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This document outlines crucial safety information and warnings associated with the use of Kaletra (lopinavir/ritonavir). Please read the following points carefully and consult your healthcare provider if you have any questions or concerns.

• Medication Interactions: Certain drugs can affect how Kaletra is processed in your body, potentially altering its effectiveness and increasing side effects. Discuss any other medications you are taking with your healthcare provider.

• Pancreatitis Risk: Although rare, some individuals have developed pancreatitis while using Kaletra. Those with high triglycerides, advanced HIV, or a history of pancreatitis are at increased risk. Inform your provider immediately if you experience symptoms like upper stomach pain, fever, nausea, or vomiting.

• Liver Issues: Kaletra usage has been linked to liver problems, which can be severe. These issues may occur shortly after beginning treatment or even after months. Regular blood tests will be conducted to monitor liver health. Symptoms to watch for include fatigue, nausea, appetite loss, light-colored stools, upper right stomach pain, jaundice, or dark urine.

• Heart Rhythm Concerns: This medication may affect heart rhythm, posing serious risks. Individuals with existing heart conditions, electrolyte imbalances, or those on other heart-affecting medications are more susceptible. Seek immediate medical attention if you experience palpitations, difficulty breathing, chest pain, or dizziness.

• Blood Sugar Levels: Kaletra can increase blood sugar levels, potentially exacerbating or leading to diabetes. If you have a history of diabetes, inform your provider. Monitoring blood sugar levels may be necessary.

• Immune System Reaction: Kaletra, in combination with other HIV therapies, can cause an overactive immune response, known as immune reconstitution syndrome. This can lead to the immune system attacking normal cells. Report any new symptoms such as fever, pain, hair loss, bulging eyes, or sweating to your provider promptly.

• Cholesterol and Triglycerides: This medication can raise cholesterol and triglyceride levels, heightening the risk of heart attack or stroke. Blood tests will be used to track these levels. Avoid using certain cholesterol medications like lovastatin and simvastatin while on Kaletra.

• Body Fat Changes: Rarely, Kaletra may cause changes in body fat distribution, such as accumulation in specific areas or loss from others. Notify your provider if you notice such changes.

• Bleeding Risks in Hemophilia: For those with hemophilia, Kaletra might increase bleeding risks. Report any unusual or persistent bleeding to your healthcare provider.

• Newborn Risks: The oral solution of Kaletra contains ethanol and propylene glycol, which could be harmful to premature newborns. Avoid using the oral solution in premature babies unless necessary. Seek immediate help if the newborn shows signs of distress, such as difficulty breathing or feeding.

• Contraindications: Do not use Kaletra with certain medications processed by the CYP3A4 liver enzyme, including alfuzosin, dronedarone, lovastatin, and simvastatin. Consult your healthcare provider if you are taking these or similar medications.

In case of an overdose, seek emergency medical attention immediately. Always follow your healthcare provider's instructions and ensure regular check-ups to monitor your health while using Kaletra.

Common side effects:

• Diarrhea
• Nausea
• Vomiting
• Headache
• Stomach upset
• Drowsiness
• Dizziness
• Bad taste in the mouth
• Trouble sleeping

Less common but important to monitor:

• Changes in taste
• Respiratory tract infections
• Feelings of weakness
• Muscle pain
• Joint pain
• Back pain
• High cholesterol levels
• High triglyceride levels
• Changes in body fat distribution

Serious side effects:

• Severe dizziness
• Fainting
• Heart rhythm changes
• Difficulty breathing
• Seizures
• Signs of kidney problems
• Unexplained weight loss
• Severe fatigue
• Persistent muscle aches
• Signs of infection
• Symptoms of a heart attack
• Severe allergic reaction

Interactions with high risk of serious adverse effects and should be avoided:

• Alfuzosin
• Alprazolam
• Amiodarone
• Apalutamide
• Rifampin
• St. John's wort
• Lovastatin
• Simvastatin
• Cobicistat
• Fosamprenavir
• Tipranavir
• Orlistat
• Dihydroergotamine
• Pimozide
• Rivaroxaban
• Midazolam
• Triazolam
• Disulfiram
• Metronidazole
• Tinidazole

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Certain alpha blockers (e.g., alfuzosin, tamsulosin)
• Certain inhaled drugs for breathing problems (e.g., fluticasone, salmeterol)
• Drugs for erectile dysfunction or pulmonary hypertension (e.g., sildenafil, tadalafil)
• Certain sedatives
• Certain statins
• Alcohol
• Marijuana (cannabis)
• Antihistamines (e.g., cetirizine, diphenhydramine)
• Drugs for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem)
• Muscle relaxants
• Opioid pain relievers (e.g., codeine)