Apo-Atazanavir: Uses, Side Effects and Dosage

What is APO-ATAZANAVIR used for?

APO-ATAZANAVIR is used in combination with other antiviral drugs to treat human immunodeficiency virus (HIV) infection in adults and pediatric patients 6 years of age and older and weighing at least 20 kg. HIV is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

How does APO-ATAZANAVIR work?

HIV destroys CD4+ (T) cells. These cells are important to help the immune system fight infection. After a large number of T cells are destroyed, AIDS develops. APO-ATAZANAVIR belongs to a family of medicines called protease inhibitors. These help control HIV infection by blocking HIV protease, an enzyme that HIV needs to multiply. This lowers the amount of HIV in your blood (called “viral load”) and allows the number of T cells in your body to increase.

APO-ATAZANAVIR does not cure HIV infection or AIDS. You may continue to develop infections or other conditions associated with HIV infection. Because of this, it is very important for you to remain under the care of a healthcare professional while taking APO-ATAZANAVIR.

What are the ingredients in APO-ATAZANAVIR?

Medicinal ingredient: atazanavir (as atazanavir sulfate).

Non-medicinal ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and sodium starch glycolate.

The capsule shells contain the following inactive ingredients: edible black ink, FD&C Blue #2 (for all strength), iron oxide black (300 mg only), iron oxide red (300 mg only), gelatin and titanium dioxide (for all strengths) and sodium lauryl sulfate (300 mg only).

Imprinting ink (edible black ink) contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.

APO-ATAZANAVIR comes in the following dosage forms:

Capsules: 150 mg, 200 mg and 300 mg of atazanavir (as atazanavir sulfate).

Do not use APO-ATAZANAVIR if:

• you are taking any medication listed in this leaflet in the Serious Drug Interactions box below.
• you are allergic to atazanavir sulfate or any of the other ingredients in APO-ATAZANAVIR.
• you have or have had severe liver disease.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-ATAZANAVIR. Talk about any health conditions or problems you may have, including if you:

• have liver problems, including Hepatitis B or C infection because the dose of APO-ATAZANAVIR may need to be reduced.
• have kidney problems.
• have or have had heart problems including a slow heartbeat or a genetic condition called “long congenital QT syndrome”.
• have problems with your electrolytes (low levels of potassium, magnesium or calcium in your blood) or suffer from excessive vomiting or diarrhea.
• have hemophilia Type A or B.
• have lactic acidosis (high levels of acid in the blood). See the Serious side effects and what to do about them table below for symptoms. Talk to your healthcare professional right away if you get these symptoms.
• are taking quetiapine (SEROQUEL*, SEROQUEL* XR), a medicine used to treat mental health problems such as schizophrenia. Serious side effects that could result in death have happened in patients taking quetiapine together with HIV protease inhibitors.

• are lactose intolerant or have one of the following rare hereditary diseases:

  • Galactose intolerance,
  • Lapp lactase deficiency, or
  • Glucose-galactose malabsorption,

because lactose is a non-medicinal ingredient in APO-ATAZANAVIR.

Other warnings you should know about:

APO-ATAZANAVIR can cause serious side effects:

• Gallbladder problems: Gallstones and gallbladder inflammation have been reported.
• Heart problems: APO-ATAZANAVIR can cause changes in the way your heart beats (heart rhythm changes).
• Immune reconstitution inflammatory syndrome: Changes to your immune system can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Autoimmune disorders can also happen. This is when the immune system attacks healthy body tissue. Examples of this include Grave's disease (which affects the thyroid gland), Guillain-Barré syndrome (which affects the nervous system) or polymyositis (which affects the muscles). Autoimmune disorders may occur many months after the start of treatment.
• Kidney stones: There have been reports of kidney stones.
• Serious skin reactions: Serious skin reactions including Stevens-Johnson syndrome (SJS), erythema multiforme and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in patients receiving APO-ATAZANAVIR.

See the Serious side effects and what to do about them table below for more information on these and other serious side effects.

