50 mg oral powder
of atazanavir
What REYATAZ is and what it is used for
REYATAZ is an antiviral (or antiretroviral ) medicine. It belongs to a group called protease inhibitors, which control human immunodeficiency virus ( HIV ) infection by blocking a protein that the HIV needs to multiply. They work by reducing the number of HIV viruses in the blood and this, in turn, strengthens your immune system. In this way, REYATAZ reduces the risk of developing HIV-related diseases.
REYATAZ oral powder can be used by children from 3 months of age and weighing at least 5 kg (see section 3 How to take REYATAZ). Your doctor has prescribed REYATAZ for you because you are infected with HIV which may cause Acquired Immune Deficiency Syndrome ( AIDS ). REYATAZ should always be used with a low dose of ritonavir and in combination with other anti-HIV medicines. Your doctor will discuss with you which combinations of these medicines together with REYATAZ are best for you.
What you need to know before taking REYATAZ
Do not take REYATAZ
- if you are allergic (hypersensitive) 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 disease before deciding whether to take REYATAZ.
- if you are taking any of these medicines: see also Using other medicines with REYATAZ
- rifampicin (an antibiotic used to treat tuberculosis )
- astemizole or terfenadine (often used to treat allergic symptoms, these medications may be over-the-counter); cisapride (used to treat acid reflux (heartburn)); pimozide (used to treat schizophrenia); quinidine or bepridil (used to correct heart rhythm); ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat headaches) and alfuzosin (used to treat prostate enlargement)
- quetiapine (used to treat schizophrenia, bipolar disorder, and major depression); lurasidone (used to treat schizophrenia)
- medicines containing St. John’s wort (Hypericum perforatum, a herbal medicine)
- triazolam and orally (taken orally) midazolam (used as a sleeping pill and/or to reduce anxiety).
- lomitapide, simvastatin, and lovastatin (used to lower blood cholesterol).
- products containing grazoprevir, including a fixed-dose combination of elbasvir and grazoprevir, and a fixed-dose combination of glecaprevir and pibrentasvir (used to treat chronic hepatitis C infection )
Do not take sildenafil with REYATAZ when sildenafil is used to treat pulmonary arterial hypertension. Sildenafil is also used to treat erectile dysfunction. Tell your doctor if you are using sildenafil to treat erectile dysfunction.
Tell your doctor immediately if this applies to you.
Warnings and cautions
REYATAZ is not a cure for HIV infection. You can continue to develop infections or diseases associated with HIV. You can still transmit HIV infection while taking this medicine, even though the risk of effective antiviral therapy is reduced. Discuss with your doctor the necessary steps to avoid infecting others.
For some people, special consideration may need to be given before or when taking REYATAZ. Talk to your doctor or pharmacist before taking REYATAZ and make sure your doctor knows the following:
- if you have hepatitis B or C.
- if you develop signs or symptoms of gallstones (pain on the right side of your stomach)
- if you have hemophilia A or B
- if you need hemodialysis
REYATAZ can affect how well your kidneys work.
Kidney stones have been reported in patients taking REYATAZ. Tell your doctor immediately if you develop signs and symptoms of kidney stones (pain in the side, blood in the urine, pain when urinating).
In some patients with advanced HIV infection ( AIDS ) and who have previously had opportunistic infections ( infections that occur due to a weakened immune system), signs and symptoms of inflammation from previous infections may occur shortly after treatment for HIV. started. These symptoms are probably due to an improvement in the body’s immune response, which enables the body to fight infections that may have been present without any obvious symptoms. Tell your doctor immediately if you notice any symptoms of infection.
In addition to opportunistic infections, autoimmune disorders (conditions in which the immune system attacks healthy body tissues) can also occur after you start taking medicines to treat your HIV infection. Autoimmune disorders can occur several months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, a weakness that starts in the hands or feet and moves to the torso, palpitations, tremors, or hyperactivity, informs your doctor immediately for the necessary treatment.
Some patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue dies due to lost blood supply to the bone). Some of the many risk factors for developing the disease are long-term antiretroviral combination therapy, use of corticosteroids, alcohol consumption, a severe weakening of the immune system, and a higher body mass index. Signs of osteonecrosis are stiffness in the joints and pain (especially in the hip, knee, and shoulders) and difficulty moving. Tell your doctor if you experience any of these symptoms.
Increased levels of bile dye in the blood (hyperbilirubinemia) have occurred in patients receiving REYATAZ. Signs of this may be a mild yellowing of the skin or eyes. Tell your doctor if you experience any of these symptoms.
Severe rash including Stevens-Johnson syndrome has been reported in patients taking REYATAZ. Tell your doctor immediately if you develop a rash.
If you notice that your heart is beating differently (changes in your heart rhythm), tell your doctor.
