Reyataz

(Ray-uh-taz)

Atazanavir (Ata-zan-a-vir)

Consumer Medicine Information

Read this leaflet carefully before taking REYATAZ. This leaflet answers some common questions about REYATAZ.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking REYATAZ against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

REYATAZ is a trade name (manufacturer’s name) for the medicine, atazanavir. REYATAZ belongs to a group of medicines called protease inhibitors.

REYATAZ is used in combination with other anti-HIV agents to treat adults and children aged between 6 and 18 years of age who are infected with Human Immunodeficiency Virus (HIV).

What is HIV:

HIV is a virus that kills important cells in the immune system over time (e.g. CD4 cells). When HIV has killed enough of the immune cells, your body becomes prone to certain types of infections. Some infections are the cause of “AIDS-defining” illnesses. This is when someone is said to have developed the Acquired Immunodeficiency Syndrome or AIDS. AIDS is a serious condition and can lead to death.

When HIV infects cells in the immune system, it takes over part of the cell’s internal workings and uses contents of the cells to produce new viruses.

REYATAZ helps to block HIV protease, an enzyme that is needed for the HIV virus to multiply. REYATAZ may lower the amount of HIV in your blood and help your body keep its supply of CD4 and T-cells. Interfering with the production of new viruses helps to reduce the total amount of HIV in the body and slows down the damage to the immune system.

REYATAZ is not a cure for HIV infection. Taking it will not necessarily prevent the illnesses that commonly occur in people with HIV infection or AIDS. You can still infect other people with HIV while you are taking this medicine.

Ask your doctor if you have any questions about why REYATAZ has been prescribed for you.

REYATAZ is not addictive. This medicine is available only with a doctor’s prescription.

It is important that you check the information below before you take REYATAZ.

Do not take REYATAZ if you have an allergy to it or to any other ingredients in the formulation listed at the end of this leaflet.

Do not take REYATAZ if you have severe liver disease.

Do not take REYATAZ if you are currently taking any of these medicines:

Rifampicin – a medicine used to treat tuberculosis

Sildenafil (Revatio) – if you are taking for pulmonary arterial hypertension

Irinotecan – a medicine used to treat some cancers

Cisapride – a medicine used to treat gastric reflux

Alfuzosin – a medicine used in bladder disorders

Asthma medications salmeterol (Seretide, Serevent)

Cholesterol reducing medicines (lovastatin, simvastatin, lomitapide)

Sleeping tablets containing midazolam or triazolam

Medicines to treat psychotic problems containing pimozide or lurasidone

Medicines to treat migraine or severe headaches which contain ergotamine

Herbal products which contain St John’s wort (Hypericum perforatum)

Protease inhibitor – indinavir (Crixivan)

Medicines to treat hepatitis C containing elbasvir/grazoprevir or glecaprevir/pibrentasvir

If you are taking REYATAZ with another medicine for the treatment of HIV called ritonavir, then you should not take certain medicines such as calcium channel blockers such as bepridil or a medication known as quinidine. You should also inform your doctor if you are taking fluticasone propionate.

If you are not sure if any of these medicines are in the products you are taking, talk to your doctor or pharmacist.

Do not use REYATAZ after the expiry date printed on the back of the pack. If this medicine is taken after the expiry date has passed, it may not work as well.

Do not take REYATAZ if the packaging is torn or shows signs of tampering.

Tell your doctor if you:

1.have allergies to:

other medicines that are called ‘protease inhibitor’

any other medicines you have been given or purchased

substances such as foods, preservatives or dyes.

