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Atazanavir and Cobicistat

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Why is this medication prescribed?

Human immunodeficiency virus (HIV) infection is treated with atazanavir and cobicistat in conjunction with other drugs in adults and children who weigh at least 77 lb (35 kg). A group of drugs known as protease inhibitors includes atazanavir. It functions by lowering the blood’s HIV concentration. A group of drugs known as pharmacokinetic boosters includes cobicistat. It functions by boosting the body’s concentration of atazanavir so that it can have a stronger impact. Even while atazanavir does not treat HIV, it may lower your risk of getting AIDS and other HIV-related conditions such serious infections or cancer. The risk of spreading the HIV virus to others may be reduced by taking these medications, engaging in safer sexual behaviour, and changing other aspects of one’s lifestyle.

How should this medicine be used?

Cobicistat and atazanavir are available as oral tablets. It is typically taken once daily with food. Take cobicistat and atazanavir at roughly the same time each day. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Take cobicistat and atazanavir exactly as prescribed. Never take it in larger or less amounts or more frequently than directed by your doctor.

Do not chew, break, or crush the tablets; instead, swallow them whole.

While controlling HIV, atazanavir and cobicistat do not treat it. It is always necessary to administer atazanavir and cobicistat as a part of a comprehensive regimen in order to treat HIV infection. It is crucial to take all of the drugs your doctor has given for treating your HIV infection at the same time in order for the drugs to continue to manage the virus. Even if you feel well, keep taking atazanavir and cobicistat. Without consulting your doctor, do not discontinue taking cobicistat and atazanavir.

Request a copy of the patient’s information from the manufacturer from your pharmacist or physician. If you have any questions, carefully read this information, then consult your physician or pharmacist.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking atazanavir and cobicistat,

  • If you have any allergies, including to atazanavir, cobicistat, other medicines, or any of the substances in atazanavir and cobicistat tablets, inform your doctor right away. Request a list of the components from your pharmacist.
  • If you are using any of the following drugs or natural remedies, let your doctor know: ergot alkaloids like dihydroergotamine (D.H.E. 45, Migranal), ergonovine, ergotamine (Ergomar, in Cafergot, in Migergot), or methylergonovine (Methergine); alfuzosin (Uroxatral); some antiviral medications used to treat hepatitis C such as elbasvir and grazoprevir (Zepatier) and glecaprevir; irinotecan (Camptosar), lurasidone (Latuda), midazolam taken orally, pimozide (Orap), ranolazine (Ranexa), and rifampin (Rimactane, Rifadin, in Rifater, in Rifamate); some drugs used to treat high cholesterol; certain drugs used to treat HIV infection; and some drugs used to treat high cholesterol. Carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Tegretol XR), phenobarbital, and phenytoin (Dilantin, Phenytek), as well as sildenafil (only the Revatio brand is used to treat lung illness), St. John’s wort, and triazolam are some drugs used to treat seizures (Halcion). If you are taking any of these drugs, your doctor probably won’t let you take atazanavir.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, herbal remedies, and dietary supplements you are now taking or intend to use. Incorporate any of the following: specific antibiotics, including erythromycin and clarithromycin (Biaxin), and specific anticoagulants (‘blood thinners’), including apixaban (Eliquis), betrixaban (Bevyxxa), dabigatran (Pradaxa), edoxaban (Savaysa), rivaroxaban (Xarelto), and warfarin (Coumadin, Jantoven); anticancer medications such as dasatinib (Sprycel), nilotinib (Tasigna), vinblastine, and vincristine; antidepressants (‘mood elevators’) a few antifungal drugs, including itraconazole (Onmel, Sporanox), ketoconazole (Extina, Nizoral, Xolegel), and voriconazole (Vfend); a few medicines used to treat arrhythmias, including amiodarone (Cordarone), disopyramide (Norpace, Norpace CR), flecainide (Tambocor), lidocaine, mexiletine; bosentan (Tracleer); calcium channel blockers such diltiazem (Cardizem, Cartia, Tiazac, others), felodipine (Plendil), nicardipine (Cardene), nifedipine (Adalat, Afeditab, Procardia), and verapamil (Calan, Verelan, in Tarka, etc.); beta blockers like labetalol (Trandate), a few cholesterol-lowering drugs (statins), including atorvastatin (Lipitor, in Caduet), fluvastatin (Lescol, Lescol XL), pravastatin (Pravachol), and rosuvastatin (Crestor); corticosteroids, including budesonide (Entocort EC), ciclesonide (Alevsco), dexamethasone, fluticasone (Flovent,  Flonase, in Advair, Breo Ellipta, Trelegy Ellipta); digoxin (Lanoxin); immunosuppressive drugs like cyclosporine (Gengraf, Neoral, Sandimmune), everolimus (Afinitor, Zortress), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf);Other drugs for treating HIV infection include efavirenz (Sustiva, in Atripla), etravirine (Intelence), maraviroc (Selzentry), ritonavir (Norvir, in Kaletra, in Viekira Pak), saquinavir (Invirase), and tenofovir (Viread, in Atripla, in Stribild, in Truvada, among others); some drugs for treating pain (Actiq, Duragesic, Lazanda, Subsys),  avanafil (Stendra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn) are examples of phosphodiesterase inhibitors (PDE-5 inhibitors) used to treat erectile dysfunction. Other examples include quetiapine (Seroquel), methadone (Dolophine, Methadone), and tramadol (Conzip, Qdolo, Rybix ODT, Ryzolt, Ultram, Ultram ER, in Ultracet); rifabutin (Mycobutin), risperidone (Risperdal), salmeterol (Serevent, in Advair), a number of sedatives including buspirone (Buspar), diazepam (Valium), flurazepam (Dalmane), and zolpidem (Ambien), a number of seizure medications including eslicarbazepine (Aptiom), and voxilaprevir, velpatasvir, and sofosbuvir (Sovaldi, Epclusa, Vosevi). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects. Tell your doctor about all of the medications you are taking, even any not on this list, since many other drugs may also interact with atazanavir.
  • If you take antacids or any other drug that contains a buffer, such as buffered aspirin (Bufferin), take atazanavir and cobicistat two hours before or two hours after the medication. Atazanavir and cobicistat should be taken two hours before or one hour after taking didanosine delayed-release capsules (Videx EC). If you’re unsure whether any of the drugs you’re taking are buffered, see your doctor or pharmacist.
  • Inform your doctor if you are taking any antacids, heartburn treatments, or ulcer medications, including cimetidine, esomeprazole (Nexium, in Vimovo), famotidine (Pepcid, in Duexis), lansoprazole (Prevacid, in Prevpac), nizatidine (Axid), omeprazole (Prilosec, in Zegerid), pantoprazole (Proton (Zantac). You could be advised by your doctor to stop taking the drug or to take it in smaller doses. Your doctor will advise you on how long you should wait before taking atazanavir and cobicistat if you decide to keep taking the medication.
  • Inform your doctor if you have or have ever had an irregular heartbeat, diabetes or excessive blood sugar, haemophilia or any other bleeding disorder, hepatitis (a viral infection of the liver), renal disease, or any other liver or heart disease.
    Inform your doctor if you are expecting a child or if you intend to do so. Call your doctor if you become pregnant while taking atazanavir and cobicistat. If you are HIV-positive and using cobicistat with atazanavir, you shouldn’t breastfeed.
  • Inform your doctor if you now or previously had any of the following conditions: irregular heartbeat, diabetes, high blood sugar, haemophilia (a condition in which blood does not clot normally), kidney disease, heart disease, hepatitis (a viral infection of the liver), or any other liver illness.
    If you are pregnant or plan to become pregnant, let your doctor know. Call your doctor if you become pregnant while taking cobicistat and atazanavir. If you have HIV and are on atazanavir and cobicistat, you shouldn’t breastfeed.
  • Atazanavir and Cobicistat may reduce the efficacy of hormonal contraceptives, so you should be aware of this (birth control pills, patches, rings, implants, and injections). Discuss birth control options with your doctor to ensure that they will be effective for you while you are on cobicistat and atazanavir.
  • Inform the surgeon or dentist that you are taking atazanavir and cobicistat if you are having surgery, including dental surgery.
  • You should be aware that even if you do not currently have diabetes, you could develop hyperglycemia (increases in blood sugar) while taking this drug. If you have any of the following side effects while taking atazanavir with cobicistat: severe thirst, frequent urination, intense hunger, blurred vision, or weakness, call your doctor right away. Calling your doctor as soon as you experience any of these symptoms is crucial because untreated high blood sugar can result in the deadly disease known as ketoacidosis. If ketoacidosis is not treated right away, it could become life-threatening. Dry mouth, nausea, vomiting, shortness of breath, fruity-smelling breath, and diminished consciousness are all signs of ketoacidosis.
  • You should be aware that when you take HIV medicine, your immune system could become stronger and start to fight other infections that were already present in your body. You might begin to exhibit signs of those infections as a result of this. Tell your doctor right away if you experience any new or worsening symptoms while taking atazanavir and cobicistat.
  • You should be aware that your body fat can change or accumulate in several places, including your breasts, upper back, neck, chest, and abdomen. It is also possible to lose fat from the face, arms, and legs.

