Bula do remedy Reyataz

the package insert of the medicine Reyataz. Active principles Sulfate Atazanavir.

what For?

REYATAZ is indicated in combination with other agents anti-retroviral for the tratamentoda HIV infection.

The efficacy of REYATAZ is based on the analysis of the level of replication of HIV in the blood and in the count of lymphocytes CD4+ studies in patients without and with previous treatment with anti-retroviral.

REYATAZ should be used during pregnancy only if the potential benefit justify the potential risk.

Contraindications

When should I not use?

REYATAZ is contraindicated to patients with known allergy to any of its ingredients, including atazanavir.

Tell your doctor about any medicine you are using before the beginning or during the treatment.

This medicine should not be used by pregnant women without medical advice.

Dosage

How to use?

REYATAZ capsules must be administered with food.

The recommended oral dose of REYATAZ is as follows:
Patients without Prior Treatment: REYATAZ 300 mg once daily plus ritonavir 100 mg once daily concomitantly with food. If there is difficulty swallowing the capsule 300 mg (2 capsules of 150 mg may be used, one then the other, keeping the dose of 300 mg once a day. OR REYATAZ 400 mg (two capsules of 200 mg) should be administered once daily concomitantly with food.

Patients with Previous Treatment: REYATAZ 300 mg should be administered with ritonavir 100 mg once daily concomitantly with food. If there is difficulty swallowing the capsule 300 mg (2 capsules of 150 mg may be used, one then the other, keeping the dose of 300 mg once a day.

The treatment of REYATAZ without ritonavir is not recommended for patients with prior treatment failure virologic earlier.

the Efficacy and safety of REYATAZ with ritonavir in doses greater than 100 mg once daily have not been established. The use of higher doses of ritonavir may alter the safety profile of atazanavir (cardiac effects, hyperbilirubinemia) and, therefore, is not recommended.

For prescription drugs and other agents retroviral drugs, in which a change in dosage may be appropriate, see – Drug Interactions.

Patients with Renal Insufficiency: For patients with renal insufficiency, including those with renal failure severe which do not suffer from hemodialysis, no dose adjustment is required for REYATAZ. Patients without prior treatment who suffer hemodialysis should receive 300 mg of REYATAZ with 100 mg of ritonavir. REYATAZ should not be administered to patients with previous treatment for HIV with renal failure severe under hemodialysis. REYATAZ without ritonavir should not be administered in patients without prior treatment who suffer from hemodialysis.

Patients with Hepatic impairment: REYATAZ should be administered with caution in patients with hepatic impairment mild to moderate. Should be considered a dose reduction to 300 mg once daily, in patients with hepatic impairment moderate that does not have failed previous treatment. REYATAZ should not be administered in patients with severe hepatic insufficiency. REYATAZ + ritonavir was not studied in patients with hepatic impairment (and not recommended) and should be used with caution in patients with hepatic impairment mild. REYATAZ + ritonavir is not recommended for patients with insufficient moderate-to-severe.

Pediatric Patients and Adolescents: has Not been established a dosing regimen for pediatric patients.

Geriatric Patients: Based on comparisons of the pharmacokinetic, dose adjustments taking into consideration the age is not recommended.

Dosing during pregnancy and the period after birth:
REYATAZ should not be administered without ritonavir. For pregnant patients, it is not necessary dose adjustment of REYATAZ, except, when administered with an antagonist of the receiver H2, or tenofovir. Your doctor will set the dosage schedule suitable for you in these cases. No dose adjustment is required for patients in the postpartum.

however, patients should be monitored for adverse events because the concentration of atazanavir may be greater during the first 2 months after birth.

Follow the guidance of your doctor, always respecting the schedules, doses and duration of treatment.

do Not stop treatment without the knowledge of your doctor.

This medicine should not be broken, opened or chewed.

If you forgot to take REYATAZ, take it as soon as possible and then take your next dose at the usual time. However, if you are within 6 hours of your next dose, do not take the missed dose. Wait and take the next dose at the right time. Do not take two doses at once. It is important that you do not forget to take REYATAZ or other anti-HIV medications that you are using.

