Atazanavir

Atazanavir is a prescription medication used in combination with other medications to treat human immunodeficiency virus (HIV) infection. Atazanavir belongs to a group of medications called protease inhibitors which work by stopping the virus from replicating.

This medication comes in capsule form and is taken once daily, with food.

Atazanavir is also available as an oral powder and is taken with food or liquid.

Common side effects of atazanavir include nausea, stomach pain, and headaches.

Atazanavir is a prescription medicine used with other anti-HIV medicines to treat people 6 years of age and older who are infected with the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

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

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

• Reyataz

The following side effects have been reported with atazanavir:

• nausea
• yellowing of the skin or eyes
• rash
• headache
• stomach pain
• vomiting
• insomnia
• numbness
• tingling, or burning of hands or feet
• dizziness
• myalgia
• diarrhea
• depression
• fever
• muscle pain

This is not a complete list of atazanavir side effects. Ask your doctor or pharmacist for more information.

Do not take atazanavir if you take the following medicines (not all brands may be listed; tell your healthcare provider about all the medicines you take). Atazanavir may cause serious, life-threatening side effects or death when used with these medicines.

• Ergot medicines: dihydroergotamine, ergonovine, ergotamine, and methylergonovine such as Cafergot, Migranal, D.H.E. 45, ergotrate maleate, Methergine, and others (used for migraine headaches)
• Orap (pimozide, used for Tourette’s disorder)
• Propulsid (cisapride, used for certain stomach problems)
• Triazolam, also known as Halcion (used for insomnia)
• Midazolam, also known as Versed (used for sedation), when taken by mouth

Do not take the following medicines with atazanavir because of possible serious side effects:

• Camptosar (irinotecan, used for cancer)
• Crixivan (indinavir, used for HIV infection). Both atazanavir and Crixivan sometimes cause increased levels of bilirubin in the blood
• Cholesterol-lowering medicines Mevacor (lovastatin) or Zocor (simvastatin)
• Uroxatral (alfuzosin, used to treat benign enlargement of the prostate)
• Revatio (sildenafil, used to treat pulmonary arterial hypertension)

Do not take the following medicines with atazanavir because they may lower the amount of atazanavir in your blood. This may lead to an increased HIV viral load. Resistance to atazanavir or cross-resistance to other HIV medicines may develop:

• Rifampin (also known as Rimactane, Rifadin, Rifater, or Rifamate, used for tuberculosis)
• St. John’s wort (Hypericum perforatum), an herbal product sold as a dietary supplement, or products containing St. John’s wort
• Viramune (nevirapine, used for HIV infection)
• Nevirapine

The following medicines are not recommended with atazanavir:

• Serevent Diskus (salmeterol) and Advair (salmeterol with fluticasone), used to treat asthma, emphysema/chronic obstructive pulmonary disease also known as COPD

Do not take the following medicine if you are taking atazanavir and Norvir together:

• Vfend (voriconazole)

The following medicines may require your healthcare provider to monitor your therapy more closely (for some medicines a change in the dose or dose schedule may be needed):

• Cialis (tadalafil), Levitra (vardenafil), or Viagra (sildenafil), used to treat erectile dysfunction. Atazanavir may increase the chances of serious side effects that can happen with Cialis, Levitra, or Viagra. Do not use Cialis, Levitra, or Viagra while you are taking atazanavir unless your healthcare provider tells you it is okay.
• Adcirca (tadalafil) or Tracleer (bosentan), used to treat pulmonary arterial hypertension
• Lipitor (atorvastatin) or Crestor (rosuvastatin). There is an increased chance of serious side effects if you take atazanavir with this cholesterol-lowering medicine.
• Medicines for abnormal heart rhythm: Cordarone (amiodarone), lidocaine, quinidine (also known as Cardioquin, Quinidex, and others)
• Mycobutin (rifabutin, an antibiotic used to treat tuberculosis)
• Buprenex, Subutex, Suboxone (buprenorphine or buprenorphine/naloxone, used to treat pain and addiction to narcotic painkillers)
• Vascor (bepridil, used for chest pain).
• Coumadin (warfarin)
• Tricyclic antidepressants such as Elavil (amitriptyline), Norpramin (desipramine), Sinequan (doxepin), Surmontil (trimipramine), Tofranil (imipramine), or Vivactil (protriptyline)
• Medicines to prevent organ transplant rejection: Sandimmune or Neoral (cyclosporin), Rapamune (sirolimus), or Prograf (tacrolimus)
• The antidepressant trazodone ( Desyrel and others)
• Fluticasone propionate (Flonase, Flovent), given by nose or inhaled to treat allergic symptoms or asthma. Your doctor may choose not to keep you on fluticasone, especially if you are also taking Norvir.
• Colchicine (Colcrys), used to prevent or treat gout or treat familial Mediterranean fever

The following medicines may require a change in the dose or dose schedule of either atazanavir or the other medicine:

• Invirase (saquinavir)
• Norvir (ritonavir)
• Sustiva (efavirenz)
• Antacids or buffered medicines
• Videx (didanosine)
• Viread (tenofovir disoproxil fumarate)
• Mycobutin (rifabutin)
• Calcium channel blockers such as Cardizem or Tiazac (diltiazem),  Covera-HS or Isoptin SR (verapamil) and others
• BIAXIN (clarithromycin)
• Medicines for indigestion, heartburn, or ulcers such as Axid (nizatidine), Pepcid AC (famotidine), Tagamet (cimetidine), or Zantac (ranitidine)

• Angioedema (a severe allergic reaction) may occur. Tell your healthcare provider right away if you have signs or symptoms of angioedema, which include the following:
  • swelling of face, eyes, lips, tongue, larynx and extremities
  • difficulty in swallowing or breathing
  • hoarseness (having difficulty making sounds when trying to speak)
  • Severe rash: Rash may develop in association with other symptoms which could be serious and potentially cause death.
 If you develop a rash with any of the following symptoms stop using atazanavir and call your healthcare provider right away:
    • shortness of breath
    • general ill feeling or "flu-like" symptoms
    • fever
    • muscle or joint aches
    • conjunctivitis (red or inflamed eyes, like "pink eye")
    • blisters
    • mouth sores
    • swelling of your face
• A change in the way your heart beats (heart rhythm change) may occur. Call your healthcare provider right away if you get dizzy or lightheaded. These could be symptoms of a heart problem.
• Diabetes and high blood sugar (hyperglycemia) sometimes happen in patients taking protease inhibitor medicines like atazanavir. Some patients had diabetes before taking protease inhibitors while others did not. Some patients may need changes in their diabetes medicine. If you have liver disease including hepatitis B or C, your liver disease may get worse when you take anti-HIV medicines like atazanavir.
• Kidney stones have been reported in patients taking atazanavir. If you develop signs or symptoms of kidney stones (pain in your side, blood in your urine, pain when you urinate) tell your healthcare provider promptly.
• Some patients with hemophilia have increased bleeding problems with protease inhibitors like atazanavir.
• Changes in body fat. These changes may include an increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the trunk. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these conditions are not known at this time.
• Immune reconstitution syndrome. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment, including atazanavir, is started.
• Gallbladder disorders (which may include gallstones and gallbladder inflammation) have been reported in patients taking atazanavir.
• Changes in amylase and lipase.
• Decrease in neutrophils.
• Increase in bilirubin.

Do not take atazanavir if you:

• are taking certain medicines (see Drug Interactions). Serious life-threatening side effects or death may happen. Before you take atazanavir, tell your healthcare provider about all medicines you are taking or planning to take. These include other prescription and nonprescription medicines, vitamins, and herbal supplements.
• are allergic to atazanavir or to any of its ingredients. The active ingredient is atazanavir sulfate. Tell your healthcare provider if you think you have had an allergic reaction to any of these ingredients.
• if you have phenylketonuria. Phenylalanine can be harmful to patients with phenylketonuria (PKU). Atazanavir oral powder contains phenylalanine (a component of aspartame).

Do not give atazanavir to:

• pediatric patients below the age of 3 months. Atazanavir is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus (a bilirubin-induced brain dysfunction).

Grapefruit and grapefruit juice may interact with atazanavir and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Tell your healthcare provider:

• If you are pregnant or plan to become pregnant. Atazanavir use during pregnancy has not been associated with an increase in birth defects. Pregnant women have experienced serious side effects when taking atazanavir with other HIV medicines called nucleoside analogues. You and your healthcare provider will need to decide if atazanavir is right for you. If you use atazanavir while you are pregnant, talk to your healthcare provider about the Antiretroviral Pregnancy Registry.
• After your baby is born, tell your healthcare provider if your baby's skin or the white part of his/her eyes turns yellow.
• If you are breastfeeding. You should not breastfeed if you are HIV-positive because of the chance of passing HIV to your baby. Also, it is not known if atazanavir can pass into your breast milk and if it can harm your baby. If you are a woman who has or will have a baby, talk with your healthcare provider about the best way to feed your baby.
• If you have liver problems or are infected with the hepatitis B or C virus.
• If you have end stage kidney disease managed with hemodialysis.
• If you have diabetes.
• If you have hemophilia.
• About all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Keep a list of your medicines with you to show your healthcare provider. For more information, Some medicines can cause serious side effects if taken with atazanavir.

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if atazanavir will harm your unborn baby.

Atazanavir is not recommended for treatment-experienced pregnant patients during the second and third trimester taking atazanavir with both tenofovir and H2-receptor antagonists (H2RA).

Tell your healthcare provider if you are breastfeeding. You should not breastfeed if you are HIV-positive because of the chance of passing HIV to your baby. Also, it is not known if atazanavir can pass into your breast milk and if it can harm your baby. If you are a woman who has or will have a baby, talk with your healthcare provider about the best way to feed your baby.

