Reyataz: detailed information

Patient Information Leaflet

REYATAZ 200 mg hard capsules

atazanavir
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What REYATAZ is and what it is used for
What you need to know before taking REYATAZ
How to take REYATAZ
Possible side effects
How to store REYATAZ
Contents of the pack and other information

1. What REYATAZ is and what it is used for

REYATAZ is an antiviral (or antiretroviral) medicine. It belongs to a group called
protease inhibitors. These medicines control human immunodeficiency virus (HIV) infection by
blocking a protein that HIV needs to replicate. By reducing the amount of HIV virus in the body, these
medicines help strengthen the immune system. In this way, REYATAZ reduces the risk of developing
HIV-related illnesses.
REYATAZ capsules can be used by both adults and children aged 6 years and older. Your doctor has
prescribed REYATAZ for you because you are infected with HIV, the virus that causes Acquired
Immunodeficiency Syndrome (AIDS). It is usually used in combination with other anti-HIV medicines.
Your doctor will discuss with you which combination of medicines to take with REYATAZ.

2. What you should know before taking REYATAZ

Do not take REYATAZ

if you are allergic to atazanavir or any of the other ingredients of this medicine (listed in section 6)
if you have moderate to severe liver problems. Your doctor will assess the severity of your liver disorder before deciding whether you can take REYATAZ
if you are taking any of the following medicines: see also Other medicines and REYATAZ
rifampicin (an antibiotic used to treat tuberculosis)
astemizole or terfenadine (commonly used to treat allergy symptoms; these medicines may be available without a prescription); cisapride (used to treat gastroesophageal reflux, sometimes referred to as heartburn); pimozide (used to treat schizophrenia); quinidine or bepridil (used to correct heart rhythm); ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat headaches); alfuzosin (used to treat benign prostatic hyperplasia)
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 midazolam (to be taken by mouth) (used to help you sleep and/or reduce anxiety)
lomitapide, simvastatin and lovastatin (used to lower blood cholesterol levels)
medicines containing grazoprevir, including the fixed-dose combination of elbasvir/grazoprevir and the fixed-dose combination of glecaprevir/pibrentasvir (used to treat chronic hepatitis C infection)
apalutamide (used to treat prostate cancer), encorafenib (used to treat cancer), and ivosidenib (used to treat cancer)
carbamazepine, phenobarbital and phenytoin (used to treat epileptic seizures)

Do not take sildenafil with REYATAZ when sildenafil is used to treat pulmonary arterial hypertension. Sildenafil is also used to treat erectile dysfunction. Inform your doctor if you are using sildenafil for erectile dysfunction.

Talk to your doctor immediately if you are in any of these situations.

Warnings and precautions

REYATAZ is not a cure for HIV infection. You may continue to develop infections or other illnesses associated with HIV infection.

Some people may require special attention before or during treatment with REYATAZ. Talk to your doctor or pharmacist before taking REYATAZ and make sure your doctor knows:

if you have hepatitis B or C
if you develop signs or symptoms of gallstones (pain in the right side of the stomach)
if you have haemophilia A or B
if you are on haemodialysis

REYATAZ may affect kidney function.
Kidney stones have been reported in patients taking REYATAZ. If you develop signs or symptoms of kidney stones (side pain, blood in urine, pain when urinating), inform your doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition occurring when the immune system attacks healthy body tissue) may also occur after starting treatment for HIV infection. Autoimmune disorders may occur many months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, initial weakness in hands and feet progressing toward the trunk, palpitations, tremor, or hyperactivity, inform your doctor immediately to receive necessary treatment.

Some patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue due to reduced blood supply to the bone). Duration 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 condition. Signs of osteonecrosis include joint stiffness, discomfort, and pain (especially in hips, knees, and shoulders) and difficulty moving. Contact your doctor if you notice any of these symptoms.

Hyperbilirubinaemia (an increase in blood bilirubin levels) has occurred in patients taking REYATAZ. Signs may include a slight yellowing of the skin and eyes. Contact your doctor if you notice any of these symptoms.

Severe skin rash, including Stevens-Johnson syndrome, has been reported in patients taking REYATAZ. If you develop a skin rash, inform your doctor immediately.

Contact your doctor if you notice changes in your heartbeat (changes in heart rhythm). Children receiving REYATAZ may require cardiac monitoring, which will be determined by the paediatrician.

Children

Do not give this medicine to children under 3 months of age and weighing less than 5 kg. The use of REYATAZ in children under 3 months of age and weighing less than 5 kg has not been studied due to the risk of serious complications.

Other medicines and REYATAZ

You must not take REYATAZ with certain medicines. These medicines are listed in the section "Do not take REYATAZ" at the beginning of Section 2.

There are other medicines you must not take with REYATAZ. Inform your doctor if you are taking, have recently taken, or might take any other medicines. In particular, it is important to mention the following:

other medicines for the treatment of HIV infection (e.g., indinavir, nevirapine, and efavirenz)
sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C)
sildenafil, vardenafil, or tadalafil (used by men to treat impotence (erectile dysfunction))
if you are taking oral contraceptives ("the pill") with REYATAZ to prevent pregnancy, make sure you take them exactly as directed by your doctor and do not miss any doses
any medicine used to treat acid-related stomach disorders (e.g., antacids taken one hour before or two hours after taking REYATAZ, H2-receptor blockers such as famotidine, and proton pump inhibitors such as omeprazole)
medicines to lower blood pressure, reduce heart rate, or correct heart rhythm (amiodarone, diltiazem, systemic lidocaine, verapamil)
atorvastatin, pravastatin, and fluvastatin (used to lower blood cholesterol levels)
salmeterol (used to treat asthma)
cyclosporine, tacrolimus, and sirolimus (medicines to reduce the activity of the immune system)
some antibiotics (rifabutin, clarithromycin)
ketoconazole, itraconazole, and voriconazole (antifungals)
apixaban, dabigatran, edoxaban, rivaroxaban, warfarin, clopidogrel, prasugrel, and ticagrelor (used to reduce blood clot formation)
lamotrigine (an antiepileptic)
irinotecan (used in cancer treatment)
elagolix (a gonadotropin-releasing hormone receptor antagonist used to treat severe endometriosis pain)
fostamatinib (used to treat chronic immune thrombocytopenia)
sedatives (e.g., injectable midazolam)
buprenorphine (used to treat opioid dependence and pain)
corticosteroids (all routes of administration; including dexamethasone).

