This drug is used with other HIV medications to help
control HIV infection. It helps to decrease the amount of HIV in your body
so your immune system can work better. This lowers your chance of getting
HIV complications (such as new infections, cancer) and improves your
quality of life. Atazanavir belongs to a class of drugs known as protease
inhibitors. Cobicistat is used to increase ("boost") the levels of
atazanavir. This helps atazanavir work better.
Atazanavir/cobicistat is not a cure for HIV infection.
To decrease your risk of spreading HIV disease to others, continue to take
all HIV medications exactly as prescribed by your doctor. Use an effective
barrier method (latex or polyurethane condoms/dental dams) during sexual
activity as directed by your doctor. Do not share personal items (such as
needles/syringes, toothbrushes, and razors) that may have contacted blood
or other body fluids. Consult your doctor or pharmacist for more
details.
Read the Patient Information Leaflet if available from
your pharmacist before you start taking atazanavir/cobicistat and each time
you get a refill. If you have any questions, ask your doctor or
pharmacist.
Take this medication by mouth with food as directed by
your doctor, usually once daily. Since this medication may cause kidney
problems, drink plenty of fluids during treatment to lower your
risk.
If you are taking antacids or buffered forms of drugs
(such as buffered aspirin), take this medication at least 2 hours before or
1 hour after these medications.
It is very important to keep taking this medication (and
other HIV medications) exactly as prescribed by your doctor. Do not skip
any doses.
For the best effect, take this medication at evenly
spaced times. To help you remember, take this medication at the same time
every day.
Do not take more or less of this drug than prescribed or
stop taking it (or other HIV medicines) even for a short time unless
directed to do so by your doctor. Doing so may cause the amount of virus to
increase, make the infection more difficult to treat (resistant), or worsen
side effects.
Nausea may occur. If this effect lasts or gets worse,
tell your doctor or pharmacist promptly.
Remember that this medication has been prescribed
because your doctor has judged that the benefit to you 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 your doctor right away if you have 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 you have 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 you are 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
your doctor, as well as the possible use of exercise to reduce this side
effect.
This medication 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 you develop 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 your 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.
Before taking atazanavir/cobicistat, tell your doctor or
pharmacist if you are allergic to atazanavir; or to cobicistat; or if you
have 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 your doctor or
pharmacist your 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)
This medication may increase the level of cholesterol
and fats (triglycerides) in your blood. HIV infection can also cause this
effect. This could increase your risk for heart problems such as a heart
attack. Discuss the risks and benefits of treatment with your doctor and
ways to lower your risk of heart disease. Tell your doctor if you have
heart problems, if you smoke, or if you have other conditions that increase
your risk of heart disease such as high blood pressure, diabetes, or high
cholesterol/triglyceride levels.
Before having surgery, tell your doctor or dentist about
all the products you use (including prescription drugs, nonprescription
drugs, and herbal products).
This medication is not recommended for use during
pregnancy. It may not work well in a pregnant woman. If you become pregnant
or think you may be pregnant, tell your doctor right away. Your doctor may
change your HIV medications.
Atazanavir passes into breast milk. It is unknown if
cobicistat passes into breast milk. Because breast milk may transmit HIV,
consult your doctor before breastfeeding.
See also How to Use section.
Drug interactions may change how your medications work
or increase your risk for serious side effects. This document does not
contain all possible drug interactions. Keep a list of all the products you
use (including prescription/nonprescription drugs and herbal products) and
share it with your doctor and pharmacist. Do not start, stop, or change the
dosage of any medicines without your doctor's approval.
Some products that may interact with this drug
include:
- drospirenone/estradiol
- elvitegravir
- certain medications used to treat chronic hepatitis C (such
as elbasvir/grazoprevir, glecaprevir/pibrentasvir)
- indinavir
- orlistat
- ritonavir
This medication can slow down the removal of other
medications from your body, which may affect how they work. Examples of
affected drugs include certain alpha blockers (such as alfuzosin,
silodosin), certain benzodiazepines (midazolam, triazolam), dronedarone,
ergot alkaloids (such as dihydroergotamine, ergotamine), irinotecan,
lurasidone, pimozide, ranolazine, rivaroxaban, salmeterol, certain drugs to
treat erectile dysfunction-ED or pulmonary hypertension (avanafil,
sildenafil), certain "statin" cholesterol drugs (lovastatin, simvastatin),
among others.
Other medications can affect the removal of this
medication from your body, which may affect how this medication works.
Examples include apalutamide, lumacaftor, mitotane, certain HIV NNRTIs
(such as efavirenz, etravirine, nevirapine), 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 your doctor or pharmacist how to use
these medications safely.
This medication may decrease the effectiveness of
hormonal birth control such as pills, patch, or ring. This could cause
pregnancy. Discuss with your doctor or pharmacist if you should use
reliable backup birth control methods while using this medication. Also
tell your doctor if you have any new spotting or breakthrough bleeding,
because these may be signs that your birth control is not working
well.
Do not use this medication with other products that
contain atazanavir or cobicistat.
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.
Do not share this medication with others.
Lab and/or medical tests (such as viral load, T-cell
counts, liver/kidney function, cholesterol/triglyceride levels, blood sugar
levels) should be done before you start taking this medication and while
you are taking it. Keep all medical and lab appointments. Consult your
doctor for more details.
If you miss a dose, take it as soon as you remember. If
it is near the time of the next dose, skip the missed dose. Take your next
dose at the regular time. Do not double the dose to catch
up.
Store at room temperature away from light and moisture.
Do not store in the bathroom. Keep all medications away from children and
pets.
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.