Dallas Voice (Dallas, Tex.), Vol. 20, No. 45, Ed. 1 Friday, March 12, 2004 Page: 38 of 72
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REYATAZ ™ (RAY-ah-taz)
(generic name = atazanavir sulfate)
ALERT: Find out about medicines that should NOT be taken with
REYATAZ (atazanavir sulfate)- Read the section "What important Informa-
tion should I know about taking REYATAZ with other medicines?"
Read the Patient Information that comes with REYATAZ before you start using
it and each time you get a refill. There may be new information. This leaflet
provides a summary about REYATAZ and does not include everything there is
to know about your medicine. This information does not take the place of
talking with your healthcare provider about your medical condition or treat-
What is REYATAZ?
REYATAZ is a prescription medicine used with other anti-HIV medicines to
treat people who are infected with the human immunodeficiency virus (HIV).
HIV is the virus that causes acquired immune deficiency syndrome (AIDS).
REYATAZ is a type of anti-HIV medicine called a protease inhibitor. HIV infec-
tion destroys CD4 (T) cells, which are important to the immune system. The
immune system helps fight infection. After a large number of T cells are
destroyed, AIDS develops. REYATAZ helps to block HIV protease, an enzyme
that is needed for the HIV virus to multiply. REYATAZ may lower the amount
of HIV in your blood, help your body keep its supply of CD4 (T) cells, and
reduce the risk of death and Illness associated with HIV.
Does REYATAZ cure HIV or AIDS?
REYATAZ does not cure HIV infection or AIDS. At present there is no cure
for HIV infection, People taking REYATAZ may still get opportunistic Infections
or other conditions that happen with HIV infection. Opportunistic infections
are infections that develop because the immune system is weak. Some of
these conditions are pneumonia, herpes virus infections, and Mycobacterium
avium complex (MAC) infections. It is very important that you see your
healthcare provider regularly while taking REYATAZ,
REYATAZ does not lower your chance of passing HIV to other people
through sexual contact, sharing needles, or being exposed to your
blood. For your health and the health of others, it is important to always prac-
tice safer sex by using a latex or polyurethane condom or other barrier to
lower the chance of sexual contact with semen, vaginal secretions, or blood,
Never use or share dirty needles.
Who should not take REYATAZ?
Do not take REYATAZ if you:
• are taking certain medicines, (See "What important information should
I know about taking REYATAZ with other medicines?") Serious life-threat-
ening side effects or death may happen. Before you take REYATAZ, tell
your healthcare provider about all medicines you are taking or planning
to take. These include other prescription and nonprescription medicines,
vitamins, and herbal supplements.
• are allergic to REYATAZ or to any of its ingredients. The active ingre-
dient is atazanavir sulfate. See the end of this leaflet for a complete list
of ingredients in REYATAZ. Tell your healthcare provider if you think you
have had an allergic reaction to any of these ingredients.
What should I tell my healthcare provider before I take REYATAZ?
Tell your healthcare provider:
• If you are pregnant or planning to become pregnant. It is not known
if REYATAZ can harm your unborn baby. Pregnant women have experi-
enced serious side effects when taking REYATAZ with other HIV medicines
called nucleoside analogues. You and your healthcare provider will need
to decide if REYATAZ is right for you. If you use REYATAZ while you are
pregnant, talk to your healthcare provider about the Antiretroviral
• If you are breast-feeding, You should not breast-feed if you are HIV-pos-
itive because of the chance of passing HIV to your baby. Also, it is not
known if REYATAZ can pass into your breast milk and if It can harm your
baby. If you are a woman who has or will have a baby, talk with your
healthcare provider about the best way to feed your baby.
• If you have liver problems or are infected with the hepatitis B or C
virus. See "What are the possible side effects of REYATAZ?"
• If you have diabetes. See "What are the possible side effects of
• If you have hemophilia. See "What are the possible side effects of
• About all the medicines you take including prescription and non-
prescription medicines, vitamins, and herbal supplements, Keep a list of
your medicines with you to show your healthcare provider. For more infor-
mation, see "What important information should I know about taking
REYATAZ with other medicines?" and "Who should not take REYATAZ?"
Some medicines can cause serious side effects if you also take REYATAZ.
How should I take REYATAZ?
• Take REYATAZ once every day exactly as instructed by your health-
care provider. Your healthcare provider will prescribe the amount of
REYATAZ that is right for you. Your dose will depend on your liver function
and on the other anti-HIV medicines that you are taking. REYATAZ is
always used with other anti-HIV medicines. If you are taking REYATAZ and
Sustiva® (efavirenz), you should also be taking Norvir® (ritonavir).
• Always take REYATAZ (atazanavir sulfate) with food (a meal or snack)
to help it work better. Swallow the capsules whole. Do not open the cap-
sules, Try to take REYATAZ at the same time each day.
