., carbamazepine, oxcarbazepine, phenobarbital, phenytoin), antibiotics (e.g., rifampin, rifapentine), dexamethasone for multiple treatments, or St John's wort. Always consult your healthcare provider for guidance.

When using this medication, some common side effects may include discomfort, swelling, redness, itching, bruising, or a hardened lump at the injection site. Other mild effects can be headaches, fatigue, nausea, or difficulty sleeping. These effects are usually not severe, but consult your healthcare provider if they persist or worsen.

On rare occasions, you might experience temporary symptoms such as sweating, shortness of breath, stomach cramps, dizziness, or numbness in the mouth following an injection. These typically resolve quickly, but it's important to inform your healthcare professional if they occur. As your immune system strengthens, it might reactivate previous infections, leading to symptoms reemerging or an overactive immune response. Seek immediate medical attention if you experience serious symptoms like unexplained weight loss, severe fatigue, persistent muscle aches, severe headaches, joint pain, tingling in extremities, vision changes, or signs of infection.

There is also a risk of more severe side effects, such as mental or mood changes, including depression or suicidal thoughts. Additionally, changes in body fat distribution may occur, affecting the upper back, stomach, arms, and legs; discuss these risks with your healthcare provider.

Rilpivirine might cause a rash, which is often not serious. However, it's crucial to seek medical help if you develop a rash, as it may indicate a severe reaction. Serious allergic reactions are rare but require immediate medical attention. Symptoms include rash, swelling, severe dizziness, or breathing difficulties. Always contact your healthcare provider if you notice any other unusual effects.