Our Key Products

PrEVOTAZTM

atazanavir and cobicistat tablets

(as atazanavir sulfate)

Download the Product Monograph

Read this carefully before you start taking EVOTAZ and each time you get a refill. This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about EVOTAZ.

What is EVOTAZ used for?

EVOTAZ is a drug, used in combination with other antiviral drugs to treat HIV-1 infection in adults.

How does EVOTAZ work?

EVOTAZ contains two active substances:

  • atazanavir, is a type of anti-HIV drug called a protease inhibitor. It blocks HIV protease, an enzyme needed for HIV to multiply.
  • cobicistat, boosts the amount of atazanavir in the blood.

What are the ingredients in EVOTAZ?

Medicinal ingredients:  Atazanavir sulfate, cobicistat

Non-medicinal ingredients: Croscarmellose sodium, crospovidone, hypromellose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, red iron oxide,  silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide, and triacetin.

EVOTAZ comes in the following dosage forms:

EVOTAZ is supplied as tablets containing atazanavir 300 mg (as atazanavir sulfate) and cobicistat 150mg.

Do not use EVOTAZ if you:

  • are allergic to EVOTAZ or to any of the other ingredients of EVOTAZ. The active ingredients are atazanavir sulfate and cobicistat. (See “What are the ingredients in EVOTAZ?”).
  • have liver disease.
  • take any of these medicines:

Type of Drug

Examples of Generic Names (Brand Names)

Alpha 1-Adrenoreceptor Antagonist (to treat enlarged prostate)

alfuzosin (Xatral*)

Antiarrhythmics (to treat abnormal heart rhythms)

quinidine (Biquin*)

Anticonvulsants (to treat epilepsy and prevent seizures)

carbamazepine (Tegretol*), phenytoin (Dilantin*), or phenobarbital

Antihistamines (to treat allergy symptoms)

astemizole1, terfenadine1

Antimycobacterials (to treat tuberculosis)

rifampin (Rifadin*, Rifater*, or Rofact*)

Antineoplastics (to treat cancer)

irinotecan (Camptosar*)

Beta 2- adrenoceptor Agonist (to treat asthma and/or chronic obstructive pulmonary disease)

salmeterol (Advair*)

Benzodiazepines (to treat trouble with sleeping and/or anxiety)

oral midazolam1, triazolam

Calcium Channel Blockers (to treat angina)

bepridil1

Ergot Derivatives (to treat migraine and headaches)

dihydroergotamine (Migranal NS*)

Gastrointestinal Motility Agents (to treat some digestive conditions)

cisapride1 (Propulsid*)

Herbal Products (to improve mood)

St. John’s Wort

HMG-CoA Reductase Inhibitors also known as statins (to lower cholesterol)

lovastatin (Mevacor*), simvastatin (Zocor*)

Neuroleptic (to treat psychiatric conditions)

pimozide (Orap*)

PDE5 Inhibitor (to treat pulmonary arterial hypertension)

sildenafil (Revatio*)

Protease Inhibitors (used to HIV infection)

indinavir (Crixivan*)

ritonavir (Norvir*)

1oral formulation of midazolam, cisapride, bepridil, astemizole and terfenadine are not marketed in Canada

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take EVOTAZ. Talk about any health conditions or problems you may have, including:

  • If you are pregnant or planning to become pregnant, or breast feeding.
  • If you have a heart problem.
  • If you have liver disease, kidney problems, hemophilia, diabetes.
  • EVOTAZ should not be used in combination with quetiapine. Serious and/or life-threatening reactions, including severe sedation and coma, have been reported for use of HIV protease inhibitors together with quetiapine. If co-administration is necessary, your doctor may need to monitor and adjust the dose of quetiapine.

Talk to your doctor right away if the following occurs while taking EVOTAZ, as these have occurred with protease inhibitors such as EVOTAZ:

  • You have changes in your heartbeat (irregular, fast, slow).
  • You start bleeding (nose, gums, bruising in skin, dark urine).
  • You have symptoms of kidney stones such as a pain in your side, blood in urine, pain when you urinate.
  • Your diabetes worsens or blood sugar increases with symptoms such as increased thirst, urination, fatigue, weakness, weight loss or gain.
  • You suffer lactic acidosis (build up of acid in the blood). The symptoms that may be signs of lactic acidosis include: feeling very weak, tired or uncomfortable; unusual or unexpected stomach discomfort; feeling cold; feeling dizzy or lightheaded; suddenly developing a slow or irregular heartbeat. This rare but serious side effect has occasionally been fatal.
  • You become pregnant.