• If you are taking antacids or Videx" (didanosine) Ohewable/Disper-
sible Buffered Tablets, take REYATAZ 2 hours before or 1 hour after
« Do not change your dose or stop taking REYATAZ without first talk-
ing with your healthcare provider. It is important to stay under a health-
care provider's care while taking REYATAZ.
• When your supply of REYATAZ starts to run low, get more from your
healthcare provider or pharmacy. It is important not to run out of REYATAZ,
The amount of HIV in your blood may increase if the medicine Is stopped
for even a short time.
• If you miss a dose of REYATAZ, take It as soon as possible and then take
your next scheduled dose at its regular time. If, however, It is within 6
hours of your next dose, do not take the missed dose. Wait and take the
next dose at the regular time. Do not double the next dose. It is impor-
tant that you do not miss any doses of REYATAZ or your other anti-
• If you take more than the prescribed dose of REYATAZ, call your
healthcare provider or poison control center right away.
Can children take REYATAZ?
REYATAZ has not been fully studied in children under 16 years of age,
REYATAZ is not recommended for use in babies under the age of 3 months.
What are the possible side effects of REYATAZ?
The following list of side effects is not complete. Report any new or contin-
uing symptoms to your healthcare provider. If you have questions about side
effects, ask your healthcare provider. Your healthcare provider may be able to
help you manage these side effects,
REYATAZ can cause the following side effects:
• yellowing of the skin or eyes. These effects may be due to increases In
bilirubin levels in the blood (bilirubin is made by the liver). Call your
healthcare provider if your skin or the white part of your eyes turn yellow.
Although these effects may not be damaging to your liver, skin, or eyes,
it is important to tell your healthcare provider promptly if they occur.
• a change in the way your heart beats (heart rhythm change). Call
your healthcare provider right away if you get dizzy or lightheaded. These
could be symptoms of a heart problem.
• diabetes and high blood sugar (hyperglycemia) sometimes happen In
patients taking protease inhibitor medicines like REYATAZ. Some patients
had diabetes before taking protease Inhibitors while others did not. Some
patients may need changes In their diabetes medicine.
• if you have liver disease including hepatitis B or C, your liver disease
may get worse when you take anti-HIV medicines like REYATAZ.
• some patients with hemophilia have increased bleeding problems with
protease inhibitors like REYATAZ,
• a serious condition called tactic acidosis syndrome (a severe buildup
of an acid in the blood that sometimes causes death). Some people who
have taken REYATAZ with anti-HIV medicines called nucleoside analogues
have developed lactic acidosis syndrome. Lactic acidosis syndrome has
happened more in people who are female or obese (very overweight),
Lactic acidosis syndrome is a medical emergency and must be treated In
the hospital. Call your healthcare provider right away and do not con-
tinue to take REYATAZ and your other anti-HIV medicines unless
instructed to by your healthcare provider if you get any of the fol-
lowing signs of lactic acidosis syndrome:
• You have persistent nausea, vomiting, or unusual or unexpected
• You feel very weak and tired,
• You have trouble breathing,
• You have weakness, especially In your arms and legs.
• changes in body fat. These changes may include an increased amount
of fat in the upper back and neck ("buffalo hump"), breast, and around
the trunk. Loss of fat from the legs, arms, and face may also happen, The
cause and long-term health effects of these conditions are not known at
Other common side effects of REYATAZ taken with other anti-HIV medicines
include nausea: headache; rash: stomach pain; vomiting; diarrhea; depres-
sion; fever; increased cough; dizziness; trouble sleeping; pain; tiredness;
back pain; numbness, tingling, or burning of hands or feet; and joint pain.
What important information should I know about taking REYATAZ with
Do not take REYATAZ if you take the following medicines (not all brands
may be listed; tell your healthcare provider about all the medicines you
take). REYATAZ may cause serious, life-threatening side effects or
death when used with these medicines.
• Ergot medicines: dihydroergotamine, ergonovlne, ergotamine, and methy-
lergonovine such as Cafergot' Migranal*, D.H.E. 45". ergotrate maleate,
Methergine', and others (used for migraine headaches).
• Halcion" (triazolam, used for I nsomn fa).
• Versed* (midazolam, used for sedation).
• Orap® (pimozide, used for Tourette's disorder).
• Propulsid* (cisapride, used for certain stomach problems).
Do not take the following medicines with REYATAZ because of possible
serious side effects:
• Camptosar® (irirotecan, used for cancer).
• Vascor' (bepridil, used for high blood pressure).
• Crixivan® (Indinavir, used for HiV infection). Both REYATAZ and Crixivan
sometimes cause increased levels of bilirubin in the blood.
