Reyataz

Name: Reyataz

Notes

Do not share this medication with others.Laboratory and/or medical tests (such as viral load, T-cell counts, liver tests, cholesterol/triglyceride levels, blood sugar levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Patient Handout

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Reyataz Interactions

Do not take Reyataz if you take the following medicines (not all brands may be listed; tell your healthcare provider about all the medicines you take). Reyataz 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 Reyataz because of possible serious side effects:

  • Camptosar (irinotecan, used for cancer)
  • Crixivan (indinavir, used for HIV infection). Both Reyataz 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 Reyataz because they may lower the amount of Reyataz in your blood. This may lead to an increased HIV viral load. Resistance to Reyataz 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 Reyataz:

  • 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 Reyataz 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. Reyataz 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 Reyataz 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 Reyataz 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 Reyataz 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)

Reyataz Precautions

  • Angioedema (a severe allergic reaction) may occur. Tell your healthcare provider right away if you have signs or symptoms of Reyataz, 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 Reyataz 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 Reyataz. 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 Reyataz.
  • Kidney stones have been reported in patients taking Reyataz. 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 Reyataz.
  • 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 Reyataz, is started.
  • Gallbladder disorders (which may include gallstones and gallbladder inflammation) have been reported in patients taking Reyataz.
  • Changes in amylase and lipase.
  • Decrease in neutrophils.
  • Increase in bilirubin.

Do not take Reyataz if you:

  • are taking certain medicines (see Drug Interactions). Serious life-threatening side effects or death may happen. Before you take Reyataz, 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 Reyataz or to any of its ingredients. The active ingredient is Reyataz. 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). Reyataz oral powder contains phenylalanine (a component of aspartame).

Do not give Reyataz to:

  • pediatric patients below the age of 3 months. Reyataz 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).

Reyataz Usage

  • Take Reyataz once every day exactly as instructed by your healthcare provider. 
Your healthcare provider will prescribe the amount of Reyataz that is right for you.
  • Take Reyataz at the same time each day.
  • If you are taking antacids or didanosine (Videx or Videx EC), take Reyataz 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 Reyataz without first talking with your healthcare provider. It is important to stay under a healthcare provider's care while taking Reyataz.
  • When your supply of Reyataz starts to run low, get more from your healthcare provider or pharmacy. It is important not to run out of Reyataz. 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 Reyataz, 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 Reyataz or your other anti-HIV medicines.
  • If you take more than the prescribed dose of Reyataz, call your healthcare provider or poison control center right away.

Capsules:

  • Always take Reyataz 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 Reyataz oral powder with food such as applesauce or yogurt. Mixing Reyataz 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, Reyataz oral powder should be mixed with infant formula and given using an oral dosing syringe. Administration of Reyataz 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 Reyataz 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 Reyataz 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 Reyataz 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 Reyataz 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 Reyataz powder administration.
  • Administer the entire dosage of Reyataz 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.

What should I discuss with my healthcare provider before taking atazanavir?

You should not use this medicine if you have ever had a severe allergic reaction to atazanavir.

Some medicines can cause unwanted or dangerous effects when used with atazanavir. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • alfuzosin;

  • cisapride;

  • irinotecan;

  • rifampin;

  • sildenafil (Revatio, for treating pulmonary arterial hypertension);

  • St. John's wort;

  • antipsychotic medicine--lurasidone, pimozide;

  • ergot medicines--dihydroergotamine, ergotamine, ergonovine, methylergonovine;

  • HIV medicines--indinavir, nevirapine;

  • medicine to lower cholesterol--lovastatin, simvastatin; or

  • sedative medicines--triazolam, oral midazolam.

To make sure atazanavir is safe for you, tell your doctor if you have ever had:

  • liver disease (especially hepatitis B or C);

  • kidney disease (or if you are on dialysis);

  • kidney stones or gallstones;

  • diabetes;

  • a bleeding disorder such as hemophilia; or

  • a heart rhythm disorder, a heart condition called "AV block."