Symptoms of an allergic reaction may include:

swelling of the face, lips, tongue or throat which may cause difficulty in swallowing or breathing, or severe and sudden onset of pinkish, itchy swellings on the skin, also called hives;

2.are pregnant or intend to become pregnant. Experience is limited with the use of REYATAZ in pregnant women. Therefore, it should not be used during pregnancy unless it is clearly needed. If there is an urgent need to consider REYATAZ during pregnancy, your doctor will discuss with you the benefits and risks of taking it;

3.are breast feeding or planning to breast-feed. It is not known whether REYATAZ passes into breast milk. Therefore to avoid possible side effects in the nursing infant, mothers should stop breast-feeding if they are taking REYATAZ (breast-feeding can also transfer HIV to babies);

4.currently experience or have experienced any medical conditions especially:

liver problems including hepatitis, yellowing of the skin or eyes (jaundice) or prior use of medicines toxic to the liver. Liver problems may cause higher levels of REYATAZ in the blood, increasing the chance of side effects

have any of the following risk factors for chronic kidney disease:

diabetes

high blood pressure

established heart problems (heart failure or heart attack) or have had a stroke

a family history of kidney failure

are obese with a body mass index (BMI) 30 or higher

are a smoker

are 60 years or older

are of Aboriginal or Torres Strait Islander origin

have a history of acute kidney injury

haemophilia, haemophiliac patients may experience increased bleeding when taking REYATAZ

any problems with irregular heart beat

diabetes or impaired glucose tolerance

If you have not told your doctor about any of the above, tell them before you use REYATAZ.

REYATAZ has the potential to adversely interact with many other drugs.

Be sure to inform your doctor of all medications you are taking including prescribed drugs, over the counter products, natural therapies, vitamin supplements and recreational drugs.

Medicines for HIV:

REYATAZ will be given with other anti-HIV medicines, some of these anti-HIV medicines may affect the way REYATAZ works, and REYATAZ may affect the way some other anti-HIV medicines work. Your doctor has all the current information on the effects these medicines have on one another and will discuss with you the combination of medicines that you should be taking.

Medicines for other conditions:

You should also tell your doctor if you are taking any of the following medicines:

Medicines to treat hepatitis (eg. telaprevir, bocepravir, sofosbuvir/velpatasvir/
voxilaprevir)

Proton-pump inhibitors or histamine-2 receptor antagonists (medicines used to treat stomach ulcers or other stomach disorders). If you plan to take or are currently taking either histamine-2 receptor antagonists (such as cimetidine, famotidine, ranitidine or other medicines in this class) or proton-pump inhibitors (such as omeprazole or others in this class of medicine), then you must speak to your doctor as these may reduce the effectiveness of REYATAZ. Depending on your medical history these medicines may not be suitable for you. Talk to your doctor for further information.

Macrolide antibiotics (clarithromycin, roxithromycin, erythromycin, or azithromycin) used to treat various infections

Antifungal medication (voriconazole) used to treat fungal infections

Anticonvulsant medications (carbamazepine, phenytoin, phenobarbital or lamotrigine) used to treat epilepsy

Erectile dysfunction agents used to treat impotence – sildenafil (Viagra), tadalafil (Cialis), vardenafil (Levitra).

Amiodarone, bepridil, lignocaine, quinidine, or tricyclic antidepressants – if you take any of these medicines, your doctor may ask you to have blood tests just to make sure that REYATAZ and the other medicine are not affecting the way each medicine works.

Calcium channel blockers (such as diltiazem, felodipine, nifedipine, nicardipine or verapamil) – medicines used to treat high blood pressure

Antacids and buffered medicines reduce the absorption of REYATAZ. These medicines should be taken one hour before or two hours after REYATAZ.

Drugs that affect the electrical activity of the heart

Oral contraceptives – REYATAZ may affect the safety and effectiveness of birth control pills or the patch. Speak to your doctor about the type of contraception that is most suitable for you.

Pain medications (buprenorphine)

Gout medications (colchicine)

Bosentan (Tracleer), a medication used to treat pulmonary arterial hypertension.

Anticoagulant medications including warfarin, betrixaban, dabigatran, edoxaban, rivaroxaban and apixaban

Your doctor will be able to advise you about the most appropriate medications to treat your condition. It is important that you tell your doctor or pharmacist about the medicines you are taking, even if they are not listed in this leaflet.

They will be able to provide you with more information than is contained within this leaflet on the medicines you need to be careful with, or should avoid while taking REYATAZ.

REYATAZ should be given only when prescribed by your doctor. Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you are new to HIV treatment, your doctor may prescribe REYATAZ 400 mg (2 x 200 mg capsules) once a day with food.