Other warnings you should know about:

You may see changes in your body fat. You may have greater amounts of fat in your neck, back, breast and around your stomach. You may lose fat from your arms, legs and face. The long-term effects of these changes are unknown.

See section on SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM, for more information.

Can I take EVOTAZ during pregnancy and breast-feeding?

  • Pregnancy: It is not known if EVOTAZ can harm your unborn baby. You and your doctor will need to decide if EVOTAZ is right for you. If you use EVOTAZ while you are pregnant, talk to your healthcare provider about the Antiretroviral Pregnancy Registry.
  • Breast-feeding: You should not breast-feed if you have HIV because of the chance of passing HIV to your baby. Talk with your doctor about the best way to feed your baby.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

No drug interactions studies have been done for EVOTAZ. The following may interact with EVOTAZ:

EVOTAZ may interact with other drugs, including those you take without a prescription. You must tell your doctor or pharmacist about all drugs, including prescription and non-prescription drugs, herbal products and supplements and street drugs, you are taking or planning to take before you take EVOTAZ. EVOTAZ should be taken in combination with other drugs to treat HIV. Do not use EVOTAZ in combination with products containing the same components (atazanavir or cobicistat), or with fixed-dose products that contain cobicistat.

EVOTAZ should not be taken with indinavir (CRIXIVAN*) as both atazanavir and CRIXIVAN* sometimes cause increased levels of bilirubin in the blood (increased levels of bilirubin can cause yellowing of the skin and the white part of the eyes). Please see section “Do not use EVOTAZ if you:”.

If you are taking didanosine (VIDEX*) buffered tablets or antacids, take EVOTAZ with a meal one hour after or more than two hours before you take these drugs. Taking them together causes less atazanavir in the blood making it less effective.

Tell your doctor if you are taking any of the following drugs:

Type of Drug

Examples of Generic Names (Brand Names)

Antiarrhythmics (to treat abnormal heart rhythms)

lidocaine, quinidine (Biquin*), amiodarone (Cordarone*), flecainide, propefenone

Antibacterials (to treat bacterial infections)

clarithromycin (Biaxin*) erythromycin, telithromycin

Anticancer (to treat cancer)

dasatinib (Sprycel*), nilotinib (Tasigna*), vincristine

Anticoagulants (to prevent the clotting of red blood cells)

warfarin (Coumadin*)

Anticonvulsants (to treat epilepsy and prevent seizures)

 lamotrigine (Lamictal*)

Antidepressants (to treat depression, anxiety, or panic disorder)
 
trazodone (Oleptro*), paroxetine (Paxil*), amitriptyline (Elavil*), desipramine, imipramine (Tofranil*)

Antifungals (to treat fungal infections)

voriconazole (Vfend*), ketoconazole (Nizoral*) and itraconazole (Sporanox*)

Antigout (to treat gout and familial Mediterranean fever)

colchicine

Antimycobacterials (to treat bacterial infections)

rifabutin (Mycobutin*)

Antipsychotics (used to treat schizophrenia and bipolar disorder) quetiapine (Seroquel*)

Βeta-Blockers (to treat heart disease)

timolol, metoprolol (Betaloc*)

Calcium Channel Blockers (to treat heart disease)

diltiazem (Cardizem*, Tiazac*), felodipine (Plendil*), verapamil (Covera-HS* or Isoptin SR*)

Corticosteroids (to treat inflammation or asthma)

fluticasone propionate (Flonase* or Flovent*), dexamethasone

Endothelin receptor antagonists (to treat pulmonary arterial hypertension)

bosentan (Tracleer*)

H2‑Receptor antagonists

famotidine (Pepcid AC*)

HCV Antiviral Agents (to treat Hepatitis C Virus [HCV])

boceprevir, telaprevir

HIV antivirals

delaviridine, etravirine, tenofovir DF, nevirapine, and efavirenz

HMG-CoA Reductase Inhibitors (to lower cholesterol levels)

atorvastatin (Lipitor*), rosuvastatin (Crestor*)

Hormonal contraceptives

progestin, estrogen

Immunosuppressants (to prevent organ transplant rejection)

cyclosporine (Sandimmune*, Neoral*), tacrolimus (Prograf*) and sirolimus (Rapamune*)

Inhaled Beta-Agonists (to treat asthma and/or chronic obstructive pulmonary disease)

salmeterol (Servent Diskus*), salmeterol with fluticasone (Advair*)

Opiods (to treat opioid dependence)

buprenorphine, fentanyl, tramadol

PDE5 Inhibitors (to treat erectile dysfunction)

sildenafil (Viagra*), or tadalafil (Cialis*)

PDE5 Inhibitors (to treat pulmonary arterial hypertension)

tadalafil (Cialis*)

Proton-pump inhibitors (to prevent or treat stomach ulcers, heartburn or acid reflux disease)

omeprazole (Losec*)

Sedatives/ hypnotics (to treat trouble with sleeping and/or anxiety)

midazolam (taken by injection), diazepam, flurazepam, zolpidem

How to take EVOTAZ:

The recommended adult dosage of EVOTAZ is one tablet once a day (1 tablet containing 300 mg atazanavir and 150 mg cobicistat).

