Atazanavir Sulfate (Page 11 of 11)

16 HOW SUPPLIED/STORAGE AND HANDLING

Atazanavir Capsules, 100 mg are blue/white size ‘2’ hard gelatin capsule filled with off-white to pale yellow granular powder and imprinted with ‘100 mg’ on blue cap with white edible ink and ‘T23’ on white body with black edible ink.
Bottles of 60 NDC 65862-710-60
Bottles of 500 NDC 65862-710-05
3 x 10 Unit-dose Capsules NDC 65862-710-03
Atazanavir Capsules, 150 mg are blue/powder blue size ‘1’ hard gelatin capsule filled with off-white to pale yellow granular powder and imprinted with ‘150 mg’ on blue cap and ‘T24’ on powder blue body with white edible ink.
Bottles of 60 NDC 65862-711-60
Bottles of 180 NDC 65862-711-18
Bottles of 500 NDC 65862-711-05
3 x 10 Unit-dose Capsules NDC 65862-711-03

Atazanavir Capsules, 200 mg are blue/blue size ‘0’ hard gelatin capsule filled with off-white to pale yellow granular powder and imprinted with ‘200 mg’ on blue cap and ‘T25’ on blue body with white edible ink.
Bottles of 60 NDC 65862-712-60
Bottles of 180 NDC 65862-712-18
Bottles of 500 NDC 65862-712-05
3 x 10 Unit-dose Capsules NDC 65862-712-03
Atazanavir Capsules, 300 mg are red/blue size ‘00’ hard gelatin capsule filled with off-white to pale yellow granular powder and imprinted with ‘300 mg’ on red cap and ‘T26’ on blue body with white edible ink.
Bottles of 30 NDC 65862-713-30
Bottles of 90 NDC 65862-713-90
Bottles of 500 NDC 65862-713-05
3 x 10 Unit-dose Capsules NDC 65862-713-03
Store at 20 o to 25 o C (68 o to 77 o F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling ( Patient Information).

Atazanavir is not a cure for HIV infection. Advise patients to remain under the care of a healthcare provider while using atazanavir.

Cardiac Conduction Abnormalities

Inform patients that atazanavir may produce changes in the electrocardiogram (e.g., PR prolongation). Tell patients to consult their healthcare provider if they are experiencing symptoms such as dizziness or lightheadedness [see Warnings and Precautions (5.1)] .

Severe Skin Reaction

Inform patients that there have been reports of severe skin reactions (e.g., Stevens-Johnson syndrome, erythema multiforme, and toxic skin eruptions) with atazanavir use. Advise patients that if signs or symptoms of severe skin reactions or hypersensitivity reactions develop, they must discontinue atazanavir and seek medical evaluation immediately [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].

Hyperbilirubinemia

Inform patients that asymptomatic elevations in indirect bilirubin have occurred in patients receiving atazanavir. This may be accompanied by yellowing of the skin or whites of the eyes and alternative antiretroviral therapy may be considered if the patient has cosmetic concerns [see Warnings and Precautions (5.8)] .
Chronic Kidney Disease
Inform patients that treatment with atazanavir may lead to the development of chronic kidney disease, and to maintain adequate hydration while taking atazanavir [see Warnings and Precautions (5.5)].

Nephrolithiasis and Cholelithiasis
Inform patients that kidney stones and/or gallstones have been reported with atazanavir use. Some patients with kidney stones and/or gallstones required hospitalization for additional management and some had complications. Discontinuation of atazanavir may be necessary as part of the medical management of these adverse events [see Warnings and Precautions (5.6)] .

Drug Interactions

Atazanavir may lead to significant interaction with some drugs; therefore, advise patients to report the use of any other prescription, nonprescription medication, or herbal products, particularly St. John’s wort, to their healthcare provider prior to use [see Contraindications (4), Warnings and Precautions (5.7)] .
Immune Reconstitution Syndrome
Advise patients to inform their healthcare provider immediately of any symptoms of infection, as in some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started [see Warnings and Precautions (5.10)] .