Diabetes and high blood sugar: There have been reports of increased blood sugar and development or worsening of diabetes in patients using protease inhibitors like APO-ATAZANAVIR. Tell your healthcare professional if you have diabetes or a history of high blood sugar. If you take insulin or oral medicines to control your blood sugar your dose might need to be changed.

Fat redistribution: Changes in body fat have been seen in some patients taking antiretroviral medicine. These changes may include increased amount of fat in the upper back and neck (buffalo hump), the breasts and around the trunk. Loss of fat from the legs, arms and face may also happen.

Pregnancy and breastfeeding:

• Tell your healthcare professional if you are pregnant, think you might be pregnant or are planning to become pregnant. It is not known if APO-ATAZANAVIR can harm your unborn baby.
• Pregnant women have experienced serious side effects when taking APO-ATAZANAVIR with other HIV medicines called nucleoside analogues.
• If you get pregnant while taking APO-ATAZANAVIR you and your healthcare professional will need to decide if APO-ATAZANAVIR is right for you.
• There is a registry for women who take antiretroviral medicines during pregnancy called the Antiretroviral Pregnancy Registry. The purpose of this registry is to collect information about the health of you and your baby. If you take APO-ATAZANAVIR while you are pregnant, talk to your healthcare professional about taking part in the registry.
• APO-ATAZANAVIR passes into breast milk. You should not take APO-ATAZANAVIR if you are breastfeeding. This is also to avoid transmission of HIV to your infant through breast milk. Talk to your healthcare professional about how to feed your baby.

Infecting others with HIV: APO-ATAZANAVIR will not stop you from passing HIV to others, although this risk is lower if you take your HIV medicine as instructed by your healthcare professional. You should take steps to avoid this by:

• Using condoms when you have oral or penetrative sex.
• Not reusing or sharing needles, syringes, or other injection equipment.

Blood tests and monitoring: APO-ATAZANAVIR can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may also interact with APO-ATAZANAVIR:

• antipsychotics, medicines used to treat mental health problems (e.g., schizophrenia and bipolar disorder) such as quetiapine (SEROQUEL* or SEROQUEL* XR), and lurasidone (LATUDA*) when used without ritonavir.
• endothelin receptor antagonists, medicines used to treat pulmonary arterial hypertension (high blood pressure in the lungs) such as bosentan (TRACLEER*) when taken with APO-ATAZANAVIR without ritonavir.
• proton pump inhibitors, medicines used for indigestion and heart burn or ulcers such as omeprazole (LOSEC*).
• Hepatitis C direct-acting antivirals, medicines used to treat Hepatitis C infections such as sofosbuvir/velpatasvir/voxilaprevir (VOSEVI*).
• inhaled beta agonists, medicines used to treat breathing problems like asthma and COPD such as salmeterol (SEREVENT DISKUS*), and salmeterol with fluticasone (ADVIR*).
• phosphodiesterase type 5 (PDE5) inhibitors for erectile dysfunction such as sildenafil (VIAGARA*), and tadalafil (CIALIS*).
• phosphodiesterase type 5 (PDE5) inhibitors for pulmonary arterial hypertension (high blood pressure in the lungs) such as sildenafil (REVATIO*), and tadalafil (ADCIRCA*).
• antiplatelets, medicines used to prevent blood clots such as clopidogrel (PLAVIX*).

• other antivirals, medicines used to treat HIV and AIDS such as didanosine (VIDEX*) buffered formulations or didanosine EC formulation. APO-ATAZANAVIR must be taken with a meal either 1 hour before or 2 hours after taking these types of drugs; tenofovir disoproxil fumarate (VIREAD*), efavirenz, saquinavir (soft gelatine capsules), ritonavir (NORVIR*), and other protease inhibitors.

