Kaletra.com

PERSONAL HEALTH TRACKER
Managing Your Health Starts with You

Use1
KALETRA® (lopinavir/ritonavir) is a prescription HIV-1 medicine that is used with
other HIV medicines to treat HIV-1 (Human Immunodeficiency Virus) infection in
adults and children 14 days of age and older. HIV is the virus that causes AIDS
(Acquired Immune Deficiency Syndrome). KALETRA is a type of HIV medicine called
a protease inhibitor. KALETRA contains two medicines: lopinavir and ritonavir. It is
not known if KALETRA is safe and effective in children under 14 days old.
KALETRA does not cure HIV infection or AIDS. People taking KALETRA may
develop infections or other conditions associated with HIV infection, including
opportunistic infections (for example, pneumonia and herpes virus infections).
KALETRA Safety Considerations:
Do not take KALETRA® (lopinavir/ritonavir) if you are allergic to any of its
ingredients, including lopinavir or ritonavir. Do not take KALETRA with certain
medicines, as they can cause serious problems, death, or make KALETRA less
effective against HIV. Patients taking KALETRA may develop changes in heart
rhythm. Some patients can also develop inflammation of the pancreas and liver
problems, which can cause death. Patients may develop new or more serious
diabetes or high blood sugar. Some patients may develop signs and symptoms
of serious infections they already have after starting anti-HIV medicines.
Patients may also develop large increases in triglycerides and cholesterol,
changes in body fat, and/or increased bleeding in people with hemophilia.
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. Please see the Important
Safety Information for more details.
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-NOW (1-888-477-2669) for assistance.
See Important Safety Information at the end of this brochure.
For additional information please see Full Prescribing Information and Medication Guide at
www.Kaletra.com.
Managing Your Health Starts with You
Your doctor or healthcare provider plays an important role in managing your health. But your role is
even more important. Being involved, asking questions and gathering information can make you aware
of your options.
With that in mind, we’ve created this useful health planner to help you keep track of your doctor’s visits,
lab results, medicine schedule and side effects.
Your Personal Health Planner includes two charts.
1. A weekly calendar for tracking:
Medications (medicines) Side Effects Your Physical Well-being (Stress, Exercise, etc.) 2. A full calendar by month for tracking:
Doctor’s Appointments HIV Viral Load CD4 T-cell count Liver Function Tests Cholesterol Levels We hope this planner helps you manage your health.
See Important Safety Information at the end of this brochure.
For additional information please see Full Prescribing Information and Medication Guide at
www.Kaletra.com.
Medications
Your doctor or healthcare provider will discuss with you how often you should take your anti-HIV medicines each day. It is very important to follow these instructions. Place an “X” on the chart when you take these medicines each day as prescribed.
Side Effects
Not everyone experiences side effects when taking HIV medications. Among those people who do experience side effects, some will have mild side effects, while others will have significant or severe ones. Your doctor can discuss the common and significant side effects that you should be aware of when taking HIV medications. Follow your doctor’s instructions on reporting and keeping track of your side effects. No matter how mild your side effects may be, always be sure to mention them to your doctor. Your doctor may have suggestions for managing side effects. Use the chart to record any side effects you may experience. Be as accurate as possible when recording the time, day and description of the side effect. The more accurate your records, the better your doctor will be able to help you.
Physical Well-Being Ratings
Rate each of the following on a scale of 1 to 7 General Well-being. How are you feeling overall? 7 = Very Good <—> 1 = Awful
Stress Level. 7 = Mellow <—> 1 = Way stressed out
Exercise. 7= Great workout <—> 1 = No exercise today
Sleep. 7= Got a full night’s rest <—> 1 = Couldn’t sleep at all
Be sure to discuss any exercise regimens with your doctor, or any concerns you have about your physical well-being.
See Important Safety Information at the end of this brochure.
For additional information please see Full Prescribing Information and Medication Guide at
www.Kaletra.com.
PERSONAL HEALTH TRACKER
WEDNESDAY
THURSDAY
SATURDAY
Medication
Side Effects
. Be as accurate as possible when recording the time al Well-Being Ratings
Rate each of the following on a scale of 1 to 7 General Well-Being. How are you feeling overall? 7 = Very Good < —> 1 = Awful Exercise. 7 = Great Workout <—> 1 = No Exercise Today Sleep. 7 = Got a Full Night’s Rest <—> 1 = Couldn’t Sleep at All See Important Safety Information at the end of this brochure.