In case of doubt, seek guidance from your doctor.

Side Effects

What are the evils that can cause me?

Post-marketing Experience
The adverse events described below have been identified during the use of REYATAZ after approval. An estimate of the frequency could not be made because the adverse events were reported voluntarily from a population of size unknown. The following events were included because of the seriousness, frequency of reporting or causal relationship with REYATAZ, or even a combination of these factors.

the Organism as a whole: edema.

the Cardiovascular System: cardiac Arrhythmias, delay in conducão impulse heart.

the Gastrointestinal System: pancreatitis.

System-Hepatic function abnormal.

Dysfunctions hepatobiliary: cholelithiasis (calculations or gall stones), cholecystitis (inflammation of gallbladder), cholestasis (decreased bile flow).

Metabolic System and Disorders Nutritional: hyperglycemia (increase of glucose in the blood), diabetes mellitus: Diabetes Mellitus / Hyperglycemia).

musculoskeletal System: arthralgia (pain in joint).

System renal: nephrolithiasis (calculus or stone in the kidneys).

Skin and Appendages: pruritus (itching), alopecia (hair loss), rash (rash) maculopapular.

Attention: this product is a medicine that has a new concentration in the country (300 mg) and, although the research has indicated the effectiveness and acceptable safety, even if indicated and used correctly, you may experience adverse events of unpredictable or unknown. In this case, tell your doctor or pharmacist.

Warnings and Precautions

what should I know before using?

Resistance / cross-resistance: varying degrees of cross-resistance among protease inhibitors have been observed. Resistance to atazanavir does not prevent the subsequent use of other protease inhibitors.

Diabetes and increased blood sugar (hyperglycemia) May occur in the development of diabetes and hyperglycemia if you use drugs protease inhibitors like REYATAZ. Some patients already had diabetes before taking protease inhibitors while others do not. Some patients may need changes in your diabetes treatment.

Effects on the Electrocardiogram: it Was observed lengthening of the interval PR (change rims in the conduction of impulse in heart) on the electrocardiogram dose-dependent, and concentration in healthy volunteers receiving atazanavir. There is limited information about the potential for drug interactions in humans between atazanavir and other drugs that prolong the interval PR in the electrocardiogram (see – Drug Interactions).

Notify your doctor if you are taking any medicine known as an inducer of interval prolongation PR (p.ex., atenolol, diltiazem, verapamil) together with REYATAZ (see – Drug Interactions).

the Skin or yellowing of the eyes: These effects may occur due to the increased level of bilirubin in the blood (bilirubin is made by the liver). Although they are not harmful to the liver, skin, or eyes, immediately inform your doctor if your skin or the white part of your eyes become yellowish.

Rash (rash)
Rash-mild (redness and itching) without other symptoms sometimes occur in patients taking REYATAZ, most often in the first weeks of use of the medicine. The rash disappear within 2 weeks without any change in treatment. Tell your doctor the occurrence of skin rash.

severe Rash: rash may occur in association with other symptoms that can be severe and potentially lead to death. If you develop a skin rash with any of the following the following symptoms, stop using REYATAZ and call your doctor immediately: shortness of breath, malaise, generalized or flu-like symptoms, fever, muscle and joint pain, conjunctivitis, blisters, sores in the mouth and swelling in the Failure, or liver failure, and liver toxicity The atazanavir is primarily metabolized by the liver, therefore care should be taken when administering this drug to patients with liver failure, since there may be increased concentrations of atazanavir. Patients co-infected with hepatitis B or C viral or with elevations marked transaminases (liver enzymes), which occurred prior to treatment, may be subject to a greater risk of developing elevation of transaminases or decompensation liver.

Nephrolithiasis (calculations or stones in the kidneys): Cases of nephrolithiasis have been reported in post-marketing period in HIV-infected patients receiving therapy with atazanavir. If signs or symptoms of nephrolithiasis occur, temporary interruption or discontinuation of therapy should be considered.

