Usual Adult Dose for HIV Infection

300 mg orally once a day

Use: In combination with other antiretroviral agents, for the treatment of HIV-1
infection

Usual Adult Dose for Chronic Hepatitis B

300 mg orally once a day
Duration of therapy: Optimum duration unknown

Usual Adult Dose for Occupational Exposure

US Public Health Service working group recommendations: 300 mg orally once a
day
Duration of therapy: 28 days, if tolerated

Comments:
-This drug and emtricitabine (as emtricitabine-tenofovir disoproxil fumarate [DF])
plus raltegravir is recommended as the preferred regimen for HIV postexposure
prophylaxis; this drug is also recommended as a component in various alternative
regimens.
-Prophylaxis should be started as soon as possible, preferably within hours after
exposure.
-The optimal duration of prophylaxis is unknown and may differ based on the
institution protocol.
-Current guidelines should be consulted for additional information.

Usual Adult Dose for Nonoccupational Exposure

US CDC recommendations: 300 mg orally once a day
Duration of therapy: 28 days

Comments:
-This drug and emtricitabine (as emtricitabine-tenofovir DF) plus (raltegravir or
dolutegravir) is recommended as the preferred regimen for nonoccupational
postexposure prophylaxis of HIV infection in adults (including pregnant women)
with CrCl at least 60 mL/min; this drug and emtricitabine (as emtricitabine-
tenofovir DF) plus darunavir/ritonavir is recommended as an alternative regimen
for such patients. If other alternatives are considered, this drug is recommended
as a component in various regimens.
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for HIV Infection

2 to less than 12 years: 8 mg/kg orally once a day
Maximum dose: 300 mg/dose

12 years or older and at least 35 kg: 300 mg orally once a day

Dose based on body weight for pediatric patients 2 years or older:

Oral powder:
10 to less than 12 kg: 80 mg (2 scoops of powder) orally once a day
12 to less than 14 kg: 100 mg (2.5 scoops of powder) orally once a day
14 to less than 17 kg: 120 mg (3 scoops of powder) orally once a day
17 to less than 19 kg: 140 mg (3.5 scoops of powder) orally once a day
19 to less than 22 kg: 160 mg (4 scoops of powder) orally once a day
22 to less than 24 kg: 180 mg (4.5 scoops of powder) orally once a day
24 to less than 27 kg: 200 mg (5 scoops of powder) orally once a day
27 to less than 29 kg: 220 mg (5.5 scoops of powder) orally once a day
29 to less than 32 kg: 240 mg (6 scoops of powder) orally once a day
32 to less than 34 kg: 260 mg (6.5 scoops of powder) orally once a day
34 to less than 35 kg: 280 mg (7 scoops of powder) orally once a day
At least 35 kg: 300 mg (7.5 scoops of powder) orally once a day

Tablets:
17 to less than 22 kg: 150 mg orally once a day
22 to less than 28 kg: 200 mg orally once a day
28 to less than 35 kg: 250 mg orally once a day
At least 35 kg: 300 mg orally once a day

Comments:
-Weight should be monitored periodically and the dose should be adjusted
accordingly.

Use: In combination with other antiretroviral agents, for the treatment of HIV-1
infection

Tenofovir disoproxil fumarate (tenofovir DF) can cause serious, life-threatening side
effects. These include a buildup of lactic acid in the blood (lactic acidosis) and
severe liver problems.
 Contact your health care provider right away if you have any of the following symptoms
that could be signs of lactic acidosis:
Feeling very weak or tired
Unusual muscle pain

Trouble breathing

Stomach pain with nausea or vomiting

Feeling cold, especially in your arms and legs

Feeling dizzy or lightheaded

Fast or irregular heartbeat

Contact your health care provider right away if you have any of the following symptoms
that could be signs of severe liver problems:

Yellowing of your skin or the whites of your eyes (jaundice)

Dark-colored urine

Light-colored bowel movements

Loss of appetite for several days or longer

Nausea

Stomach pain

If you have both HIV and hepatitis B virus (HBV) infection and take tenofovir DF, your HBV
infection may get much worse (flare up) if you stop taking tenofovir DF. The HBV drug
adefovir dipivoxil (brand name: Hepsera) should not be taken with tenofovir DF.

While taking tenofovir DF, it is important to keep all of your appointments with your health
care provider.
What is tenofovir disoproxil fumarate?

