atazanavir 50 mg oral powder packet

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Medication name

Generic name:
Atazanavir powder packet - oral

Pronunciation
(A-ta-ZAN-a-vir)

Brand name(s)
Reyataz

Uses

This form of atazanavir is used with other HIV medications for infants and children to help control HIV infection. It helps to decrease the amount of HIV in the body so your child's immune system can work better. This lowers the chance of getting HIV complications (such as new infections, cancer) and improves your child's quality of life.

Atazanavir belongs to a class of drugs known as protease inhibitors. This form of atazanavir must be given with a certain other protease inhibitor (ritonavir) to increase ("boost") the levels of atazanavir. This helps atazanavir work better.

Atazanavir is not a cure for HIV infection. To decrease the risk of spreading HIV disease to others, your child should continue to take all HIV medications exactly as prescribed by the doctor. Do not share your child's personal items (such as needles/syringes, toothbrushes) that may have contacted blood or other body fluids. Consult the doctor or pharmacist for more details.

Other uses

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This product may also be used to lessen the risk of HIV infection after contact with the virus (for example, due to a needle stick). Ask your doctor for more details.

How to use

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start giving atazanavir to your child and each time you get a refill. If you have any questions, ask the doctor or pharmacist.

This medication is taken by mouth. Give this medication to your child as directed by the doctor, usually once daily. Open the packet and mix its contents with food (such as applesauce, yogurt) as directed. If your child cannot eat solid food, this medication may be mixed with liquid (such as milk, infant formula, or water). If your child is younger than 6 months and cannot eat solid food or drink from a cup, mix this medication with infant formula as directed and give it to your child using an oral syringe. Do not use a baby bottle. Give the dose within 1 hour after mixing with food or liquid. Also, give your child's ritonavir dose right after this medication.

Since this medication may cause kidney problems, give plenty of fluids during treatment to lower the risk.

The dosage is based on your child's medical condition, weight, response to treatment, and other medications your child may be taking. Be sure to tell the doctor and pharmacist about all the products your child uses (including prescription drugs, nonprescription drugs, and herbal products).

If your child is taking antacids or buffered forms of drugs (such as buffered aspirin), give atazanavir at least 2 hours before or 1 hour after these medications.

For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same time every day.

It is very important to continue giving this medication (and other HIV medications) exactly as prescribed by the doctor. Do not skip any doses. Do not give more or less of this drug than prescribed or stop giving it (or other HIV medicines) even for a short time unless directed to do so by the doctor. Doing so may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.

Side effects

Headache or nausea may occur. If either of these effects lasts or gets worse, tell the doctor or pharmacist promptly.

Remember that this medication has been prescribed because the doctor has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.

As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including:

  • unexplained weight loss
  • severe tiredness
  • muscle aches/weakness that doesn't go away
  • headaches that are severe or don't go away
  • joint pain
  • numbness/tingling of the hands/feet/arms/legs
  • vision changes
  • signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores)
  • signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter)
  • signs of a certain nerve problem known as Guillain-Barre syndrome (such as unsteadiness, loss of coordination, trouble swallowing/speaking/chewing, trouble moving your eyes)

Tell the doctor right away if your child has any serious side effects, including:

  • increased thirst/urination
  • dizziness
  • lightheadedness
  • signs of kidney problems (such as pain in side/back/abdomen, painful urination, blood in the urine, change in the amount of urine)
  • signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)

Get medical help right away if your child has any very serious side effects, including:

  • signs of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating)

Changes in body fat may occur while your child is taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with the doctor, as well as the possible use of exercise to reduce this side effect.

Atazanavir can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if your child develops any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking atazanavir, tell the doctor or pharmacist if your child is allergic to it; or if your child has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell the doctor or pharmacist your child's medical history, especially of:

  • liver problems (including hepatitis B or C infections)
  • kidney problems (including kidney stones)
  • heart problems (such as heart rhythm problems, irregular heartbeat, coronary artery disease, heart attack)
  • a certain bleeding problem (hemophilia)

Atazanavir may increase the level of cholesterol and fats (triglycerides) in the blood. HIV infection can also cause this effect. This could increase your child's risk for heart problems such as a heart attack. Discuss the risks and benefits of treatment with the doctor and ways to lower the risk of heart disease. Tell the doctor if your child has heart problems or other conditions that increase the risk of heart disease such as high blood pressure, diabetes, or high cholesterol/triglyceride levels.

This medication may contain aspartame. If your child has phenylketonuria (PKU) or any other condition that requires your child to limit/avoid aspartame (or phenylalanine) in the diet, ask the doctor or pharmacist about using this medication safely.

Before having surgery, tell the doctor or dentist about all the products your child uses (including prescription drugs, nonprescription drugs, and herbal products).

Atazanavir should not be given to children younger than 3 months because of the risk of very serious side effects.

This form of atazanavir is not usually used by adults. It is unlikely to be used during pregnancy or breastfeeding. Consult the doctor if you have any questions about this medication.

Drug interactions

See also How to Use section.

Drug interactions may change how medications work or increase the risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products your child uses (including prescription/nonprescription drugs and herbal products) and share it with the doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without the doctor's approval.

Some products that may interact with this drug include:

  • certain medications used to treat chronic hepatitis C (such as elbasvir/grazoprevir, glecaprevir/pibrentasvir)
  • a certain combination HIV medication (elvitegravir/cobicistat/emtricitabine/tenofovir)
  • indinavir
  • nevirapine
  • orlistat

Atazanavir can slow down the removal of other medications from your child's body, which may affect how they work. Examples of affected drugs include certain alpha blockers (such as alfuzosin, silodosin), certain benzodiazepines (midazolam, triazolam), ergot alkaloids (such as dihydroergotamine, ergotamine), irinotecan, lomitapide, pimozide, a certain drug to treat erectile dysfunction-ED or pulmonary hypertension (sildenafil), certain "statin" cholesterol drugs (lovastatin, simvastatin), salmeterol, among others.

Other medications can affect the removal of atazanavir from your child's body, which may affect how atazanavir works. Examples include apalutamide, bosentan, efavirenz, etravirine, lumacaftor, certain rifamycins (such as rifampin, rifapentine), certain drugs used to treat seizures (such as carbamazepine, phenobarbital, phenytoin, primidone), St. John's wort, among others.

Prescription and nonprescription drugs to treat heartburn, indigestion, or ulcers (including H2 blockers such as famotidine, proton pump inhibitors such as lansoprazole/omeprazole) reduce stomach acid and decrease the absorption of atazanavir. This may prevent atazanavir from working well. Ask the doctor or pharmacist how to use these medications safely.

If you are breastfeeding your child, ask the doctor if any medications that you are using may pass into the breast milk and interact with this medication.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe dizziness, lightheadedness.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as viral load, T-cell counts, kidney/liver function, cholesterol/triglyceride levels, blood sugar levels) should be done while your child is taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed dose

If you miss a dose, give it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Give the next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not open the packet until you are ready to use the medication. Do not store in the bathroom. Keep all medications away from children and pets.

After mixing, this medication may be stored at room temperature for up to 1 hour.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Important note

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised August 2024.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.