16 JUNE 27, 2003
www.houston voice.com HOUSTON VOICE
llcapinavir/ritonavir) onl solution
-U.ERT: Kind oul jboul medicines thai should NOT be taken with
KALETRA. Please also read the section
"MEDICINES YOU SHOULD NOT TAKE WITH KALETRA.'
Generic Name: lopinavir/ritonavir
Read (his leaflet carefully before you start taking KALETRA. Also, read it
each dine you get your KALETRA prescription refilled, in case something
has changed. This information does not take ihe place of lalking with your
doctor when you start this medicine and il check ups. Ask your doctor if you
have any questions about KALETRA.
KALETRA is a combination of [wo medicines. They are lopinavir and
ritonavir. KALETRA is a Type of medicine called an HIV (human immun
odefciency virusj protease (PRO-tee-ascj inhibitor. KALETRA is always
used in combination with other anti-HIV medicines to treat people with
human immunodeficiency virus (HJV) infection. KALETRA is for adulls
and for children age 6 months and older.
HIV infection destroys CD., (T) cells, which arc important to (he immune
system. After a large number of T cells are destroyed, acquired immune
deficiency .yndrorne (AIDS) develops.
KALETRA blocks HIV protease, a chemical which is needed for HIV to
multiply. KALETRA reduces the amount of HIV in your blood and increases Ihe number of T cells. Reducing the amount of HIV in the blood -educes
the chance of death or mfections thai happen when your immune system is
weak 'opportunistic infections).
Duel KALETRA eyre HIV or AIOS?
KALETRA does not cure HIV infection or AIDS. The long-term
effects of KALETRA are not known at this time. People taking
KALETRA may still yet opportunistic in tec lions or other conditions
that happen with HIY infection. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex
I MAC) infections.
Deis KALETRA reduce the risk ol pissing HIV lo others'
KALETRA does not reduce the risk of passing HIV to others through sexual contact or blood contamination. Continue lo practice safe sex and do
not use or share dirty needles.
How shoele" I take KALETRA'
• Yrw-toijJdtaayiindera doctor sc^
your neatmenl ur stop (reacment without lir-a talking with your doctor.
• You must lake KALETRA every day exactly as your doctor prescribed il.
The dose of KALETRA may be different for you than for other patients.
Follow the directions from your doctor, exactly as written on the label.
• Dosing in adults (including children 12 years of age and older): The usual
dose for adults is 3 capsules (400/ lfJOin4lor5.0rnLc*iheor^soluw«tw«
a day i rnornmg and night), m comNnamm with other am-
• Dosing in children from 6 months to 12 yean of age: Children from
6 months to 12 years of age can also take KALETRA. The child's
doctor will decide ihe nght dose based on the child's weight.
• Take KALETRA with food to help it work better
• Do not change your dose or stop taking KALETRA without first talking
with your doctor.
• When your KALETRA supply starts to run low, get more from your
doctor or pharmacy. This is very important because the amount of virus
in your blood may increase if ihe medicine is stopped for even a short
time. The vims may develop resistance to KALETRA and become
harder lo treat
• Be stare lo set up a schedule and follow it carefully
• Only take medicine rhat has been prescribed specifically for you Do not
give KALETRA to others or take medicine prescribed for someone else.
It is important that you do not miss any doses. If you miss a dose of
KALETRA. lake it as soon as possible and then take your next Kbe-duled
dose at its regular time. If it is almost time for your next dose, do not take
the missed dose. Wait and take the next dose at the regular tune. Do not
double the next dose
WW UfHts il I take too leech KALETRA?
If you suspect thai you look more than the prescribed dose of this medicine,
contact yew local poison cootrol center or emergency room imrrwiaiely
As wuh all prescription medicines. KALETRA should be kept out of ihe
reach of young children. KALETRA liquid contains a Large amount of
alcohol. If a toddler or young child accidentally drinks more than (he recommended dose of KALETRA. it could make him/her sick from loo
much alcohol. Contact your local poison control center or emergency
room irnirtediately if this happens.
Who sbnwnottakt KALETRA'
Together with your doctor, you need to decide whether KALETRA is
right for you.
