Atazanavir And Cobicistat (Evotaz)

Trade Name

EVOTAZ

Active Ingredient

Power

300; 150 mg/1; mg/1

Type / form

Tablets

Status

Manufacturer

E.R. Squibb & Sons, L.L.C.

Storage and handling for EVOTAZ

ATAZANAVIR SULFATE; COBICISTAT HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Atazanavir And Cobicistat (Evotaz) which is also known as EVOTAZ and Manufactured by E.R. Squibb & Sons, L.L.C.. It is available in strength of 300; 150 mg/1; mg/1 per ml. Read more

Atazanavir And Cobicistat (Evotaz) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

About GNH

GNH India a Global Orphan Drug specialist renowned for its adherence to stringent quality standards. GNH India holds ISO 9001:2015 certification and WHO Good Storage and Distribution Practices (GSDP) compliance, ensuring the highest levels of safety and reliability in our operations.

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  • No data
  • Dosage and Administration
  • u00a0u00a0Laboratory Testing Prior to Initiation and During Treatment with EVOTAZ u00a0u00a0u00a03/2018Contraindications u00a0u00a0u00a03/2018
  • Warnings and Precautions
  • u00a0u00a0u00a0u00a0Chronic Kidney Disease u00a0u00a0u00a03/2018
  • EVOTAZ is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults.
  • Limitations of Use:
  • EVOTAZ is a two-drug combination of atazanavir, a human immunodeficiency virus (HIV-1) protease inhibitor, and cobicistat, a CYP3A inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. n
  • Limitations of Use
  • Use of EVOTAZ in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions. n
  • No data
  • Pretreatment testing:
  • Renal impairment:
  • Hepatic impairment:
  • EVOTAZ tablets contain 342 mg atazanavir sulfate, equivalent to 300 mg of atazanavir, and 150 mg of cobicistat and are oval, biconvex, pink, film-coated, and debossed with u201c3641u201d on one side and plain on the other side.
  • u2022
  • (3)
  • EVOTAZ is contraindicated:
  • Table 1 displays drugs that are contraindicated with EVOTAZ.
  • No data
  • Cardiac conduction abnormalities:
  • Severe skin reactions:
  • Chronic kidney disease
  • Nephrolithiasis and cholelithiasis
  • Hepatotoxicity:
  • Antiretrovirals that are not recommended:
  • Hyperbilirubinemia:
  • (5.11)n- (5.12n- 6.2)n- (5.13)
  • Hemophilia:
  • The following adverse reactions are discussed in greater detail in other sections of the labeling:
  • For additional safety information about atazanavir and cobicistat, consult the full prescribing information for these individual products.
  • Most common adverse reactions seen with atazanavir coadministered with cobicistat (greater than 5%, Grades 2-4) are jaundice and rash. n
  • Coadministration of EVOTAZ can alter the concentration of other drugs and other drugs may alter the concentration of EVOTAZ, which may result in known or potentially significant drug interactions. The potential drug-drug interactions must be considered prior to and during therapy. , , n
  • No data
  • u00a0
  • Lactation:
  • (8.2)
  • Treatment for overdosage with EVOTAZ should consist of general supportive measures, including monitoring of vital signs and ECG, and observations of the patientu2019s clinical status. There is no specific antidote for overdose with EVOTAZ. Since atazanavir is extensively metabolized by the liver and both atazanavir and cobicistat are highly bound plasma proteins, it is unlikely that EVOTAZ will be significantly removed by hemodialysis or peritoneal dialysis.
  • Atazanavir:n- [see , n- Arrayn- and ]
  • EVOTAZ is a fixed-dose combination tablet for oral administration containing the active ingredients atazanavir and cobicistat. Atazanavir is an HIV-1 protease inhibitor. Cobicistat is a mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A family. EVOTAZ tablets contain 342 mg of atazanavir sulfate, equivalent to 300 mg of atazanavir, and 150 mg of cobicistat, as well as the following inactive ingredients in the tablet core: croscarmellose sodium, crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate, and stearic acid. The tablets are film-coated with a coating material containing the following inactive ingredients: hypromellose, red iron oxide, talc, titanium dioxide, triacetin.
  • Atazanavir:n- Sn- Sn- Sn- S
  • Atazanavir sulfate is a white to pale-yellow crystalline powder. It is slightly soluble in water (4-5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 u00b1 3u00b0C.
  • Cobicistat:n- Rn- Rn- S
  • Cobicistat is adsorbed onto silicon dioxide. Cobicistat on silicon dioxide is a white to pale yellow solid with a solubility of 0.1 mg/mL in water at 20u00b0C.