Children receiving REYATAZ may need to have their hearts monitored. This is determined by your child’s doctor.
Children
Do not give this medicine to children younger than 3 months and weighing less than 5 kg. The use of REYATAZ in children less than 3 months of age 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 are listed under Do not take REYATAZ, at the beginning of section 2.
Other medicines may not be taken with REYATAZ. 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:
- other medicines to treat HIV infection (eg 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 contraceptives ( contraceptive pills ) with REYATAZ to prevent pregnancy, take it exactly according to the instructions given to you by your doctor, and do not miss a dose
- medicines used to treat diseases related to the acid in the stomach (eg antacids to be taken 1 hour before or two hours after administration of REYATAZ, H 2 blockers such as famotidine, and proton pump inhibitors such as omeprazole)
- medicines that lower blood pressure, decrease the heart rate, or affect the heart rhythm ( amiodarone, diltiazem, systemic lidocaine, verapamil)
- atorvastatin, pravastatin, and fluvastatin (used to lower blood cholesterol)
- salmeterol (used to treat asthma )
- cyclosporine, tacrolimus, and sirolimus (medicines that reduce the effects of the body’s immune system)
- certain antibiotics (rifabutin, clarithromycin)
- ketoconazole , itraconazole and voriconazole (antifungal)
- apixaban, dabigatran, edoxaban, rivaroxaban and warfarin ( anticoagulants , used to prevent blood clots)
- carbamazepine, phenytoin, phenobarbital, lamotrigine (used to treat epilepsy )
- irinotecan (used to treat cancer)
- sedatives (eg midazolam given as an injection )
- buprenorphine (used to treat opioid abuse and pain).
Some medicines can be affected by ritonavir, a medicine taken with REYATAZ. It is important to tell your doctor if you are taking fluticasone or budesonide (given through the nose or inhaled to treat allergic symptoms or asthma ).
REYATAZ with food and drink
See section 3 How to take REYATAZ.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. Atazanavir, the active substance in REYATAZ, is excreted in human milk. Patients should not breastfeed while taking REYATAZ. Women infected with HIV are advised not to breastfeed as the virus can be transmitted through breast milk.
Driving and using machines
Do not drive or use machines if you feel dizzy or faint and contact your doctor immediately.
REYATAZ oral powder contains:
- 63 mg aspartame per sachet . Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria, a rare genetic disease where phenylalanine accumulates because the body can not eliminate it properly.
- 1.3 g sucrose per sachet. This must be considered in patients with diabetes mellitus. May be harmful to teeth. If you have been told by your doctor that your child has an intolerance to some sugars, contact your doctor before giving this medicine to your child.
How to take REYATAZ
Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure. This way you can be sure that you get the full effect of the medicine and reduce the risk of the virus developing resistance to the treatment.
For children (from 3 months of age and weighing at least 5 kg), your child’s doctor will determine the correct dose based on the child’s weight. The dose of a REYATAZ oral powder for children is calculated based on body weight and is taken once daily with food and ritonavir as follows:
| Body weight(kg) | REYATAZ dose once daily (mg) | Ritonavir dose * once daily (mg) |
| 5 – less than 15 | 200 mg (4 sachets a ) | 80 mg b |
| 15 – less than 35 | 250 mg (5 sachets a ) | 80 mg b |
| At least 35 | 300 mg (6 sachets a ) | 100 mg c |
| a Each sachet contains 50 mg REYATAZb Ritonavir oral solutionc Ritonavir oral solution or capsule / tablet |
REYATAZ is also available as capsules for use in adults and children who are at least 6 years old and weigh at least 15 kg, and who can swallow capsules. Switching to REYATAZ capsules is encouraged as soon as the patient is inclined to swallow capsules.
A dose change may be necessary when switching between oral powder and capsules. Your doctor will determine the correct dose based on your baby’s weight.
There are no dosing recommendations for REYATAZ in children less than 3 months of age.
Instructions for REYATAZ oral powder:
- For children who can drink from a cup, REYATAZ oral powder must be taken with food or drink. If REYATAZ oral powder is mixed with water, food should also be taken at the same time.
- For children who are unable to eat solid food or drink from a cup, REYATAZ oral powder must be mixed with infant formula and should be given using a dosing syringe in the mouth. Ask your pharmacist for a dosing syringe. Do not use a baby bottle to give REYATAZ mixed with infant formula.
- See the “Instructions for Use” at the end of the package leaflet for how to prepare and give a dose of REYATAZ oral powder.
- REYATAZ oral powder should be given within 60 minutes of mixing.
If you take more REYATAZ than you should
Yellowing of the skin and/or eyes (jaundice) and irregular heartbeat (QTc prolongation) may occur if you or your child takes too much REYATAZ.
If you accidentally take or give more REYATAZ oral powder than recommended, contact your HIV doctor immediately or contact your nearest hospital for advice.
