| WHY is this medicine prescribed?
| HOW should this medicine be used?
| Are there OTHER USES for this medicine?
| What SPECIAL DIETARY instructions should I follow?
| What should I do IF I FORGET to take a dose?
| What SIDE EFFECTS can this medicine cause?
| What should I know about STORAGE and DISPOSAL of this medication?
| What should I do in case of OVERDOSE?
| What OTHER INFORMATION should I know?
WHY is this medicine prescribed?
The combination of atazanavir and cobicistat is used along with other medications to treat human immunodeficiency virus (HIV) infection. Atazanavir is in a class of medications called protease inhibitors. It works by decreasing the amount of HIV in the blood. Cobicistat is in a class of medications called CYP3A inhibitors. It helps to increase the amount of atazanavir in the body so that the medication will have a greater effect. Although atazanavir and cobicistat will not cure HIV, these medications may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other life-style changes may decrease the risk of transmitting the HIV virus to other people.
HOW should this medicine be used?
The combination of atazanavir and cobicistat comes as a tablet to take by mouth. It is usually taken with food once a day. Take atazanavir and cobicistat at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take atazanavir and cobicistat exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
The combination of atazanavir and cobicistat helps to control HIV infection, but it does not cure it. Continue to take atazanavir and cobicistat even if you feel well. Do not stop taking atazanavir and cobicistat without talking to your doctor.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking atazanavir and cobicistat,
- tell your doctor and pharmacist if you are allergic to atazanavir and cobicistat, any other medications, or any of the ingredients in atazanavir and cobicistat tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor if you are taking any of following medications or herbal products: alfuzosin (Uroxatral); cisapride (Propulsid) (not available in the US); colchicine (Colcrys, Mitigare); dronedarone (Multaq); ergot alkaloids such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, in Cafergot, in Migergot), or methylergonovine (Methergine); indinavir (Crixivan); irinotecan (Camptosar); lovastatin (Altoprev, in Advicor); lurasidone (Latuda); midazolam by mouth; nevirapine (Viramune), pimozide (Orap); ranolazine (Ranexa); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); sildenafil (only Revatio brand used for lung disease); simvastatin (Zocor, in Simcor, in Vytorin); St. John's wort; and triazolam (Halcion). Your doctor will probably tell you not to take atazanavir and cobicistat if you are taking one or more of these medications.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, herbal products, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: certain antibiotics such as clarithromycin (Biaxin, in Prevpac), erythromycin (E.E.S, Erytab, others), and telithromycin (Ketek); anticoagulants ('blood thinners') such as apixaban (Eliquis), dabigatran (Pradaxa), rivaroxaban (Xarelto), and warfarin (Coumadin, Jantoven); antidepressants ('mood elevators') such as amitriptyline, desipramine (Norpramin), imipramine (Surmontil, Tofranil), nortriptyline (Pamelor), paroxetine (Brisdelle, Paxil, Pexeva), protriptyline (Vivactil), trazodone (Oleptro), and trimipramine (Surmontil); certain antifungals such as itraconazole (Onmel, Sporanox), ketoconazole (Extina, Nizoral, Xolegel), and voriconazole (Vfend); antipsychotics such as perphenazine, risperidone (Risperdal), and thioridazine; beta blockers such as carvedilol (Coreg), metoprolol (Lopressor, Toprol XL, others), and timolol; boceprevir (Victrelis); bosentan (Tracleer); buprenorphine (Buprenex, Butrans, in Bunavail, in Suboxone, in Zubsolv); calcium channel blockers such as amlodipine (Norvasc, in Amturnide, in Tekamlo), diltiazem (Cardizem, Cartia, Dilacor, Tiazac, others), felodipine (Plendil), nifedipine (Adalat, Afeditab, Procardia), and verapamil (Calan, Covera H-S, Verelan, in Tarka); certain cholesterol-lowering medications (statins) such as atorvastatin (Lipitor, in Caduet, in Liptruzet), fluvastatin (Lescol), pravastatin (Pravachol), and rosuvastatin (Crestor); corticosteroids such as dexamethasone; dasatinib (Sprycel); fentanyl (Duragesic, Fentora, Subsys, others); medications for irregular heartbeat such as amiodarone (Cordarone, Nexterone, Pacerone), digoxin (Lanoxin), disopyramide (Norpace), flecainide, lidocaine (Xylocaine, in Octocaine, others), mexiletine, propafenone (Rythmol), and quinidine (in Nuedexta); medications that suppress the immune system such as cyclosporine (Gengraf, Neoral, Sandimmune), everolimus (Afinitor, Zortress), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf); other medications for HIV or AIDS including efavirenz (Sustiva, in Atripla), etravirine (Intelence), maraviroc (Selzentry), ritonavir (Norvir, in Kaletra, in Viekira Pak), saquinavir (Invirase), and tenofovir (Viread, in Atripla, in Complera, in Stribild, in Truvada); paclitaxel (Abraxane, Taxol); certain phosphodiesterase inhibitors (PDE-5 inhibitors) used for erectile dysfunction such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn); methadone (Dolophine, Methadose), naloxone (Evzio, Zubsolv, others); nilotinib (Tasigna); repaglinide (Prandin, in Prandimet); rifabutin (Mycobutin); salmeterol (Serevent, in Advair); sedatives such as buspirone, diazepam (Valium), midazolam by injection, and zolpidem (Ambien, Edluar, Zolpmist, others); simeprevir (Olysio); and telaprevir (no longer available in the U.S); certain seizure medications such as carbamazepine (Carbatrol, Epitol, Tegretol, others), clonazepam (Klonopin), lamotrigine (Lamictal), oxcarbazepine (Oxtellar XR, Trileptal), phenytoin (Dilantin, Phenytek), and phenobarbital; certain inhaled steroids such as budesonide (Rhinocort, in Symbicort) and fluticasone (Flonase, Flovent, in Advair); tramadol (Conzip, Ultram, in Ultracet); vinblastine, and vincristine (Marqibo Kit). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with atazanavir and cobicistat, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
- if you are taking antacids, didanosine delayed-release capsules (Videx EC), or any other buffered medication such as buffered aspirin (Bufferin), take atazanavir and cobicistat with food 2 hours before or 1 hour after you take the medication. Ask your doctor or pharmacist if you are not sure if any of the medications you are taking are buffered.
- tell your doctor if you are taking a medication for indigestion, heartburn, or ulcers such as cimetidine, esomeprazole (Nexium, in Vimovo), famotidine (Pepcid, in Duexis), lansoprazole (Prevacid), nizatidine (Axid), omeprazole (Prilosec, in Zegerid), pantoprazole (Protonix), rabeprazole (AcipHex), or ranitidine (Zantac). Your doctor may tell you not to take the medication or to take a lower dose of the medication. If you are to continue taking the medication, your doctor will tell you how much time you should allow between taking the medication and taking atazanavir and cobicistat.
- tell your doctor if you have or have ever had diabetes or high blood sugar, an irregular heartbeat, hemophilia (a condition in which the blood does not clot normally) or any other bleeding disorder, hepatitis (a viral infection of the liver) or any other liver disease, kidney, or heart disease.
- tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking atazanavir and cobicistat, call your doctor. You should not breast-feed if you are infected with HIV and are taking atazanavir and cobicistat.
- you should know that atazanavir and cobicistat may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, implants, and injections). Talk to your doctor about methods of birth control that will work for you while you are taking atazanavir and cobicistat.
- you should know that you may experience hyperglycemia (increases in your blood sugar) while you are taking this medication, even if you do not already have diabetes. Tell your doctor immediately if you have any of the following symptoms while you are taking atazanavir and cobicistat: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar that is not treated can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include: dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.
- you should know that while you are taking atazanavir and cobicistat your body fat may increase or move to different areas of your body such as the back of your neck and upper shoulders ('buffalo hump'), stomach, and breasts. You may lose fat from your arms, legs, face, and buttocks. Talk to your doctor if you notice any of these changes in your body fat.
- you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body. This may cause you to develop symptoms of those infections. If you have new or worsening symptoms at anytime during your treatment with atazanavir and cobicistat, be sure to tell your doctor.
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
If your next dose is due in 12 hours or more, take the missed dose as soon as you remember it. However, if the next dose will be taken in less than 12 hours, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Atazanavir and cobicistat may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment:
- irregular heartbeat
- feeling faint or lightheadedness
- yellowing of skin or eyes (especially in newborn infants)
- pain in your back, side, or stomach
- pain or burning with urination
- blood in urine
- dark-colored urine
- light-colored bowel movements
If you develop a severe rash with any of the following symptoms, stop taking atazanavir and cobicistat and call your doctor immediately or get emergency medical treatment:
- general ill feeling or 'flu-like' symptoms
- muscle or joint aches
- red or swollen eyes
- blisters or peeling skin
- mouth sores
- swelling of your face
- painful, warm, or red lump under your skin
Atazanavir and cobicistat may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( Web Site) or by phone (1-800-332-1088).
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What should I do in case of OVERDOSE?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- yellowing of skin or eyes
What OTHER INFORMATION should I know?
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to atazanavir and cobicistat.
Keep a supply of atazanavir and cobicistat on hand. Do not wait until you run out of medication to refill your prescription.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: May 15, 2015.
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