Dallas Voice (Dallas, Tex.), Vol. 28, No. 13, Ed. 1 Friday, August 12, 2011 Page: 36 of 56
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(lopinavir/ritonavir) Oral Solution
CONSUMER BRIEF SUMMARY
CONSULT PACKAGE INSERT FOR FULL
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 medical condition or treatment. You and your doctor should 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
• 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 may be higher if you:
° already have a history of abnormal heart rhythm or other types
of heart disease.
o 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
• 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-HIV-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 under
14 days 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 OT Syndrome.
• have liver problems, including Hepatitis 8 or Hepatitis C.
• have diabetes.
• have hemophilia, People who take KALETRA may have increased
• 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
• 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
• 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 KALETRA 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:
° ergotamlne tartrate (Cafergot®, Migergot, Ergomar, Ergostat,
Medihaler Ergotamine, Wigraine, Wigrettes)
o 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
• 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 (UroxatraP)
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
• certain cholesterol lowering medicines, such as atorvastatin
(Lipitor®) or rosuvastatin (Crestor®)
• certain other antiretroviral medicines, such as efavirenz (Atripla®
and Sustiva®), nevlrapine (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®)
• medicines for tuberculosis (TB), such as rifabutin (Mycobutin®)
• inhaled steroid medicines, such as fluticasone propionate
• inhaled medicines such as salmeterol (Serevent®) or salmeterol
in combination with fluticasone propionate (Advair®). Your doctor
may need to change to a different medicine
• medicines for gout, such as colchicine (Colcrys®}
• medicines to treat pulmonary arterial hypertension (PAH), such as
bosentan (Tracleer®) or tadalafil (Adclrca®)
• pain medicines, such as fentanyl (Duragesic®, lonsys™, Fentora®}
If you are not sure if you are taking a medicine above, ask
How should I take KALETRA?
Take KALETRA every day exactly as prescribed by your doctor.
It is very important to set up a dosing schedule and follow it every
Do not change your treatment or stop treatment without first
talking with your doctor.
Swallow KALETRA tablets whole. Do not chew, break, or crush
KALETRA tablets can be taken with or without food.
If you are taking both Videx® (didanosine) and KALETRA:
° didanosine can be taken at the same time as KALETRA tablets,
® take didanosine either one hour before or two hours after taking
KALETRA oral solution.
Do not miss a dose of KALETRA, This could make the virus harder
to treat, If you forget to take KALETRA, take the missed dose
right away. If it is almost time for your next dose, do not take the
missed dose. Instead, follow your regular dosing schedule by
taking your next dose at its regular time. Do not take more than
one dose of KALETRA at one time.
If you take more than the prescribed dose of KALETRA, call your
local poison control center or emergency room right away.
Take KALETRA oral solution with food to help it work better.
If KALETRA is being used for your child, tell your doctor if your
child's weight changes.
KALETRA should not be given one time each day in children.
When giving KALETRA to your child, give KALETRA exactly as
KALETRA oral solution contains propylene glycol and a large
amount of alcohol. KALETRA oral solution should not be given to
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Nash, Tammye. Dallas Voice (Dallas, Tex.), Vol. 28, No. 13, Ed. 1 Friday, August 12, 2011, newspaper, August 12, 2011; Dallas, Texas. (digital.library.unt.edu/ark:/67531/metapth239180/m1/36/: accessed February 21, 2018), University of North Texas Libraries, Digital Library, digital.library.unt.edu; crediting UNT Libraries Special Collections.