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This safety information is crucial for understanding the potential risks and necessary precautions associated with the medication Complera. It is essential for both patients and healthcare professionals to be aware of these details:

• Worsening of Hepatitis B: Discontinuing Complera can lead to severe exacerbation of hepatitis B symptoms. It is imperative not to stop the medication without consulting a healthcare provider. If you are advised to stop or switch medications, regular laboratory tests will be necessary to monitor liver health and the hepatitis B virus (HBV).

• Liver Problems and Toxicity: Although rare, medications like emtricitabine and tenofovir in Complera can cause serious liver issues, such as lactic acidosis with hepatic steatosis. Individuals with pre-existing liver diseases or infections are at higher risk. Complera is not suitable for those with moderate to severe liver conditions. Liver function should be checked before starting Complera and monitored regularly during treatment. Symptoms of liver problems include loss of appetite, abdominal pain, muscle pain, difficulty breathing, extreme fatigue, and sudden weakness. Discontinue use and seek emergency medical help if these symptoms occur.

• Depression and Mood Changes: Complera may cause negative mood changes, including depression and suicidal thoughts. If you experience any mood alterations or thoughts of self-harm, contact your healthcare provider immediately. This risk is heightened for individuals with a history of mental health issues.

• Kidney Problems: Some patients may experience kidney issues while on Complera, either immediately or over time. Avoid using other medications that could harm the kidneys, such as high-dose NSAIDs (e.g., Motrin, Advil, Aleve, Mobic, Voltaren). Regular lab tests are recommended to monitor kidney function, especially for those with a history of kidney damage or using other kidney-affecting drugs.

• Bone Problems: Complera can reduce bone mineral density, increasing the risk of osteoporosis and fractures. Calcium and vitamin D supplements may help mitigate these effects. Your healthcare provider may order bone density tests if you have fractures or other risk factors for bone issues.

• Immune Reconstitution Syndrome: As HIV medications reduce virus levels, the immune system may begin to recover, potentially leading to inflammation as it fights off existing infections. This is particularly relevant for patients with weakened immune systems or untreated infections. Notify your healthcare provider if you experience fever, breathing difficulties, or sudden health changes after starting Complera.

These warnings are designed to inform and protect users of Complera. Always consult with your healthcare provider to understand the full scope of risks and the necessary precautions.

When taking this medication, you might experience mild side effects such as headaches, difficulty sleeping, diarrhea, tiredness, dizziness, or skin discoloration, including small spots or darkening of the palms and soles. These are common and generally not serious, but if they persist or worsen, it’s important to seek medical advice.

As your immune system strengthens, it might begin to combat previous infections, potentially leading to a return of disease symptoms. This could occur shortly after starting treatment or even months later. Serious symptoms such as unexplained weight loss, persistent severe tiredness or muscle aches, severe headaches, joint pain, numbness or tingling in extremities, vision changes, signs of infection (fever, chills, swollen lymph nodes, breathing troubles), or a non-healing skin sore should prompt immediate medical attention.

Additionally, be vigilant for signs of an overactive thyroid, such as irritability, nervousness, heat intolerance, rapid heartbeat, bulging eyes, or a goiter. Rarely, the medication can lead to Guillain-Barre syndrome, characterized by unsteadiness, coordination loss, swallowing or speech difficulties, and eye movement problems.

Liver disease symptoms can include persistent nausea or vomiting, loss of appetite, abdominal pain, yellowing of the skin or eyes, and dark urine. Kidney issues may manifest as changes in urine output or blood in the urine, and mental health changes like depression or suicidal thoughts need urgent discussion with a healthcare provider.

In rare instances, a severe blood disorder known as lactic acidosis may occur, with symptoms such as deep, rapid breathing, drowsiness, or unusual weakness. Changes in body fat distribution or bone loss are possible side effects, so discuss these with your healthcare provider, who may suggest exercise or supplements.

Rashes can occur and are usually benign, but since they might signal a severe reaction, seek medical help if you develop one. While a serious allergic reaction is rare, immediate medical attention is critical if you experience rash, itching, swelling, severe dizziness, or breathing difficulties. Always consult your healthcare provider if you notice any other unusual effects.

Certain medications and supplements can interact with Complera, potentially affecting its effectiveness or increasing side effects. It's crucial to inform your healthcare provider about all the medications and supplements you are taking, including prescription, over-the-counter, vitamins, and herbal products. Here are some important interactions to be aware of:

Medications to Avoid with Complera:

• Harmful to Kidneys: Adefovir, Orlistat, Aminoglycosides like Amikacin and Gentamicin.
• Proton Pump Inhibitors (PPIs): Dexlansoprazole, Esomeprazole, Lansoprazole, Omeprazole, Pantoprazole, Rabeprazole.
• Other HIV Treatments: Avoid combining with products containing Didanosine, Emtricitabine, Tenofovir, or Lamivudine. Also, do not use with Rilpivirine unless Rifabutin is prescribed.

Medications that Affect Rilpivirine Removal:

• Steroids: Dexamethasone.
• Antibiotics: Erythromycin, Telithromycin.
• Rifamycins: Rifampin, Rifapentine.
• Herbal Supplements: St. John's Wort.
• Seizure Medications: Carbamazepine, Oxcarbazepine, Phenobarbital, Phenytoin, Primidone.

Medications Usually Not Recommended but May Be Used with Adjustments:

• Various medications such as Abametapir, Aceclofenac, and many others. If these are necessary, your doctor may need to adjust doses or monitor you closely.

Medications That May Increase Side Effects:

• Drugs like Boceprevir, Darunavir, Lopinavir, Ritonavir, and Tipranavir may increase side effects but could be essential for treatment. Your doctor will adjust the therapy as needed.

Always consult your healthcare provider for advice specific to your health situation.