  • Always take EVOTAZ tablets with food (a meal or snack). Swallow the tablets whole. Do not break, cut, or crush the tablets. Take EVOTAZ at the same time each day.
  • Do not change your dose or stop taking EVOTAZ without first talking with your healthcare provider. It is important to stay under a healthcare provider’s care while taking EVOTAZ.
  • Always keep EVOTAZ on hand so you don’t run out. When you travel or need to stay in the hospital, make sure you will have enough EVOTAZ to last until you can get a new supply.

Overdose:

If you think you have taken too much EVOTAZ, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose of EVOTAZ by 12 hours or less, take it right away and then take your next scheduled dose at the usual time. If you miss a dose and it is more than 12 hours from the time you should have taken EVOTAZ, do not take the missed dose. Wait and take the next dose at the usual time. Do not double the next dose. It is important that you do not miss any doses of EVOTAZ or your other anti-HIV drugs.

What are possible side effects from using EVOTAZ?

The following is not a complete list of side effects reported with EVOTAZ. If you experience any side effects not listed here, contact your doctor. Your doctor can discuss with you a more complete list of side effects.

  • If you have liver disease including hepatitis B or C, your liver disease may get worse when you take anti-HIV drugs like EVOTAZ.
  • Changes in your immune system (Immune Reconstitution Inflammatory Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time, or you could develop an autoimmune disease in which your immune system reacts against your own body (e.g. Graves’ disease (which affects the thyroid gland), Guillain-Barre syndrome (which affects the nervous system) or polymyositis (which affects the muscles) and it may develop at any time, sometimes months later after the start of HIV therapy). Sometimes symptoms can be severe, so if you develop high temperature (fever), joint or muscle pain, redness, rash, swelling, or fatigue or any new symptoms contact your doctor straight away.

Tell your doctor right away about these or any other unusual symptoms. If the condition persists or worsens, seek medical attention.

 


Serious side effects and what to do about them

Symptom / effect

Talk to your healthcare professional

Stop taking drug and get immediate medical help

Only if severe

In all cases

COMMON

 

 

 

Rash (redness & itching)

 

 

Hyperbilirubinemia (high levels of bilirubin in the blood) with symptom such as yellowing of the skin or eyes

 

 

UNCOMMON

 

 

 

Frequent nausea, vomiting & stomach pain

(occurs more often in women, particularly if very overweight)

 

 

Kidney stones and symptoms such as a pain in the side, blood in the urine, and painful urination

 

 

Worsening diabetes or high blood sugar levels with symptoms such as unusual thirst, frequent urination, fatigue, weight gain or loss, or blurred vision

 

 

Gall bladder problems with symptoms such as abdominal pain, yellowing of the skin, nausea, vomiting, fever, and chills

 

 

Heart rhythm changes with symptoms such as fast or slow heartbeat, irregular heartbeat

 

 

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.


Reporting Side Effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

  • Online at MedEffect;
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Consumer Side Effect Reporting Form and sending it by:
    - Fax to 1-866-678-6789 (toll-free), or
    - Mail to: Canada Vigilance Program
                   Health Canada, Postal Locator 0701E Ottawa, ON
                   K1A 0K9
    Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store EVOTAZ Tablets at 25°C, with excursions permitted to 15°C - 30°C.

Keep out of reach and sight of children.

If you want more information about EVOTAZ:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website http://www.bmscanada.ca, or by calling 1-866-463-6267.

This leaflet was prepared by Bristol-Myers Squibb Canada.  Montreal, Canada H4S 0A4

Last Revised: August 16, 2016

EVOTAZ TM of Bristol-Myers Squibb Company used under licence by Bristol-Myers Squibb Canada.

SPRYCEL*, VIDEX*, and COUMADIN* are registered trademarks of Bristol-Myers Squibb Company used under licence by Bristol-Myers Squibb Canada. Other brands listed are trademarks of their respective owners.