Some medicines may interact with ritonavir, a medicine taken with REYATAZ.
It is important that you inform your doctor if you are taking an inhaled or nasal corticosteroid (through the nose), including fluticasone or budesonide (used to treat allergy symptoms or asthma).

REYATAZ with food and drink

It is important that you take REYATAZ with food (a meal or substantial snack), as this helps the medicine to be absorbed.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.

Atazanavir, the active substance in REYATAZ, is excreted in breast milk. Patients must not breastfeed while taking REYATAZ.

Breastfeeding is not recommended for HIV-positive women, as HIV infection can be transmitted to the infant through breast milk.

If you are breastfeeding or considering breastfeeding, you must discuss this with your doctor as soon as possible.

Driving and using machines

If you feel dizzy or lightheaded, do not drive or operate machinery and contact your doctor immediately.

REYATAZ contains lactose.
If your doctor has informed you that you have an intolerance to certain sugars (e.g., lactose), contact your doctor before taking this medicine.

3. How to take REYATAZ

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.
This way, you can be sure that the medicine will be fully effective and will reduce the risk of the virus
developing resistance to treatment.
For adults, the recommended dose of REYATAZ capsules is 300 mg once daily
with 100 mg of ritonavir, taken once daily with food, in combination with other anti-HIV medicines. Your doctor may adjust the dose of REYATAZ depending on your anti-HIV therapy.
For children (from 6 years to less than 18 years of age), the paediatrician will determine the appropriate dose based on the child's weight. The dose of REYATAZ capsules in children is calculated according to body weight and is taken once daily with food and 100 mg of ritonavir, as indicated below:

Body weight (kg)	REYATAZ once-daily dose (mg)	Ritonavir once-daily dose*
from 15 to less than 35	200	100
at least 35	300	100

REYATAZ is also available as an oral powder for use in children who are at least 3 months old and weigh at least 5 kg. It is recommended to switch from REYATAZ oral powder to REYATAZ capsules as soon as patients are able to swallow capsules regularly.
When switching between the oral powder and capsules, a dosage adjustment may be necessary. Your doctor will determine the appropriate dose based on the child's weight.
There are no recommended dosages of REYATAZ for pediatric patients under 3 months of age.
Take REYATAZ capsules with food (a meal or substantial snack). Swallow the capsules whole. Do not open the capsules.
If you take more REYATAZ than you should
If you or the child takes a higher dose of REYATAZ than prescribed, yellowing of the skin and/or eyes (jaundice) and irregular heartbeat (QTc interval prolongation) may occur.
If you accidentally take more REYATAZ capsules than prescribed by your doctor, contact your doctor or the nearest hospital immediately for advice.
If you forget to take REYATAZ
If you forget to take a dose, take the missed dose as soon as possible with food, then continue with the next scheduled dose. However, if the next dose is due soon, do not take the missed dose. Wait and take only the next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose.
If you stop taking REYATAZ
Do not stop treatment with REYATAZ without first discussing it with your doctor.
If you have any doubts about using this medicine, consult your doctor.

4. Possible side effects

During treatment for HIV, an increase in weight and in blood levels of lipids and glucose may occur. This is partly related to the recovery of health, lifestyle, and, in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.

Inform your doctor immediately if you experience any of the following serious side effects:

Skin rash and itching have been reported, occasionally severe. Skin rash usually disappears within 2 weeks without any change in REYATAZ treatment. However, severe rash may develop, sometimes associated with other symptoms that could be serious. Stop taking REYATAZ and inform your doctor immediately if you develop severe rash or rash accompanied by flu-like symptoms, blisters, fever, mouth sores, muscle or joint pain, facial swelling, eye inflammation causing redness (conjunctivitis), painful, warm or red lumps (nodules).
Yellowing of the skin or whites of the eyes (jaundice) due to high levels of bilirubin in the blood has been commonly reported. This side effect is usually not harmful in adults and infants over 3 months of age; however, it may be a sign of a serious condition. Inform your doctor immediately if your skin or the whites of your eyes turn yellow.
Changes in heart rhythm (alterations in heartbeat) may occasionally occur. Inform your doctor immediately if you experience dizziness, feel lightheaded, or faint suddenly. These may be symptoms of a serious heart problem.
Liver problems may occur uncommonly. Your doctor should perform blood tests before and during treatment with REYATAZ. If you have liver problems, including hepatitis B or C infection, your liver condition may worsen. Inform your doctor immediately if you notice dark urine (tea-colored), itching, yellowing of the skin or whites of the eyes, stomach pain, pale stools, or nausea.
Gallstones may occur uncommonly in people taking REYATAZ. Symptoms of gallstones may include pain in the upper right or central abdomen, nausea, vomiting, fever, or yellowing of the skin or whites of the eyes.
REYATAZ may affect kidney function.
Kidney stones may occur uncommonly in people taking REYATAZ. Inform your doctor immediately if you notice symptoms of kidney stones, including pain in the lower back or abdomen, blood in the urine, or pain when urinating.