What is tenofovir disoproxil fumarate?

Tenofovir DF is a prescription medicine approved by the U.S. Food and Drug

Administration (FDA) for the treatment of HIV infection in adults and children 2 years of age
and older. Tenofovir DF is always used in combination with other HIV medicines.

Tenofovir DF belongs to a class (group) of HIV drugs called nucleoside reverse

transcriptase inhibitors (NRTIs). NRTIs block an HIV enzyme called reverse transcriptase.
(An enzyme is a protein that starts or increases the speed of a chemical reaction.) By
 blocking reverse transcriptase, NRTIs prevent HIV from multiplying and can reduce the
amount of HIV in the body.

HIV medicines can't cure HIV/AIDS, but taking a combination of HIV medicines (called an
HIV regimen) every day helps people with HIV live longer, healthier lives. HIV medicines also
reduce the risk of HIV transmission. If you are taking HIV medicines, including tenofovir DF,
don't cut down on, skip, or stop taking them unless your health care provider tells you to.

Tenofovir DF is also effective against HBV and approved by FDA for the treatment of
chronic HBV infection in adults and children 12 years of age and older. For information on
the HBV-related use of tenofovir DF in people with HIV, please refer to the HBV section of
the Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected
Adults and Adolescents.
What should I tell my health care provider before taking tenofovir disoproxil fumarate?

What should I tell my health care provider before taking

tenofovir disoproxil fumarate?

Before taking tenofovir DF, tell your health care provider:

If you are allergic to tenofovir DF or any other medicines.
If you have liver problems, including HBV infection.

If you have kidney problems.

If you have bone problems.

If you have any other medical conditions.

If you are pregnant or plan to become pregnant. Whether tenofovir DF can harm an
unborn baby is unknown. Tenofovir DF should be used during pregnancy only if clearly
needed. Talk to your health care provider about possible risks with taking tenofovir DF when
pregnant.

If you are breastfeeding or plan to breastfeed. Do not breastfeed if you are infected
with HIV or are taking tenofovir DF.

If you are using hormone-based birth control (such as pills, implants, or vaginal
rings). For more information about using birth control and HIV medicines at the same time,
view the AIDSinfo HIV and Birth Control infographic.

About other prescription and nonprescription medicines, vitamins, nutritional

supplements, and herbal products you are taking or plan to take. Tenofovir DF may affect
the way other medicines or products work, and other medicines or products may affect how
tenofovir DF works. Taking tenofovir DF together with certain medicines or products may
cause serious, life-threatening side effects.

How should I take tenofovir disoproxil fumarate?

 How should I take tenofovir disoproxil fumarate?

Tenofovir DF (brand name: Viread) comes in the following forms and strengths:
150-mg tablets
200-mg tablets

250-mg tablets

300-mg tablets

Oral powder (40 mg of tenofovir DF per 1 g of powder)

Take tenofovir DF according to your health care provider's instructions.

Tenofovir DF tablets should be swallowed whole and can be taken with or without food.
People who are unable to swallow the tablets whole may take the oral powder. Use the
provided dosing scoop to measure the oral powder. Mix the oral powder with soft foods that
can be swallowed without chewing, such as applesauce, baby food, or yogurt. Take
the dose of oral powder right after mixing it. Do not mix the oral powder with liquid.

Always take tenofovir DF in combination with other HIV medicines.

If you take too much tenofovir DF, contact your health care provider or local poison control
center (1-800-222-1222) right away, or go to the nearest hospital emergency room.

For more information on how to take tenofovir DF, see the FDA drug label from DailyMed.
(DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)
What should I do if I forget a dose?

What should I do if I forget a dose?

If you miss a dose of tenofovir DF, take the missed dose as soon as you remember it. But if
it is almost time for your next dose, skip the missed dose and just take your next dose at
the regular time. Do not take two doses at the same time to make up for a missed dose.
What side effects can tenofovir disoproxil fumarate cause?

What side effects can tenofovir disoproxil fumarate cause?

Tenofovir DF may cause side effects. Most side effects from tenofovir DF are manageable,
but a few can be serious. Serious side effects of tenofovir DF include a buildup of lactic
acid in the blood (lactic acidosis) and severe liver problems. (See the WARNING box
above.)

