What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Black triangle. This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

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Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/15/1025/001, EU/1/15/1025/002.

EVOTAZ 300 mg/150 mg film-coated tablets

Package leaflet: Information for the user

EVOTAZ 300 mg/150 mg film-coated tablets

atazanavir/cobicistat

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What EVOTAZ is and what it is used for
2. What you need to know before you take EVOTAZ
3. How to take EVOTAZ
4. Possible side effects
5. How to store EVOTAZ
6. Contents of the pack and other information

1. What EVOTAZ is and what it is used for

EVOTAZ contains two active substances:

  • atazanavir, an antiviral (or antiretroviral) medicine. It is one of a group called protease inhibitors. These medicines control human immunodeficiency virus (HIV) infection by stopping production of a protein that HIV needs for its multiplication. They work by reducing the amount of HIV in your body and this in turn, strengthens your immune system. In this way atazanavir reduces the risk of developing illnesses linked to HIV infection.
  • cobicistat, a booster (pharmacokinetic enhancer) to help improve the effects of atazanavir. Cobicistat, does not directly treat your HIV, but boosts the levels of atazanavir in the blood. It does this by slowing down the breakdown of atazanavir which will make it stay in the body for longer.

EVOTAZ may be used by adults aged 18 years of age and older who are infected with HIV, the virus that causes acquired immunodeficiency syndrome (AIDS). It is normally used in combination with other anti-HIV medicines to help control your HIV infection. Your doctor will discuss with you which combination of these medicines with EVOTAZ is best for you.

2. What you need to know before you take EVOTAZ

Do not take EVOTAZ:

  • if you are allergic to atazanavir, cobicistat or any of the other ingredients of this medicine (listed in section 6)
  • if you have moderate to severe liver problems
  • if you are taking any of these medicines: see also Other medicines and EVOTAZ
    • rifampicin (an antibiotic used to treat tuberculosis)
    • carbamazepine, phenobarbital and phenytoin (antiepileptics used to prevent seizures)
    • astemizole or terfenadine (commonly used to treat allergy symptoms, these medicines may be available without prescription); cisapride (used to treat gastric reflux, sometimes called heartburn); pimozide (used to treat schizophrenia); amiodarone, dronedarone, quinidine, lidocaine (injectable) or bepridil (used to correct heart rhythm); ergotamine, dihydroergotamine, ergonovine, ergometrine and methylergonovine (used to treat headaches); and alfuzosin (used to treat enlarged prostatic gland)
    • quetiapine (used to treat schizophrenia, bipolar disorder and major depressive disorder); lurasidone (used to treat schizophrenia)
    • medicines containing St. John’s wort (Hypericum perforatum, a herbal preparation).
    • triazolam and oral (taken by mouth) midazolam (used to help you sleep and/or to relieve anxiety)
    • simvastatin, lovastatin, and lomitapide (used to lower blood cholesterol)
    • avanafil (used to treat erectile dysfunction)
    • colchicine (used to treat gout), if you have kidney and/or liver problems
    • dabigatran and ticagrelor (used to prevent and reduce the blood clots)
    • grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination, and glecaprevir/pibrentasvir fixed dose combination (used to treat chronic hepatitis C infection)

Do not take sildenafil with EVOTAZ when sildenafil is used for the treatment of pulmonary arterial hypertension. Sildenafil is also used for the treatment of erectile dysfunction. Tell your doctor if you are using sildenafil for the treatment of erectile dysfunction.

Tell your doctor at once if any of these apply to you.

Warnings and precautions

Some people will need special care before or while taking EVOTAZ. Talk to your doctor or pharmacist before taking EVOTAZ.

EVOTAZ is not a cure for HIV infection. You may continue to develop infections or other illnesses linked to HIV infection. You can still pass on HIV to other people when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid infecting other people.

Make sure your doctor knows:

  • if you have liver problems
  • if you develop signs or symptoms of gall stones (pain in your right side). Gall stones have been reported in patients taking atazanavir, a component of EVOTAZ.
  • if you have type A or B haemophilia
  • if you have problems with your kidneys or require haemodialysis. Kidney stones have been reported in patients taking atazanavir, a component of EVOTAZ. If you develop signs or symptoms of kidney stones (pain in your side, blood in your urine, pain when you urinate), please inform your doctor immediately
  • if you are taking oral contraceptives ("the Pill") to prevent pregnancy. If you are currently using an oral contraceptive or using a patch contraceptive to prevent pregnancy, you should use an additional or different type of contraception (e.g. condom)

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 is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately. In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.

Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.

Hyperbilirubinaemia (an increase in the level of bilirubin in the blood) has occurred in patients receiving EVOTAZ. The signs may be a mild yellowing of the skin or eyes. If you notice any of these symptoms please inform your doctor.