Other side effects reported in patients treated with REYATAZ are listed below:
Common (may affect up to 1 in 10 people)

headache
vomiting, diarrhoea, abdominal pain (stomach discomfort), nausea, dyspepsia (indigestion)
fatigue (extreme tiredness)

Uncommon (may affect up to 1 in 100 people)

peripheral neuropathy (numbness, weakness, tingling or pain in arms and legs)
hypersensitivity (allergic reaction)
asthenia (unusual tiredness or weakness)
weight decrease, weight increase, anorexia (loss of appetite), increased appetite
depression, anxiety, sleep disorders
disorientation, amnesia (memory loss), dizziness, drowsiness, changes in dream activity
syncope (fainting), hypertension (high blood pressure)
dyspnoea (shortness of breath)
pancreatitis (inflammation of the pancreas), gastritis (inflammation of the stomach), aphthous stomatitis (mouth ulcers and oral inflammation), dysgeusia (altered taste), flatulence (intestinal gas), dry mouth, abdominal distension
angioedema (severe swelling of the skin and other tissues, most frequently lips and eyes)
alopecia (unusual hair loss or thinning), pruritus (itching)
muscular atrophy (reduction in muscle mass), arthralgia (joint pain), myalgia (muscle pain)
interstitial nephritis (inflammation of the kidney), haematuria (blood in urine), proteinuria (excess protein in urine), pollakiuria (increased frequency of urination)
gynaecomastia (enlargement of the breasts in men)
chest pain, malaise (general feeling of being unwell), fever
insomnia (difficulty falling asleep)

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

gait disorders (abnormal walking)
oedema (swelling)
hepatosplenomegaly (enlargement of the liver and spleen)
myopathy (muscle pain, muscle weakness with fatigue not caused by physical exercise)
renal pain

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store REYATAZ

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, carton or blister. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What REYATAZ contains

The active substance is atazanavir. Each capsule contains 200 mg of atazanavir (as sulfate).
The other components are crospovidone, monohydrate lactose and magnesium stearate. The capsule shell and ink contain gelatin, shellac, ammonium hydroxide, simethicone, propylene glycol, indigo carmine (E132) and titanium dioxide (E171).

Description of the appearance of REYATAZ and contents of the pack
Each REYATAZ 200 mg capsule contains 200 mg of atazanavir.
Blue, opaque capsule printed in white ink with "BMS 200 mg" on one half and "3631" on the other half.
REYATAZ 200 mg hard capsules are supplied in bottles containing 60 capsules. One or three bottles of 60 hard capsules are provided in a carton.
REYATAZ 200 mg hard capsules are also supplied in blisters packed in cartons containing 60 capsules.
Not all pack sizes may be marketed.

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

Manufacturer
CATALENT ANAGNI S.R.L.
Loc. Fontana del Ceraso snc
Strada Provinciale 12 Casilina, 41
03012 Anagni (FR)
Italy

Swords Laboratories Unlimited Company T/A Bristol-Myers Squibb Pharmaceutical Operations,
External Manufacturing
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Package leaflet: information for the user

REYATAZ 300 mg hard capsules

atazanavir
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What REYATAZ is and what it is used for
What you need to know before taking REYATAZ
How to take REYATAZ
Possible side effects
How to store REYATAZ
Contents of the pack and other information

1. What REYATAZ is and what it is used for

REYATAZ is an antiviral (or antiretroviral) medicine. It belongs to a group called
protease inhibitors. These medicines control human immunodeficiency virus (HIV) infection by
blocking a protein that HIV needs to replicate. These medicines work by reducing the amount of HIV
virus in the body, thereby strengthening the immune system. In this way, REYATAZ reduces the risk
of developing diseases associated with HIV infection.
REYATAZ capsules can be used in both adults and children aged 6 years and older. Your doctor has
prescribed REYATAZ for you because you are infected with HIV, the virus that causes Acquired
Immunodeficiency Syndrome (AIDS). REYATAZ is usually used in combination with other anti-HIV
medicines. Your doctor will discuss with you which combination of these medicines with REYATAZ is
best.

2. What you should know before taking REYATAZ

Do not take REYATAZ

if you are allergic to atazanavir or to any of the other ingredients of this medicine (listed in section 6)
if you have moderate to severe liver problems. Your doctor will assess the severity of your liver condition before deciding whether you can take REYATAZ
if you are taking any of the following medicines: see also Other medicines and REYATAZ
rifampicin (an antibiotic used to treat tuberculosis)
astemizole or terfenadine (commonly used to treat allergy symptoms; these medicines may be available without a prescription); cisapride (used to treat gastric reflux, sometimes referred to as heartburn); pimozide (used to treat schizophrenia); quinidine or bepridil (used to correct heart rhythm); ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat headaches); alfuzosin (used to treat benign prostatic hyperplasia)
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 midazolam (to be taken by mouth) (used to help you sleep and/or reduce anxiety)
lomitapide, simvastatin, and lovastatin (used to lower blood cholesterol levels)
medicines containing grazoprevir, including the fixed-dose combination of elbasvir/grazoprevir and the fixed-dose combination of glecaprevir/pibrentasvir (used to treat chronic hepatitis C infection)
apalutamide (used to treat prostate cancer), encorafenib (used to treat cancer), and ivosidenib (used to treat cancer)
carbamazepine, phenobarbital, and phenytoin (used to treat epileptic seizures)

Warnings and precautions
REYATAZ is not a cure for HIV infection. You may continue to develop infections or other diseases associated with HIV infection.