• Take atazanavir once every day exactly as instructed by your healthcare provider. 
Your healthcare provider will prescribe the amount of atazanavir that is right for you.
• Take atazanavir at the same time each day.
• If you are taking antacids or didanosine (Videx or Videx EC), take atazanavir 2 hours before or 1 hour after these medicines.
• If you are taking medicines for indigestion, heartburn, or ulcers such as Axid (nizatidine), Pepcid AC (famotidine), Tagamet  (cimetidine), Zantac (ranitidine), AcipHex (rabeprazole), Nexium (esomeprazole), Prevacid (lansoprazole), Prilosec (omeprazole), or Protonix (pantoprazole), talk to your healthcare provider.
• Do not change your dose or stop taking atazanavir without first talking with your healthcare provider. It is important to stay under a healthcare provider's care while taking atazanavir.
• When your supply of atazanavir starts to run low, get more from your healthcare provider or pharmacy. It is important not to run out of atazanavir. The amount of HIV in your blood may increase if the medicine is stopped for even a short time.
• If you miss a dose of atazanavir, take it as soon as possible and then take your next scheduled dose at its regular time. If, however, it is within 6 hours of your next dose, do not take the missed dose. Wait and take the next dose at the regular time. Do not double the next dose. It is important that you do not miss any doses of atazanavir or your other anti-HIV medicines.
• If you take more than the prescribed dose of atazanavir, call your healthcare provider or poison control center right away.

Capsules:

• Always take atazanavir with food (a meal or snack) to help it work better. Swallow the capsules whole. Do not open the capsules.

Oral powder:

• It is preferable to mix atazanavir oral powder with food such as applesauce or yogurt. Mixing atazanavir oral powder with a beverage (milk, infant formula, or water) may be used for infants who can drink from a cup. For young infants (less than 6 months) who cannot eat solid food or drink from a cup, atazanavir oral powder should be mixed with infant formula and given using an oral dosing syringe. Administration of atazanavir and infant formula using an infant bottle is not recommended because full dose may not be delivered.
• Determine the number of packets (4 or 5 packets) that are needed.
• Prior to mixing, tap the packet to settle the powder. Use a clean pair of scissors to cut each packet along the dotted line.

Mixing with food: Using a spoon, mix the recommended number of atazanavir oral powder packets with a minimum of one tablespoon of food (such as applesauce or yogurt). Feed the mixture to the infant or young child. Add an additional one tablespoon of food to the small container, mix, and feed the child the residual mixture.

Mixing with a beverage such as milk or water in a small drinking cup: Using a spoon, mix the recommended number of atazanavir oral powder packets with a minimum of 30 mL of the beverage. Have the child drink the mixture. Add an additional 15 mL more of beverage to the drinking cup, mix, and have the child drink the residual mixture. If water is used, food should also be taken at the same time.

Mixing with liquid infant formula using an oral dosing syringe and a small medicine cup: Using a spoon, mix the recommended number of atazanavir oral powder packets with 10 mL of prepared liquid infant formula. Draw up the full amount of the mixture into an oral syringe and administer into either right or left inner cheek of infant. Pour another 10 mL of formula into the medicine cup to rinse off remaining atazanavir oral powder in cup. Draw up residual mixture into the syringe and administer into either right or left inner cheek of infant.

• Administer ritonavir immediately following atazanavir powder administration.

• Administer the entire dosage of atazanavir oral powder (mixed in the food or beverage) within one hour of preparation (may leave the mixture at room temperature during this one hour period). Ensure that the patient eats or drinks all the food or beverage that contains the powder. Additional food may be given after consumption of the entire mixture.

Take atazanavir exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you. The dosage of atazanavir must be individualized.

The recommended oral dosage of atazanavir depends on the treatment history of the patient and the use of other coadministered drugs. When coadministered with H2-receptor antagonists or proton-pump inhibitors, dose separation may be required.

When coadministered with didanosine buffered or enteric-coated formulations, atazanavir should be given (with food) 2 hours before or 1 hour after didanosine.

Adults: the recommended daily dose range is 300 mg to 400 mg.

Patients with end stage renal disease may require a lower dose of atazanavir.

Children (patients 6 to less than 18 years of age): The recommended daily dose range is 150 mg to 400 mg.

Recommended Dosage of atazanavir Oral Powder in pediatric patients (at least 3 months of age and weighing at least 10 kg and less than 25 kg) is:

• 10 kg to less than 15 kg= 200 mg (4 packets)
• 15 kg to less than 25 kg= 250 mg (5 packets)
  • Each packet contains 50 mg of atazanavir

If you take more than the prescribed dose of atazanavir, call your healthcare provider or your local Poison Control Center right away.

• Store atazanavir capsules at room temperature, 59° to 86° F (15° to 30° C). Do not store this medicine in a damp place such as a bathroom medicine cabinet or near the kitchen sink.
• Keep your medicine in a tightly closed container.
• Keep all medicines out of the reach of children and pets at all times. Do not keep medicine that is out of date or that you no longer need. Dispose of unused medicines through community take-back disposal programs when available or place atazanavir in an unrecognizable, closed container in the household trash.