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Reyataz (Atazanavir)

What Reyataz is and what it is used for

Reyataz is an antiviral (or antiretroviral) medicine. It is one of a group called protease inhibitors. These medicines control Human Immunodeficiency Virus (HIV) infection by stopping a protein that the HIV needs for its multiplication. They work by reducing the amount of HIV in your body and this in turn, strengthens your immune system. In this way Reyataz reduces the risk of developing illnesses linked to HIV infection.

Reyataz capsules may be used by adults and children 6 years of age and older. Your doctor has prescribed Reyataz for you because you are infected by the HIV that causes Acquired Immunodeficiency Syndrome (AIDS). It is normally used in combination with other anti-HIV medicines. Your doctor will discuss with you which combination of these medicines with Reyataz is best for you.

Reyataz is not a cure for HIV infection. You may continue to develop infections or other illnesses linked to HIV infection. Treatment with Reyataz does not reduce the risk of passing HIV to others through sexual contact or blood contamination. You must continue to take appropriate precautions to avoid giving the virus to others.

Before you take Reyataz

Do not take Reyataz

  • if you are allergic (hypersensitive) to atazanavir or any of the other ingredients of Reyataz
  • if you have moderate to severe liver problems. Your doctor will evaluate how severe your liver disease is before deciding whether you can take Reyataz
  • if you are taking any of these medicines: see also Taking other medicines with Reyataz
    • rifampicin, an antibiotic used to treat tuberculosis
    • astemizole or terfenadine (commonly used to treat allergy symptoms, these medicines may be available without prescription); cisapride (used to treat gastric reflux, sometimes called heartburn); pimozide (used to treat schizophrenia); quinidine or bepridil (used to correct heart rhythm); ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat headaches)
    • medicines containing St. John’s wort (Hypericum perforatum, a herbal preparation).
    • triazolam and oral (taken by mouth) midazolam (used to help you sleep and/or to relieve anxiety).

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

Take special care with Reyataz

Some people will need special care before or while taking Reyataz. Before taking this medicine, make sure your doctor knows:

  • if you have hepatitis B or C
  • if you have type A or B haemophilia
  • if you have diabetes
  • if you require haemodialysis
  • if you are taking oral contraceptives (“the Pill”) to prevent pregnancy
  • if you are taking omeprazole or other proton pump inhibitors; or famotidine or other H2-receptor antagonists (used to treat diseases related to the acid in the stomach)
  • if you notice changes in body fat. Redistribution, accumulation, or loss of body fat may occur in patients receiving antiretroviral therapy

Kidney stones have been reported in patients taking Reyataz. If you develop signs or symptoms of kidney stones (pain in your side, blood in your urine, pain when you urinate), please inform your doctor immediately.

In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately.

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

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

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

Use in Children

Reyataz capsules can be taken by children at least 6 years of age and older and weighing at least 15 kg who are able to swallow the capsules (see How to take Reyataz).

Children receiving Reyataz may require their heart to be monitored. Your child’s doctor will decide this.

Taking other medicines

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

There are other medicines that may not mix with Reyataz. Please tell your doctor if you are taking or have recently taken any other medicines including medicines obtained without a prescription. It is especially important to mention these:

  • other medicines to treat HIV infection
  • sildenafil (used by men to treat impotence (erectile dysfunction))

if you are taking an oral contraceptive (“the Pill”) with Reyataz, be sure to take it exactly as instructed by your doctor and not miss any doses.

  • any medicines used to treat diseases related to the acid in the stomach (e.g. antacids, H2-blockers and proton pump inhibitors)
  • medicines to lower blood pressure, to slow heart rate, or to correct heart rhythm
  • simvastatin, lovastatin, and atorvastatin (used to lower blood cholesterol)
  • nevirapine and efavirenz (used to treat HIV)
  • cyclosporin, tacrolimus, and sirolimus (medicines to decrease the effects of body’s immune system)
  • certain antibiotics (rifabutin, clarithromycin)
  • ketoconazole, itraconazole, and voriconazole (antifungals)
  • warfarin (anticoagulant, used to reduce the blood clots)
  • irinotecan (used to treat cancer)
  • sedative agents (e.g. midazolam administered by injection)
  • buprenorphine (used to treat opioid addiction and pain).

Some medicines may interact with ritonavir, a medicine that is taken with Reyataz. It is important to tell your doctor if you are taking fluticasone or budesonide (given by nose or inhaled to treat allergic symptoms or asthma).

Taking Reyataz with food and drink

It is important that you take Reyataz with food (a meal or a substantial snack) as this helps the body absorb the medicine.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant or planning to become pregnant. Also be sure to tell your doctor if you are breast-feeding. It is recommended that women infected with HIV do not breast-feed because the virus might be transmitted through the breast milk.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. If you feel dizzy or lightheaded, contact your doctor immediately.

Important information about some of the ingredients of Reyataz

If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.

How to take Reyataz

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

The usual adult dose of Reyataz capsules is 300 mg once daily with 100 mg ritonavir once daily and with food, in combination with other anti-HIV medicines. Your doctor may adjust the dose of Reyataz according to your anti-HIV therapy.

For children (6 to less than 18 years of age), your child’s doctor will decide the right dose based on your child’s weight. The dose of Reyataz capsules for children is calculated by body weight and is taken once daily with food and 100 mg ritonavir as shown below:

Body Weight (kg) Reyataz Dose once daily (mg) Ritonavir Dose once daily (mg)
15 to less than 20 150 100
20 to less than 40 200 100
at least 40 300 100

Ritonavir capsules, tablets or oral solution may be used.

There are no dosing recommendations for Reyataz in paediatric patients less than 6 years of age or weighting less than 15 kg.