Some people may require special attention before or during treatment with REYATAZ. Talk to your doctor or pharmacist before taking REYATAZ and make sure your doctor knows:

if you have hepatitis B or C
if you develop signs or symptoms of gallstones (pain in the right side of the stomach)
if you have haemophilia A or B
if you are on haemodialysis

In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after starting treatment for HIV infection. Autoimmune disorders may occur many months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, initial weakness in hands and feet spreading upwards towards the trunk, palpitations, tremors, or hyperactivity, contact your doctor immediately to receive appropriate treatment.

Some patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue due to reduced blood supply to the bone). Duration of combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this condition. Signs of osteonecrosis include joint stiffness, discomfort, and pain (especially in hips, knees, and shoulders) and difficulty moving. Consult your doctor if you notice any of these symptoms.

Hyperbilirubinaemia (an increase in blood bilirubin levels) has occurred in patients taking REYATAZ. Signs may include mild yellowing of the skin and eyes. Consult your doctor if you notice any of these symptoms.

Severe skin rash, including Stevens-Johnson syndrome, has been reported in patients taking REYATAZ. If you develop a skin rash, inform your doctor immediately.

Consult your doctor if you notice changes in your heartbeat (changes in heart rhythm). Children receiving REYATAZ may require cardiac monitoring, which will be determined by the paediatrician.

Children
Do not give this medicine to children younger than 3 months of age and weighing less than 5 kg. The use of REYATAZ in children under 3 months of age and weighing less than 5 kg has not been studied due to the risk of serious complications.

Other medicines and REYATAZ
You must not take REYATAZ with certain medicines. These medicines are listed in the section Do not take REYATAZ, at the beginning of Section 2.

other medicines for the treatment of HIV infection (e.g., indinavir, nevirapine, and efavirenz)
sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C)
sildenafil, vardenafil, or tadalafil (used by men to treat impotence (erectile dysfunction))
if you are taking oral contraceptives ("the pill") with REYATAZ to prevent pregnancy, make sure you take them exactly as directed by your doctor and do not miss any doses
any medicine used to treat acid-related stomach disorders (e.g., antacids taken one hour before or two hours after taking REYATAZ, H2-receptor blockers such as famotidine, and proton pump inhibitors such as omeprazole)
medicines to lower blood pressure, reduce heart rate, or correct heart rhythm (amiodarone, diltiazem, systemic lidocaine, verapamil)
atorvastatin, pravastatin, and fluvastatin (used to lower blood cholesterol levels)
salmeterol (used to treat asthma)
cyclosporine, tacrolimus, and sirolimus (medicines to reduce immune system activity)
some antibiotics (rifabutin, clarithromycin)
ketoconazole, itraconazole, and voriconazole (antifungals)
apixaban, dabigatran, edoxaban, rivaroxaban, warfarin, clopidogrel, prasugrel, and ticagrelor (used to reduce blood clot formation)
lamotrigine (an antiepileptic)
irinotecan (used in cancer treatment)
elagolix (gonadotropin-releasing hormone receptor antagonist, used to treat severe endometriosis pain)
fostamatinib (used to treat chronic immune thrombocytopenia)
sedatives (e.g., injectable midazolam)
buprenorphine (used to treat opioid dependence and pain)
corticosteroids (all routes of administration; including dexamethasone).

Some medicines may interact with ritonavir, a medicine taken with REYATAZ.
It is important that you inform your doctor if you are taking an inhaled or nasal corticosteroid (administered through the nose), including fluticasone or budesonide (used to treat allergic symptoms or asthma).

REYATAZ with food and drink
It is important that you take REYATAZ with food (a meal or substantial snack), as this helps the medicine to be absorbed.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
Atazanavir, the active substance in REYATAZ, is excreted in breast milk. Patients must not breastfeed while taking REYATAZ.
Breastfeeding is not recommended for HIV-positive women, as HIV infection can be transmitted to the infant through breast milk.
If you are breastfeeding or considering breastfeeding, you must discuss this with your doctor as soon as possible.

Driving and using machines
If you feel dizzy or lightheaded, do not drive or operate machinery and contact your doctor immediately.

REYATAZ contains lactose.
If your doctor has informed you that you have an intolerance to certain sugars (e.g., lactose), contact them before taking this medicine.

3. How to take REYATAZ

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.
This way, you can be sure that the medicine will be fully effective and will reduce the risk of the virus
developing resistance to treatment.
The recommended dose of REYATAZ capsules for adults is 300 mg once daily
with 100 mg of ritonavir, taken once daily with food, in combination with other
anti-HIV medicines. Your doctor may adjust the dose of REYATAZ depending on your anti-HIV therapy.
For children (from 6 to less than 18 years of age), the paediatrician will determine the appropriate
dose based on the child's body weight. The dose of REYATAZ capsules in children is calculated according
to body weight and is taken once daily with food and 100 mg of ritonavir, as indicated below:

Body weight (kg)	REYATAZ dose once daily (mg)	Ritonavir dose* once daily (mg)
from 15 to less than 35	200	100
at least 35	300	100

REYATAZ is also available as an oral powder for use in children at least 3 months of age and weighing at least 5 kg. It is recommended to switch from REYATAZ oral powder to REYATAZ capsules as soon as patients are able to swallow capsules regularly.
When switching from oral powder to capsules, a dosage adjustment may be necessary. Your doctor will determine the appropriate dose based on the child's weight.
There are no recommended dosages of REYATAZ for pediatric patients under 3 months of age.
Take REYATAZ capsules with food (a meal or substantial snack). Swallow the capsules whole. Do not open the capsules.
If you take more REYATAZ than you should
If you or the child takes too high a dose of REYATAZ, yellowing of the skin and/or eyes (jaundice) and irregular heartbeat (QTc interval prolongation) may occur.
If you accidentally take more REYATAZ capsules than prescribed by your doctor, contact your doctor or the nearest hospital immediately for advice.
If you forget to take REYATAZ
If you miss a dose, take it as soon as possible with food, then take the next dose at the scheduled time. However, if the next dose is due soon, do not take the missed dose. Wait and take only the next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose.
If you stop taking REYATAZ
Do not stop treatment with REYATAZ without first discussing it with your doctor.
If you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
When you are being treated for HIV infection, it is not always easy to determine whether side effects are caused by REYATAZ, by other medicines you are taking, or by the HIV infection itself.
Tell your doctor if you notice anything unusual about your health.
During treatment for HIV, you may experience an increase in weight and in blood lipid and glucose levels.
This is partly related to the recovery of health status and lifestyle, and, in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.