Atazanavir oral powder may contain phenylalanine. Talk to your doctor before using this form of atazanavir if you have phenylketonuria (PKU).

HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection. Your dose needs may be different during pregnancy and for a short time after childbirth.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of atazanavir on the baby.

Atazanavir can make birth control pills, patches, injections, or vaginal rings less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking atazanavir.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Atazanavir should not be given to a child younger than 3 months old and weighing less than 11 pounds (5 kilograms).

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 6 hours away. Do not take extra medicine to make up the missed dose.

Atazanavir side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking atazanavir and call your doctor at once if you have:

  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

  • severe pain in your side or lower back, painful urination, blood in your urine;

  • high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss;

  • liver or gallbladder problems--nausea, vomiting, upper stomach pain, itching, fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • severe skin reaction--fever, flu symptoms, mouth sores, burning or redness in your eyes, swelling in your face or tongue, muscle or joint pain, skin pain and warmth or blistering.

Atazanavir may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with atazanavir. Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;

  • chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

  • cold sores, sores on your genital or anal area;

  • rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

  • trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common side effects may include:

  • fever;

  • nausea, vomiting, stomach pain, diarrhea;

  • muscle pain, mild itching or rash;

  • headache, dizziness, depressed mood, sleep problems (insomnia);

  • numbness, tingling, or burning pain in your hands or feet; or

  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Uses for Reyataz

Treatment of HIV Infection

Atazanavir with low-dose ritonavir (ritonavir-boosted atazanavir): Treatment of HIV-1 infection in adults, adolescents, and pediatric patients ≥3 months of age;1 used in conjunction with other antiretrovirals.1 28 29 200 201

Atazanavir with cobicistat (cobicistat-boosted atazanavir): Treatment of HIV-1 infection in adults;238 239 used in conjunction with other antiretrovirals.200 238 239

Unboosted atazanavir (i.e., without low-dose ritonavir or cobicistat): Treatment of HIV-1 infection in adults and adolescents ≥13 years of age;1 used in conjunction with other antiretrovirals.1 2 3 4 7 14

Atazanavir usually used in conjunction with a pharmacokinetic enhancer (i.e., low-dose ritonavir or cobicistat).1 200 201 238 239 Pharmacokinetic enhancer (pharmacokinetic booster) used to improve atazanavir's pharmacokinetic profile.1 200 238 239 Low-dose ritonavir and cobicistat are not interchangeable in antiretroviral regimens;200 238 239 these pharmacokinetic enhancers have different dosage and administration requirements and are associated with different adverse effects, precautions, contraindications, and drug interactions.200 238 239

When ritonavir-boosted atazanavir used, single-entity atazanavir is given with single-entity ritonavir.1

When cobicistat-boosted atazanavir used, fixed combination containing both drugs (atazanavir/cobicistat) can be used;238 alternatively, single-entity atazanavir is given with single-entity cobicistat.239 Assess estimated Clcr in all patients prior to initiation of cobicistat-boosted atazanavir (see Renal Effects under Cautions).238 239

For initial treatment in antiretroviral-naive adults and adolescents, experts state that ritonavir-boosted atazanavir in conjunction with tenofovir alafenamide fumarate (TAF) and emtricitabine or ritonavir-boosted atazanavir in conjunction with tenofovir disoproxil fumarate (tenofovir DF) and emtricitabine (or lamivudine) are alternative PI-based regimens.200 These experts state that cobicistat-boosted atazanavir in conjunction with TAF and emtricitabine or cobicistat-boosted atazanavir in conjunction with tenofovir DF and emtricitabine (or lamivudine) are alternative PI-based regimens for initial treatment in antiretroviral-naive adults and adolescents†.200 Ritonavir-boosted or cobicistat-boosted atazanavir in conjunction with abacavir and lamivudine are other regimen options for initial treatment in antiretroviral-naive patients when recommended or alternative regimens cannot be used, but use only in those with baseline plasma HIV RNA levels <100,000 copies/mL who are human leukocyte antigen (HLA)-B*5701 negative.200

