Why is this medication prescribed?

Atazanavir and Cobicistat are prescribed in combination to treat HIV-1 infection in adults and pediatric patients (weighing at least 35 kg) who have not previously received antiretroviral therapy or to replace the current antiretroviral regimen in those who have achieved stable virologic suppression.

Atazanavir is an antiretroviral protease inhibitor that prevents the virus from multiplying by blocking the action of the enzyme protease, which HIV needs to replicate. Cobicistat is a pharmacokinetic enhancer or “booster” that increases the effectiveness of Atazanavir by inhibiting the enzymes that metabolize Atazanavir, thus increasing its concentration in the blood.

How should this medicine be used?

Atazanavir and Cobicistat should be used as follows:

• Dosage: The combination is typically taken as one tablet once daily with food. The exact dosage will be determined by your doctor based on your medical condition, response to treatment, and any other medications you are taking. It’s essential to take the medication at the same time each day to maintain a consistent level in the bloodstream.
• Administration: Swallow the tablet whole with a meal to ensure adequate absorption. Do not crush, break, or chew the tablets.
• Additional Instructions: It is important to continue taking Atazanavir and Cobicistat, even if you feel well, to prevent the virus from becoming resistant. Regularly follow up with your doctor for monitoring and to manage any side effects or changes in your condition.
• Missed Dose: If you miss a dose and it is within 12 hours of the time you usually take it, take the missed dose with food as soon as you remember. If more than 12 hours have passed, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

Always follow your healthcare provider’s instructions and consult them if you have any concerns or experience side effects.

Other uses for this medicine

Atazanavir and Cobicistat are primarily used for the treatment of HIV-1 infection. They are not commonly prescribed for other conditions outside of their approved use in HIV management. However, healthcare providers may occasionally use them off-label for experimental or investigational purposes in clinical studies related to HIV or other viral infections, depending on emerging research.

What special precautions should I follow?

Special Precautions for Atazanavir and Cobicistat:

• Allergies: Inform your doctor if you have any known allergies to Atazanavir, Cobicistat, or any other medications. Also, let them know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals.
• Medical History: Share your complete medical history with your doctor, especially if you have or have had liver problems (such as hepatitis B or C), kidney disease, heart problems, diabetes, hemophilia, high blood pressure, or high cholesterol.
• Drug Interactions: Atazanavir and Cobicistat can interact with many medications, including other antiretrovirals, anticoagulants, anticonvulsants, certain heart medications, and others. Always provide a full list of all medications, supplements, and herbal products you are taking to your healthcare provider. Avoid taking any new medications or stopping any current ones without consulting your doctor.
• Heart Rhythm Problems: Atazanavir can cause changes in heart rhythm (prolongation of the QT interval). Inform your doctor if you have a history of heart rhythm problems or are taking medications that may affect your heart rhythm.
• Liver Function: This combination can affect liver function. Regular blood tests may be required to monitor your liver health. Inform your doctor immediately if you notice symptoms such as yellowing of the skin or eyes (jaundice), dark urine, severe stomach/abdominal pain, or persistent nausea/vomiting.
• Kidney Health: Atazanavir may cause kidney stones or other kidney-related issues. Inform your healthcare provider if you experience back pain, pain during urination, or blood in your urine.
• Pregnancy and Breastfeeding: Inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding. Atazanavir and Cobicistat may not be safe during pregnancy or breastfeeding.
• Use of Antacids: Avoid taking antacids containing aluminum or magnesium within 2 hours before or 1 hour after taking Atazanavir and Cobicistat, as they may reduce the effectiveness of the medication.
• Photosensitivity: Atazanavir may make your skin more sensitive to sunlight. Wear protective clothing and sunscreen when outdoors.
• Adherence to Treatment: Adherence is crucial to prevent viral resistance. Do not skip doses or stop treatment without consulting your doctor.

Always follow your healthcare provider’s guidance and report any unusual symptoms or side effects promptly.

What special dietary instructions should I follow?

• Take with Food: Always take Atazanavir and Cobicistat with food to enhance absorption and ensure the medication works effectively.
• Avoid High-Fat Meals: Try to avoid high-fat meals as they can affect the absorption of the medication.
• Stay Hydrated: Drink plenty of water, especially if you are at risk of kidney stones or if advised by your doctor.

What should I do if I forget a dose?