Tell your doctor immediately if you develop any of the following serious side effects:

Skin rash and itching have been reported, occasionally severe. Skin rash usually disappears within 2 weeks without any change in REYATAZ treatment. However, severe rash may develop, sometimes associated with other symptoms that can be serious. Stop taking REYATAZ and tell your doctor immediately if you develop severe rash or rash accompanied by flu-like symptoms, blisters, fever, mouth sores, muscle or joint pain, facial swelling, eye inflammation causing redness (conjunctivitis), or painful, hot, red lumps (nodules).
Yellowing of the skin or whites of the eyes (jaundice) due to high levels of bilirubin in the blood has been commonly reported. This side effect is usually not harmful in adults and infants over 3 months of age; however, it may be a sign of a serious condition.
Tell your doctor immediately if your skin or the whites of your eyes turn yellow.
Changes in heart rhythm (changes in the way the heart beats) may occur occasionally. Tell your doctor immediately if you feel dizzy, lightheaded, or if you faint suddenly. These may be symptoms of a serious heart problem.
Liver problems may occur uncommonly. Your doctor should perform blood tests before and during treatment with REYATAZ. If you have liver problems, including hepatitis B or C infection, your liver condition may worsen. Tell your doctor immediately if you notice dark urine (tea-colored), itching, yellowing of the skin or whites of the eyes, stomach pain, pale stools, or nausea.
Gallstones may occur uncommonly in people taking REYATAZ. Symptoms of gallstones may include pain in the upper right or central abdomen, nausea, vomiting, fever, or yellowing of the skin or whites of the eyes.
REYATAZ may affect kidney function.
Kidney stones may occur uncommonly in people taking REYATAZ. Tell your doctor immediately if you notice symptoms of kidney stones, including pain in the lower back or abdomen, blood in the urine, or pain when urinating.

Other side effects reported in patients treated with REYATAZ are listed below:
Common (may affect up to 1 in 10 people)

headache
vomiting, diarrhoea, abdominal pain (stomach discomfort), nausea, dyspepsia (indigestion)
fatigue (extreme tiredness)

Uncommon (may affect up to 1 in 100 people)

peripheral neuropathy (numbness, weakness, tingling or pain in arms and legs)
hypersensitivity (allergic reaction)
asthenia (unusual tiredness or weakness)
weight decrease, weight increase, anorexia (loss of appetite), increased appetite
depression, anxiety, sleep disorders
disorientation, amnesia (memory loss), dizziness, drowsiness, changes in dream activity
syncope (fainting), hypertension (high blood pressure)
dyspnoea (shortness of breath)
pancreatitis (inflammation of the pancreas), gastritis (inflammation of the stomach), aphthous stomatitis (mouth ulcers and oral inflammation), dysgeusia (altered taste), flatulence (intestinal gas), dry mouth, abdominal distension
angioedema (severe swelling of the skin and other tissues, most frequently lips and eyes)
alopecia (unusual hair loss or thinning), itching
muscle atrophy (reduction in muscle mass), arthralgia (joint pain), myalgia (muscle pain)
interstitial nephritis (inflammation of the kidney), haematuria (blood in urine), proteinuria (excess protein in urine), pollakiuria (increased frequency of urination)
gynaecomastia (enlargement of the breasts in men)
chest pain, malaise (general feeling of being unwell), fever
insomnia (difficulty falling asleep)

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

gait disturbances (abnormal walking pattern)
oedema (swelling)
hepatosplenomegaly (enlargement of the liver and spleen)
myopathy (muscle pain, muscle weakness with fatigue not caused by physical exercise)
kidney pain

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or nurse.
You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store REYATAZ

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, the carton or the blister. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What REYATAZ contains

The active substance is atazanavir. Each capsule contains 300 mg of atazanavir (as sulfate).
The other components are crospovidone, monohydrate lactose and magnesium stearate. The capsule shell and printing ink contain gelatin, shellac, ammonium hydroxide, simethicone, red iron oxide, black iron oxide, yellow iron oxide, propylene glycol, indigo carmine (E132) and titanium dioxide (E171).

Description of the appearance of REYATAZ and contents of the pack
Each REYATAZ 300 mg capsule contains 300 mg of atazanavir.
Red and blue opaque capsule, printed in white ink on one half with "BMS 300 mg" and "3622" on the other half.
REYATAZ 300 mg hard capsules are supplied in bottles containing 30 capsules. One or three bottles of 30 hard capsules are provided in a carton.
REYATAZ 300 mg hard capsules are also supplied in blisters packed in cartons containing 30 capsules.
Not all pack sizes may be marketed.