For initial treatment in antiretroviral-naive pediatric patients, experts state that ritonavir-boosted atazanavir in conjunction with 2 nucleoside reverse transcriptase inhibitors (NRTIs) is a preferred regimen in those ≥3 years of age and an alternative regimen in those 3 months to <3 years of age weighing 5–25 kg.201

Experts state that unboosted atazanavir is not recommended for initial treatment in antiretroviral-naive adults, adolescents, or children because it is less potent than boosted atazanavir.200 201 201

Unboosted atazanavir should not be used in antiretroviral-experienced (previously treated) patients with prior virologic failure.1 200 If using ritonavir-boosted atazanavir or cobicistat-boosted atazanavir in antiretroviral-experienced patients, treatment should be guided by number of baseline primary PI resistance substitutions.1 238

Postexposure Prophylaxis following Occupational Exposure to HIV (PEP)

Postexposure prophylaxis of HIV infection following occupational exposure† (PEP) in health-care personnel and others exposed via percutaneous injury (e.g., needlestick, cut with sharp object) or mucous membrane or nonintact skin (e.g., chapped, abraded, dermatitis) contact with blood, tissue, or other body fluids that might contain HIV.199

USPHS recommends a 3-drug regimen of raltegravir and emtricitabine and tenofovir DF as preferred regimen for PEP following occupational exposures to HIV.199 Ritonavir-boosted atazanavir and 2 NRTIs is one of several alternative regimens.199 Preferred dual NRTI option for PEP regimens is emtricitabine and tenofovir DF; alternatives are tenofovir DF and lamivudine, zidovudine and lamivudine, or zidovudine and emtricitabine.199

Management of occupational exposures to HIV is complex and evolving; consult infectious disease specialist, clinician with expertise in administration of antiretroviral agents, and/or National Clinicians’ Postexposure Prophylaxis Hotline (PEPline at 888-448-4911) whenever possible.199 Do not delay initiation of PEP while waiting for expert consultation.199

Postexposure Prophylaxis following Nonoccupational Exposure to HIV (nPEP)

Postexposure prophylaxis of HIV infection following nonoccupational exposure† (nPEP) in individuals exposed to blood, genital secretions, or other potentially infectious body fluids that might contain HIV when the exposure represents a substantial risk for HIV transmission.198 Used in conjunction with other antiretrovirals.198

When nPEP indicated in adults and adolescents ≥13 years of age with normal renal function, CDC states preferred regimen is either raltegravir or dolutegravir used in conjunction with emtricitabine and tenofovir DF (given as emtricitabine/tenofovir DF; Truvada);198 recommended alternative regimen in these patients is ritonavir-boosted darunavir used in conjunction with emtricitabine/tenofovir DF.198

CDC states that ritonavir-boosted atazanavir is an alternative antiretroviral that can be used in nPEP regimens.198

Consult infectious disease specialist, clinician with expertise in administration of antiretroviral agents, and/or the National Clinicians’ Postexposure Prophylaxis Hotline (PEPline at 888-448-4911) if nPEP indicated in certain exposed individuals (e.g., pregnant women, children, those with medical conditions such as renal impairment) or if considering a regimen not included in CDC guidelines, source virus is known or likely to be resistant to antiretrovirals, or healthcare provider is inexperienced in prescribing antiretrovirals.198 Do not delay initiation of nPEP while waiting for expert consultation.198

Stability

Storage

Oral

Capsules

Atazanavir: 25°C (may be exposed to 15–30°C).1

Powder

Atazanavir: <30°C in original packet.1 After mixing with food or beverage, may store for up to 1 hour at room temperature (20–30°C).1

Tablets

Atazanavir/cobicistat: 25°C (may be exposed to 15–30°C).238

Reyataz 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
  • Abdominal or stomach discomfort, fullness, or pain
  • bloating
  • blood in the urine
  • blurred vision
  • chest pain or discomfort
  • chills
  • clay-colored stools
  • constipation
  • dark-colored 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
  • stomachache
  • sweating
  • swelling
  • tightness in the chest
  • trouble with 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.

