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This document outlines vital safety information and warnings associated with the use of Cimduo (lamivudine / tenofovir). It is crucial to thoroughly understand these details and consult with your healthcare provider if you have any questions or concerns.

• Worsening of Hepatitis B: If you have a hepatitis B infection, do not stop taking Cimduo without first speaking to your healthcare provider. Discontinuing the medication can lead to a worsening of your hepatitis B symptoms. Follow your provider’s instructions carefully, get regular liver function tests, and report any symptoms of hepatitis B, such as fever, fatigue, nausea, vomiting, dark urine, clay-colored stools, or yellowing of the skin or eyes.

• High Acid Levels and Liver Damage: Although rare, some individuals using HIV medications like Cimduo have experienced severe blood acid issues and liver damage. Be vigilant for symptoms like loss of appetite, stomach pain, nausea, vomiting, muscle pain, rapid shallow breathing, extreme fatigue, and sudden weakness. Discontinue use and seek emergency medical attention immediately if these symptoms occur.

• Kidney Problems: Cimduo may cause kidney issues, which can manifest soon after starting or over time. Avoid combining it with other kidney-harming medications, such as high doses of NSAIDs (e.g., ibuprofen, naproxen). Regular blood tests are important to monitor kidney health. Report symptoms like leg and feet swelling, difficulty urinating, or confusion to your provider promptly. Additionally, be aware of bone or muscle pain and fractures as potential indicators of kidney problems.

• Pancreatitis: Some patients may develop pancreatitis while taking Cimduo, especially children with a history of pancreatitis or previous use of NRTIs. Discontinue the medication and seek medical help if you or your child experiences abdominal pain radiating to the back, nausea, vomiting, rapid heartbeat, or fever.

• Bone Problems: There is a risk of decreased bone mineral density leading to osteoporosis and fractures. Discuss the potential need for calcium and vitamin D supplements with your provider and consider bone density testing if you have a history of fractures or other bone health concerns.

• Immune Reconstitution Syndrome: As Cimduo strengthens the immune system, it may cause inflammation due to immune reconstitution syndrome. Be alert to opportunistic infections and notify your healthcare provider if you experience fever, difficulty breathing, or sudden health changes after starting the medication.

• Fat Distribution Changes: Some patients may notice changes in body fat distribution, such as increased fat in the abdomen and upper back, with decreased fat in the face, arms, and legs. The reasons for these changes are not fully understood.

This safety information is intended to help you use Cimduo responsibly. Always follow your healthcare provider’s guidance and report any adverse effects or concerns immediately.

When taking this medication, some users may experience common side effects such as dizziness, headaches, diarrhea, nausea, and trouble sleeping. These are usually mild, but if they persist or worsen, consulting a healthcare provider is recommended. Additionally, some individuals may notice a rash, pain including back and joint pain, depression, fever, stomach pain, anxiety, or a general lack of energy. These effects are generally not serious, yet it is advisable to seek advice if they cause concern.

Other reported side effects include an upset stomach, vomiting, muscle aches, insomnia, and numbness or tingling in the limbs. These may also include symptoms of pneumonia. While these side effects can be uncomfortable, they are often manageable with medical guidance.

More serious side effects, though rare, require immediate medical attention. These include high blood acid levels, known as lactic acidosis, which can manifest as appetite loss, severe muscle pain, fast and shallow breathing, and extreme tiredness. Liver issues may present as fever, nausea, dark urine, stomach pain, and yellowing of the skin or eyes. Kidney problems might include difficulty urinating, confusion, or pain in the bones or muscles. Pancreatitis is another serious condition indicated by severe stomach pain, nausea, and a rapid heartbeat.

Additionally, changes in body fat distribution and an increased risk of bone loss may occur. While these changes are not fully understood, discussing preventive measures such as exercise, calcium, and vitamin D with a healthcare provider is beneficial. A very serious allergic reaction is rare but warrants immediate medical care if symptoms like severe dizziness, difficulty breathing, or swelling of the face, tongue, or throat occur. Always contact a healthcare provider if any severe or unexpected side effects arise.