Serious skin rash, including Stevens-Johnson syndrome, may develop in patients taking EVOTAZ. If you develop a rash inform your doctor immediately.

EVOTAZ may affect how well your kidneys work.

If you notice a change in the way your heart beats (heart rhythm changes), please inform your doctor.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age. The use of EVOTAZ in children and adolescents has not yet been studied.

Other medicines and EVOTAZ

You must not take EVOTAZ with certain medicines. These are listed under Do not take EVOTAZ, at the start of section 2.

There are other medicines that may not be taken together or may require a change in their mode of administration when taken with EVOTAZ. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is especially important to mention these:

  • medicines containing ritonavir or cobicistat (booster agents)
  • other medicines to treat HIV infection (e.g. indinavir, didanosine, tenofovir disoproxil, tenofovir alafenamide, efavirenz, etravirine, nevirapine and maraviroc)
  • boceprevir, simeprevir and sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C)
  • sildenafil, vardenafil and tadalafil (used by men to treat impotence [erectile dysfunction])
  • if you are taking an oral contraceptive ("the Pill")
  • any medicines used to treat diseases related to the acid in the stomach (e.g. antacids, H2-blockers like famotidine and proton pump inhibitors like omeprazole)
  • disopyramide, flecainide, mexiletine, propafenone, digoxin, bosentan, amlodipine, felodipine, nicardipine, nifedipine, verapamil, diltiazem, metoprolol and timolol (medicines to lower blood pressure, to slow heart rate or to correct heart rhythm)
  • atorvastatin, pravastatin, fluvastatin, pitavastatin and rosuvastatin (used to lower blood cholesterol)
  • salmeterol (used to treat asthma)
  • ciclosporin, tacrolimus and sirolimus (medicines to decrease the effects of body's immune system)
  • certain antibiotics (rifabutin, clarithromycin)
  • ketoconazole, itraconazole, voriconazole and fluconazole (antifungals)
  • metformin (used to treat type 2 diabetes)
  • warfarin, apixaban, edoxaban and rivaroxaban (used to reduce blood clots)
  • irinotecan, dasatinib, nilotinib, vinblastine and vincristine (used to treat cancer)
  • trazodone (used to treat depression)
  • perphenazine, risperidone, thioridazine, midazolam (given by injection), buspirone, clorazepate, diazepam, estazolam, flurazepam and zolpidem (used to treat nevous system disorders)
  • buprenorphine (used to treat opioid addiction and pain)

It is important to tell your doctor if you are taking: Corticosteroids including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These medicines are used to treat allergies, asthma, inflammatory bowel diseases, inflammatory conditions of the eyes, joints and muscles and other inflammatory conditions. If alternatives cannot be used, its use should only take place after medical evaluation and under close monitoring by your doctor for corticosteroid side effects.

Pregnancy and breast-feeding

EVOTAZ should not be used during pregancy, because the drug levels in your blood may be lower during pregancy and may no longer be high enough to control HIV. Your doctor may prescribe different medicines if you become pregnant while taking EVOTAZ.

Atazanavir, a component of EVOTAZ is excreted in human milk. It is unknown if cobicistat, the other component of EVOTAZ, is excreted in human milk but it has been shown in animals that it is excreted in milk. Talk to your doctor about breast-feeding if you are taking EVOTAZ. Patients should not breast-feed while taking EVOTAZ. It is recommended that women infected with HIV do not breast-feed because the virus might be transmitted through the breast milk.

Driving and using machines

Some patients have reported dizziness when taking atazanavir or cobicistat, active substances of EVOTAZ. If you feel dizzy or lightheaded, please contact your doctor immediately.

3. How to take EVOTAZ

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. This way, you can be sure your medicine is fully effective and you reduce the risk of the HIV-virus developing resistance to the treatment.

The recommended adult dose of EVOTAZ is one tablet daily by mouth and with food, in combination with other anti-HIV medicines. Swallow the tablet whole; do not crush or chew the tablets.

If you take more EVOTAZ than you should

If you accidentally take more EVOTAZ than your doctor recommended, contact your doctor at once or contact the nearest hospital for advice.

If you forget to take EVOTAZ

If you miss a dose of EVOTAZ by 12 hours or less, take it right away with food 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 medicines.

If you stop taking EVOTAZ

Do not stop taking EVOTAZ before talking to your doctor.

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. When treating HIV infection, it is not always easy to identify what side effects are caused by EVOTAZ, by the other medicines you are taking, or by the HIV infection itself. Tell your doctor if you notice anything unusual about your health.

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.

The following side effects may occur when taking EVOTAZ.