OR

REYATAZ 300 mg once daily (either as one 300 mg capsule or two 150 mg capsules) with ritonavir (100 mg daily) taken with food.

If you have been on previous HIV treatment, the usual dose is REYATAZ 300 mg once daily (either as one 300 mg capsule or two 150 mg capsules) with ritonavir (100 mg daily) taken with food.

You doctor will tell you what dose of REYATAZ you should take.

If you are between the ages of 6 and 18 years old, the dose of REYATAZ will be different. Please follow your doctor’s instructions.

Swallow the capsules whole with a drink such as a glass of water or fruit juice. The dose of REYATAZ should be taken with food.

You may take REYATAZ Capsules at any time. It is recommended, however, that you take your medicine at about the same time each day. Taking REYATAZ at the same time each day will have the best effect. It will also help you remember when to take the capsules.

Talk to your doctor or pharmacist to work out when it is best for you to take your doses of REYATAZ.

REYATAZ helps control your condition but does not cure it. Therefore you must take REYATAZ every day as directed by your doctor. Continue taking REYATAZ for as long as your doctor tells you to.

Do not stop taking REYATAZ unless your doctor tells you to – even if you feel better.

If it is almost time for your next dose, skip the dose you missed and take the next dose when you are meant to take it.

Otherwise take it as soon as you remember, and then go back to taking it as you would normally.

Do not take a double dose to make up for the dose you missed. This may increase the chance of you getting an unwanted side effect. If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints and inform your doctor that you have missed a dose. It is very important not to miss your doses of REYATAZ. If you miss doses the virus may become resistant to your HIV medicines.

Immediately call your doctor or the Poisons Information Centre on 131126 in Australia, or go to the Accident and Emergency Centre at your nearest hospital if you or anyone else takes too much REYATAZ.

Do this even if there are no signs of discomfort or poisoning.

If you become pregnant while taking REYATAZ, tell your doctor immediately. Pregnant women have experienced serious side effects when taking atazanavir (the active ingredient in REYATAZ) in combination with Videx^® (didanosine) and Zerit^® (stavudine).

If you are about to start taking any new medicines, tell your doctor and pharmacist that you are taking REYATAZ. REYATAZ may interfere with the medicine you are taking.

If you are about to have any medical tests, tell your doctor that you are taking REYATAZ. REYATAZ may interfere with the results of these tests.

If you plan to have surgery, tell your doctor or dentist that you are taking REYATAZ. You may wish to discuss disclosure issues with your doctor about who should know you are taking REYATAZ.

You should have your liver functions and blood tested when your doctor advises on a regular basis to ensure that your body chemistry is functioning normally and that REYATAZ is working.

Do not give REYATAZ to anyone else, even if they have the same condition as you.

Do not use REYATAZ to treat any other complaints unless your doctor tells you to.

Do not stop taking REYATAZ without checking with your doctor.

Be careful driving or operating machinery until you know how REYATAZ affects you. Some patients taking REYATAZ have experienced dizziness. It is not known if this was caused by REYATAZ. Make sure you know how you react to REYATAZ before you drive a car, operate machinery or do anything else that could be dangerous if you are dizzy.

Make sure that you visit your doctor regularly throughout your entire course of treatment with REYATAZ.

Things that may help your general health are suggested below:

exercise

healthy eating

stress reduction

counselling

regular visits to your doctor to monitor your health

good oral hygiene

support groups

Talk with your doctor about all of the above suggestions. You can also access further information about HIV and services for people with HIV by contacting your local AIDS Council, Positive Living Centre or PLWHA organisation.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking REYATAZ. REYATAZ helps most people with HIV infection but it may have unwanted side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects

Your doctor may monitor your kidney function prior to, and during your treatment with REYATAZ. Your doctor may switch you to an alternative treatment if your kidney

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

nausea, diarrhoea, dyspepsia (upset stomach), flatulence (wind)

headache, fatigue, dizziness, insomnia

vomiting

loss of strength and energy

These are some of the more common side effects of REYATAZ.