For additional information please see Full Prescribing Information and Medication Guide at
www.Kaletra.com
Viral Load
As your HIV therapy takes effect, your viral load should go down. Remember, your viral load is the amount of HIV virus in your body. The lower your viral load, the better.
As your HIV therapy takes effect, your CD4 cell count should go up. Remember, your CD4 cel s keep you healthy by fighting infections. The higher your CD4 cell count, the better. Immune reconstitution 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.
Liver Function Tests
There are a number of tests that measure liver function. These are blood tests that measure the levels of enzymes (proteins that cause or increase chemical reactions in living things) or pigments found in the liver. Two of the most common liver tests are: ALT (Alanine Aminotransferase) – ALT is measured to determine if the liver is damaged or diseased. Elevated levels of ALT may help diagnose liver diseases such as hepatitis and cirrhosis.
AST (Aspartate Aminotransferase) – AST is another measure that can help diagnose liver disease.
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 fol owing signs and symptoms: loss of appetite, yel owing of skin or eyes (jaundice), dark-colored urine, pale-colored stools, itchy skin, and/or stomach area (abdominal) pain.
Cholesterol Level Tests
Cholesterol tests, such as a lipid panel, is a blood test that measures lipids-fats and fatty substances in your body. Some of the lipids include cholesterol and triglycerides.
Total cholesterol (TC) is a direct cholesterol measurement that measures al cholesterol molecules
in the blood.
Triglycerides (TG) are the main form of fat in the body.
KALETRA may cause increases in certain fat (triglycerides and cholesterol) levels in your blood. Large increases of triglycerides and cholesterol can be seen in blood test results of some people who take KALETRA. Your doctor should do blood tests to check your cholesterol and triglyceride levels before you start taking KALETRA and during your treatment.
See Important Safety Information at the end of this brochure.
For additional information please see Full Prescribing Information and Medication Guide at
www.Kaletra.com.
FEBRUARY
Doctor’s Appointment Results
V Viral Load
(copies/mL)
4 T-Cell Count
Liver Functi
Cholesterol Levels
SEPTEMBER
NOVEMBER
DECEMBER
Doctor’s Appointment Results
V Viral Load
(copies/mL)
4 T-Cell Count
Liver Functi
Cholesterol Levels
See Important Safety Information at the end of this brochure.
For additional information please see Full Prescribing Information and Medication Guide at
www.Kaletra.com
Use and Important Safety InformationAbout KALETRA (lopinavir/ritonavir) Use1
KALETRA® (lopinavir/ritonavir) is a prescription HIV-1 medicine that is used with other HIV medicines to treat
HIV-1 (Human Immunodeficiency Virus) infection in adults and children 14 days of age and older. HIV is the virus
that causes AIDS (Acquired Immune Deficiency Syndrome). KALETRA is a type of HIV medicine called a protease
inhibitor. KALETRA contains two medicines: lopinavir and ritonavir. It is not known if KALETRA is safe and
effective in children under 14 days old.
KALETRA does not cure HIV infection or AIDS. People taking KALETRA may develop infections or other
conditions associated with HIV infection, including opportunistic infections (for example, pneumonia and
herpes virus infections).
Important Safety Information1
What is KALETRA?
KALETRA® (lopinavir/ritonavir) is a prescription HIV-1 medicine that is used with other HIV medicines to treat
HIV-1 (Human Immunodeficiency Virus) infection in adults and children 14 days of age and older. HIV is the
virus that causes AIDS (Acquired Immune Deficiency Syndrome). KALETRA is a type of HIV medicine called a
protease inhibitor. KALETRA contains two medicines: lopinavir and ritonavir. It is not known if KALETRA is safe
and effective in children under 14 days old.
KALETRA does not cure HIV infection or AIDS. People taking KALETRA may develop infections or other
conditions associated with HIV infection, including opportunistic infections (for example, pneumonia
and herpes virus infections).
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. For more information, see “Who should not take KALETRA?”
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.
Who should not take KALETRA?
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.
Do not take KALETRA if you are taking certain medicines.
For additional information please see Full Prescribing Information and Medication Guide at
www.Kaletra.com.
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.
Do not take KALETRA if you take any of the following medicines: alfuzosin (Uroxatral®); cisapride
(Propulsid®, Quicksolv®); ergot containing medicines, including ergotamine (Cafergot® and others),
dihydroergotamine (D.H.E. 45® or Migranal®), and methylergonovine (Methergine®); lovastatin (Advicor®,
Altoprev®, or Mevacor®); midazolam oral syrup; pimozide (Orap®); rifampin (Rifadin®, Rifamate®, Rifater®, or
Rimactane®); sildenafil (Revatio®) when used for the treatment of pulmonary arterial hypertension; simvastatin
(Zocor®, Vytorin®, or Simcor®); products containing St. John’s wort (Hypericum perforatum); or triazolam
(Halcion®).
