Description
Atazanavir is used together with other medicines for 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
- Powder
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 younger than 3 months of age. Use is not recommended in children 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 kidney, liver, or heart problems, which may require caution in patients receiving atazanavir.
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
- Amiodarone
- Apalutamide
- Bepridil
- Bromocriptine
- Carbamazepine
- Cisapride
- Colchicine
- Crizotinib
- Dihydroergotamine
- Dronedarone
- Drospirenone
- Elbasvir
- Encorafenib
- Enzalutamide
- Ergoloid Mesylates
- Ergonovine
- Ergotamine
- Flibanserin
- Fluconazole
- Fosphenytoin
- Glecaprevir
- Grazoprevir
- Indinavir
- Irinotecan
- Irinotecan Liposome
- Itraconazole
- Ivosidenib
- Ketoconazole
- Lefamulin
- Levoketoconazole
- Lisuride
- Lomitapide
- Lovastatin
- Lumacaftor
- Lurasidone
- Maraviroc
- Mesoridazine
- Metergoline
- Methylergonovine
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.
- Abametapir
- Acalabrutinib
- Adagrasib
- Ado-Trastuzumab Emtansine
- Alfentanil
- Alprazolam
- Aluminum Carbonate, Basic
- Aluminum Hydroxide
- Aluminum Phosphate
- Amineptine
- Amisulpride
- Amitriptyline
- Amitriptylinoxide
- Amlodipine
- Amoxapine
- Amprenavir
- Anagrelide
- Apixaban
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Artemether
- Asenapine
- Astemizole
- Atidarsagene Autotemcel
- Atorvastatin
- Atrasentan
- Avacopan
- Avanafil
- Avapritinib
- Axitinib
- Azithromycin
- Bedaquiline
- Benzhydrocodone
- Betamethasone
- Betrixaban
- Boceprevir
- Bosentan
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
- Dienogest
- Estradiol
- Ethinyl Estradiol
- Ethynodiol
- Etonogestrel
- Gestodene
- Levonorgestrel
- Mestranol
- Norethindrone
- Norgestimate
- Norgestrel
- Telaprevir
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 (bleeding problem) or
- Hyperglycemia (high blood sugar) or
- Kidney disease or
- Liver disease (eg, hepatitis B or C)—Use with caution. May make these conditions worse.
- Heart block or
- Heart conduction problems (eg, prolonged PR interval)—Use with caution. May increase the chance of having side effects.
- Phenylketonuria—The oral powder contains phenylalanine, which can make this condition worse.
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 comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor or pharmacist if you have any questions.
This medicine may be taken in combination with other medicines that are used to treat HIV infection. Take all of the medicines your doctor has prescribed at the right time of day and in the correct order. Do not stop using your medicine unless your doctor tells you to.
This medicine is available in 2 forms. You may use a capsule or an oral powder. Your doctor may adjust your dose if you need to switch from one form to another.
It is important that atazanavir be taken with food.
Swallow the capsule whole. Do not open it.
For patients using the oral powder:
- Determine the number of packets that are needed. Do not open a packet until you are ready to use it.
- Mix the oral powder with food (eg, applesauce or yogurt) or a beverage (milk, infant formula, water). You may mix it in a container or a cup and use an oral dosing syringe or small medicine cup to give it to a child.
- After mixing your medicine with food or liquid, use the mixture right away or within 1 hour. Be sure to drink or swallow all of the mixture.
If you are also using antacids or didanosine (Videx®), take atazanavir 2 hours before or 1 hour after these medicines.
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. For patients who are also taking atazanavir in combination with both H2RA and tenofovir, the dose is usually 400 mg with 100 mg of ritonavir (Norvir®) once a day.
- Pregnant patients—300 mg with 100 mg of ritonavir (Norvir®) once a day. For pregnant patients who are also taking atazanavir in combination with both H2RA or tenofovir, the dose is usually 400 mg with 100 mg of ritonavir (Norvir®) once a day.
- Children 6 to 17 years and weighing 35 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 300 mg with 100 mg of ritonavir (Norvir®) once a day.
- Children 6 to 17 years and weighing 15 to less than 35 kg—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 200 mg with 100 mg of ritonavir (Norvir®) once a day.
- Children 6 to 17 years and weighing less than 15 kg—Use of capsules is not recommended.
- For HIV infection (patient never had HIV treatment):
- Adults—300 milligrams (mg) with 100 mg of ritonavir (Norvir®) once a day. For patients who are unable to tolerate ritonavir, the dose is usually 400 mg (without ritonavir) once day. For patients who are also taking atazanavir in combination with efavirenz, the dose is usually 400 mg with 100 mg of ritonavir (Norvir®) once a day.
- Pregnant patients—300 mg with 100 mg of ritonavir (Norvir®) once a day.
- Children 6 to 17 years and weighing 35 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 300 mg with 100 mg of ritonavir (Norvir®) once a day. For children at least 13 years old and weighing 40 kilograms (kg) who are unable to tolerate ritonavir, the dose is usually 400 mg (without ritonavir) once day.
