JUNE 25, 2004
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(lopinavir/ritonavir) oral solution
ALERT: Find out about medicines that
should NOT be taken with KALETRA. Please
also read the section "MEDICINES YOU
SHOULD NOT TAKE WITH KALETRA."
Generic Name: lopinavir/ritonavir
Read this leaflet carefully before you start taking KALETRA. Abo,
read it each time you get your KALETRA prescription refilled, in case
something has changed. This information does not take the place of
lalking with your doctor when you start this medicine and al check tips.
Ask your doctor if you have any questions aboul KALETRA.
Before taking your medicine, make sure you have received the correct
medicine. Compare the name above with the name on your bottle and
the appearance of your medicine with the description provided below.
Contact your pharmacist immediately il' you believe a dispensing error
What is KALETRA and how does it work?
KALFTRA is a combination of two medicines. They are lopinavir and
ritonavir KALETRA is a type of medicine called an HIV (human
immunodeficiency virus) protease tPRO-tee-asei inhibitor. KALETRA is
always used in combination with other anti-HIV medicines to treat
people with human immunodeficiency virus (HIV) infection. KALETRA
is for adults and for children age 6 months and older.
HIV infection destroys CO* (T) cells, which are important to the
immune system. Altera large number ofTcells are destroyed, acquired
immune deficiency syndrome (AIDS) develops.
KALETRA blocks HIV protease, a chemical which is needed for HIV
io multiply. KALETRA reduces the amount of HIV in your blood and
increases the number of T cells. Reducing the amount of HIV in the
blood reduces the chance of death or infections that happen when your
immune system is weak (opportunistic infections).
Does KALETRA cure HIV or AIDS?
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 get opportunistic infections or other conditions that happen with HIV infection. Some of these conditions are
pneumonia, herpes virus infections, and Mycobacterium avium
complex (MAC) infections.
Does KALETRA reduce the risk of passing HIV to others?
KALETRA does not reduce the risk Of passing HiV to others through
sexual contact or blood contamination. Continue to practice sale sex
and do not use or share dirty needles.
How should I take KALETRA?
• You should stay under a doctor's care when taking KALETRA Do
not change your treatment or stop treatment without first talking with
• You must take KALETRA every day exactly as your doctor prescribed it. 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 I including children 12 years of age and older): The
usual dose for adults is 3 capsules (400/100 mg) or 5.0 mL of the oral
solution twice a day (morning and night), in combination with other
• Dosing m children from 6 months to 12 years of age: Children from
6 months to 12 years of age can also take KALETRA. The child's
doctor will decide the right dose based on the child's weight.
• Take KALETRA with food to help it work better.
• Do not change your dose or stop taking KALFTRA 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 ot
vims in your blood may increase if the medicine is stopped lor even
a short time. The virus may develop resistance to KALETRA and
become harder to treat.
• Be sure to set up a schedule and follow it carefully.
• Only take medicine that has been prescribed specifically for you. Do not
give KALETRA to others or take medicine prescribed lor some
What should I do if I miss a dose of KALETRA?
It is important thai you do not miss any doses. If you BOSS t
KALETRA. take it as goon as possible and then take your next sched
uled do.se at its regular time. If it is almost time for your next dose, do
not lake the missed dose. Wait and take the next dose at the regular
time. Do not double the next dose.
What happens if I take too much KALETRA?
Ispecl that you took more than the prescribed dose of this medicine.
contact your local poison control center or emergency room immediately.
As with all prescription medicines. KALETRA should be kept out of
Ihe reach of young children. KALFTRA liquid contains a large amount
of alcohol. If a toddler or young child accidentally drinks more than fhe
recommended dose of KALETRA. il could make him/her sick from too
much alcohol. Contact your local poison control center or emergency
room immediately if this happens.
Who should not take KALETRA?
Together with your doctor, you need to decide whether KALFTRA is
right for you.
• Do noi take KALFTRA if you are taking certain medicines. These
could cause serious side effects that could cause death. Before you
take KALETRA. you must tell your doctor about all the medicines
you are laking or are planning to take. These include other prescription and non-prescription medicines and herbal supplements.
For more information about medicines you should not take wilh
KALETRA, please read the section titled "MEDICINES YOU
SHOULD NOT TAKE WITH KALFTRA '
• Do not take KALETRA if you have an allergy to KALETRA or any
of its ingredients, including ritonavir or lopinavir.
Can 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 take KALETRA.
MEDICINES YOU SHOULD NOT TAKE WITH KALETRA:
• Do not take the following medicines with KALETRA because ihcy
can cause serious problems or death if taken with KALETRA.
- Dihydroergolamine, ergonovine, ergotamine and methyler-
gonovine such as Cafergot®. Migranal®. D.H.E. 45 •>. Ergotrate
Maleate. Methergine. and others
- Halcion'- (triazolam)
- Hismanal'; lasiemi/oie)
- Orap* (pimozide)
- Propulsid* (cisapride)
- Seldane® (terfenadinei
• Do not lake KALETRA with rifampin, also known as Rimactane®,
Rifadin®, Rifater*, or Rifamate®. Rifampin may lower (he amount of
KALETRA in your blood and make ii less effective.
• Do not take KALETRA with St Johns wort (hypericum perforatum), an herbal product sold as a dietary .supplement, or products
containing St. John's wort. Talk with your doctor if you are taking or
planning to take St. John's wort. Taking St. 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-lowering medicines
Mevacor* (lovastatin) or Zocor* (simvastatin) because of possible
serious reactions. There is also an increased nsk of drug interactions
between KALETRA and Lipitor* laiorvastalml; talk to your doctor
before you take anv of these cholesterol-reducing medicines with
Medicines that require dosage adjustments:
lible that your doctor may need lo increase or decrease the dose erf
Other medicines when you are also taking KALETRA. Remember to tell your
doctor all medicines you are taking or plan to take.