Fat Redistribution

Inform patients that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy including protease inhibitors and that the cause and long-term health effects of these conditions are not known at this time [see Warnings and Precautions (5.11)].

Dosing Instructions

Advise patients to take atazanavir with food every day and take other concomitant antiretroviral therapy as prescribed. Atazanavir must always be used in combination with other antiretroviral drugs. Advise patients that they should not alter the dose or discontinue therapy without consulting with their healthcare provider. Tell patients if a dose of atazanavir is missed, they should take the dose as soon as possible and then return to their normal schedule; however, if a dose is skipped the patient should not double the next dose.

Pregnancy

Inform pregnant patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atazanavir during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry [see Use in Specific Populations (8.1)].
Lactation
Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk. Atazanavir can also be passed to the baby in breast milk and it is not known whether it could harm the baby [see Use in Specific Populations (8.2)].

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India
Issued: April 2018

PATIENT INFORMATION

Atazanavir Capsules

(A-ta-ZAN-a-vir)

Important: Ask your healthcare provider or pharmacist about medicines that should not be taken with a tazanavir capsules. For more information, seeWho should not take atazanavir capsules?andWhat should I tell my healthcare provider before taking atazanavir capsules?

What are atazanavir capsules ?

Atazanavir capsules are a prescription HIV-1 (Human Immunodeficiency Virus-type 1) medicine that is used with other antiretroviral medicines to treat HIV-1 infection in adults and children at least 6 years of age and older and weighing at least 15 kg. HIV-1 is the virus that causes AIDS (Acquired Immunodeficiency Syndrome).

Atazanavir capsules should not be used in children younger than 3 months of age.

When used with other antiretroviral medicines to treat HIV-1 infection, atazanavir capsules may help:

  • reduce the amount of HIV-1 in your blood. This is called “viral load”.
  • increase the number of CD4+ (T) cells in your blood that help fight off other infections.

Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).

Atazanavir capsules do not cure HIV-1 infection or AIDS. You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses.

Who should not take atazanavir capsules?

Do not take atazanavir capsules if you:

  • are allergic to atazanavir or any of the ingredients in atazanavir capsules. See the end of this leaflet for a complete list of ingredients in atazanavir capsules.
  • are taking any of the following medicines. Taking atazanavir capsules with these medicines may affect how atazanavir capsules work. Atazanavir capsules may cause serious life-threatening side effects or death when used with these medicines:
    • alfuzosin (UROXATRAL ®)
    • cisapride (PROPULSID ®)
    • elbasvir/grazoprevir (ZEPATIER ®)
    • ergot medicines including:
      • ergotamine tartrate (CAFERGOT ® , MIGERGOT ® , ERGOMAR ® , ERGOSTAT ® , MEDIHALER ® , Ergotamine, WIGRAINE ® , WIGRETTES ®)
      • dihydroergotamine mesylate (D.H.E. 45 ® , MIGRANAL ®)
      • methylergonovine (METHERGINE ®)
    • glecaprevir/pibrentasvir (MAVYRET ®)
    • indinavir (CRIXIVAN ®)
    • irinotecan (CAMPTOSAR ®)
    • lurasidone (LATUDA ®) if atazanavir is used with ritonavir (NORVIR ®)
    • lovastatin (ADVICOR ® , ALTOPREV ® , MEVACOR ®
    • midazolam (VERSED ®), when taken by mouth for sedation
    • nevirapine (VIRAMUNE ® , VIRAMUNE XR ®)
    • pimozide (ORAP ®)
    • rifampin (RIFADIN ® , RIFAMATE ® , RIFATER ® , RIMACTANE ®)
    • sildenafil (REVATIO ®), when used for the treatment of pulmonary arterial hypertension
    • simvastatin (SIMCOR ® , VYTORIN ® , ZOCOR ®)
    • St. John’s wort ( Hypericum perforatum)
    • triazolam (HALCION ®)

Serious problems can happen if you or your child takes any of the medicines listed above with atazanavir capsules.