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

Manufacturer
CATALENT ANAGNI S.R.L.
Loc. Fontana del Ceraso snc
Strada Provinciale 12 Casilina, 41
03012 Anagni (FR)
Italy
Swords Laboratories Unlimited Company T/A Bristol-Myers Squibb Pharmaceutical Operations,
External Manufacturing
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Package leaflet: Information for the user

REYATAZ 50 mg oral powder

atazanavir
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What REYATAZ is and what it is used for
What you need to know before taking REYATAZ
How to take REYATAZ
Possible side effects
How to store REYATAZ
Contents of the pack and other information

1. What REYATAZ is and what it is used for

REYATAZ is an antiviral (or antiretroviral) medicine. It belongs to a group called
protease inhibitors. These medicines control human immunodeficiency virus (HIV) infection by
blocking a protein that HIV needs to replicate. By reducing the amount of HIV in the body, these
medicines help strengthen the immune system. In this way, REYATAZ reduces the risk of developing
HIV-related illnesses.
REYATAZ oral powder can be used in children who are at least 3 months old and weigh at least 5 kg
(see section 3 How to take REYATAZ). Your doctor has prescribed REYATAZ because you are infected
with HIV, the virus that causes Acquired Immunodeficiency Syndrome (AIDS). REYATAZ must always
be taken with a low dose of ritonavir and in combination with other anti-HIV medicines. Your doctor will
discuss with you which combination of medicines to use with REYATAZ.

2. What you should know before taking REYATAZ

Do not take REYATAZ

if you are allergic to atazanavir or any of the other ingredients of this medicine (listed in section 6)
if you have moderate to severe liver problems. Your doctor will assess the severity of your liver condition before deciding whether you can take REYATAZ
if you are taking any of the following medicines: see also Other medicines and REYATAZ
rifampicin (an antibiotic used to treat tuberculosis)
astemizole or terfenadine (commonly used to treat allergy symptoms; these medicines may be available without a prescription); cisapride (used to treat gastric reflux, sometimes referred to as heartburn); pimozide (used to treat schizophrenia); quinidine or bepridil (used to correct heart rhythm); ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat headaches); alfuzosin (used to treat benign prostatic hyperplasia)
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 midazolam (to be taken by mouth) (used to help you sleep and/or reduce anxiety)
lomitapide, simvastatin, and lovastatin (used to lower cholesterol levels in the blood)
medicines containing grazoprevir, including the fixed-dose combination of elbasvir/grazoprevir and the fixed-dose combination of glecaprevir/pibrentasvir (used to treat chronic hepatitis C infection)
apalutamide (used to treat prostate cancer), encorafenib (used to treat cancer), ivosidenib (used to treat cancer)
carbamazepine, phenobarbital, and phenytoin (used to treat epileptic seizures)

Warnings and precautions

REYATAZ is not a cure for HIV infection. You may continue to develop infections or other diseases associated with HIV infection.

Some people may require special attention before or during treatment with REYATAZ. Talk to your doctor or pharmacist before taking REYATAZ and make sure your doctor knows:

if you have hepatitis B or C
if you develop signs or symptoms of gallstones (pain in the right side of the abdomen)
if you have haemophilia A or B
if you are on haemodialysis

REYATAZ may affect kidney function.
Kidney stones have been reported in patients taking REYATAZ. If you develop signs or symptoms of kidney stones (side pain, blood in the urine, pain during urination), inform your doctor immediately.

In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections, inflammatory signs and symptoms of previous infections may occur shortly after starting anti-HIV treatment. These symptoms are believed to result from an improved immune response, allowing the body to fight infections that may have been present without clear symptoms. If you notice any signs of infection, inform your doctor immediately. In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after starting treatment for HIV infection. Autoimmune disorders may occur many months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, initial weakness in hands and feet spreading towards the trunk, palpitations, tremor, or hyperactivity, contact your doctor immediately to receive appropriate treatment.

Some patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue due to reduced blood supply to the bone). The duration of combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this condition. Signs of osteonecrosis include joint stiffness, discomfort, pain (especially in hips, knees, and shoulders), and difficulty moving. Contact your doctor if you notice any of these symptoms.

Hyperbilirubinaemia (an increase in bilirubin levels in the blood) has occurred in patients taking REYATAZ. Signs may include mild yellowing of the skin and eyes. Contact your doctor if you notice any of these symptoms.

Severe skin rash, including Stevens-Johnson syndrome, has been reported in patients taking REYATAZ. If a skin rash develops, inform your doctor immediately.

Contact your doctor if you notice changes in your heartbeat (changes in heart rhythm). Children receiving REYATAZ may require cardiac monitoring, which will be determined by the paediatrician.

Children

Do not give this medicine to children under 3 months of age and weighing less than 5 kg. The use of REYATAZ in children under 3 months of age and weighing less than 5 kg has not been studied due to the risk of serious complications.

Other medicines and REYATAZ

You must not take REYATAZ with certain medicines. These medicines are listed in the section Do not take REYATAZ, at the beginning of Section 2.

other medicines used to treat HIV infection (e.g., indinavir, nevirapine, and efavirenz)
sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C)
sildenafil, vardenafil, or tadalafil (used by men to treat impotence (erectile dysfunction))
if you are taking oral contraceptives ("the pill") with REYATAZ to prevent pregnancy, make sure you take them exactly as directed by your doctor and do not miss any doses
any medicine used to treat acid-related stomach disorders (e.g., antacids taken one hour before or two hours after taking REYATAZ, histamine H-receptor blockers such as famotidine, and proton pump inhibitors such as omeprazole)
medicines to lower blood pressure, reduce heart rate, or correct heart rhythm (amiodarone, diltiazem, systemic lidocaine, verapamil)
atorvastatin, pravastatin, and fluvastatin (used to lower cholesterol levels in the blood)
salmeterol (used to treat asthma)
cyclosporine, tacrolimus, and sirolimus (medicines that reduce the activity of the immune system)
certain antibiotics (rifabutin, clarithromycin)
ketoconazole, itraconazole, and voriconazole (antifungals)
apixaban, dabigatran, edoxaban, rivaroxaban, warfarin, clopidogrel, prasugrel, and ticagrelor (used to reduce blood clot formation)
lamotrigine (an antiepileptic)
irinotecan (used in cancer treatment)
elagolix (a gonadotropin-releasing hormone receptor antagonist used to treat severe endometriosis-related pain)
fostamatinib (used to treat chronic immune thrombocytopenia)
sedatives (e.g., injectable midazolam)
buprenorphine (used to treat opioid dependence and pain)
corticosteroids (all routes of administration; including dexamethasone).

