Atazanavir (a-ta-ZAN-a-vir), Cobicistat (koe-BIK-i-stat)

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.

Brand Name(s):

Evotaz

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine with food or milk.
• Contact your doctor or pharmacist when your supply of this medicine is low. Do not allow yourself to run out of this medicine.
• 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.

• You must avoid many other medicines while you are using cobicistat with atazanavir. These medicines used together could cause serious health problems, including death. Medicines you must avoid include the following: alfuzosin, carbamazepine, cisapride, dronedarone, drospirenone/ethinyl estradiol, elbasvir/grazoprevir, glecaprevir/pibrentasvir, indinavir, irinotecan, lomitapide, lovastatin, lurasidone, midazolam, nevirapine, phenobarbital, phenytoin, pimozide, ranolazine, rifampin, sildenafil for pulmonary hypertension, simvastatin, St John's wort, triazolam, and ergot medicines (including dihydroergotamine, ergotamine, methylergonovine). Do not use this medicine together with colchicine if you have kidney or liver disease.
• Some medicines can affect how cobicistat/atazanavir works. Tell your doctor if you are using any of the following:
  • Bosentan, clonazepam, clopidogrel, digoxin, efavirenz, eslicarbazepine, etravirine, famotidine, lamotrigine, oxcarbazepine, prasugrel, quetiapine, ritonavir, salmeterol, sofosbuvir/velpatasvir/voxilaprevir, tenofovir, ticagrelor, voriconazole
  • Blood pressure medicine (including beta-blockers, calcium channel blockers)
  • Blood thinners (including apixaban, betrixaban, dabigatran, edoxaban, rivaroxaban)
  • Medicine for cancer (including dasatinib, nilotinib, vinblastine, vincristine)
  • Medicine for heart rhythm problems (including amiodarone, disopyramide, flecainide, lidocaine, mexiletine, propafenone, quinidine)
  • Medicine to treat depression (including SSRIs, TCAs, trazodone)
  • Medicine to treat infection (including clarithromycin, erythromycin, telithromycin)
  • NSAID pain or arthritis medicine
  • Steroid medicine
• If you use antacids, take them 2 hours before or 2 hours after you take this medicine.
• Take this medicine at least 2 hours before or 1 hour after taking didanosine.

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.
• Tell your doctor if you are pregnant, or if you have kidney disease, liver disease, diabetes, heart rhythm problems, or bleeding problems (including hemophilia).
• Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
• This medicine may cause the following problems:
  • Heart rhythm problems
  • Serious skin reactions
  • Kidney problems, including chronic kidney disease or Fanconi syndrome (when used together with tenofovir DF)
  • Kidney stones or gallstones
  • Liver problems
  • High blood sugar
  • Increased risk of bleeding
  • Lactic acidosis (too much acid in the blood) in pregnant women
• 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.
• Do not stop using this medicine unless your doctor tells you to. If you stop the medicine even for a short time, the virus may become harder to treat.
• Always practice safe sex, even if your partner also has HIV. If you stop taking this medicine or do not take it as prescribed, you may spread HIV to others. Do not reuse or 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, red skin rash
• Change in how much or how often you urinate, red or pink urine, lower back or side pain
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fast, pounding, or uneven heartbeat, dizziness or lightheadedness
• 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, face, 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