Dallas Voice (Dallas, Tex.), Vol. 28, No. 19, Ed. 1 Friday, September 23, 2011 Page: 25 of 48
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KALETRA Use and Important Safety Information1
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KALETRA" (lopinavir/ritonavir) is a prescription anti-HIV-1
medicine called a protease inhibitor that contains
lopinavir and ritonavir. KALETRA is used with other anti-
HIV-1 medicines to increase the chance of treatment
response in people with human immunodeficiency virus
(HtV-1) infection. It is not known if KALETRA is safe and
effective in children under 14 davs old.
KALETRA does not cure HIV-1 infection or AIDS and does
not stop vou from passing HIV-1 to others. You mav still
get opportunistic infections or other conditions that
happen with HIV-1.
Important Safety Information
Do not take KALETRA if you are allergic to KALETRA or
any of its ingredients, including lopinavir or ritonavir. Skin
rashes, some of them severe, can occur in people who
take KALETRA. Tell your doctor if you had a rash when
you took another medicine for HIV or if you notice any
skin rash when you take KALETRA.
The list of drug interactions below is not complete. You
must tell your doctor about all medicines you are taking or
planning to take, including those without a prescription,
vitamins, and herbal products.
Serious problems or death can happen if you take
these medicines with KALETRA: ergot-containing
medicines, including ergotamine (Cafergof and others),
dihydroergotamine (D.H.E. 45® and others), ergonovine
(Ergotrate®), and methylergonovine (Methergine®);
triazolam (Halciocf ); midazolam oral syrup; pimozide
(Orap3*); lovastatin (Mevacor'); simvastatin (Zocor);
rifampin (Rimactane", Rifadin*. Rifater®, or Rifamate®);
sildenafil (Revatio®) only when used to treat pulmonary
arterial hypertension; alfuzosin (Uroxatral "); or products
containing St. John's wort (Hypericum perforatum).
The following medicines may need changes if you
take KALETRA: birth control pills that contain estrogen
("the pill"), birth control (contraceptive) patches,
nilotinib (Tastgna) and dasatinib (SpryceH, atorvastatin
(Lipitor®), rosuvastatin (Crestor®), efavirenz (Atripla®
and Sustiva®), nevirapine (Viramune®), amprenavir
(Agenerase"), fosamprenavir (Lexiva"), nelfinavir
(Viracepf), phenytoin (Dilantin"), carbamazepine
(Tegretol"5), phenobarbital, sildenafil (Viagra" ), tadalafil
(Cialis®, Adcirca). vardenafil (Levitra®), rifabutin
(Mycobutin ®), inhaled fluticasone (Flonase®), salmeterol
(Serevent4) and salmeterol in combination with
fluticasone propionate (Advair ), colchicine (Colcrys;).
bosentan (Tracleer®),fentanyl (Duragesic , lonsys™,
Fentora') and methadone.
KALETRA should not be taken once daily if you take
carbamazepine (Tegretol1" and EpitoFJ), phenobarbital
(Luminal'), or phenytoin (Dilantin"").
There is an increased risk of certain problems when
you take medicines used for the treatment of erectile
problems such as sildenafil (Viagra®), tadalafil (Cialis®),
or vardenafil (Levitra®) with KALETRA, because the
interaction with these medicines may result in an increase
in their side effects, such as low blood pressure (dizziness
or fainting), vision changes, and/or erections lasting more
than 4 hours. Tell your doctor right away if you experience
any of these side effects.
KALETRA oral solution contains propylene glycol and
a large amount of alcohol.
• KALETRA oral solution should not be given to babies
younger than 14 days of age unless your doctor thinks
it is right for your baby. Babies taking KALETRA oral
solution may have side effects. Call your doctor right
away if your baby appears too sleepy or their breathing
• Talk with your doctor if you take or plan to take
metronidazole (Flagyl") or disulfiram (Antabuse®).
You can have severe nausea and vomiting if you take
these medicines with KALETRA.
KALETRA can cause serious side effects:
KALETRA may not be right for you. Tell your doctor
about all your medical conditions.
Changes in your heart rhythm and the electrical
activity of your heart can occur when taking KALETRA.
These changes 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, or if you take other medicines that can affect your
heart rhythm while you take KALETRA. Tell your doctor
right away if you experience dizziness, lightheadedness,
fainting, and/or a sensation of abnormal heartbeats.
Liver problems, including death, can happen in people
who take KALETRA. Blood tests in people who take
KALETRA may show possible liver problems. People with
liver disease such as hepatitis B or C who take KALETRA
may have worsening liver disease. People should tell their
doctor right away if they have any of the following signs
and symptoms: loss of appetite, yellowing of skin or eyes
(jaundice), dark-colored urine, pale-cotored stools, itchy
skin, and/or stomach area (abdominal) pain.
Inflammation of the pancreas (pancreatitis), which
may be serious and cause death, has occurred in some
people who take KALETRA. You have a higher chance of
having pancreatitis if you have had it before. Tell your
doctor if you have nausea, vomiting, and/or abdominal
pain, as these may be signs of pancreatitis.
Immune reconstitute syndrome may occur after
starting anti-HIV medicines, including KALETRA. This
happens when you develop signs and symptoms
of serious infections you already have, which may
require additional treatment.
Large increases in certain fat (triglycerides and
cholesterol) levels in the blood have occurred in some
people receiving KALETRA. The long-term chance of
getting complications such as heart attacks or strokes due
to these increases in triglycerides and cholesterol caused
by protease inhibitors is not known at this time.
New or more serious diabetes and high blood sugar
(hyperglycemia) have occurred in some people who
take protease inhibitors, including KALETRA. Tell your
doctor if you notice an increase in thirst or urinate often
while taking KALETRA.
Changes in body fat have been seen in some people who
take anti-HtV therapy. The cause and long-term health
effects of these conditions are not known at this time
Increased bleeding has occurred in some people
with hemophilia who take protease inhibitors,
If you are taking birth control pills or using patches to
prevent pregnancy, you should use an extra form or a
different type of birth control, since birth control pills or
patches may not work as well while you take KALETRA.
Talk to your doctor about how to prevent pregnancy
while taking KALETRA.
It is not known if KALETRA will harm your unborn baby.
If you are pregnant or planning to become pregnant, you
should teil your doctor.
If you take KALETRA during pregnancy, you should 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.
Do not breast-feed while taking KALETRA. There is a chance
HIV can be passed to your baby through breast milk and
your baby may have serious side effects from KALETRA.
Common side effects of KALETRA include diarrhea,
nausea, stomach area (abdominal) pain, feeling weak,
vomiting, headache, or upset stomach. These are not all
of the possible side effects of KALETRA.
The long-term effects of KALETRA are not known at this time.
This is the most important information to know about
KALETRA. For more information, talk with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).
If you cannot afford your medication, contact: www.pparx.org or call the toll-free number (1-888-4PPA-N0W) or (1-888-477-2669) for assistance,
For additional information about KALETRA, call 1 -866-KALETRA (1-866-525-3872) or visit KALETRA.com.
Please see Brief Summary of Prescribing Information on the following pages.
Reference: 1. KALETRA [package insert]. North Chicago, IL: Abbott Laboratories.
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Nash, Tammye. Dallas Voice (Dallas, Tex.), Vol. 28, No. 19, Ed. 1 Friday, September 23, 2011, newspaper, September 23, 2011; Dallas, Texas. (digital.library.unt.edu/ark:/67531/metapth239186/m1/25/: accessed May 28, 2017), University of North Texas Libraries, Digital Library, digital.library.unt.edu; crediting UNT Libraries Special Collections.