WARNING

Darunavir, Cobicistat, Emtricitabine, and Tenofovir are medications used to treat HIV/AIDS. While they can be effective in managing the virus, they also come with potential risks and side effects:

• Gastrointestinal Issues: Nausea, vomiting, diarrhea, and abdominal pain are common side effects.
• Liver Problems: These drugs can sometimes cause liver inflammation or damage, particularly in people with pre-existing liver conditions.
• Kidney Issues: Tenofovir, in particular, may lead to kidney problems, including decreased kidney function and potential kidney failure.
• Metabolic Effects: They can lead to metabolic changes, such as increased cholesterol levels, insulin resistance, or changes in body fat distribution.
• Skin Reactions: Some individuals may experience skin reactions like rash or itching.
• Drug Interactions: These medications can interact with other drugs, potentially reducing their effectiveness or increasing the risk of side effects.
• Immune Reconstitution Inflammatory Syndrome (IRIS): When starting HIV treatment, some individuals may experience an inflammatory response as the immune system strengthens, leading to symptoms like fever, swollen lymph nodes, or worsening of existing infections.
• Allergic Reactions: Rarely, severe allergic reactions can occur, characterized by symptoms like difficulty breathing, swelling of the face or throat, and hives.

It’s important for individuals taking these medications to be monitored regularly by their healthcare provider to manage and mitigate these risks effectively.

Why is this medication prescribed?

The combination of darunavir, cobicistat, emtricitabine, and tenofovir is used to treat human immunodeficiency virus (HIV) infection in adults and children weighing at least 88 pounds (40 kg) who have not been treated with other HIV medications or to replace current medication therapy in certain people already taking HIV medications. Tenofovir, cobicistat, emtricitabine, and darunavir belong to the class of drugs known as antivirals. Emtricitabine, tenofovir, and darunavir reduce the quantity of HIV in the blood. Cobicistat aids in extending the half-life of darunavir in the body, maximizing its therapeutic impact. While darunavir, cobicistat, emtricitabine, and tenofovir alone cannot cure HIV, the combination of these drugs may lower your risk of contracting HIV-related diseases including cancer or severe infections as well as acquired immunodeficiency syndrome (AIDS). By taking these drugs, having safer sexual relations, and changing other aspects of your lifestyle, you may be able to reduce the risk of HIV infection.

How should this medicine be used?

Darunavir, cobicistat, emtricitabine, and tenofovir are often combined into a single tablet known as a fixed-dose combination for the treatment of HIV infection. One common brand name for this combination is called “Symtuza.” Here’s how this combination is typically used:

• Dosage: The recommended dosage of Symtuza or similar fixed-dose combinations containing darunavir, cobicistat, emtricitabine, and tenofovir may vary depending on factors such as the patient’s age, weight, renal function, and previous HIV treatment history. It’s essential to follow the dosage instructions provided by the healthcare provider or pharmacist carefully.
• Administration: The tablet is usually taken orally once daily with food. Taking it with food helps to improve the absorption of the medications and reduces the risk of gastrointestinal side effects.
• Adherence: It’s crucial to take darunavir, cobicistat, emtricitabine, and tenofovir consistently at the same time each day. Missing doses or not following the prescribed regimen can lead to treatment failure and the development of drug-resistant strains of HIV.
• Monitoring: Regular monitoring of HIV viral load, CD4 cell count, and liver function tests is typically recommended while taking these medications to assess the effectiveness of treatment and monitor for any potential side effects.
• Side Effects: Common side effects of darunavir, cobicistat, emtricitabine, and tenofovir may include nausea, diarrhea, headache, fatigue, and rash. It’s essential to report any persistent or severe side effects to the healthcare provider.
• Drug Interactions: These medications may interact with other drugs, including over-the-counter medications, supplements, and recreational drugs. It’s essential to inform the healthcare provider about all medications and substances being used to avoid potential interactions.
• Duration of Treatment: Treatment with darunavir, cobicistat, emtricitabine, and tenofovir is usually lifelong once initiated. Stopping treatment abruptly can lead to rebound of HIV replication and progression of the infection.

As always, individualized treatment plans should be discussed with a healthcare provider, who can provide guidance based on the patient’s specific medical history and needs.

Other uses for this medicine

While darunavir, cobicistat, emtricitabine, and tenofovir are primarily used in combination for the treatment of HIV infection, there may be other off-label uses or investigational uses for these medications. However, it’s essential to note that using medications for off-label purposes should only be done under the guidance and supervision of a healthcare provider.

What special precautions should I follow?