Very common (may affect more than 1 in 10 people)

  • ocular icterus (presence of jaundice in the white part of the eyes, i.e. the eyes become yellow)
  • nausea
  • jaundice (when the skin and/or eyes become yellow)

Common (may affect up to 1 in 10 people)

  • increased appetite, dysgeusia (impairment of the sense of taste), dry mouth
  • headache, dizziness
  • insomnia (difficulty sleeping), abnormal dreams, somnolence (sleepiness)
  • vomiting, diarrhoea, abdominal pain (stomach pain of discomfort), dyspepsia (indigestion), bloated or distended tummy (abdomen), flatulence (wind)
  • hyperbilirubinaemia (increased levels of bilirubin in the blood)
  • rash
  • fatigue (extreme tiredness)

Uncommon (may affect up to 1 in 100 people)

  • torsade de pointes (life threatening irregular heart beat)
  • hypersensitivity (allergic reaction)
  • anorexia (loss of appetite), weight loss, weight gain
  • depression, anxiety, sleep disorder
  • disorientation, amnesia (loss of memory)
  • peripheral neuropathy (numbness, weakness, tingling or pain in the arms and legs)
  • syncope (fainting), hypertension (high blood pressure)
  • dyspnoea (shortness of breath)
  • pancreatitis (inflammation of the pancreas), gastritis (inflammation of the stomach), stomatitis aphthous (mouth ulcers and cold sores)
  • hepatitis (inflammation of the liver)
  • angioedema (severe swelling of the skin and other tissues most often the lips or the eyes)
  • urticaria (itchy rash), alopecia (unusual hair loss or thinning), pruritus (itching)
  • muscle atrophy (muscle shrinkage), arthralgia (joint pain), myalgia (aching muscles)
  • nephrolithiasis (formation of kidney stones), interstitial nephritis (kidney inflammation), hematuria (blood in the urine), proteinuria (excess protein in the urine), pollakiuria (increased frequency of urination), chronic kidney disease (how well your kidneys work)
  • gynaecomastia (breast enlargement in men)
  • chest pain, malaise (generally feeling unwell), fever
  • asthenia (unusual tiredness or weakness)
  • serious skin rashes (allergic reactions including rash, a high temperature, increased levels of liver enzymes seen in blood tests, an increase in a type of white blood cell [esosinophilia] and/or enlarged lymph nodes) (see section 2)
  • gallbladder disorders (gallstones and gallbladder inflammation)

Rare (may affect up to 1 in 1,000 people)

  • QTc prolongation (irregular heart beat)
  • gait disturbance (abnormal manner of walking)
  • oedema (swelling), palpitation (fast or irregular heart beat)
  • hepatosplenomegaly (enlargement of the liver and spleen)
  • vesiculobullous rash (visible accumulation of fluid under the skin), eczema (skin rash), vasodilatation (widening of blood vessels)
  • Stevens-Johnson syndrome (allergic reactions including serious skin rash, a high temperature and enlarged lymph nodes) (see section 2).
  • myopathy (aching muscles, muscle tenderness or weakness not caused by exercise)
  • kidney pain

People who already have type A or B haemophilia may notice increased bleeding.

There have been reports of unusual heart beat in patients taking atazanavir-containing regimen.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store

Malta

ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal

5. How to store EVOTAZ

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What EVOTAZ contains

  • The active substances are atazanavir and cobicistat. Each film-coated tablet contains 300 mg of atazanavir (as sulphate), and 150 mg cobicistat.
  • The other ingredients are:
    Tablet core - microcrystalline cellulose (E460(i)), croscarmellose sodium (E468), sodium starch glycolate, crospovidone (E1202), stearic acid (E570), magnesium stearate (E470b), hydroxypropyl cellulose (E463), silicon dioxide (E551)
    Film-coating - hypromellose (hydroxypropyl methyl cellulose, E464), titanium dioxide (E171), talc (E553b), triacetin (E1518), red iron oxide (E172)

What EVOTAZ looks like and contents of the pack

EVOTAZ tablets are pink, oval, biconvex, film coated tablet of approximate dimensions of 19 mm x 10.4 mm, debossed on one side with "3641" and plain-faced on the other side of the tablet.

EVOTAZ film-coated tablets are supplied in bottles of 30 tablets. The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets.

Not all packages may be marketed in your country.

Marketing Authorisation Holder

Bristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867
Ireland

Manufacturer

Bristol-Myers Squibb S.r.l.
Contrada Fontana del Ceraso
03012 Anagni (FR)
Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom
Bristol-Myers Squibb Pharmaceuticals Ltd
Tel: + 44 (0800) 731 1736

This leaflet was last revised in November 2019

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.