- Children 6 to 17 years and weighing 15 to less than 35 kg—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 200 mg with 100 mg of ritonavir (Norvir®) once a day.
- Children 6 to 17 years and weighing less than 15 kg—Use of capsules is not recommended.
- For HIV infection (patient already had HIV treatment):
- For oral dosage form (oral powder):
- For HIV infection:
- Children 3 months of age and older and weighing at least 25 kilograms (kg) who are unable to swallow the capsule—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 300 milligrams (mg) (6 packets) with 100 mg of ritonavir (Norvir®) once a day.
- Children 3 months of age and older and weighing 15 to less than 25 kg—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 250 mg (5 packets) with 80 mg of ritonavir (Norvir®) once a day.
- Children 3 months of age and older and weighing 5 to less than 15 kg—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 200 mg (4 packets) with 80 mg of ritonavir (Norvir®) once a day. For children weighing 5 to less than 10 kg and cannot tolerate the 200 mg dose and have not taken an HIV protease inhibitor, they may take 150 mg (3 packets) once a day.
- Children younger than 3 months of age or weighing less than 5 kg—Use is not recommended.
- For HIV infection:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Do not open a packet of oral powder until you are ready to use it. You may keep the powder with food or liquid mixture at room temperature for up to 1 hour.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests are needed to check for unwanted effects.
Do not use this medicine if you are also using alfuzosin (Uroxatral®), amiodarone (Pacerone®) with ritonavir, apalutamide (Erleada®), carbamazepine (Tegretol®), cisapride (Propulsid®), elbasvir/grazoprevir (Zepatier®), encorafenib (Braftovi®), glecaprevir/pibrentasvir (Mavyret®), indinavir (Crixivan®), irinotecan (Camptosar®), ivosidenib (Tibsovo®), lomitapide (Juxtapid®), lovastatin (Altocor®, Mevacor®), lurasidone (Latuda®) with ritonavir, nevirapine (Viramune®), oral midazolam (Versed®), phenobarbital (Solfoton®), phenytoin (Dilantin®), pimozide (Orap®), quinidine (Cardioquin®) with ritonavir, rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®), salmeterol (Advair®, Serevent®), sildenafil (Revatio®), simvastatin (Zocor®), triazolam (Halcion®), or ergot medicines (eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, D.H.E. 45®, Ergomar®, Ergostat®, Ergotrate®, Methergine®, Migranal®, or Wigraine®).
This medicine may cause heart rhythm problems. Tell your doctor right away if you get dizzy or lightheaded, have a fast or irregular heartbeat, or feel like fainting.
Check with your doctor right away if you 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 cause serious kidney problems, including chronic kidney disease. Your doctor may want your urine tested before and during treatment with this medicine. Talk to your doctor if you have concerns.
This medicine may increase your risk of having kidney stones. Check with your doctor right away if you 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 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, a diaphragm, or contraceptive foam or jelly.
Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, including pneumonia or tuberculosis, or may result in a flare-up of a hidden autoimmune disorder (eg, Graves disease, polymyositis, Guillain-Barré syndrome, or autoimmune hepatitis).
Serious skin reactions (eg, Stevens-Johnson syndrome, erythema multiforme, toxic skin eruptions) can occur with this medicine. Check with your doctor right away if you have 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 may cause you to have excess body fat. Tell your doctor if you notice changes in your body shape, including 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.
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.
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 (eg, St. John’s wort) or vitamin supplements.
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
- Bloating
- blood in the urine
- blurred vision
- chest pain, discomfort, or tightness
- chills
- clay-colored stools
- constipation
- dark urine
- decreased appetite
- diarrhea
- dizziness or lightheadedness
- dry mouth
- fainting
- fast heartbeat
- fast, shallow breathing
- fever
- flushed, dry skin
- fruit-like breath odor
- gaseous abdominal or stomach pain
- general feeling of discomfort
- headache
- hives, itching, or skin rash
- increased hunger
- increased thirst
- increased urination
- indigestion
- irregular heartbeat
- loss of appetite
- loss of consciousness
- muscle pain or cramping
- nausea
- pain in the groin or genitals
- pain in the stomach, side, or abdomen, possibly radiating to the back
- recurrent fever
- severe nausea or vomiting
- sharp back pain just below the ribs
- sleepiness
- slow or irregular heartbeat
- stomach discomfort or fullness
- sweating
- swelling
- trouble breathing
- unexplained weight loss
- unpleasant breath odor
- unusual tiredness or weakness
- vomiting
- vomiting of blood
- 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
- Back pain
- cough, increased
- discouragement
- extra body fat
- feeling sad or empty
- irritability
- loss of interest or pleasure
- trouble concentrating
- trouble sleeping
Less common
- Burning, numbness, tingling, or painful sensations
- difficulty with moving
- muscle stiffness
- pain
- pain in the joints
- unsteadiness or awkwardness
- weakness in the arms, hands, legs, or feet
Incidence not known
- Hair loss or thinning of the hair
- 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.
DRG-20062091