Tell your doctor or pharmacist immediately if you notice any of the following

tingling of the hands or feet

abdominal pain, abdominal distension or tenderness, vomiting

changes to the distribution of fat on your body

pain in the joints, muscle pain

ulcers in the mouth, oesophagus (pain or burning on swallowing) or stomach (pain or indigestion)

rash

change in heart rhythm, fainting

These are serious side effects. You may need urgent medical attention or hospitalization.

Yellowing of the skin or eyes

One of the other side effects that can occur with REYATAZ is yellowing of the skin (jaundice) or eyes (scleral icterus). Yellowing of the skin or eyes is caused by an increase in a substance called bilirubin. Bilirubin is formed naturally by the breakdown of red blood cells and is usually excreted by the liver.

Call your doctor if your skin or the whites of your eyes turn yellow. Although it is unlikely that these effects will cause damage to your skin, eyes or liver, It is important that you tell your doctor promptly if they occur.

Gallbladder disorders (which may include gallstones and gallbladder inflammation)

If you develop any signs or symptoms of gallstones (pain in the right or middle upper stomach, fever, nausea or vomiting, or yellowing of skin and whites of eyes), tell your doctor promptly.

Kidney Stones

If you develop signs or symptoms of kidney stones (pain in your side, blood in your urine, pain when you urinate) tell your doctor promptly.

If any of the following happen, tell your doctor immediately, or go to the Accident and Emergency Centre at your nearest hospital:

liver problems including yellowing of the skin or eyes, also called jaundice; this may occur with vomiting, fever and dark coloured urine

lactic acidosis – symptoms include nausea, vomiting, unusual or unexpected stomach discomfort, feeling very weak and tired, short of breath, or weakness in arms and legs

allergic reaction – swelling of the face, lips, or throat which makes breathing difficult

These are very serious side effects. If you have them, you may have had a serious reaction to REYATAZ. You may need urgent medical attention or hospitalisation.

This is not a complete list of side effects, other side effects not listed above may also occur in some patients.

Tell your doctor if you notice anything that is making you feel unwell.

Do not be alarmed by this list of possible side effects. You may not experience any of them or only some of them.

Store REYATAZ capsules in a cool dry place where the temperature stays below 25°C.

Keep your capsules in the bottle until it is time to take them. If you take the capsules out of the bottle they may not keep as well.

Do not store REYATAZ or any other medicine in the bathroom or near the kitchen sink. Do not leave it in the car. Heat and dampness can destroy some medicines.

Keep REYATAZ capsules where children cannot reach them. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

If your doctor tells you to stop taking REYATAZ capsules, or the capsules have passed their expiry date, ask your pharmacist what to do with any that are left over.

REYATAZ Capsules come in four types of capsules:

REYATAZ 150 mg capsules – blue and powder blue capsules, marked “BMS 150 mg” in white and “3624” in blue; 60 capsules per bottle

REYATAZ 200 mg capsules – blue capsules, marked “BMS 200 mg” and “3631” in white; 60 capsules per bottle

REYATAZ 300 mg capsules – red and blue capsules, marked “BMS 300 mg” and “3622” in white; 30 capsules per bottle.

Each capsule contains:

Active ingredients:

REYATAZ 150 mg capsules – 150 mg of atazanavir as the sulfate per capsule

REYATAZ 200 mg capsules – 200 mg of atazanavir as the sulfate per capsule

REYATAZ 300 mg capsules – 300 mg of atazanavir as the sulfate per capsule

Other ingredients:

Lactose monohydrate, crospovidone and magnesium stearate.

The capsule shell is made from gelatin, titanium dioxide and FD&C blue#2; the 300 mg capsule shell also contains red iron oxide, black iron oxide and yellow iron oxide.

REYATAZ 150 mg – AUST R 99055

REYATAZ 200 mg – AUST R 99056

REYATAZ 300 mg – AUST R 134967

Bristol-Myers Squibb Australia Pty Ltd,

4 Nexus Court, Mulgrave,

Victoria 3170, Australia

 

This information in no way replaces the advice of your doctor or pharmacist.

 

Date of Preparation: March 2020