  • No data
  • No data
  • The safety and efficacy of atazanavir coadministered with cobicistat were evaluated in a randomized, double-blind, active-controlled trial (Study 114) in HIV-1 infected treatment-naive subjects with baseline estimated creatinine clearance above 70 mL/min (N=692). In Study 114, subjects were randomized in a 1:1 ratio to receive either atazanavir 300 mg coadministered with cobicistat 150 mg once daily or atazanavir 300 mg coadministered with ritonavir 100 mg once daily. All subjects received concomitant treatment with 300 mg of tenofovir DF and 200 mg of emtricitabine once a day administered as a single tablet. Randomization was stratified by screening HIV-1 RNA level (u2264100,000 copies/mL or >100,000 copies/mL).
  • The mean age of subjects was 37 years (range: 19-70); 83% were male, 60% were White, 18% were Black, and 12% were Asian. The mean baseline plasma HIV-1 RNA was 4.8 log copies/mL (range: 3.2-6.4). The mean baseline CD4+ cell count was 352 cells/mm (range: 1-1455) and 17% had CD4+ cell counts u2264200 cells/mm. Forty percent (40%) of patients had baseline viral loads >100,000 copies/mL.
  • Virologic outcomes in Study 114 through Week 144 are presented in Table 9. In Study 114, the mean increase from baseline in CD4+ cell count at Week 144 was 281 cells/mm3 in patients receiving atazanavir coadministered with cobicistat and 297 cells/mm3 in patients receiving atazanavir coadministered with ritonavir.
  • EVOTAZ tablets, 300 mg atazanavir and 150 mg cobicistat, are oval, biconvex, pink, film-coated, debossed with u201c3641u201d on one side and plain on the other side. Each bottle contains 30 tablets (NDC-0003-3641-11), a silica gel desiccant and is closed with a child-resistant closure.
  • Store EVOTAZ tablets at 25u00b0C (77u00b0F); excursions permitted between 15u00b0C and 30u00b0C (59u00b0F and 86u00b0F) [see USP Controlled Room Temperature]. Keep container tightly closed.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • u00a0u00a0
  • EVOTAZn- (EV-oh-taz)(atazanavir and cobicistat)tablet
  • Read this Patient Information before you start taking EVOTAZ and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
  • What is EVOTAZ?
  • EVOTAZ is a prescription HIV-1 (Human Immunodeficiency Virus) medicine used with other antiretroviral medicines to treat HIV-1 infection in adults. HIV is the virus that causes AIDS (Acquired Immunodeficiency Syndrome).
  • EVOTAZ contains the prescription medicines REYATAZ (atazanavir) and TYBOST (cobicistat).
  • It is not known if EVOTAZ is safe and effective in children under 18 years of age.
  • When used with other antiretroviral medicines to treat HIV-1 infection, EVOTAZ may help:
  • 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).
  • EVOTAZ does not cure HIV-1 infection or AIDS. You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses.
  • Avoid doing things that can spread HIV-1 infection to others:
  • Ask your healthcare provider if you have any questions about how to prevent passing HIV to other people.
  • Who should not take EVOTAZ?
  • Do not take EVOTAZ if you:
  • What should I tell my healthcare provider before taking EVOTAZ?
  • Before taking EVOTAZ, tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines you take,n- Keep a list of your medicines to show your healthcare provider and pharmacist.
  • How should I take EVOTAZ?
  • What are the possible side effects of EVOTAZ?
  • EVOTAZ can cause serious side effects, including:
  • The most common side effects of EVOTAZ were yellowing of the skin and rash.
  • 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 EVOTAZ. For more information ask your healthcare provider or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
  • How should I store EVOTAZ?
  • Keep EVOTAZ and all medicines out of the reach of children.
  • General information about EVOTAZ
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use EVOTAZ for a condition for which it was not prescribed. Do not give EVOTAZ 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 EVOTAZ that is written for health professionals.
  • For more information, call 1u2011800u2011321u20111335.
  • What are the ingredients in EVOTAZ?
  • Active ingredients:
  • Inactive ingredients:
  • Revised: March 2018
  • See section for a complete list of available packages of EVOTAZ.
  • NDC 0003-3641-1130 Tabletsn n (atazanavir and cobicistat) tablets300 mg/150 mgRx onlyn n n n

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