Atazanavir and Cobicistat

Atazanavir/cobicistat is a prescription medication used to treat human immunodeficiency virus (HIV) infection in adults.

It is a single product containing 2 medications: atazanavir and cobicistat.

Atazanavir belongs to a group of drugs called protease inhibitors. It works by decreasing the amount of HIV in the blood.

Cobicistat belongs to a group of drugs called pharmacokinetic enhancers. Cobicistat helps to keep atazanavir in the body longer so that the medication will have a greater effect.

This medication comes in tablet form and is taken typically once a day, with food. Common side effects of atazanavir/cobicistat include yellowing of the skin or eyes and nausea.

Atazanavir/cobicistat is a prescription medication used to treat human immunodeficiency virus (HIV) infection in adults.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Atazanavir and Cobicistat may be found in some form under the following brand names:

• Evotaz

Serious side effects have been reported with atazanavir/cobicistat. See the “Drug Precautions” section.

Common side effects of atazanavir/cobicistat include the following:

• Yellowing of skin 
• Yellowing of eyes
• Nausea
• Rash

This is not a complete list of side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that use the enzyme CYP3A4 such as budesonide (Entocort), astemizole (Hismanal), cisapride (Propulsid), cyclosporine (Neoral, Gengraf, Sandimmune), darifenacin (Enablex), dihydroergotamine (Migranal), fentanyl (Abstral, Fentora, Onsolis, Actiq), pimozide (Orap), quinidine (Cardioquin, Duraquin, Quinact), sirolimus (Rapamune), tacrolimus (Prograf), terfenadine (Seldane), fluticasone (Flovent HFA, Flonase), eletriptan (Relpax), lovastatin (Mevacor), quetiapine (Seroquel), sildenafil (Viagra, Revatio), and simvastatin (Zocor)
• medications that use an enzyme CYP2C8 such as amiodarone (Cordarone), cabazitaxel (Jevtana), carbamazepine (Tegretol), chloroquine (Aralen), diclofenac (Voltaren), ibuprofen (Advil), paclitaxel (Taxol), rosiglitazone (Avandia), repaglinide (Prandin), treprostinil (Tyvaso)
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, and nimodipine (Nimotop)
• medications that block a protein in the body (CYPA4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone
• anticoagulant (blood thinner) medications such as warfarin (Coumadin, Jantoven), heparin, enoxaparin (Lovenox), fondaparinux (Arixtra), rivaroxaban (Xarelto), and apixaban (Eliquis) 
• medications that reduce the acid level in your stomach such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), rabeprazole (Aciphex), cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), ranitidine (Zantac)
• anti-arrhythmia medications such as procainamide (Procanbid, Procan), disopyramide (Norpace, Rythmodan), lidocaine (Xylocaine, Lidoderm), phenytoin (Dilantin), mexiletine (Mexitil), flecainide (Tambocor), propafenone (Rythmol), amiodarone (Cordarone, Pacerone), sotalol (Betapace), dofetilide (Tikosyn), dronedarone (Multaq), digoxin (Lanoxin), and adenosine (Adenocard)

This is not a complete list of drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with atazanavir/cobicistat including the following:

• Heart rhythm abnormalities. Tell your healthcare provider right away if you get dizzy or lightheaded. These could be symptoms of a heart problem.
• Severe Rash. Skin rash is common with atazanavir/cobicistat but can sometimes be severe. Skin rash usually goes away within 2 weeks without any change in treatment. Severe rash may develop with other symptoms which could be serious. If you develop a severe rash or a rash with any of the following symptoms, call your healthcare provider or go to the nearest hospital emergency room right away.
  • general feeling of discomfort or “flu-like” symptoms
  • fever
  • muscle or joint aches
  • swelling of your face
  • red or inflamed eyes, like “pink eye”
  • (conjunctivitis)
  • blisters
  • mouth sores
  • painful, warm, or red lump under your skin
• Kidney damage. Atazanavir/cobicistat when taken with certain other medicines, can cause new or worse kidney problems, including kidney failure. Your healthcare provider should check your kidneys before you start and while you are taking atazanavir/cobicistat.
• Kidney stones have happened in some people who take atazanavir. Tell your healthcare provider right away if you get symptoms of kidney stones, which may include pain in your low back or low stomach area, blood in your urine, or pain when you urinate.
• Gallstones have happened in some people who take atazanavir. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include:
  • pain in the right or middle upper stomach area
  • fever
  • nausea and vomiting
  • your skin or the white part of your eyes turns yellow
• Liver damage. If you have liver problems, including hepatitis B or C infection, your liver problems may get worse when you take
  atazanavir/cobicistat. Your healthcare provider will do blood tests to check your liver before you start atazanavir/cobicistat and during treatment. Tell your
  healthcare provider right away if you get any of the following symptoms:
  • your skin or the white part of your eyes turns yellow
  • dark (tea-colored) urine
  • light colored stools
  • nausea
  • itching
  • stomach-area pain
• Diabetes or rises in blood sugar ave happened and worsened in some people who take protease inhibitor medicines like atazanavir/cobicistat. Some people have had to start taking medicine to treat diabetes or have had to change their diabetes medicine
• Increased bleeding problems in in people with hemophilia have happened when taking protease inhibitors including atazanavir/cobicistat.
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new symptoms after starting your HIV-1 medicine.
• Changes in body fat can happen in people taking HIV-1 medicines. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known.
• Yellowing of the skin or the white part of your eyes is common with atazanavir/cobicistat but may be a symptom of a serious problem. These effects may be due to increases in bilirubin levels in the blood (bilirubin is made by the liver). Although these effects may not be damaging to your liver, skin, or eyes, tell your healthcare provider right away if your skin or the white part of your eyes turns yellow.

Do not take atazanavir/cobicistat if you:

• are allergic to atazanavir, cobicistat or to any of its ingredients 
• have had severe, life-threatening rashes in the past
• take medications that can interact with atazanavir or cobicistat

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of atazanavir/cobicistat, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking atazanavir/cobicistat, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to atazanavir, cobicistat or to any of its ingredients
• have liver problems, including hepatitis B or C virus infection
• have heart problems
• have kidney problems
• have diabetes
• have hemophilia
• have had severe, life-threatening rashes in the past
• take other anti-HIV medications
• are or plan to become pregnant. Pregnant women have developed a serious condition called lactic acidosis (a build-up of lactic acid in the blood) when taking atazanavir/cobicistat with certain other HIV medicines.
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Atazanavir/cobicistat falls into category ­B. There are no well-done studies that have been done in humans with atazanavir/cobicistat. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Hormonal forms of birth control, such as injections, vaginal rings or implants, contraceptive patch, and some birth control pills may not work during treatment with atazanavir/cobicistat. Talk to your healthcare provider about forms of birth control that may be used during treatment with atazanavir/cobicistat.

Pregnancy Registry. There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if atazanavir/cobicistat crosses into human milk. However, it is not recommended for HIV-infected mothers to breastfeed because there is a risk of transmitting HIV to the infant from the breast milk. 

Take atazanavir/cobicistat exactly as prescribed.

Atazanavir/cobicistat comes in tablet form and is taken once a day, with food.

Do not take two doses of atazanavir/cobicistat the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose is atazanavir 300 mg/cobicistat 150 mg.

If you take too much atazanavir/cobicistat, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If atazanavir/cobicistat is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store atazanavir/cobicistat at room temperature
• Keep this and all medicines out of the reach of children.