What special dietary instructions should I follow?

If you plan to consume grapefruits or grapefruit juice while taking this medication, consult your doctor.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Cobicistat with atazanavir may have negative side effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Eyes or skin that have a yellow tint
  • Rash
  • Nausea
  • Diarrhea
  • Headache

Some adverse effects can be very harmful. Get emergency medical care if you encounter any of the following symptoms, or call your doctor right away:

  • Unsteady heartbeat
  • Dizziness
  • Experiencing dizziness or faintness
  • Vision alterations
  • Yellowing of the eyes or skin (especially in newborn infants)
  • Aches in the low back or abdomen
  • Difficulty urinating
  • Urinary blood
  • Vomiting
  • Reduced appetite
  • Less urinations
  • Urine with a dark colour
  • Colored-light bowel motions

Stop taking atazanavir and cobicistat and seek emergency medical attention if you have any of the following symptoms in addition to a severe rash:

  • Widespread malaise or symptoms resembling the flu
  • Fever
  • Aching muscle or joint
  • Eye swelling or redness
  • Flaking or blistering skin
  • Oral sores
  • Your face or neck swelling
  • Sore, warm, or colourful bump on your body

Cobicistat with atazanavir may also have other adverse effects. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Store it away from excessive heat and moisture at room temperature (not in the bathroom).

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

In case of emergency/overdose

Call 1-800-222-1222 to reach the poison control hotline in the event of an overdose. You can get information online at https://www.poisonhelp.org/help. Call emergency services at 911 right away if the sufferer has fallen, experienced a seizure, is having problems breathing, or cannot be roused.

Overdose symptoms could include:

  • Skin or eye yellowing
  • Altered heart rhythm, or irregular heartbeat

What other information should I know?

Keep all of your appointments with your physician and the lab. To determine how well atazanavir and cobicistat are working in your body, your doctor may or may not prescribe certain lab tests.

Atazanavir and cobicistat should be kept on hand. Do not put off getting a refill on your prescription until you are out of medicine.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Evotaz®
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