If you forget to take REYATAZ
If you forget to take a dose or if you forget to give your child a dose, take or give the missed dose as soon as possible with food and then give or take the next dose at the usual time. If it is almost time for your or your child’s next dose, do not take or give the missed dose one. Wait and take or give the next dose at the usual time. Do not take or give a double dose to make up for a forgotten dose.
If you stop taking REYATAZ
Do not stop taking REYATAZ before talking to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, REYATAZ can cause side effects, although not everybody gets them. When treating HIV infection, it is difficult to know which side effects are caused by REYATAZ, 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 treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to restored health and lifestyle, but when it comes to blood lipids, there can sometimes be a connection with HIV drugs. The doctor will perform tests to find such changes.
Talk to your doctor immediately if you develop any of the following serious side effects:
- Skin rash and itching that can sometimes be severe have been reported. The rash usually disappears within 2 weeks without any change in your REYATAZ treatment. The severe rash can develop along with other symptoms that can be severe. Stop taking REYATAZ and talk to your doctor immediately if you get a severe rash or rash with flu-like symptoms, blisters, fever, cold sores, muscle or joint pain, swelling of the face, inflammation of the eye that causes redness ( conjunctivitis ), painful, hot, or red nodules ( nodules ).
- Yellowing of the skin or the white part of your eyes caused by high levels of bilirubin in the blood has been reported as common. This side effect is usually not dangerous in adults and children older than 3 months but could be a symptom of a serious problem. If your skin or the white part of your eyes turns yellow, talk to your doctor immediately.
- Changes in how your heart beats (changes in heart rate) can sometimes occur. Talk to your doctor immediately if you become dizzy, or if you suddenly faint. These can be symptoms of a serious heart problem.
- Liver problems are less common. Your doctor should do blood tests before you start REYATAZ and during treatment. If you have liver problems including hepatitis B or C infection, you may experience a worsening of your liver problems. Talk to your doctor immediately if you get dark (tea-colored) urine, itching, yellowing of the skin or the white part of your eyes, pain around the abdomen, pale stools, or nausea.
- Gallbladder problems are less common in people taking REYATAZ. Symptoms of gallbladder problems may include pain in the right or middle of the upper abdomen, nausea, vomiting, fever, or yellowing of the skin or the white part of the eyes.
- REYATAZ can affect how well your kidneys work.
- Kidney stones are less common in people taking REYATAZ. Talk to your doctor immediately if you experience symptoms of kidney stones that may include pain in the lower back or lower abdomen, blood in the urine, or pain when urinating.
Other reported side effects in patients treated with REYATAZ:
Common (may affect up to 1 in 10 users):
- headache
- vomiting, diarrhea, stomach pain, nausea, dyspepsia (indigestion)
- extreme fatigue
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 loss, weight gain, anorexia (loss of appetite), increase in appetite
- depression, anxiety, sleep disorders
- disorientation, memory loss, dizziness, drowsiness, abnormal dreams
- syncope (fainting), hypertension (high blood pressure )
- dyspnoea (shortness of breath)
- pancreatitis (inflammation of the pancreas), gastritis (gastritis), aphthous stomatitis (cold sores and colds), dysgeusia (change of taste), flatulence (flatulence), dry mouth, distended abdomen
- angioedema (severe swelling of the skin and other tissues, usually your lips or eyes)
- alopecia (hair loss), itching
- muscle atrophy (muscle wasting), arthralgia (joint pain), myalgia (muscle pain)
- interstitial nephritis (inflammation of the kidneys), hematuria (blood in the urine), proteinuria (increased amount of protein in the urine), pollakiuria (increased urination)
- gynecomastia (breast augmentation in men)
- chest pain, malaise, fever
- insomnia
Rare (may affect up to 1 in 1,000 users):
- abnormal gait
- edema (swelling)
- hepatosplenomegaly (enlargement of the liver and spleen)
- myopathy (muscle pain, muscle weakness, not caused by exercise)
- kidney pain
How to store REYATAZ
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 carton or sachet. The expiration date is the last day of the specified month.
No special storage instructions. Do not open the sachet until the oral powder is to be used.
After mixing the oral powder with food or drink, the mixture can be stored at room temperature (maximum 30 ° C) for up to 1 hour.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is atazanavir. Each sachet contains 50 mg of atazanavir (as sulphate).
- The other ingredients are aspartame (E951), sucrose, and orange/vanilla flavors.
What the medicine looks like and the contents of the pack
Each dose of REYATAZ 50 mg oral powder contains 50 mg atazanavir.
One pack size is available: 1 carton with 30 sachets.
Marketing Authorisation 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 Center
Shannon Industrial Estate
Shannon, Co. Clare, V14 DD39
Ireland