Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Reyataz

Descriptions


Atazanavir is used in combination with other medicines, in the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Atazanavir will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease from occurring. Atazanavir will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Capsule

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of atazanavir in children 3 months to less than 6 years of age. However, use is not recommended in infants younger than 3 months of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of atazanavir in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution in patients receiving atazanavir.

Pregnancy

Information about this atazanavir-oral-route
Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Alfuzosin
  • Amifampridine
  • Cisapride
  • Colchicine
  • Crizotinib
  • Dabrafenib
  • Dihydroergotamine
  • Dronedarone
  • Ergoloid Mesylates
  • Ergonovine
  • Ergotamine
  • Fentanyl
  • Ibrutinib
  • Irinotecan
  • Ivabradine
  • Lomitapide
  • Lovastatin
  • Lurasidone
  • Maraviroc
  • Methylergonovine
  • Methysergide
  • Midazolam
  • Pazopanib
  • Pimozide
  • Piperaquine
  • Posaconazole
  • Quetiapine
  • Ranolazine
  • Rifampin
  • Romidepsin
  • Sildenafil
  • Silodosin
  • Simvastatin
  • St John's Wort
  • Tolvaptan
  • Trabectedin
  • Triazolam
  • Vemurafenib
  • Vinflunine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Ado-Trastuzumab Emtansine
  • Amiodarone
  • Amitriptyline
  • Amlodipine
  • Artemether
  • Atorvastatin
  • Avanafil
  • Axitinib
  • Bedaquiline
  • Boceprevir
  • Bosentan
  • Bosutinib
  • Brentuximab Vedotin
  • Buprenorphine
  • Cabazitaxel
  • Cabozantinib
  • Carbamazepine
  • Cimetidine
  • Clarithromycin
  • Clomipramine
  • Clozapine
  • Cyclophosphamide
  • Dasatinib
  • Dexlansoprazole
  • Diltiazem
  • Disopyramide
  • Docetaxel
  • Domperidone
  • Enzalutamide
  • Eslicarbazepine Acetate
  • Esomeprazole
  • Etravirine
  • Everolimus
  • Famotidine
  • Felodipine
  • Fluoxetine
  • Fluticasone
  • Fosamprenavir
  • Fosphenytoin
  • Garlic
  • Iloperidone
  • Imipramine
  • Indinavir
  • Ixabepilone
  • Lansoprazole
  • Lapatinib
  • Levomilnacipran
  • Lidocaine
  • Lofepramine
  • Lumefantrine
  • Macitentan
  • Minocycline
  • Nevirapine
  • Nicardipine
  • Nifedipine
  • Nilotinib
  • Nizatidine
  • Omeprazole
  • Ondansetron
  • Oxycodone
  • Pantoprazole
  • Phenobarbital
  • Phenytoin
  • Piperaquine
  • Pomalidomide
  • Ponatinib
  • Quinidine
  • Rabeprazole
  • Ranitidine
  • Regorafenib
  • Retapamulin
  • Rifabutin
  • Rifapentine
  • Rosuvastatin
  • Salmeterol
  • Saquinavir
  • Simeprevir
  • Sunitinib
  • Tacrolimus
  • Tadalafil
  • Tamsulosin
  • Temsirolimus
  • Tenofovir Disoproxil Fumarate
  • Ticagrelor
  • Tipranavir
  • Toremifene
  • Trimipramine
  • Venlafaxine
  • Verapamil
  • Vilanterol
  • Vincristine
  • Vincristine Sulfate Liposome

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Cobicistat
  • Dapsone
  • Desogestrel
  • Didanosine
  • Dienogest
  • Drospirenone
  • Efavirenz
  • Estradiol Cypionate
  • Estradiol Valerate
  • Ethinyl Estradiol
  • Ethynodiol Diacetate
  • Etonogestrel
  • Levonorgestrel
  • Lopinavir
  • Medroxyprogesterone Acetate
  • Mestranol
  • Methadone
  • Norelgestromin
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Pitavastatin
  • Telaprevir
  • Trazodone

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Diabetes or
  • Gallbladder problems or
  • Hemophilia (a bleeding problem) or
  • Hyperglycemia (high blood sugar) or
  • Kidney disease or
  • Liver disease (e.g., hepatitis B or C)—Use with caution. May make these conditions worse.
  • Heart block or
  • Heart conduction problems (e.g., prolonged PR interval)—May change the way your heart beats and increase your chance of getting side effects.
  • Kidney disease, severe or
  • Liver disease, severe—Should not be used in patients with these conditions.

Proper Use

Take this medicine exactly as directed by your doctor. Do not change the dose or stop using this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

This medicine may be taken in combination with other medicines that are used to treat HIV infection. Check with your doctor for information and dose amounts.

It is important that atazanavir be taken with food.

Swallow the capsule whole. Do not open it.

If you are also using antacids or didanosine (Videx®), take atazanavir 2 hours before or 1 hour after taking these medicines.