Before you take Viagra (sildenafilI with KALETRA, talk to your
doctor about problems these two medicines can cause when taken
together. You may get increased side effects of VIAGRA, such as
low blood pressure, vision changes, and penis erection lasting more
than 4 huurs. If an erection lasts longer than 4 hours, get medical
help right away to avoid permanent damage to your penis. Your
doctor can explain these symptoms to you.
• If you are taking oral contraceptives ("ihe 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™), nevirapine (Viramune*), Agenerase (ampre-
navir)andViracept (nelfinavir) may lower the amounl of KALETRA
in your blood. Your doctor may increase your dose of KALETRA if
you are also taking efavirenz. nevirapine. amprenavir or nelfinavir.
• It you are laking Mycobutin® (rifabutin), your doctor will lower the
dose of Mycobuiin.
• A change in therap* should be considered if vou are taking
Phenytotfi (Dilantin* and others!
Carbamazepine (Tegretol* and others)
These medicines may lower the amounl of KALFTRA in your blood
and make it less effective.
• Other Special Considerations:
KALETRA oral solution contains alcohol. Talk with >oiu A
you are taking or planning to take metronidazole or disullirain.
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 possible side effects of KALETRA?
• This list of side effecis is not complete. If you have questions about
side effecis. ask your doctor, nurse, or pharmacist. You should report
any new or continuing symptoms to your doctor right away, Your
doctor may be able to help you manage these side effects.
• The most commonly reported side effects ■ erfty that
are (bought to be drug related are: abdominal pain, abnormal Stools
tbowel movements), diarrhea, feeling weak/tired, headache, and oau-
i hildren taking KALETRA may sometimes gel a skin rash.
• Blood tests in patients taking KALETRA may show possible liver prob
lems. People with Kver disease such as Hepatitis B and Hepatitis C who
take KALFTRA may have worsening liver disease. Liver problems
including death have occurred in patienis taking KALETRA In studies,
it is unclear if KALFTRA caused these liver problems because sum,'
patients had other illnesses or were taking Other medicines
• Some patients taking KALETRA can develop serious problems wuh
their pancreas (pancreatitis), which may cause death. You have a
higher chance of having pancreatitis if you have had il before. Tell
your doctor 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-term chance of getting complications such as heart attacks
ur Stroke due to increases in triglycerides and cholesterol caused by
protease inhibitors is not known al this time.
• Diabetes and high blood sugar (hyperglycemia) occur in patients taking protease inhibitors such as KALETRA. Some patienis had diabetes before starting protease inhibitors, others did not* Some
palients need changes in their diabetes medicine. Others needed new
• Changes in body fat have been seen in some patients taking anti-
relroviral therapy. These changes may include increased amounl of
fat in the upper hack and neck ("buffalo hump"), breast, and around
the mink. Loss of la! from the legs, arms and face may also happen.
The cause and long term health effects of these conditions are not
known at this time.
• Some patients with hemophilia have increased bleeding with pro
• There have been other side effects in palients taking KAI II R \
However, these side effects may have hectl due lo Other medicines
thai patients were taking or to the illness itself. Some of these side
effects can be serious.
What should I tell my doctor before taking KALETRA?
• // you are pregnant or planning t" become pregnant: The effecis ol
KALETRA on pregnant women or (heir unborn babies are not known.
■ // you ore breast-feeding: Do not breast-feed -tf you are taking
KALETRA. You should nol breast-feed if you have HIV II you are
a woman who has or will have a baby, talk with your doctor about
the best way to feed your baby. You should be aware thai if your baby
does not already have HIV. there is a chance that HIV can be transmitted through breast-feeding.
• If you have liver problem*: If you have liver problems or arc infeel
ed with Hepatitis B or Hepatitis C, you should tell your doctor before
• if wit have diabetes: Some people taking protease inhibitors develop new
or more serums diabetes or high blood sugar. Tell your doctor if you have
diabetes or an increase in (hirst or frequent urination
• If wu have hemophilia: Patients taking KALETRA may have
How do I store KALETRA?
• Keep KALETRA and all other medicines oul of the reach of children
• Refrigerated KALETRA capsules and oral solution remain stable
until the expiration dale prinled on the label. II stored at room temperature up to 77 F (25 (■'). KALETRA capsules and oral solution
should be used within 2 mouths.
• Avoid exposure to excessive heat.
Do nol keep medicine thai is oul of date or thai you no longer need Be
sure lhal if you throw ,uiy medicine away, il is out of the. reach of children.
General advice about prescription medicines:
Talk to your doctor or other health care provider if vou have any questions aboul [his medicine or your condition. Medicines are sometimes
prescribed for purposes oiher Ihan those listed m a Patient Information
Leaflet If you-havc any concerns aboul this medicine, ask your doctor
Your doctor or pharmacist can give you information about (Ins mcdi
cine that was Written foi hcallh care professionals Do nol use this med
icine for a condition for which it was not prescribed, Do noi share this
medicine with other people.
■ The bonds listed are trademarks ol their respective owners and are not
trademarks of Abbot) Laboratories. The makers ol these brands are noi
affiliated with and do not endorse Abbott Laboratories or its products.
Revised: February. 2(K)4
N0HTH CHICAGO. IL 60064. U.S.A.
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