Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (By mouth)
Cobicistat (koe-BIK-i-stat), Darunavir (dar-UE-na-vir), Emtricitabine (em-trye-SYE-ta-been), Tenofovir Alafenamide (ten-OF-oh-vir al-a-FEN-a-mide)
Treats HIV infection. HIV causes AIDS. This medicine does not cure HIV or AIDS, but combinations of drugs may slow the progress of the disease.
SymtuzaThere may be other brand names for this medicine.
When This Medicine Should Not Be Used:This medicine is not right for everyone. Do not use it if you had an allergic reaction to darunavir, cobicistat, emtricitabine, or tenofovir alafenamide.
How to Use This Medicine:
- Your doctor will tell you how much medicine to use. Do not use more than directed.
- Do not stop using this medicine without checking first with your doctor. If you stop the medicine even for a short time, the virus may become harder to treat. Contact your doctor or pharmacist when your supply is running low so you do not run out.
- It is best to take this medicine with food or milk.
- If you cannot swallow the tablet whole, you may cut it into two using a tablet cutter. Take both halves of the tablet right away.
- Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
- Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
- Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
- Do not use this medicine together with alfuzosin, carbamazepine, cisapride, dihydroergotamine, dronedarone, elbasvir/grazoprevir, ergotamine, ivabradine, lovastatin, lurasidone, methylergonovine, naloxegol, oral midazolam, phenobarbital, phenytoin, pimozide, ranolazine, rifampin, sildenafil, simvastatin, St John's wort, or triazolam.
- Do not use this medicine together with colchicine if you have kidney or liver disease.
- There are many drugs that can interact with this medicine. Make sure your doctor knows about all other medicines you are using, especially the following:
- Acyclovir, artemether/lumefantrine, avanafil, bosentan, buspirone, cidofovir, cyclosporine, diazepam, estazolam, everolimus, ganciclovir, gentamicin, salmeterol, sildenafil, simeprevir, sirolimus, tacrolimus, tadalafil, ticagrelor, valacyclovir, valganciclovir, vardenafil, zolpidem
- Birth control pills
- Blood pressure medicine (including beta blockers, calcium channel blockers)
- Blood thinner (including apixaban, rivaroxaban, warfarin)
- Medicine for heart rhythm problems (including amiodarone, digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone, quinidine)
- Medicine to treat an infection (including clarithromycin, erythromycin, itraconazole, ketoconazole, posaconazole, rifabutin, rifampin, rifapentine, telithromycin, voriconazole)
- Medicine to treat cancer (including dasatinib, nilotinib, vinblastine, vincristine)
- Medicine to treat depression or mental health problems
- Medicine to treat seizures (including clonazepam, eslicarbazepine, oxcarbazepine)
- Narcotic pain medicine (including buprenorphine, buprenorphine/naloxone, fentanyl, methadone, oxycodone)
- NSAID pain or arthritis medicine
Warnings While Using This Medicine:
- It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (including condoms or spermicide) along with your pills.
- Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
- Tell your doctor if you have kidney disease, liver disease (including hepatitis B or C), diabetes, hemophilia, or an allergy to sulfa drugs.
- This medicine may cause the following problems:
- Worsening of hepatitis B infection (if the medicine is stopped)
- Liver problems
- Serious skin reactions
- New or worsening kidney problems
- Lactic acidosis (too much acid in the blood)
- High blood sugar level, which could become permanent
- Increased risk of bleeding
- Your immune system may get stronger when you start taking HIV medicines. This could cause a hidden infection in your body to become active. Tell your doctor right away if you notice any changes in your health.
- This medicine will not keep you from giving HIV to others. Always practice safe sex, even if your partner also has HIV. Do not share needles or other items that may have blood or body fluids on them.
- Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
- Keep all medicine out of the reach of children. Never share your medicine with anyone.
Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:
- Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
- Blistering, peeling, or red skin rash
- Change in how much or how often you urinate, cloudy urine
- Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
- Fast breathing, trouble breathing, lightheadedness, severe weakness, tiredness, confusion
- Increased hunger or thirst
- Unusual bleeding, bruising, or weakness
If you notice these less serious side effects, talk with your doctor:
- Weight gain around your neck, upper back, breast, or waist
If you notice other side effects that you think are caused by this medicine, tell your doctor
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
Last Updated: 10/10/2019