What should I tell my healthcare provider before taking atazanavir capsules?

Before taking atazanavir capsules, tell your healthcare provider if you:

  • have heart problems
  • have liver problems, including hepatitis B or C virus infection
  • are receiving dialysis treatment
  • have diabetes
  • have hemophilia
  • have any other medical conditions
  • are pregnant or plan to become pregnant. Talk to your healthcare provider about taking atazanavir capsules during your pregnancy or if you are planning to become pregnant while you are taking atazanavir capsules.
    • Hormonal forms of birth control, such as injections, vaginal rings or implants, contraceptive patch, and some birth control pills may not work during treatment with atazanavir capsules. Talk to your healthcare provider about forms of birth control that may be used during treatment with atazanavir capsules.
    • Pregnancy Registry. There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
    • After your baby is born , tell your healthcare provider if your baby’s skin or the white part of the eyes turns yellow.
  • are breastfeeding or plan to breastfeed. Do not breastfeed if you are taking atazanavir capsules. You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. Atazanavir can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some medicines interact with atazanavir capsules. Keep a list of your medicines to show your healthcare provider and pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that interact with atazanavir capsules. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take atazanavir capsules with other medicines.

How should I take atazanavir capsules?

  • Take atazanavir capsules exactly as your healthcare provider tells you to.
  • Do not change your dose or stop taking atazanavir capsules unless your healthcare provider tells you to.
  • Stay under the care of your healthcare provider during treatment with atazanavir capsules.
  • Atazanavir capsules must be used with other antiretroviral medicines.
  • Take atazanavir capsules 1 time each day.
  • Atazanavir comes as capsules.
  • Take atazanavir capsules with food.
  • Swallow the capsules whole. Do not open the capsules.
  • Your child’s healthcare provider will prescribe the right dose of atazanavir capsules based on your child’s weight.
  • If you miss a dose of atazanavir capsules, take it as soon as you remember. Then take the next dose at your regular time. Do not take 2 doses at the same time.
  • If you take too much atazanavir, call your healthcare provider or go to the nearest hospital emergency room right away.

When your supply of atazanavir capsules starts to run low , get more from your healthcare provider or pharmacy. It is important not to run out of atazanavir capsules. The amount of HIV-1 in your blood may increase if the medicine is stopped for even a short time. The virus may become resistant to atazanavir capsules and harder to treat.

What are the possible side effects of atazanavir capsules?

Atazanavir capsules can cause serious side effects, including:

  • A change in the way your heart beats (heart rhythm change). Tell your healthcare provider right away if you get dizzy or lightheaded. These could be symptoms of a heart problem.
  • Skin rash. Skin rash is common with atazanavir capsules but can sometimes be severe. Skin rash usually goes away within 2 weeks without any change in treatment. Severe rash may develop in association with other symptoms which could be serious. If you develop a severe rash or a rash with any of the following symptoms, stop taking atazanavir capsules and call your healthcare provider right away:
    • general feeling of discomfort or “flu-like” symptoms
    • fever
    • muscle or joint aches
    • red or inflamed eyes, like “pink eye” (conjunctivitis)
    • blisters
    • mouth sores
    • swelling of your face
    • painful, warm, or red lump under your skin
  • Yellowing of your skin or the white part of your eyes is common with atazanavir capsules, and is usually not harmful in adults and infants older than 3 months of age; but it could also be a symptom of a serious problem. These effects may be due to increases in bilirubin levels in your blood (bilirubin is made by the liver). Although these effects may not be damaging to your liver, skin, or eyes, tell your healthcare provider right away if your skin or the white part of your eyes turns yellow.
  • Liver problems. If you have liver problems, including hepatitis B or C infection, your liver problems may get worse when you take atazanavir capsules. Your healthcare provider will do blood tests to check your liver before you start atazanavir capsules and during treatment. Tell your healthcare provider right away if you get any of the following symptoms:
    • dark “tea-colored” urine
    • your skin or the white part of your eyes turns yellow
    • light colored stools
    • nausea
    • itching
    • stomach-area pain
  • Chronic kidney disease. Atazanavir capsules may affect how well your kidneys work. Your healthcare provider will do blood and urine tests to check your kidneys before you start atazanavir capsules and during treatment.
  • Kidney stones have happened in some people who take atazanavir capsules. Tell your healthcare provider right away if you get symptoms of kidney stones which may include, pain in your low back or low stomach-area, blood in your urine, or pain when you urinate.
  • Gallbladder problems have happened in some people who take atazanavir capsules. Tell your healthcare provider right away if you get symptoms of gallbladder problems which may include:
    • pain in the right or middle upper stomach area
    • fever
    • nausea and vomiting
    • your skin or the white part of your eyes turns yellow
  • Diabetes and high blood sugar (hyperglycemia) have happened or have worsened in some people who take protease inhibitor medicines like atazanavir capsules. Some people have had to start taking medicine to treat diabetes or have had to change their diabetes medicine.
  • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new symptoms after starting atazanavir capsules.
  • Changes in body fat can happen in people taking HIV-1 medicines. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known.
  • Increased bleeding problems in people with hemophilia have happened when taking protease inhibitors like atazanavir capsules.

