KALETRA® (kuh-LEE-tra)
(lopinavir/ritonavir) Tablets
KALETRA® (kuh-LEE-tra)
(lopinavir/ritonavir) Oral Solution
CONSUMER BRIEF SUMMARY
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FULL PRESCRIBING INFORMATION
Patient Information
Read the Medication Guide that comes with KALETRA before you start taking it and each time you get a refill. There may
be new information. This information does not take the place of talking with your doctor about your medicai condition or
treatment. You and your doctor shouid talk about your treatment with KALETRA before you start taking it and at regular
check-ups. You should stay under your doctor’s care when taking KALETRA.
What is the most important information I
should know about KALETRA?
KALETRA may cause'Serious side effects,
including;
• Interactions with other medicines. It is
important to know the medicines that should
not be taken with KALETRA. Read the section
“What should I tell my doctor before taking
KALETRA?"
• Changes in your heart rhythm and the electrical
activity of your heart. These changes may be
seen on an EKG (electrocardiogram) and can lead to
serious heart problems. Your risk for these problems
maybe higher if you;
0 already have a history of abnormal heart rhythm or
other types of heart disease.
0 take other medicines that can affect your heart
rhythm while you take KALETRA.
Tell your doctor right away if you have any of these
symptoms while taking KALETRA:
• dizziness
• lightheadedness
• fainting '
• sensation of abnormal heartbeats
See the section below “What are the possible side
effects of KALETRA?” for more information about
serious side effects.
What is KALETRA?
KALETRA is a prescription anti-HIV medicine that
contains two medicines: lopinavir and ritonavir.
KALETRA is called a protease inhibitor that is used
with other anti-HlV-1 medicines to treat people with
human immunodeficiency virus (HIV-1) infection.
HIV-1 is the virus that causes AIDS (Acquired Immune
Deficiency Syndrome).
It is not known if KALETRA is safe and effective in
children underUdavs old.
Who should not take KALETRA?
• Do not take KALETRA if you are taking certain
medicines. For more information about medicines
you should not take with KALETRA, please see
“Can I take other medicines with KALETRA?”
and consult with your doctor about all other
medicines you take.
• Do not take KALETRA if you have an allergy to
KALETRA or any of its ingredients, including ritonavir
and lopinavir.
What should I tell my doctor before
taking KALETRA?
KALETRA may not be right for you. Tell your doctor
about all your medical conditions, including if you;
• have any heart problems, including if you have a
condition called Congenital Long QT Syndrome.
• have liver problems, including Hepatitis B or ■
Hepatitis C.
• have diabetes.
• have hemophilia. People who take KALETRA may
have increased bleeding.
• have low potassium in your blood.
• are pregnant or plan to become pregnant. It is not .
known if KALETRA will harm your unborn baby. Birth
control pills or patches may not work as well while
you take KALETRA. To prevent pregnancy while taking
KALETRA, women who take birth control pills or use
estrogen patch for birth control should either use a
different type of birth control or an extra form of birth
control. Talk to your doctor about how to prevent
pregnancy while taking KALETRA.
• take KALETRA during pregnancy, talk with your doctor
about how you can take part in an antiretroviral
pregnancy registry. The purpose of the pregnancy
registry is to follow the health of you and your baby.
• are breast-feeding. Do not breast-feed if you are
taking KALETRA. You should not breast-feed if you'
have HIV-1. If you are a woman who has or will have
a baby while taking KALETRA, talk with your doctor
about the best way to feed your baby. If your baby
does not already have HIV-1, there is a chance that
HIV-1 can be passed to your baby through your breast
milk.
Tell your doctor about all the medicines you take,
including prescription and non-prescription medicines,
vitamins, and herbal supplements. Many medicines .
interact with KALETRA. Do not start taking a new
medicine without telling your doctor or pharmacist. Your
doctor can tell you if it is safe to take WLETRA with
other medicines. Your doctor may need to change the
dose of other medicines while you take KALETRA.
Medicines you should not take with KALETRA.
Serious problems or death can happen if you take
these medicines with KALETRA;
• ergot containing medicines, including:
° ergotamine tartrate (Cafergot®, Migergot, Ergomar,
Ergostat, Medihaler Ergotamine, Wigraine,
Wigrettes)
.0 dihydroergotamine mesylate (D.H.E. 45®, Embolex,
Migranal®)
o ergonovine, ergonovine and methylergonovine
(Ergotrate, Methergine), ergotamine and
methylergonovine
° Ergotrate Maleate, methylergonovine maleate
(Methergine)
• triazolam (Halcion®), midazolam hydrochloride oral
syrup
• pimozide (Orap®)
• the cholesterol lowering medicines lovastatin
(Mevacor®) or simvastatin (Zocor®)
• sildenafil (Revatio®) only when used for the
treatment of pulmonary arterial hypertension. (See
“Medicines that may need changes” and “What are
the possible side effects of Kaletra?” for information
about the use of sildenafil for erectile problems.)
• alfuzosin (Uroxatral®)
Medicines that you should not take with KALETRA
since they may make KALETRA not work as well:
• the herbal supplement St. John’s Wort (hypericum
perforatum)
• rifampin (Rimactane®, Rifadin®, Rifater®, or
Rifamate®)
Medicines that may need changes:
• birth control pills that contain estrogen (“the pill") or
the birth control (contraceptive) patches
• certain anticancer medicines, such as nilotinib
(Tasigna®) and dasatinib (Sprycel®)
• certain cholesterol lowering medicines, such as
atorvastatin (Lipitor®) or rosuvastatin (Creator* *)
• certain other antiretroviral medicines, such as
efavirenz (Atripla® and Sustiva®), nevirapine
(Viramune®), amprenavir (Agenerase®) and nelfinavir
(Viracept®)
• anti-seizure medicines; such as phenytoin (Dilantin*)
carbamazepine, (Tegretol®), phenobarbital
• medicines for erectile problems, such as sildenafil
(Viagra®), tadalafil (Cialis®), or vardenafil (Levitra*)
8 qnotes Oct. 30-Nov. 12.2010