Some medicines may interact with ritonavir, a medicine taken with REYATAZ.
It is important that you inform your doctor if you are taking a corticosteroid administered by inhalation or nasal spray (e.g., fluticasone or budesonide), used to treat allergic symptoms or asthma.

REYATAZ with food and drinks
See section 3 How to take REYATAZ.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
Atazanavir, the active substance in REYATAZ, is excreted in breast milk. Patients must not breastfeed while taking REYATAZ.
Breastfeeding is not recommended for HIV-positive women, as HIV infection can be transmitted to the infant through breast milk.
If you are breastfeeding or considering breastfeeding, you must discuss this with your doctor as soon as possible.

Driving and using machines
If you feel dizzy or lightheaded, do not drive or operate machinery and contact your doctor immediately.

REYATAZ oral powder contains:

63 mg of aspartame per sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine to accumulate because the body cannot properly metabolise it.
1.3 g of sucrose per sachet. This should be taken into account in patients with diabetes mellitus. It may be harmful to teeth. If your child has been diagnosed with an intolerance to certain sugars, contact your doctor before giving this medicine to your child.

3. How to take REYATAZ

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.
This way, you can be sure that the medicine will be fully effective and will reduce the risk of the virus developing resistance to treatment.
For children (at least 3 months of age and weighing at least 5 kg), the doctor will determine the correct dose based on the child's weight. The dose of REYATAZ oral powder for children is calculated according to body weight and is taken once daily with food and ritonavir as shown below:

Body weight (kg)	REYATAZ once-daily dose (mg)	Ritonavir dose* once-daily (mg)
from 5 to less than 15	200 mg (4 sachetsa)	80 mgb
from 15 to less than 35	250 mg (5 sachetsa)	80 mgb
at least 35	300 mg (6 sachetsa)	100 mgc

REYATAZ is also available in capsule form for use in adults and children aged at least 6 years who weigh at least 15 kg and are able to swallow capsules. It is recommended to switch from REYATAZ oral powder to REYATAZ capsules as soon as patients are able to swallow capsules regularly.

When switching from oral powder to capsules, a change in dosage may be necessary. Your doctor will determine the appropriate dose based on the child's weight.

There are no recommended dosages of REYATAZ for pediatric patients under 3 months of age.

Instructions for REYATAZ oral powder:

For children able to drink from a cup, REYATAZ oral powder should be taken with food or drink. If REYATAZ oral powder is mixed with water, food must also be consumed at the same time.
For children unable to eat solid food or drink from a cup, REYATAZ oral powder must be mixed with infant formula and administered using an oral syringe. Ask your pharmacist for an oral syringe. Do not use a baby bottle to administer REYATAZ mixed with infant formula.
See the section "Instructions for use" at the end of this leaflet for details on how to prepare and administer a dose of REYATAZ oral powder.
REYATAZ oral powder must be administered within 60 minutes of preparing the mixture.

If you take more REYATAZ than you should
If you or the child takes an overdose of REYATAZ, yellowing of the skin and/or eyes (jaundice) and irregular heartbeat (QTc interval prolongation) may occur.
If you accidentally take more REYATAZ capsules than prescribed by your doctor, contact your doctor or the nearest hospital immediately for advice.

If you forget to take REYATAZ
If you forget to take a dose or forget to administer it to the child, take or administer the missed dose as soon as possible with food, then continue with the next dose at the scheduled time. However, if the next dose is due soon, do not take or administer the missed dose. Wait and take or administer the next dose at the scheduled time.
Do not take or administer a double dose to make up for a forgotten dose.

If you stop taking REYATAZ
Do not stop treatment with REYATAZ before discussing it with your doctor.
If you have any doubts about how to use this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
When you are being treated for HIV infection, it is not always easy to determine whether side effects are caused by REYATAZ, by other medicines you are taking, or by the HIV infection itself.
Inform your doctor if you notice any unusual changes in your health.
During treatment for HIV, an increase in weight and in blood levels of lipids and glucose may occur. This is partly related to improved health, lifestyle, and, in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.
Inform your doctor immediately if you develop any of the following serious side effects:

Skin rash and itching have been reported, which may occasionally be severe. Skin rash usually disappears within 2 weeks without any change in REYATAZ treatment. However, severe rash may develop, sometimes associated with other symptoms that can be serious. Stop taking REYATAZ and inform your doctor immediately if you develop severe rash or rash accompanied by flu-like symptoms, blisters, fever, mouth sores, muscle or joint pain, facial swelling, eye inflammation causing redness (conjunctivitis), or painful, hot, red lumps (nodules).
Yellowing of the skin or whites of the eyes (due to high levels of bilirubin in the blood) has been commonly reported. This side effect is usually not harmful in adults and infants over 3 months of age; however, it may be a sign of a serious condition. Inform your doctor immediately if your skin or the whites of your eyes turn yellow.
Changes in heart rhythm (changes in heartbeat) may occur occasionally. Inform your doctor immediately if you experience dizziness, feel lightheaded, or faint suddenly. These may be symptoms of a serious heart problem.
Liver problems may occur uncommonly. Your doctor should perform blood tests before and during treatment with REYATAZ. If you have liver problems, including hepatitis B or C infection, your liver condition may worsen. Inform your doctor immediately if you notice dark urine (tea-colored), itching, yellowing of the skin or whites of the eyes, stomach pain, pale stools, or nausea.
Gallstones may occur uncommonly in people taking REYATAZ. Symptoms of gallstones may include pain in the upper right or central part of the stomach, nausea, vomiting, fever, or yellowing of the skin or whites of the eyes.
REYATAZ may affect kidney function.
Kidney stones may occur uncommonly in people taking REYATAZ. Inform your doctor immediately if you notice symptoms of kidney stones, including pain in the lower back or stomach, blood in the urine, or pain when urinating.