• If Less than 12 Hours Have Passed: Take the missed dose with food as soon as you remember.
• If More than 12 Hours Have Passed: Skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Atazanavir and Cobicistat can cause a range of side effects, though not everyone will experience them. Here are some common and serious side effects:

Common Side Effects:

• Nausea and Vomiting: These are among the most frequently reported side effects.
• Diarrhea: Loose or frequent stools may occur.
• Jaundice: Yellowing of the skin or eyes due to elevated bilirubin levels is common with Atazanavir.
• Rash: Mild to moderate skin rashes may occur.
• Headache: Some individuals may experience headaches.
• Abdominal Pain: Stomach or abdominal discomfort or pain is a potential side effect.
• Dizziness or Lightheadedness: These may occur, especially when getting up too quickly from a sitting or lying position.

Serious Side Effects:

• Heart Rhythm Changes: Atazanavir can cause prolongation of the QT interval, leading to irregular heartbeat or fainting. Seek immediate medical help if you experience dizziness, fainting, or rapid/irregular heartbeat.
• Liver Problems: Symptoms like dark urine, severe stomach/abdominal pain, persistent nausea or vomiting, and yellowing of the skin or eyes should be reported to your doctor immediately.
• Kidney Stones: Atazanavir may cause kidney stones, leading to pain in the back or side, blood in the urine, or pain during urination.
• Hyperbilirubinemia: Elevated bilirubin levels can cause yellowing of the skin or eyes (jaundice).
• Skin Rash or Severe Allergic Reactions: Serious rashes, itching, swelling, dizziness, and trouble breathing may indicate an allergic reaction.
• Immune Reconstitution Syndrome: When starting HIV treatment, your immune system may become stronger and start to fight infections that were previously hidden. Symptoms depend on the infection being fought.
• Severe Skin Reactions: Such as Stevens-Johnson syndrome, which can cause severe blistering, peeling, and rash.
• Lactic Acidosis: A rare but serious buildup of lactic acid in the blood, causing unusual tiredness, muscle pain, trouble breathing, or irregular heartbeats.

Less Common Side Effects:

• Changes in body fat distribution (lipodystrophy).
• Increased cholesterol or triglyceride levels.
• Insomnia or sleep disturbances.
• Depression or mood changes.

If you experience any of these side effects or other unusual symptoms, contact your healthcare provider immediately.

What should I know about storage and disposal of this medication?

Storage and Disposal of Atazanavir and Cobicistat :

Storage:

• Keep the medication in its original container, tightly closed, at room temperature (20°C to 25°C or 68°F to 77°F).
• Protect from moisture, heat, and direct light.
• Do not store the medication in the bathroom, as humidity may affect its stability.
• Ensure the medication is stored in a safe place, out of reach of children and pets.

Disposal:

• Do not dispose of the medication by flushing it down the toilet or pouring it into a drain unless instructed to do so.
• Dispose of the medication through a medicine take-back program if available. If not, ask your pharmacist or local waste disposal company for proper disposal methods.

In case of emergency/overdose

• Recognize Symptoms of Overdose: Symptoms of an overdose may include severe dizziness, fainting, heart rhythm changes (such as rapid or irregular heartbeat), extreme nausea, vomiting, and severe jaundice (yellowing of the skin or eyes).
• Immediate Actions: If you suspect an overdose, call your local poison control center at 1-800-222-1222 (in the U.S.) or seek emergency medical help immediately.
• Provide Information: Be prepared to provide information such as the name of the medication, the amount taken, and the time of ingestion.

What other information should I know?

• Regular Medical Follow-Ups: Keep all appointments with your doctor and lab. Regular monitoring, including blood tests, may be required to check for side effects or changes in your condition.
• Adherence to Treatment: Do not stop taking Atazanavir and Cobicistat without consulting your doctor, even if you feel well, as doing so may result in viral resistance or treatment failure.
• Avoid Sharing Medication: This medication is prescribed for your specific condition; do not share it with others, even if they have the same symptoms.
• Wear Medical Identification: Consider wearing a medical alert bracelet or carrying an ID card stating that you are taking Atazanavir and Cobicistat, particularly if you have significant health conditions.
• Monitor for Side Effects: Be vigilant for side effects and report any new or worsening symptoms to your healthcare provider.

Always follow your healthcare provider’s instructions and consult them if you have any questions or concerns about your medication.