Serious problems can happen if you or your child take any of the medicines listed above with KALETRA.
What should I tell my doctor before taking KALETRA?
KALETRA may not be right for you. Tell your doctor about all of your medical conditions, including if you
have any heart problems including if you have a condition called congenital long QT syndrome; have or had
pancreas problems, or liver problems, including hepatitis B or hepatitis C; diabetes; hemophilia (people who
take KALETRA may have increased bleeding); low potassium in your blood; or are pregnant or plan to become
pregnant (it is not known if KALETRA will harm your unborn baby).
Tell your doctor about all of the medicines you take. Especially tell your doctor if you take: medicine to
treat HIV, estrogen-based contraceptives (birth control pills and patches), medicines to treat cancer, avanafil
(Stendra®), sildenafil (Viagra®), tadalafil (Cialis®), vardenafil (Levitra®), boceprevir (Victrelis®), budesonide
(Rhinocort®, Symbicort®, Pulmicort®, or Entocort® EC), colchicine (Colcrys®), dexamethasone (Maxidex®,
Ozurdex®), fentanyl (Abstral®, Actiq®, Duragesic®, Fentora®, Lazanda®, Onsolis®, or Subsys®), fluticasone
(Cutivate®, Flonase®, Flovent®, Flovent® Diskus, Flovent® HFA, Veramyst®), itraconazole (Onmel™, Sporanox®),
ketoconazole (Extina®, Ketozole®, Nizoral®, Xolegel®), prednisone, rivaroxaban (Xarelto®), salmeterol (Serevent®)
or salmeterol when taken in combination with fluticasone (Advair Diskus®, Advair® HFA), tadalafil (Adcirca®) for
the treatment of pulmonary arterial hypertension, telaprevir (Incivek®), trazodone (Oleptro™), or voriconazole
(Vfend®).
KALETRA should not be taken once daily if you take carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®, Phenytek®), efavirenz (Atripla®, Sustiva®), nevirapine (Viramune®), or nelfinavir (Viracept®).
There is an increased risk of certain problems when you take medicines used for the treatment of
erectile problems, such as avanafil (Stendra®), sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil
(Levitra®), with KALETRA, 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 has changed.
• 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.
For additional information please see Full Prescribing Information and Medication Guide at
www.Kaletra.com.
Copyright 2013 AbbVie Inc. North Chicago, IL 60064 1434086-1335002 What are the possible side effects of KALETRA?
KALETRA can cause serious side effects:
KALETRA may not be right for you. Tell your doctor about all of your medical conditions.
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.
Liver problems, including death, can happen in people who take KALETRA. Your doctor should do blood
tests before and during your treatment with KALETRA to check your liver function. Some people with liver
disease, such as hepatitis B or C, who take KALETRA may have worsening liver disease. Tell your doctor
right away if you have any of the following signs and symptoms: loss of appetite, yellowing of skin or eyes
(jaundice), dark-colored urine, pale-colored stools, itchy skin, and/or stomach area (abdominal) pain.
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 your immune system (Immune Reconstitution Syndrome) can happen when you start taking
HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in
your body for a long time. Call your doctor right away if you start having new symptoms after starting your HIV
medicine.
Large increases in certain fat (triglycerides and cholesterol) levels in the blood have occurred in some
people receiving KALETRA. Your doctor should do blood tests to check your cholesterol and triglyceride levels
before you start taking KALETRA and during your treatment.
Changes in body fat have been seen in some people who take anti-HIV 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,
including KALETRA.
Pregnancy
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 tell 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 collect information about the health of you and your baby.
Do not breast-feed. It is not known if KALETRA can be passed to the baby through your breast milk and
whether it could harm your baby. Also, mothers with HIV-1 should not breast-feed because HIV-1 can be
passed to the baby in the breast milk.
Common side effects of KALETRA include diarrhea, nausea, increased fats in blood (triglycerides or
cholesterol), or vomiting. These are not all of the possible side effects of KALETRA.
This is the most important information to know about KALETRA. For more information, talk with your doctor.
Reference: 1. KALETRA [package insert].
For additional information please see Full Prescribing Information and Medication Guide at
www.Kaletra.com.
Copyright 2013 AbbVie Inc. North Chicago, IL 60064 1434086-1335002

Source: http://www.kaletra.com/Common/pdf/kaletra_health_tracker.pdf