This medicine comes with a patient information leaflet. Read and follow this carefully. Ask your doctor if you have any questions.

If you miss a dose or forget to use your medicine, use it as soon as you can. If your next regular dose is less than 6 hours away, wait until then to use the medicine and skip the missed dose.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules):
    • For HIV infection (patient already had HIV treatment):
      • Adults—300 milligrams (mg) with 100 mg of ritonavir (Norvir®) once a day.
      • Children 6 to 17 years of age—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 150 to 300 mg with 100 mg of ritonavir (Norvir®) once a day.
      • Children 3 months to less than 6 years of age—Use and dose must be determined by your doctor.
      • Infants younger than 3 months of age—Use is not recommended.
    • For HIV infection (patient never had HIV treatment):
      • Adults—300 milligrams (mg) with 100 mg of ritonavir (Norvir®) once a day.
      • Children 6 to 17 years of age—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 150 to 300 mg with 100 mg of ritonavir (Norvir®) once a day.
      • Children 3 months to less than 6 years of age—Use and dose must be determined by your doctor.
      • Infants younger than 3 months of age—Use is not recommended.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Do not throw any unused medicine in the trash. Flush it down the toilet or take it to a community take-back program when available.

Precautions

It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not use this medicine if you are also using alfuzosin (Uroxatral®), cisapride (Propulsid®), indinavir (Crixivan®), irinotecan (Camptosar®), lovastatin (Altocor®, Mevacor®), nevirapine (Viramune®), oral midazolam (Versed®), pimozide (Orap®), rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®), salmeterol (Advair®, Serevent®), sildenafil (Revatio®), simvastatin (Zocor®), triazolam (Halcion®), or ergot medicines (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, D.H.E. 45®, Ergomar®, Ergostat®, Ergotrate®, Methergine®, Migranal®, or Wigraine®).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter [OTC]) medicines, and herbal (e.g., St. John’s wort) or vitamin supplements.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may increase your risk of having kidney stones. Check with your doctor right away and stop using this medicine if you or your child have blood in your urine, nausea and vomiting, pain in the groin or genitals, or sharp back pain just below the ribs.

This medicine may increase blood sugar levels. Check with your doctor if you or your child notice a change in the results of your blood or urine sugar tests.

Birth control pills may not work as well while you are using atazanavir. To keep from getting pregnant, use an additional form of birth control along with your pills. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.

When you start taking HIV medicines, your immune system may get stronger. If you have certain infections, such as pneumonia or tuberculosis, you or your child may notice new symptoms when your body tries to fight them. If this occurs, be sure to tell your doctor.

Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you or your child have any of the following symptoms while using this medicine: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; itching; joint or muscle pain; red skin lesions, often with a purple center; skin rash; sore throat; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.

Tell the doctor in charge that you or your child are using this medicine before you have any medical tests. The results of some tests may be affected by this medicine.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

  1. Abdominal or stomach discomfort, fullness, or pain
  2. bloating
  3. blood in the urine
  4. blurred vision
  5. chest pain or discomfort
  6. chills
  7. clay-colored stools
  8. constipation
  9. dark colored urine
  10. decreased appetite
  11. diarrhea
  12. dizziness or lightheadedness
  13. dry mouth
  14. fainting
  15. fast heartbeat
  16. fast, shallow breathing
  17. fever
  18. flushed, dry skin
  19. fruit-like breath odor
  20. gaseous abdominal or stomach pain
  21. general feeling of discomfort
  22. headache
  23. hives
  24. increased hunger
  25. increased thirst
  26. increased urination
  27. indigestion
  28. irregular heartbeat
  29. itching
  30. loss of appetite
  31. loss of consciousness
  32. muscle pain or cramping
  33. nausea
  34. pain in the groin or genitals
  35. pain in the stomach, side, or abdomen, possibly radiating to the back
  36. recurrent fever
  37. severe nausea or vomiting
  38. sharp back pain just below the ribs
  39. shortness of breath
  40. skin rash
  41. sleepiness
  42. slow or irregular heartbeat
  43. stomachache
  44. sweating
  45. swelling
  46. tightness in the chest
  47. trouble with breathing
  48. unexplained weight loss
  49. unpleasant breath odor
  50. unusual tiredness or weakness
  51. vomiting
  52. vomiting of blood
  53. wheezing
  54. yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Back pain
  2. cough, increased
  3. discouragement
  4. extra body fat
  5. feeling sad or empty
  6. irritability
  7. loss of interest or pleasure
  8. trouble concentrating
  9. trouble sleeping

Less common

  1. Burning, numbness, tingling, or painful sensations
  2. difficulty with moving
  3. muscle stiffness
  4. pain
  5. pain in the joints
  6. sleeplessness
  7. unable to sleep
  8. unsteadiness or awkwardness
  9. weakness in the arms, hands, legs, or feet

Incidence not known

  1. Hair loss or thinning of the hair
  2. rash with flat lesions or small raised lesions on the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.