Take Reyataz capsules with food (a meal or a substantial snack). Swallow the capsules whole. Do not open the capsules.

If you take more Reyataz than you should

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

If you forget to take Reyataz

If you miss a dose, take the missed dose as soon as possible with food and then take your next scheduled dose at its regular time. If it is almost time for your next dose, do not take the missed dose. Wait and take the next dose at its regular time. Do not take 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.

Possible side effects

Like all medicines, Reyataz can cause side effects, although not everybody gets them. When treating HIV infection, it is not always easy to identify what side effects are caused by 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.

The frequency of possible side effects listed below is defined using the following convention:

very common: affects more than 1 user in 10
common: affects 1 to less than 10 users in 100
uncommon: affects 1 to less than 10 users in 1,000
rare: affects 1 to less than 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated from the available data

Patients treated with Reyataz have reported the following side effects: Common:

  • headache
  • ocular icterus (presence of jaundice seen in the white part of the eyes)
  • vomiting, diarrhoea, abdominal pain (stomach pain of discomfort), nausea, dyspepsia (indigestion)
  • jaundice (yellowing of the skin and/or eyes)
  • rash
  • lipodistrophy syndrome (body changes due to fat redistribution, accumulation, or loss of body fat), fatigue (extreme tiredness)

Uncommon:

  • peripheral neuropathy (numbness, weakness, tingling or pain in the arms and legs)
  • hypersensitivity (allergic reaction)
  • asthenia (unusual tiredness or weakness)
  • weight decreased, weight gain, anorexia (loss of appetite), appetite increased
  • depression, anxiety, sleep disorder
  • disorientation, amnesia (loss of memory), dizziness, somnolence (sleepiness), abnormal dream
  • syncope (fainting), hypertension (high blood pressure)
  • dyspnoea (shortness of breath)
  • pancreatitis (inflammation of the pancreas), gastritis (inflammation of the stomach), stomatitis aphthous (mouth ulcers and cold sores), dysgeusia (impairment of the sense of taste), flatulence (wind), dry mouth, abdominal distension
  • hepatitis (inflammation of the liver)
  • urticaria (itchy rash), alopecia (unusual hair loss or thinning), pruritus (itching)
  • muscle atrophy (muscle shrinkage), arthralgia (joint pain), myalgia (aching muscles)
  • nephrolithiasis (formation of kidney stones), hematuria (blood in the urine), proteinuria (excess protein in the urine), pollakiuria (increased frequency of urination)
  • gynaecomastia (breast enlargement in men)
  • chest pain, malaise (generally feeling unwell), fever
  • insomnia (difficulty sleeping) Rare:
  • gait disturbance (abnormal manner of walking)
  • oedema (swelling), palpitation (fast or irregular heart beat)
  • hepatosplenomegaly (enlargement of the liver and spleen)
  • vesiculobullous rash (visible accumulation of fluid under the skin), eczema (skin rash), vasodilatation (widening of blood vessels)
  • myopathy (aching muscles, muscle tenderness of weakness, not caused by exercise)
  • kidney pain Not known:
  • Torsades de pointes (life threatening irregular heart beat)
  • QTc prolongation (irregular heart beat)
  • Diabetes mellitus (body cannot remove sugar from the blood normally)
  • Hyperglycaemia (high sugar levels in the blood)
  • Nephrolithiasis (kidney stones)
  • Gallbladder disorders (gallstones and gallbladder inflammation)

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

There have been reports of raised blood sugar and developing or worsening of diabetes in people using protease inhibitors. Also, there have been reports of unusual heart beat in both adult and paediatric patients using Reyataz.

Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes include increased amounts of fat in the upper back and neck (“buffalo hump”), breast, and around the abdomen (“belly”). Loss of fat from the legs, arms and face may also happen. The cause and long-term health effects of these conditions are not known at this time.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your HIV doctor or nurse.

How to store Reyataz

Keep out of the reach and sight of children.

Do not use Reyataz after the expiry date which is stated on the label, carton or blister. The expiry date refers to the last day of that month.

Do not store above 25 °C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Reyataz contains

The active substance is atazanavir. Each capsule contains 150 mg, 200 mg or 300 mg of atazanavir (as sulphate).

The other ingredients are crospovidone, lactose monohydrate, and magnesium stearate. The capsule shell and printing ink contain gelatine, shellac, ammonium hydroxide, simethicone, propylene glycol, indigocarmin (E132) and titanium dioxide (E171). The 300 mg capsules also contain red iron oxide, black iron oxide & yellow iron oxide.

What Reyataz looks like and contents of the pack 150 mg:

Each capsule of Reyataz 150 mg contains 150 mg atazanavir.

Opaque blue and powder blue capsule printed with white and blue inks, with “BMS 150 mg” on one half and with “3624” on the other half.

Each capsule of Reyataz 200 mg contains 200 mg atazanavir.

Opaque blue capsule printed with white ink, with “BMS 200 mg” on one half and with “3631” on the other half.

Each capsule of Reyataz 300 mg contains 300 mg atazanavir.

Opaque red and blue capsule printed with white ink, with “BMS 300 mg” on one half and with “3622” on the other half.

Reyataz 150 mg & 200 mg hard capsules are supplied in bottles of 60 capsules.

Reyataz 150 mg & 200 mg hard capsules are also supplied in blister strips in packs of 60 capsules.

Reyataz 300 mg hard capsules are supplied in bottles of 30 capsules. Either one or three bottles of 30 hard capsules are provided in one carton.

Reyataz 300 mg hard capsules are also supplied in blister strips in packs of 30 capsules.

Reyataz also comes as a powder for adult patients who have difficulty swallowing capsules. Reyataz oral powder must not be used in children who can not swallow the capsules.

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