Other possible side effects of tenofovir DF include:

New or worsening kidney problems, including kidney failure.
 Bone problems, including bone pain, softening, or thinning (osteopenia), which may
lead to fractures.

Changes in body fat (including gain or loss of fat).

Immune reconstitution inflammatory syndrome (IRIS), a condition that sometimes

occurs when the immune system begins to recover after treatment with an HIV medicine. As
the immune system gets stronger, it may have an increased response to a previously hidden
infection.

Tell your health care provider if you have any side effect that bothers you or that does not
go away.

These are not all the possible side effects of tenofovir DF. To learn more about possible
side effects of tenofovir DF, read the drug label or package insert or talk to your health care
provider or pharmacist.

The AIDSinfo fact sheet on HIV Medicines and Side Effects also includes information that
may apply to tenofovir DF.

You can also report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online
at https://www.accessdata.fda.gov/scripts/medwatch/.
How should tenofovir disoproxil fumarate be stored?

Atazanavir can cause serious, life-threatening side effects. These include heart rhythm
problems, severe rash, liver problems, and life-threatening drug interactions.

Contact your health care provider right away if you have any of the following symptoms
that could be signs of heart rhythm problems:
Dizziness
Lightheadedness

Stop taking atazanavir and contact your health care provider right away if you have a
severe rash or a rash combined with any of the following symptoms:
General ill feeling or flu-like symptoms
Fever

Muscle or joint aches

Red or inflamed eyes, like pink eye (conjunctivitis)

Blisters

Mouth sores
 Swelling of the face

Painful, warm, or red lump under your skin

In people with liver problems, including infection with hepatitis B virus (HBV) or hepatitis C
virus (HCV), atazanavir can cause worsening of liver problems. Contact your health care
provider right away if you have any of the following symptoms that could be signs of liver
problems:
Yellowing of your skin or the whites of your eyes (jaundice)
Dark-colored urine

Light-colored bowel movements

Nausea

Itching

Pain in the stomach area (abdominal pain)

While taking atazanavir, it is important to keep all of your appointments with your health
care provider.
What is atazanavir?

What is atazanavir?

Atazanavir is a prescription medicine approved by the U.S. Food and Drug

Administration (FDA) for the treatment of HIV infection in adults and children 3 months of
age and older who weigh at least 11 pounds (5 kg). Atazanavir is always used in
combination with other HIV medicines.

Atazanavir belongs to a class (group) of HIV medicines called protease inhibitors (PIs). PIs
block an HIV enzyme called protease. (An enzyme is a protein that starts or increases the
speed of a chemical reaction.) By blocking protease, PIs prevent HIV from multiplying and
can reduce the amount of HIV in the body.

HIV medicines cant cure HIV/AIDS, but taking a combination of HIV medicines (called an
HIV regimen) every day helps people with HIV live longer, healthier lives. HIV medicines also
reduce the risk of HIV transmission.
What should I tell my health care provider before taking atazanavir?

What should I tell my health care provider before taking

atazanavir?

Before taking atazanavir, tell your health care provider:

If you are allergic to atazanavir or any other medicines.
 If you have heart problems.

If you have liver problems, including HBV or HCV infection.

If you have phenylketonuria (PKU). Atazanavir oral powder includes an artificial

sweetener (aspartame) that contains phenylalanine. Phenylalanine may be harmful to people
with PKU.

If you are receiving kidney dialysis treatment.

If you have diabetes.

If you have hemophilia.

If you have any other medical conditions.

If you are pregnant or plan to become pregnant. Talk to your health care provider
about taking atazanavir when pregnant. After your baby is born, tell your health care provider
if your babys skin or the white part of the eyes turns yellow.

If you are breastfeeding or plan to breastfeed. Do not breastfeed if you are infected
with HIV or are taking atazanavir.

If you are using hormone-based birth control (such as pills, implants, or vaginal
rings). Atazanavir may make these forms of birth control less effective. Your health care
provider can help you decide how to adjust your birth control while you are taking atazanavir.
For more information about using birth control and HIV medicines at the same time, view
the AIDSinfo HIV and Birth Control infographic.

About other prescription and nonprescription medicines, vitamins, nutritional

supplements, and herbal products you are taking or plan to take. Atazanavir may affect the
way other medicines or products work, and other medicines and products may affect how
atazanavir works. Taking atazanavir together with certain medicines or products may cause
serious, life-threatening side effects.

How should I take atazanavir?