The most common side effects of atazanavir capsules include:

  • nausea
  • headache
  • stomach-area pain
  • vomiting
  • trouble sleeping
  • numbness, tingling, or burning of hands or feet
  • dizziness
  • muscle pain
  • diarrhea
  • depression
  • fever

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of atazanavir capsules. For more information, ask your healthcare provider or pharmacist.

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

How should I store atazanavir capsules?

  • Store atazanavir capsules at room temperature, between 20° to 25°C (68° to 77°F).
  • Keep capsules in a tightly closed container.

Keep atazanavir capsules and all medicines out of the reach of children.

General information about the safe and effective use of atazanavir capsules

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use atazanavir capsules for a condition for which it was not prescribed. Do not give atazanavir capsules to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about atazanavir capsules that is written for health professionals.

For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.

What are the ingredients in atazanavir capsules?

Active ingredient: atazanavir sulfate

Inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: FD&C blue 2, gelatin, iron oxide black, iron oxide red, iron oxide yellow, and titanium dioxide. The capsules are printed with ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and titanium dioxide.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Brands listed are the trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India Issued: April 2018

DRUG: Atazanavir Sulfate

GENERIC: Atazanavir

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 70518-1365-0

COLOR: red

SHAPE: CAPSULE

SCORE: No score

SIZE: 24 mm

IMPRINT: 300mg;T26

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • ATAZANAVIR SULFATE 300mg in 1

INACTIVE INGREDIENT(S):

  • CROSPOVIDONE (15 MPA.S AT 5%)
  • FERRIC OXIDE YELLOW
  • TITANIUM DIOXIDE
  • FERRIC OXIDE RED
  • POTASSIUM HYDROXIDE
  • PROPYLENE GLYCOL
  • FD&C BLUE NO. 2
  • LACTOSE MONOHYDRATE
  • MAGNESIUM STEARATE
  • FERROSOFERRIC OXIDE
  • GELATIN, UNSPECIFIED
  • SHELLAC
Remedy_Label
(click image for full-size original)
ATAZANAVIR SULFATE atazanavir capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-1365(NDC:65862-713)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATAZANAVIR SULFATE (ATAZANAVIR) ATAZANAVIR 300 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
FD&C BLUE NO. 2
GELATIN, UNSPECIFIED
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color red, blue Score no score
Shape CAPSULE Size 24mm
Flavor Imprint Code 300mg;T26
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-1365-0 30 CAPSULE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204806 08/09/2018
Labeler — REMEDYREPACK INC. (829572556)

Revised: 09/2019 REMEDYREPACK INC.

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