How Supplied/Storage and Handling

                                       

                   

                                 

Reyataz Capsules

Reyataz® (atazanavir) capsules are available in the following strengths and configurations of plastic bottles with child-resistant closures.

*  150 mg atazanavir equivalent to 170.8 mg atazanavir sulfate.
    200 mg atazanavir equivalent to 227.8 mg atazanavir sulfate.
    300 mg atazanavir equivalent to 341.69 mg atazanavir sulfate.

Product Strength*

Capsule Shell Color (cap/body)

Markings on Capsule
(ink color)

Capsules per Bottle

NDC Number

cap

body

150 mg

blue/powder blue

BMS 150 mg (white)

3624
(blue)

60

0003-3624-12

200 mg

blue/blue

BMS 200 mg (white)

3631
(white)

60

0003-3631-12

300 mg

red/blue

BMS 300 mg
(white)

3622
(white)

30

0003-3622-12

Store Reyataz capsules at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].

Reyataz Oral Powder

Reyataz oral powder is an orange-vanilla flavored powder, packed in child-resistant packets. Each packet contains 50 mg of atazanavir equivalent to 56.9 mg of atazanavir sulfate in 1.5 g of powder. Reyataz oral powder is supplied in cartons (NDC 0003-3638-10) of 30 packets each. [See Dosage and Administration (2.4).]

Store Reyataz oral powder below 30°C (86°F). Once the Reyataz oral powder is mixed with food or beverage, it may be kept at room temperature 20°C to 30°C (68°F-86°F) for up to 1 hour prior to administration. Store Reyataz oral powder in the original packet and do not open until ready to use.

Reyataz 150 mg Capsules Representative Packaging

See HOW SUPPLIED section for a complete list of available packages of Reyataz.

NDC 0003-3624-12
Bristol-Myers Squibb
60 Capsules
Reyataz®
(atazanavir) capsules
150 mg
Rx only

Note to pharmacist: Do not cover ALERT box with pharmacy label.
ALERT: Find out about medicines that should NOT be taken with Reyataz®

Important information

Some medicines can cause unwanted or dangerous effects when used with Reyataz. Your doctor may need to change your treatment plan if you use any of the following drugs: alfuzosin, cisapride, indinavir, irinotecan, lovastatin, simvastatin, pimozide, rifampin, sildenafil (for treating pulmonary arterial hypertension), St. John's wort, triazolam, oral midazolam, or ergot medicine (dihydroergotamine, ergotamine, ergonovine, methylergonovine).

Before taking this medicine

You should not use Reyataz if you have ever had a severe allergic reaction to atazanavir.

Some medicines can cause unwanted or dangerous effects when used with Reyataz. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • alfuzosin;

  • cisapride;

  • irinotecan;

  • rifampin;

  • sildenafil (Revatio, for treating pulmonary arterial hypertension);

  • St. John's wort;

  • antipsychotic medicine - lurasidone, pimozide;

  • ergot medicines - dihydroergotamine, ergotamine, ergonovine, methylergonovine;

  • HIV medicines - indinavir, nevirapine;

  • medicine to lower cholesterol - lovastatin, simvastatin; or

  • sedative medicines - triazolam, oral midazolam.

To make sure Reyataz is safe for you, tell your doctor if you have ever had:

  • liver disease (especially hepatitis B or C);

  • kidney disease (or if you are on dialysis);

  • kidney stones or gallstones;

  • diabetes;

  • a bleeding disorder such as hemophilia; or

  • a heart rhythm disorder, a heart condition called "AV block."

Reyataz oral powder may contain phenylalanine. Talk to your doctor before using this form of atazanavir if you have phenylketonuria (PKU).

HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection. Your dose needs may be different during pregnancy and for a short time after childbirth.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of atazanavir on the baby.

Reyataz can make birth control pills, patches, injections, or vaginal rings less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking this medicine.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Reyataz should not be given to a child younger than 3 months old and weighing less than 11 pounds (5 kilograms).

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