• Do not lake KALETRA if you are taking certain medicines. These could
cause scnous side effects that could cause death. Before you take
KALETRA. you must tell your doctor about all me medicines you are
taking or are planning to take. These include other prescription and nonprescription medicines and herbal supplements.
For more mforrnaiion about medicines you should not lake with KALETRA,
please read the section, tilled "MEDiaNES YOU SHOULD NOT TAKE
• Do rrf lake KAIETRA if;*™ lira anally
ingredient-i inciiidinajj nkmav-'u w kir^rtavir.
Cm I take KALETRA with other medications?'
KALETRA may interact with other medicines, including those you take
without a prescription. You must tell your doctor about all the medicines
you are taking or planning to take before you lake KALETRA,
MEDICINES YOU SHOULD NOT TAKE WITH KALETRA:
• Do not take the following medicines with KALETRA because they can
cause serious, problems or death if taken with KALETRA.
- Dihydroergotamine. crgooovine. ergotamine and methylergonovine
such as Cafergot*. Migranal* D.H.E. 45*, Ergotrate Maleate.
Methergine, and others
- Halcion* (triazolam)
- Hismanal** tastemii-olcj
- Orap* (pimoude)
- Rythrool* (propafenone)
- Seldane* (terfenadine)
- Tambocot™ (flecainide)
- Versed* (midazolam)
• Do not take KALETRA wilh rifampin, aLso known as Rimactane*.
Rifadin*. Rifatei*. or Rifamate* Rifampin may lower the amount of
KALFTRA in your blood and make il less effective.
■ Do not take KALETRA with Si. John's wort (hypencum perforatumj. an
herbal product sold as a dietary supplement, or products containing Si.
John's wort Talk with your doctor if you are taking or planning to take
Si John's wort Taking Si. John's wort may decrease KALETRA levels
and lead to increased viral load and possible resistance to KALETRA or
cross-resistance to other anti-HIV medicines.
• Do not take KALETRA with the cholesterol-towering medicines
Mevacor* (krvasiaiin) or Zocor* (simvastatin) because of possible serious
reactions. There is also an increased risk of drug interactions between
KALETRA and Lipitor* (atorvastatin); talk to your dotfi* before you take
any of these cholesterol-reducing medicines with KALETRA.
Medicines that require dosa-ac adiKtmnrts:
Il is possible that your doctor may need lo increase or decrease the dose
of other medicines when you are also taking KALETRA. Remember to
tell your doctor all medicines you are taking or plan to lake.
Before yon take Vtagra* fsiita-dl wtti l-LALF^
abort prrt-Mr-jm these two medicines can taut wheat taken Uvjether. You
My get rtowrtd side effects of VIAGRA, s*d^ Iriw Morjd pr-r-am
viHM crtfraer-s, ^ perw
tMts lor*er than 4 bows, get maia^m^r.^ra^toatMptnmaiaM
ill iiii; i f; p"~~ v~" rrlrrlnr ir ■■■■■*■■-■--•■■--•■ -i*mrHnnrti ;rn
• If you are taking oral contraceptives ('the pill") to prevent pregnancy.
you should use an additional or different type of contraception since
KALETRA may reduce the effectiveness of oral contraceptives.
• Efavirenz (Sustiva™) or nevirapine (Viramune*) may lower ihe
amount of KALETRA in your blood. Your doctor may increase your
dose of KALETRA if you are also taking efavirenz ot nevirapine.
• If you are taking Mycobutin* (rifabutin), your doctor will lower the
• A change in therapy should be o>nsackred if you are taking
Pherryioin I Dilantin* and others)
Carbama/epine (Tegretol* and othersj
These medicines may lower the amount of KALETRA in your Wood and
make it less effective.
• Other Special <
KALETRA oral solution contains alcohol Talk with your doctor if you
are taking or planning to take metronidazole or disulfiram Severe nausea and vomiting can occur.
■ If you are taking both didanosine | Videx*) and KALETRA:
Didanosine (Videx*) should be taken one hour before or two hours
What are the •folhle site effects of ULETRA?
