M JUNE 3,2005
www.houstonvoice.com HOUSTON VOICE
PATIENT INFORMATION *««
(generic name = atazanavir sulfate) Capsules
ALERT: FM out about medicinea tot should MOT be taken wtth REYATAZ. Read the section "What important information 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 lo know about your medicine. This information does not take the place of talking with your healthcare
provider about your medical condition or treatment.
What is REYATAZ?
REYATAZ is a prescription medicine used with other anti-HIV medicines to treat people who are infected with me
human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).
REYATAZ is a type of anti-Htv medicine called a protease inhibitor. HIV infection destroys CD4-t (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 ot CD4+ (T) cells,
and reduce the risk of death and illness associated with HIV.
Does REYATAZ cue WV or ABS?
REYATAZ does not cure HIV Infection or AH)S. At present there is no cure tor 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 white taking REYATAZ.
REYATAZ does rwt tower your chance of passing WV 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
practice safer sex by using a latex or potyurethane condom or other barrier to lower the chance ot sexual
contact with semen, vaginal secretions, or blood. Never use or share dirty needles
Who should mt take REYATAZ?
Do not take REYATAZ It you:
• an taking certain medicines. (See "What important information shouW I know about taking REYATAZ with
other medicines?') Serious life-threatening side effects or death may happen. Before you take REYATAZ, tell
your healthcare provider about all medicines you are taking or planning to lake. These include other prescription and nonprescription medicines, vitamins, and herbal supplements.
• art allergic to REYATAZ or to any of its ingredients. The active ingredient is atazanavir sulfate. See the end
of this leaflet tor a complete list of ingredients in REYATAZ. Tell your healthcare provider if you think you have
had an anergic reaction to any ot these ingredients
What #nuU I tea my Iwakhcare provider More I take REYATAZ?
TeU your healthcare provider
• It you trt pregnant or planning to become pregnant It is not known it REYATAZ can harm your unborn
baby. Pregnant women have experienced 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 Pregnancy
• If you are breast-feeding You should not breast-feed if you are HIV-positive 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 nave Mvor problem or are infected wtth the hepatfbs B or C virus. See "What are the possible side
effects of REYATAZ?"
• If you have diaii-toi See 'What are the possible side effects ot REYATAZ?'
• If you hava hamopMHa. See 'What are the possible side effects of REYATAZ?"
• About al the medicines you take, including prescription and nonprescription medicines, vitamins, and
herbal supplements. Keep a list of your medicines with you to show your healthcare provider. For more information, see "Whet 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 taken with REYATAZ.
rtow should I take REYATAZ
• Take REYATAZ one* every day exactly as instructed by your Healthcare provider Your healthcare
provider will presence the amount of REYATAZ that is right for you.
- For adults who have never taken anti-HIV medicines before, the usual dose is 400 mg (two 200-mg
capsules) once daily taken with food.
- For adults who have taken anti-HIV medicines in the past, the usual dose is 300 mg |two 150-mg capsules)
plus too mg of NORVIR* (ritonavir) once daily taken with food.
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-m\ medicines. If you are taking REYATAZ with SUSTNA* (etavirenzj or
with VtREAD* (tenotow disoproxil fumarate). you should also be taking NORVIR* (ritonavir).
• Always like REYATAZ with food (a meal or snack) to help it work better. Swallow the capsules whole-
Do not open the opsin Take REYATAZ at the same time each day.
2 hours before or 1 hour after these medicines.
• Do not change your doae or stop taking REYATAZ *
It is mportarrt to May under a healthcare provider's care while taking REYATAZ.
• When year supply of REYATAZ starts to run tow. get more from your healthcare provider or pharmacy. It is
important not to run out of REYATAZ. The amount of HTV 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 doee at its
regular time. it. however, it is within G hours of your next dose, do not take the missed doee wait and take
the next dose at the regular tune. 0o not double the next dose. It is Important lhat you do not min any doses
of REYATAZ or your other ana-HN madMnae.
• If you take mora than the praecrthid doae of REYATAZ. can your healthcare provider or poison control
center right away.
Can (Moron take REYATAT
REYATAZ has not been fully studied in children under 16 years of age. REYATAZ should not be used in babies
under the age of 3 months.
What are the possible side enacts of REYATAr
The following list ol side effects is nol complete. Report any new or continuing symptoms to your healthcare
provider. If you have questions about side effects, ask your heetti*^ provider Your heaflheare prowto
to help you manage these side effects.
The toeowng side effects haw been reported w* REYATAZ.
• rash (redness and itching) sometimes occurs in patents taking REYATAZ, most often in the first few weeks
after the medicine is started. Rashes usually go away within 2 weeks with no change in treatment. Tell your
healthcare provider if rash occurs.
• yehuwing of the skki or eyas These effects may be due to increases in bilirubin levels in the blood
(bilirubin is made by Ihe liver). Call your healthcare provider if your skin or the white part of your eyes turn
yellow. Although these effects may not be damagmg to your liver, skin, or eyes, it is important to ten your
healthcare provider promptly if they occur
• a change in the way your heart boats (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 Mood sugar (hyparprycamla) sometimes happen m patients faking protease inhibitor
medicines like REYATAZ. Some pabents had diabetes before taking protease inhibitors while others did not.
Some patients may need changes in their diabetes medicine
• it you have Hirer dtseaee including hepatitis B or C, your liver disease may get worse when you take anti-
HIV medicines like REYATAZ.
la have increased bleeding problems with protease Inhibitors like REYATAZ.
is In body fat. These changes may include an increased amount of fat in fhe 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 this lime.