• antacids, medicines used to treat heartburn and stomach upset; APO-ATAZANAVIR must be taken with a meal either 1 hour before or 2 hours after taking these types of drugs.
• antiarrhythmics, medicines used to treat irregular heartbeat such as lidocaine (when given by injection).
• anticoagulants, medicines used to thin the blood and prevent blood clots such as warfarin (COUMADIN*), dabigatran (PRADAXA*), and edoxaban (LIXIANA*).
• antidepressants, medicines used to treat depression such as tricyclic antidepressants, amitriptyline (ELAVIL*), imipramine (TOFRANIL*), and trazodone (OLEPTRO*).
• anticonvulsants, medicines used to prevent seizures such as lamotrigine (LAMICTAL*).
• antifungals, medicines used to treat fungal infections such as ketoconazole (NIZORAL*), itraconazole (SPORANOX*), and voriconazole (VFEND*).
• antimycobacterials, medicines used to treat infections like tuberculosis (TB) such as rifabutin (MYCOBUTIN*).
• benzodiazepines, medicines often used to treat anxiety such as midazolam when injected.
• gonadotropin-releasing hormone antagonist receptor (GnRH) antagonists, medicines used to suppress sex hormone production such as elagolix (ORILISSA*).
• calcium channel blockers, medicines used to lower blood pressure such as diltiazem (CARDIZEM* or TIAZAC*), desacetyl diltiazem, felodipine (PLENDIL*), nifedipine (ADALAT*), nicardipine (CARDENE*), and verapamil (SOPTIN* or VERELAN*).
• kinase inhibitors, medicines used to treat low blood platelets such as fostamatinib (TAVALISSE*).
• hydroxymethylglutaryl-CoA (HMG-CoA) reductase inhibitors, medicines used to lower cholesterol such as atorvastatin (LIPITOR*), and rosuvastatin (CRESTOR*).
• immunosuppressants, medicines used in organ transplants such as cyclosporin (SANDIMMUNE* or NEORAL*), tacrolimus (PROGRAF*), and sirolimus (RAPAMUNE*).
• corticosteroids, medicines used to treat inflammation such as dexamethasone, and fluticasone propionate (FLONASE* or FLOVENT*).
• antibiotics, medicines used to treat bacterial infections such as clarithromycin (BIAXIN*).
• oral contraceptives, medicines used for birth control such as ethinyl estradiol, norgestimate, and norethindrone.
• stomach acid reducing agents such as famotidine (PEPCID AC*).

How to take APO-ATAZANAVIR:

• Take APO-ATAZANAVIR exactly as your healthcare professional has told you. Do not change your dose or stop taking APO-ATAZANAVIR without talking to your healthcare professional.
• APO-ATAZANAVIR should always be taken with other antiretrovirals used to treat HIV infection.
• APO-ATAZANAVIR should be taken with food at about the same time each day.
• APO-ATAZANAVIR capsules should not be opened, they should be swallowed whole with water.

Usual dose:

For adults, who have never taken HIV medicines before:

• 300 mg once daily taken with ritonavir 100 mg once daily;

  OR

• 400 mg (two 200 mg capsules) once daily (without ritonavir).

For adults who have taken HIV medicines before:

• 300 mg once daily taken with ritonavir 100 mg once daily.

For children from 6 to 18 years of age, weighing at least 20 kg:

• Your child’s healthcare professional will decide on the dose that is best for them depending on their weight.

Overdose:

Missed Dose:

If you forget to take a dose, take the dose you missed as soon as possible with some food, and then return to your normal schedule. However, if a dose is skipped, do not double the next dose. Continue as normal with your next dose.

What are possible side effects from using APO-ATAZANAVIR?

These are not all the possible side effects you may have when taking APO-ATAZANAVIR If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• nausea,
• vomiting,
• diarrhea,
• abdominal pain,
• indigestion,
• headache,
• dizziness,
• insomnia,
• fever,
• muscle pain.

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Store at 15°C to 30°C. Protect from moisture.

Keep out of reach and sight of children.

If you want more information about APO-ATAZANAVIR:

• Talk to your healthcare professional.

• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website:

  • https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.

Last Revised: SEP 06, 2024

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