• This list of side effects is not complete If you have questions aboul side
effecis, ask your (lector, nurse, or pharmacist. You should report any
new or continuing syjnr^firns lo your doctor right away. Your doctor
may be able lo help you manage these side effects.
The most commonly reported side effects of moderate severity lhat are
[bought lo be drug related are: abdominal pain, abnormal stools (bowel
movements J. diarrhea, feeling weak/tired, headache, and nausea
taking KALETRA may sometimes get a skin rash.
inpatients laking KAIETRA may show possible liver prob-
wiih liver disease such as Hepatitis B and Hepatitis C who
:A may have worsening liver disease. Liver problems
in-; 11(ding dcsih have occurred in patients taking KAIJTRA. In studies,
it is nuclear if KALETRA caused these bver problems because some
pailiertc had other illnesses or were laking other medicines
• Some patterns taking KAliiTRA can develop serious problems with
their pancreas (pancreatitisi, which may cause death You have a higher chance of having pancreatitis if you have had it before. Tell your doc*
lor if you have nausea, vomiting, or abdominal pain. These may be
signs of pancreatitis
• Some patients have large increases in triglycerides and cholesterol. The
long-lerm chance of gelling complications such as heart attacks or
stroke due lo increases in triglycerides and cholesterol caused by protease inhibitors is not known at this time.
• Diabetes and high blood sugar (hyperglycemia) occur in patients laking
protease inhibitors such as KALETRA. Some patients had diabetes before
starting protease inhibitors, others did not. Some patients need changes in
their diabetes medicine. Others needed new diabetes medicine.
• Changes in body fat have been seen in some patients taking antiretroviral therapy These changes may include increased amount of fat in the
upper back and neck ("buffalo hump'), breast, and around ihe trunk.
Loss of fat from (he legs, arms and face may also happen. The cause and
long lerm health effects of these conditions are not known at this lime,
• Some patients with hemophilia have increased bleeding with pmiea.se
• There have been other side effects in pauenis laking KAIETRA, However,
these side effecis may have been due lo other medicines thai pauenis were
taking or io ihe illness itself. Some of these side effecis can be serious.
What should I loll my doctor before laking KALETRA?
• If you are pregnant or planning Ui become pregnant: The effects of
KALETRA on pregnant women or their unborn babies are not known
• If von are breast-feeding: Do not breast-feed if you are taking KALETRA
You should not breast-feed if you have HIV If you arc a woman who has
or will have a baby, talk with your doctor aboul the best way to feed your
baby You should be aware that if your baby does not already have HIV,
there is a chance that HIV can be Oansmiited through rrreast-feeding.
• If you have liver problems: If you have liver problems or are infected wilh
Hepatitis B or Hepatitis C. you should lell your doctor before taking
• If you have diabetes: Some people laking protease inhibitors develop
new or more scnous diabetes or high blood sugar. Tell your doctor if
you have diabetes or an increase in thirst or frequent urination.
• If you have hemophilia: Patients taking KALETRA may have increased
How io I store KALETRA?
• Keep KALETRA and all other medicines oul of the reach of children.
• Refrigerated KALETRA capsules and oral solution remain Ma-bes unit)
the expiration date printed on ihe label. If stored at room temperature
up to 77"F (25°Ct. KALETRA capsules and oral solution should be
used within 2 months
• Avoid exposure lo excessive heat.
Do not keep medicine thai is out of date or lhat you no longer need. Be
sure that if you throw any medicine away, il is oul of the reach of children.
General a*rice aoeal ■reKription medicines:
Talk to your doctor or other healthcare provider it yw have any questions
aboul this medicine ur your condition. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information
Leaflet. If you have any concerns aboul this medicine, ask your doctor
Your doctor or pharmacist can give you information about this medicine
Dial was written for health care professionals Do not use this medicine
for a condition for which it was not prescribed. Do not share this mcdi
cine with other people
• The brands listed are trademarks of their respective owners and are not
trademarks of Alihc* I^lwratories. Tne makers of ihese brands are not
affiliated with arid do not endorse Abbott l-ahrtratori.es or its products.
Ref 03 5239-R8
Revised: January, 2003
1 ABBOTT UWOfliWOHES