• medicines for tuberculosis (TB), such as rifabutin
(Mycobutin®)
• inhaled steroid medicines, such as fluticasone
propionate (Flonase®)
• inhaled medicines such as salmeteroi (Serevent®)
or salmeteroi 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
(Adcirca®)
• pain medicines, such as fentanyl (Duragesic®,
lonsys™, Fentora®) and methadone
If you are not sure if you are taking a medicine
above, ask your doctor.
How Should! 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 day.
• 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.
• KALETRA tablets can be taken with or without food.
• If you are taking both Videx® (didanosine) and
KALETRA:
o didanosine can be taken at the same time as
KALETRA tablets, without food,
o 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 prescribed.
• KALETRA oral solution contains a large amount of
alcohol.
0 If a young child drinks more than the
recommended dose, it could make them sick from
too much alcohol. Contact your local poison control
center or emergency room right away.
0 Talk with your doctor if you take or plan to take
metronidazole or disulfiram. You can have severe
nausea and vomiting if you take these medicines
with KALETRA.
• When your KALETRA supply starts to run low, get
more from your doctor or pharmacy. It is important
not to run out of KALETRA. The amount of HIV-1 virus
in your blood may increase if the medicine is stopped
for even a short time. The virus may become resistant
to KALETRA and become harder to treat.
• KALETRA can be taken with acid reducing agents
used for heartburn or reflux such as omeprazole
(Prilosec®) and ranitidine (Zantac®) with no dose
adjustment.
• KAiLETRA should not be administered once daily in
combination with carbamazepine (Tegretol® and
Epitol®), phenobarbital (Luminal®), or phenytoin
(Dilantin* *).
Avoid doing things that can spread HIV infection.
KALETRA does not stop you from passing HIV infection
to others. Do not share needles, other injection
equipment or personal items that can have blood
or body fluids on them, like toothbrushes and razor
blades. Always practice safer sex by using a latex or
polyurethane condom to lower the chance of sexual
contact with semen, vaginal secretions, or blood.
What are the possible side effects of
KALETRA?
KALETRA can cause serious side effects.
• See “What is the most important information I
should know about KALETRA? ”
• Liver problems. 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 and Hepatitis C who take KALETRA may
have worsening liver disease. Tell your healthcare
provider right away if you have any of these signs and
symptoms of liver problems:
^ loss of appetite
c yellow skin and whites of eyes (jaundice)
^ dark-colored urine
o pale colored stools, itchy skin
' stomach area (abdominal) pain.
• Inflammation of the pancreas (pancreatitis).
Some people who take KALETRA get inflammation of
the pancreas which may be serious and cause death.
You have a higher chance of getting pancreatitis if
you have had it before. Tell your doctor if you have
nausea, vomiting, or abdominal pain while taking
KALETRA. These may be signs of pancreatitis.
• increases in certain fat (triglycerides aiid
cholesterol) levels in your blood. Large increases
of triglycerides and cholesterol can be seen in blood
test results of some people who take KALETRA.
The long-term chance of getting complications
such as heart attacks or stroke due to increases in
triglycerides and cholesterol caused by protease
inhibitors is not known at this time^
• Diabetes and high blood sugar (hyperglycemia).
Some people who take protease inhibitors including
KALETRA get new or more serious diabetes, or high
blood sugar. Tell your doctor if you notice an increase
• in thirst or urinate often while taking KALETRA.
• Changes in body fat. Changes in body fat in
some people who take antiretroviral therapy. These
•changes may include increased amount of fat in the
upper back and neck (“buffalo hump”), breast, and
around the trunk. Loss of fat 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.
• Increased bleeding for hemophiliacs. Some
people with hemophilia have increased bleeding
with protease inhibitors including KALETRA.
• Increased risk of certain problems when vou
take medicines used for the treatment of
erectile problems such as sildenafil (Viaora*).
tadalafil (Cialis*). or vardenafil (Levitra*) with
KALETRA:
° low blood pressure. If vou oet dizzy or faint, vou
need to lie down. Tell vour doctor if vou feel dizzv.
or have fainting soells.
° vision changes. Tell vour doctor right awav if vou
have vision changes.
° penis erection lasting more than 4 hours. If vou
are a male and have an erection that lasts lonoer
than 4 hours, get medical help right awav to avoid
permanent damage to vour penis. Your doctor can
explain these symptoms to vou.
• Allergic reactions. Skin rashes, some of them
severe, can occur in people who take KALETRA. Tell
your healthcare provider if you had a rash when you
took another medicine for your HiV infection or if you
notice any skin rashlwhen you take KALETRA.
Common side effects of KALETRA include:
• diarrhea
• nausea
• stomach area (abdominal) pain
• feeling weak
• vomiting
• headache
• upset stomach
These are not ail of the possible side effects of
KALETRA. For more information, ask your doctor or
pharmacist. Tell your doctor about any side effect that
bothers you or that does not go away.
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1 -800-FDA-
1088.
How Should I Store KALETRA?
KALETRA tablets:
• Store KALETRA tablets at room temperature,
between 59°F to 86°F (15°C to 30°C).
• Do not keep KALETRA tablets out of the container
it comes in for longer than 2 weeks, especially in
areas where there is a lot of humidity. Keep the
container closed tightly.
KALETRA oral solution:
• Store KALETRA oral solution in a refrigerator,
between 36°F to 46°F (2°C to 8°C). KALETRA oral
solution that is kept refrigerated may be used until
the expiration date printed on the label.
Oct. 30-Nov. 12.2010 qnotes 9