Other common side effects of REYATAZ taken with other anti-HIV medicines include nausea; headache; stomach
pain; vomiting; diarrhea, depression; lever; dizziness; trouble sleeping; numbness, tingling, or burning of hands
or feet; and muscle pain.
Wha< nportant rtormation should I lox»
Do not take REYATAZ If you take the following medicines (not all brands may be listed; tali your healthcare provider about all the medicines you take). REYATAZ may causa serious, life-threatening sMa
effects or death when used wtth these medicines
> Ergot medicines; dinydroeroptamine, ergonovlne, ergotamine, and methylergonovine such as CAFERG0T",
MIGRANA1*. D.H.E. 45*. ergotrate maleate. METHERGINE*. and others (used for migraine headaches).
• HALCION* (triazolam, used for insomnia).
• VERSED* (midazolam, used for sedation).
• 0RAP* (pimozide, used for Tourette's disorder).
• PROPULSID* (cisapride, used for certain stomach problems).
• CAMPT0SAR* (irtnotecan, used tor cancer).
• CRIXIVAN* (indinavir, used for HTV infection). Both REYATAZ and CRIXIVAN sometimes cause increased levels of
bilirubin in the blood.
• Cholesterol-towering medicines MEVAC0R* (lovastatin) or Z0C0R* (simvastatin).
h REYATAZ because they may tower the amounl of REYATAZ in your
1 The may lead to an increased UN viral load. Resistance to REYATAZ or cross-resistance to other HfV medicines
• Rifampin (also known as RIMACTANE*, RIFADIN*, RIFATER*, or RIFAMATE*. used tor tuberculosis).
• St John's wort irfypencum 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 as AcipHex* (rabeprazole), NEXIUM*
lesomeprazoie), PREVACID* (lansoprazole). PRILOSEC* (omeprazole), or PROT0NIX* (pantoprazole).
Oo not take Ihe totoving medicines if you are taking REYATAZ and NOITVir togtrtw*:
• VFEND* (voriconazore).
Ttw tolrrwing medfcines may require your health
• CuVJS* itadalafili, LEVTTRA* (vardenafll), or VIAGRA* (sildenafil) REYATAZ may increase the chances of serious
side effects that can happen with CIALIS. LEVTTRA, or VIAGRA Do not use CIALIS, LEVTTRA or VIAGRA while
you are taking REYATAZ unless your healthcare provider tells you it is okay.
■ UPfTOR* (atorvastatin). There is an increased chance of serious side effects If you take REYATAZ with this
• Medicines for abnormal heart rhythm; C0RDAR0NE* (amiodarone). Iidocalne, quinidine (also known as
CARDtOQUIN*. QUINIDEX*, and others).
• VASCOfl* (bedndii. used for chest pain).
• COUMADIN* (warfarin).
• Tricyclic antidepressants such as ELAVIL* (amrtriptyfine), NORPRAMIN* (desipramme), SINEQUAN* (doxepm),
SURM0NT1L* (trimipramlne), TOFRANIL* (Imipramine), or VFVACT1L* (protriptyHne).
• Medicines to prevent organ transplant rejection: SANDIMMUNE* or NE0RAL* (eyefosporine). RAPAMUNE*
i.sirohmusi. or PROGRAF* (tacrolimus).
onga in to doae or doaa schsduto of attar REYATAZ or to otor
• F0RT0VASE*. INWRASE" (saquinavir)
• NOflVrR* (ritonavir)
• SUSTTVA* (efavirenz).
• VIDEX* (didanosine] or antacids.
• VfftEAD* (tenofowr disoproxil fumarate).
i MYCOBUTIN* (rifabutin).
■ Calcium channel btockere such as CAROIZEM* or TIAZAC* (dUCazem). COVERA-HS* or ISOPTIN SR*
(verapamil) and others
• BIAXIN* iclanthromycm).
■ Medicines for indigestion, heartburn, or ulcers such as AXID* (nizatidine), PEPCID AC* (famotidine), TAGAMET*
(cpmeodmei or ZANTAC* (ranitidine).
•to patch" should dnoaa a (Merer* Wnd of crjr*acar«on. REYATAZ may
Hi control pals or Ihe patch. Talc to your healthcare prowler about choosing an
affect the safety and effectiveness of t
1. Know all to medicines you take.
2. TtH your healthcare provider about all to medicines you take.
3. Do not start a now medicine without talking to your heartoare provider,
• Store REYATAZ (atazanavir sulfate) Capsules at room temperature. 59° to B6* F (15s 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 dosed container
• Throw away REYATAZ when it is outdated or no longer needed by flushing if down to toilet or pouring ft down
General ntarmeton *out REYATAZ
This medr-cme was prescribed for your particular condition. Do not use REYATAZ for another condition Do not
grve REYATAZ to other people, even if they have the same symptoms you have It may harm them Keep
REYATAZ and ai medicines out of to reach ot children and pats
This summary does not include everything there is to know about REYATAZ. Medicines are sometimes
prescribed for Mndibons that are nol mentioned in patent information leaflets. Remember, no written summary
can replace careful discussion with your healthcare provider. If you would like more Information, talk wilh your
healthcare provider or you can call t -800-426-7644
" VIDEX* is a registered trademark of Bnstol-Myers Squibb Company. COUMADIN* and SUSTIVA* are registered
trademarks of Bristol-Myers Squibb Pharma Company Other brands listed are the trademarks ol their respective owners and are not trademarks of Bristol-Myers Squibb Company.
•^jfj-* Bristol-Myers Squibb Company
Princeton, NJ 08543 USA
This Patient information Leaflet has been approved by the U.S. Food and Drug Administration
Based on package Insert dated Jury 2004.11&8954A2 Revised July 2004