Hemophilia: Some patients with hemophilia have increased problems of bleeding when treated with protease inhibitors like REYATAZ.

Redistribution of fat: redistribution / accumulation of body fat, including obesity, increased dorsocervical fat (hump-buffalo), loss of peripheral fat and on the face, enlargement breast, and “appearance cushingoide”, have been observed in patients receiving antiretroviral therapy. The mechanism and long-term consequences of these events are currently unknown. A causal relationship has not been established.

Syndrome of immune reconstitution In some patients with advanced infection by HIV (AIDS) and a history of opportunistic infections, signs and symptoms of inflammation from previous infections may occur soon after starting anti-HIV treatment, including REYATAZ.

Pregnancy: If you are pregnant or plan to become pregnant, the use of REYATAZ during pregnancy was not associated with an increase in birth defects. Pregnant women had severe side effects when they took REYATAZ with other medicines to treat HIV, called nucleoside analogues. Your doctor will decide if REYATAZ is right for you. After the birth, if the skin or the white part of the baby’s eyes become yellow, the doctor should be reported.

Breastfeeding: You should not breastfeed if you are HIV-positive because there is the possibility of transmitting HIV to your baby. In addition, it is not known if REYATAZ can pass into breast milk and if it can harm your baby.

hygiene Measures: This medicine does not cure HIV infection or AIDS. Patients may continue to acquire opportunistic infections or other conditions associated with HIV infection. Opportunistic infections are those that develop because of immunity (defence system of your body) is low. Therefore, you must remain under continuous medical supervision. REYATAZ does not reduce the possibility of transmitting HIV to other people through sexual contact, sharing needles, or exposure to your blood. For your health and that of others, it is important to always practice safe sex, using a condom or other barrier to lower the chance of contact with the sperm, vaginal secretions or blood. Never use or share contaminated syringes.

paediatric Use: The dosage schedule for the use of REYATAZ in pediatric patients has not been established.

Use geriatric: clinical Studies of REYATAZ did not include sufficient number of patients 65 years of age or older to determine whether they respond differently from younger patients.

Fit due to age is not recommended. In general, you should have proper care in the administration and monitoring of REYATAZ in elderly patients reflecting the greater frequency in this population of hepatic, renal, or decreased heart, disease, concomitant or other drug therapies.

Effect on ability to drive machines
No studies on effects on ability to drive and operate machinery was performed, when it is used REYATAZ.

do Not use this medicine without the knowledge of your doctor. It can be dangerous to your health.

Overdose

what to do if someone use a larger amount than is recommended?

The human experience of superdose acute with REYATAZ is limited. Single Doses up to 1200 mg were administered to healthy volunteers without effects symptomatic unfavorable. A superdose single of 29.2 g of REYATAZ autoadministrada by a patient infected by HIV (73 times the recommended dose of 400 mg) was associated with block bifascicular (change in impulse conduction cardiac) coronary artery disease interval prolongation PR (change in impulse conduction cardiac). These events resolved spontaneously. With high doses that produce exposures to high to the drug, can be observed in jaundice (yellowish color of the skin and mucous membranes) due to hyperbilirubinemia nãoconjugada (indirect) (no changes in liver function test associated with) or prolongation of the interval PR.

The treatment of superdose with REYATAZ should consist of measures of general support, including monitoring of vital signs and ecg, and observations of the clinical status of the patient. If indicated, elimination of atazanavir are not absorbed must be carried out by means of êmese (induction of vomiting) or gastric lavage. The administration of activated charcoal may also be used in order to assist in removal of the medicine is not absorbed.

there is No specific antidote to the superdose with REYATAZ. Dialysis is not commonly beneficial in removing significant of this medicine.

In the case of use of large amount of this medicine, look for fast medical help and take the packaging or package insert for the drug, if possible. Call 0800 722 6001 if you need more guidance.