How should I take atazanavir?

Atazanavir (brand name: Reyataz) comes in the following forms and strengths:
150-mg, 200-mg, and 300-mg capsules
Oral powder (50 mg of atazanavir per packet)

Atazanavir capsules are for use in adults and in children 6 years of age and older.
Atazanavir oral powder must be taken with ritonavir and is for use in children 3 months of
age and older who weigh at least 11 pounds (5 kg).

Take atazanavir according to your health care providers instructions.

Take atazanavir with food. Swallow the capsules whole. Do not open the capsules.
 Atazanavir oral powder must be mixed with food or liquid. For a child who can take food,
mix the oral powder with food such as applesauce or yogurt, instead of a liquid (milk, infant
formula, or water). If atazanavir oral powder is mixed with water, your child must eat food
right after taking the oral powder and water mixture. For infants less than 6 months old
and who cannot eat solid food or drink from a cup, first mix the oral powder with infant
formula. Then use an oral dosing syringe to give the oral powder and formula mixture to the
infant. (Ask your pharmacist for a dosing syringe.) (Give ritonavirright away after your child
has taken atazanavir oral powder mixed with food or liquid.) For instructions on using
atazanavir oral powder, see the Patient Information leaflet that comes with the medicine.

Always take atazanavir in combination with other HIV medicines.

If you take too much atazanavir, contact your health care provider or local poison control
center (1-800-222-1222) right away, or go to the nearest hospital emergency room.

For more information on how to take atazanavir, see the FDA drug label from DailyMed.
(DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)
What should I do if I forget a dose?

What should I do if I forget a dose?

If you miss a dose of atazanavir, take the missed dose as soon as you remember it. But if it
is almost time for your next scheduled dose, skip the missed dose and just take your next
dose at the regular time. Do not take two doses at the same time to make up for a missed
dose.
What side effects can atazanavir cause?

What side effects can atazanavir cause?

Atazanavir may cause side effects. Many side effects from HIV medicines, such as nausea
or occasional dizziness, are manageable. See the AIDSinfo fact sheet on HIV Medicines and
Side Effectsfor more information.

Some side effects of atazanavir can be serious. Serious side effects of atazanavir include
heart rhythm problems, severe rash, liver problems, and life-threatening drug
interactions. (See the WARNING box above.)

Other possible side effects of atazanavir include:

Mild rash (redness and itching).
Yellowing of your skin or the whites of your eyes (jaundice), caused by increases
in bilirubin levels in your blood. Contact your health care provider right away if you have this
side effect.

Chronic kidney disease.

 Diabetes and high blood sugar (hyperglycemia).

Changes in body fat (including gain or loss of fat).

Immune reconstitution inflammatory syndrome (IRIS), a condition that sometimes

occurs when the immune system begins to recover after treatment with an HIV medicine. As
the immune system gets stronger, it may have an increased response to a previously hidden
infection.

Increased bleeding problems in people with hemophilia.

Gallbladder problems. Contact your health care provider right away if you develop
symptoms of gallbladder problems (pain in your right or middle upper stomach area, fever,
nausea and vomiting, or jaundice).

Kidney stones. Contact your health care provider if you have pain in your low back or
low stomach area, blood in your urine, or pain when urinating.

Tell your health care provider if you have any side effect that bothers you or that does not
go away.

These are not all the possible side effects of atazanavir. To learn more about possible side
effects of atazanavir, read the drug label or package insert or talk to your health care
provider or pharmacist.

You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online

at https://www.accessdata.fda.gov/scripts/medwatch/.
How should atazanavir be stored?

How should atazanavir be stored?

Store atazanavir capsules at room temperature, 68F to 77F (20C to 25C).
Keep atazanavir capsules in the container that they came in and keep the container
tightly closed.

Keep atazanavir oral powder below 86F (30C).

Store atazanavir oral powder in the original packet. Do not open until ready to use.

After atazanavir oral powder is mixed with food or liquid, it may be kept at room
temperature, 68F to 86F (20C to 30C), for up to 1 hour. Use atazanavir oral powder within
1 hour after mixing with food or liquid.

Do not use atazanavir if the original seal over the container opening is broken or
missing.

Throw away atazanavir that is no longer needed or expired (out of date). Follow FDA
guidelines on how to safely dispose of unused medicine.

Keep atazanavir and all medicines out of reach of children.