As for special precautions to follow when using darunavir, cobicistat, emtricitabine, and tenofovir:

• Allergic Reactions: Inform your healthcare provider if you have any known allergies to darunavir, cobicistat, emtricitabine, tenofovir, or any other medications. Allergic reactions to these medications are rare but can occur.
• Drug Interactions: These medications can interact with other drugs, including over-the-counter medications, supplements, and recreational drugs. Make sure to inform your healthcare provider about all medications and substances you are taking to avoid potential interactions.
• Liver Function: Darunavir, cobicistat, emtricitabine, and tenofovir can affect liver function. Regular monitoring of liver function tests is typically recommended while taking these medications, especially in patients with pre-existing liver conditions.
• Kidney Function: Tenofovir, in particular, can affect kidney function. Your healthcare provider may monitor your kidney function regularly while you are taking these medications, especially if you have pre-existing kidney conditions.
• Pregnancy and Breastfeeding: It’s essential to discuss the risks and benefits of using darunavir, cobicistat, emtricitabine, and tenofovir during pregnancy or while breastfeeding with your healthcare provider. Some HIV medications may be used during pregnancy to prevent transmission to the baby, but the decision should be made in consultation with a healthcare provider.
• Adherence: It’s crucial to take darunavir, cobicistat, emtricitabine, and tenofovir consistently and as prescribed. Missing doses or not following the prescribed regimen can lead to treatment failure and the development of drug-resistant strains of HIV.
• Side Effects: Monitor for any side effects while taking these medications and report any persistent or severe symptoms to your healthcare provider.

Always follow your healthcare provider’s instructions and guidance when using darunavir, cobicistat, emtricitabine, and tenofovir, and do not make any changes to your treatment regimen without consulting them first.

What special dietary instructions should I follow?

• Food Intake: Darunavir should be taken with food to improve absorption, so it’s recommended to take the medication with a meal or snack. This also applies to fixed-dose combinations containing cobicistat, emtricitabine, and tenofovir.
• Hydration: Maintaining adequate hydration is important while taking these medications, especially tenofovir, which can affect kidney function.

What should I do if I forget a dose?

• As Soon as Possible: If you forget to take a dose of darunavir, cobicistat, emtricitabine, or tenofovir, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule.
• Do Not Double Dose: Do not take a double dose to make up for a missed one, as this can increase the risk of side effects and complications.
• Consult Your Healthcare Provider: If you frequently forget doses or are unsure about what to do when you miss a dose, consult your healthcare provider for guidance.

What side effects can this medication cause?

Darunavir, cobicistat, emtricitabine, and tenofovir are generally well-tolerated medications, but like all drugs, they can cause side effects in some people. Here are some potential side effects associated with each medication:

• Diarrhea
• Headache
• Stomach discomfort
• Gas
• Dark yellow or brown urine; light-colored bowel movements; loss of appetite; nausea; vomiting; right upper stomach-area pain; or yellow skin or eyes
• Increased or decreased urination
• Weakness; muscle pain; shortness of breath or fast breathing; stomach pain with nausea and vomiting; cold or blue hands and feet; dizziness, lightheadedness; or fast or abnormal heartbeat
• Sore throat; fever; chills; cough; and other signs of infection
• Severe rash or rash with one or more of the following: fever, muscle or joint aches, red or swollen eyes, blisters or peeling skin, mouth sores, or swelling of face or neck

It’s important to note that not everyone will experience these side effects, and some individuals may experience side effects that are not listed here. Additionally, side effects can vary in severity from person to person. If you experience any persistent or severe side effects while taking darunavir, cobicistat, emtricitabine, or tenofovir, it’s important to inform your healthcare provider. They can provide guidance on managing side effects or adjusting your treatment regimen if necessary.

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

Storage and disposal:

Storage:

• Store these medications at room temperature away from moisture and heat.
• Keep them in their original packaging or container to protect them from light.
• Do not store these medications in the bathroom, as moisture and humidity can affect their stability.

Disposal:

• Dispose of any unused or expired medication properly according to local guidelines or regulations.
• Do not flush these medications down the toilet or pour them down the drain unless instructed to do so by a healthcare provider or pharmacist.
• Instead, consult with a pharmacist or local waste disposal facility for proper disposal methods, such as using a medication take-back program.

In case of emergency/overdose

• In case of an overdose or emergency, call your local emergency services or poison control center immediately.
• If possible, have the medication packaging or container with you to provide information to healthcare professionals.
• Symptoms of overdose may include severe nausea, vomiting, diarrhea, dizziness, and confusion. Seek medical attention promptly if you suspect an overdose.

What other information should I know?

• Inform all healthcare providers, including dentists and pharmacists, that you are taking darunavir, cobicistat, emtricitabine, and tenofovir. This includes disclosing your complete medication list, including prescription, over-the-counter, and herbal products.
• Attend all scheduled appointments for monitoring your HIV infection and response to treatment.
• Avoid sharing these medications with others, even if they have similar symptoms or conditions. These medications are prescribed specifically for individual patients based on their medical history and HIV treatment needs.
• Keep these medications out of reach of children and pets.
• Follow all instructions provided by your healthcare provider or pharmacist regarding the use, dosing, and administration of darunavir, cobicistat, emtricitabine, and tenofovir.

By following these guidelines for storage, disposal, and emergency procedures, as well as staying informed about your medication regimen, you can help ensure the safe and effective use of darunavir, cobicistat, emtricitabine, and tenofovir in managing your HIV infection.