Other side effects reported in patients treated with REYATAZ are listed below:
Common (may affect up to 1 in 10 people)

headache
vomiting, diarrhoea, abdominal pain (stomach discomfort), nausea, dyspepsia (indigestion)
fatigue (extreme tiredness)

Uncommon (may affect up to 1 in 100 people)

peripheral neuropathy (numbness, weakness, tingling or pain in arms and legs)
hypersensitivity (allergic reaction)
asthenia (unusual tiredness or weakness)
weight decrease, weight increase, anorexia (loss of appetite), increased appetite
depression, anxiety, sleep disorders
disorientation, amnesia (memory loss), dizziness, somnolence (drowsiness), changes in dream activity
syncope (fainting), hypertension (high blood pressure)
dyspnoea (shortness of breath)
pancreatitis (inflammation of the pancreas), gastritis (inflammation of the stomach), aphthous stomatitis (mouth ulcers and inflammation of the oral cavity), dysgeusia (altered taste), flatulence (intestinal gas), dry mouth, abdominal distension
angioedema (severe swelling of the skin and other tissues, most frequently lips and eyes)
alopecia (unusual hair loss or thinning), pruritus (itching)
muscle atrophy (reduction in muscle mass), arthralgia (joint pain), myalgia (muscle pain)
interstitial nephritis (inflammation of the kidney), haematuria (blood in urine), proteinuria (excess protein in urine), pollakiuria (increased frequency of urination)
gynaecomastia (enlargement of breasts in men)
chest pain, malaise (general feeling of discomfort), fever
insomnia (difficulty sleeping)

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

gait disturbances (abnormal walking pattern)
oedema (swelling)
hepatosplenomegaly (enlargement of the liver and spleen)
myopathy (muscle pain, muscle weakness with fatigue not caused by physical exercise)
kidney pain

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or nurse.
You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store REYATAZ

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or sachet. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions. Do not open the sachet until ready for use.
After mixing the oral powder with food or drink, it may be stored at room temperature (not above 30°C) for up to 1 hour.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What REYATAZ contains

The active substance is atazanavir. Each sachet contains 50 mg of atazanavir (as sulfate).
The other ingredients are aspartame (E951), sucrose and orange-vanilla flavouring.

Description of the appearance of REYATAZ and contents of the pack
Each sachet of REYATAZ 50 mg oral powder contains 50 mg of atazanavir.
One pack size is available: 1 carton containing 30 sachets.
Marketing Authorization Holder
Bristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland
Manufacturer
Swords Laboratories Unlimited Company T/A Lawrence Laboratories
Unit 12 & 15, Distribution Centre
Shannon Industrial Estate
Shannon, Co. Clare, V14 DD39
Ireland
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
Instructions for use
These instructions will guide you on how to prepare and administer a dose of REYATAZ oral powder.
Please make sure to read and understand these instructions before administering this medicine to the child.
The paediatrician will determine the correct dose based on the child's age and weight.
Always administer the medicine to the child within 60 minutes of preparing the mixture.
Before administering the medicine

Determine the dose and number of REYATAZ oral powder sachets required (see section 3, How to take REYATAZ).
Before use, tap the sachet gently. Cut each sachet along the dotted line.
Choose the appropriate option listed below to administer REYATAZ oral powder to the child. You may use larger volumes or amounts of infant liquid formula, beverage, or food. Ensure that the child consumes all of the infant formula, beverage, or food containing the medicine.

Prepare and administer the medicine with infant liquid formula using a medicine cup or small container and an oral syringe (ask your pharmacist for an oral syringe):

Take a medicine cup or small container and pour in the contents of the sachets.
Add 10 mL of infant liquid formula and mix using a spoon.
Place the tip of the syringe into the mixture and pull back the plunger to draw up the entire amount of infant liquid formula.
Place the syringe into the child's mouth against the cheek and push the plunger to release the medicine.
Add another 10 mL of infant liquid formula to the cup or container and collect the remaining oral powder from the cup or container.
Place the tip of the syringe into the mixture and pull back the plunger to draw up the entire amount of infant liquid formula.
Place the syringe into the child's mouth against the cheek and push the plunger to release the medicine.
Administer the recommended dose of ritonavir to the child immediately after administering REYATAZ oral powder.

Prepare and administer the medicine with beverages

Pour the contents of the sachets into a small cup.
Add 30 mL of beverage and mix with a spoon.
Have the child drink the mixture.
Add another 15 mL of beverage, mix, and have the child drink the mixture.
If water is used, food must also be taken at the same time.

Prepare and administer the medicine with food

Pour the contents of the sachets into a small container.
Add at least one tablespoon of food and mix.
Have the child eat the mixture.
Add another tablespoon of food to the container, mix, and have the child eat it again.

If you have any questions about how to prepare and administer a dose of REYATAZ oral powder, please consult your doctor, pharmacist, or nurse.