• Cholesterol-lowering medicines Mevacor (lovastatin) or Zocor®
Do not take the following medicines with REYATAZ (atazanavir sulfate)
because they may lower the amount of REYATAZ in your blood. This may
lead to an increased HIV viral load. Resistance to REYATAZ or cross-resist-
ance to other HIV medicines may develop:
■ Rifampin (also known as Rimactane®, Rifadin', Rifater*, or Rifamate®,
used for tuberculosis).
• St John's wort (Hypericum perforatum), an herbal product sold as a
dietary supplement, or products containing St. John's wort,
• "Proton-pump inhibitors" used for indigestion, heartburn, or ulcers such
asAcipHex" (rabeprazole), Nexiunr® (esomeprazole). Prevacid® (lansopra-
zole), Prilosec" (omeprazole), or Protonix® (pantoprazole).
The following medicines may require your healthcare provider to mon-
itor your therapy more closely:
• Viagra" (sildenafil). REYATAZ may increase the chances of serious side
effects that can happen with Viagra, Do not use Viagra while you are tak-
ing REYATAZ (atazanavir sulfate), unless your healthcare provider tells you
It is okay.
• Lipitor" (atorvastatin). There is an increased chance of serious side
effects if you lake REYATAZ with this cholesterol-lowering medicine.
• Medicines for abnormal heart rhythm; Cordarone* (amiodarone), lido-
caine, quinidine (also known as Cardioquin®, Quinidex', and others).
• Coumadin" (warfarin).
• Tricyclic antidepressants such as Elavil5 (amitriptyline), Norpramin®
(desipramine), Sinequan' (doxepin), Surmontii' (trimipramine),Tofranil'
(imipramine), orVivactil* (protriptyiine).
• Medicines to prevent organ transplant rejection: Sandimmune*' or
Neorai® (cyclosporlne), Rapamune" (sirolimus), or Prograf® (tacrolimus).
The following medicines may require a change in the dose or dose
schedule of either REYATAZ or the other medicine:
• Sustiva® (efavirenz).
• Fortovase®, Invirase' (saquinavir).
• Norvir® (ritonavir).
• Mycobutin® (rifabutin).
• Calcium channel blockers such as Cardizem* or Tiazac' (diltiazem),
Covera-HS' or Isoptin SR* (verapamil) and others.
• Biaxin® (clarithromycin),
• oral contraceptives ("the pill").
• Videx* (didanosine) or antacids.
• Medicines for indigestion, heartburn, or ulcers such as Axid® (nizatidine),
Pepcid AC1 (famotidine), Tagamet* (cimetidine), or Zantac* (ranitidine).
1. Know all the medicines you take.
2. Tell your healthcare provider about all the medicines you take.
3. Do not start a new medicine without talking to your healthcare
How should I store REYATAZ?
• Store REYATAZ Capsules at room temperature, 59° to 86° F (15° to
30° C), Do not store this medicine in a damp place such as a bathroom
medicine cabinet or near the kitchen sink.
• Keep your medicine in a tightly closed container.
• Throw away REYATAZ when it is outdated or no longer needed by flush-
ing it down the toilet or pouring it down the sink.
General information about REYATAZ
This medicine was prescribed for your particular condition. Do not use
REYATAZ for another condition. Do not give REYATAZ to other people, even if
they have the same symptoms you have. It may harm them. Keep REYATAZ
and all medicines out of the reach of children and pets
This summary does not include everything there is to know about REYATAZ.
Medicines are sometimes prescribed for conditions that are not mentioned in
patient information leaflets. Remember, no written summary can replace
careful discussion with your healthcare provider, If you would like more infor-
mation, talk with your healthcare provider or you can call 1 -800-426-7644.
What are the ingredients in REYATAZ?
Active Ingredient: atazanavir sulfate
Inactive Ingredients: Crospovidone, lactose monohydrate (milk sugar),
magnesium stearate, gelatin, FD&C Blue #2, and titanium dioxide.
'Videx® is a registered trademark of Bristol-Myers Squibb Company.
Coumadin* and Sustiva® are registered trademarks of Bristol-Myers
Squibb Pharma Company. Other brands listed are the trademarks of their
respective owners and are not trademarks of Bristol-Myers Squibb
This Patient Information Leaflet has been approved by the U.S. Food and Drug
■ Bristol-Myers Squibb Company
Princeton NI OS 543
Issued June 2003
Based on 1158020 (06/03)
38 I dallasvoice.com I 03.12.04
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Vercher, Dennis. Dallas Voice (Dallas, Tex.), Vol. 20, No. 45, Ed. 1 Friday, March 12, 2004, newspaper, March 12, 2004; Dallas, Texas. (texashistory.unt.edu/ark:/67531/metapth238885/m1/38/: accessed February 21, 2018), University of North Texas Libraries, The Portal to Texas History, texashistory.unt.edu; crediting UNT Libraries Special Collections.