Darunavir, cobicistat, emtricitabine, and tenofovir alafenamide: Patient drug information

Warning

Hepatitis B has gotten worse when this drug was stopped in some people with hepatitis B. Close follow-up for a few months is needed when therapy is stopped in people who have hepatitis B. Do not stop taking this drug without calling your doctor.
This drug is not approved to treat hepatitis B. Hepatitis B testing needs to be done before taking this drug.

What is this drug used for?

It is used to treat HIV infection.

What do I need to tell my doctor BEFORE I take this drug?

If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
If you have any of these health problems: Kidney disease or liver disease.
If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this drug, like certain drugs that are used for high cholesterol, migraines, or mood problems. There are many drugs that must not be taken with this drug.
If you are taking any other drugs to treat HIV.
If you are pregnant or may be pregnant. Do not take this drug if you are pregnant.
If you are breast-feeding. Do not breast-feed while you take this drug.
This is not a list of all drugs or health problems that interact with this drug.
This drug interacts with many other drugs. The chance of severe, life-threatening, or deadly side effects may be raised. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take this drug?

Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
If you have a sulfa (sulfonamide) allergy, talk with your doctor.
Have blood work checked as you have been told by the doctor. Talk with the doctor.
High blood sugar has happened with this drug. This includes diabetes that is new or worse.
Check your blood sugar as you have been told by your doctor.
Tell your doctor if you have signs of high blood sugar like confusion, feeling sleepy, unusual thirst or hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
This drug may cause high cholesterol and triglyceride levels. Talk with the doctor.
Some people with hemophilia have had times of more bleeding when taking drugs like this one. If you have hemophilia, talk with your doctor.
Kidney problems like kidney failure have happened with this drug. Tell your doctor if you have ever had kidney problems.
This drug is not a cure for HIV. Stay under the care of your doctor.
This drug does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors.
Rarely, this drug may cause a swollen liver and a buildup of acid in the blood. Sometimes, this may be deadly. The risk may be higher in females, in overweight people, and in people who have taken drugs like this one for a long time.
A severe and sometimes deadly reaction has happened. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. If you have questions, talk with the doctor.
Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking this drug.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
Signs of too much lactic acid in the blood (lactic acidosis) like fast breathing, fast heartbeat, a heartbeat that does not feel normal, very bad upset stomach or throwing up, feeling very sleepy, shortness of breath, feeling very tired or weak, very bad dizziness, feeling cold, or muscle pain or cramps.
Muscle or joint pain.
Change in body fat.
Swollen gland.
Changes in your immune system can happen when you start taking drugs to treat HIV. If you have an infection that you did not know you had, it may show up when you take this drug. Tell your doctor right away if you have any new signs after you start this drug, even after taking it for several months. This includes signs of infection like fever, sore throat, weakness, cough, or shortness of breath.
Liver problems have rarely happened with this drug. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause severe health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
Diarrhea.
Feeling tired or weak.
Upset stomach.
Headache.
Gas.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to your national health agency.

How is this drug best taken?

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
Take this drug with food.
Some products may be broken in half. If you are not sure if you can break this product in half, talk with the doctor.
Take this drug at the same time of day.
Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
It is important that you do not miss or skip a dose of this drug during treatment.

What do I do if I miss a dose?

Take a missed dose as soon as you think about it, with food.
If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
Do not take 2 doses at the same time or extra doses.
If you are not sure what to do if you miss a dose, call your doctor.

How do I store and/or throw out this drug?

Store at room temperature in a dry place. Do not store in a bathroom.
Store in the original container. Do not take out the antimoisture cube or packet.
Keep lid tightly closed.
Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

General drug facts

If your symptoms or health problems do not get better or if they become worse, call your doctor.
Do not share your drugs with others and do not take anyone else's drugs.
Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This generalized information is a limited summary of diagnosis, treatment, and/or medication information. It is not meant to be comprehensive and should be used as a tool to help the user understand and/or assess potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a specific patient. It is not intended to be medical advice or a substitute for the medical advice, diagnosis, or treatment of a health care provider based on the health care provider's examination and assessment of a patient's specific and unique circumstances. Patients must speak with a health care provider for complete information about their health, medical questions, and treatment options, including any risks or benefits regarding use of medications. This information does not endorse any treatments or medications as safe, effective, or approved for treating a specific patient. UpToDate, Inc. and its affiliates disclaim any warranty or liability relating to this information or the use thereof. The use of this information is governed by the Terms of Use, available at https://www.wolterskluwer.com/en/know/clinical-effectiveness-terms.

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Darunavir, cobicistat, emtricitabine, and tenofovir alafenamide: Patient drug information