"Important Safety Facts"

Do not take KALETRA with certain medicines, as they can cause serious problems, death, or make KALETRA less effective against HIV.

Do not take KALETRA if you are allergic to KALETRA or any of its ingredients, including lopinavir or ritonavir.

Some patients taking KALETRA can develop inflammation of the pancreas and liver problems, which can cause death.

Patients may develop changes in heart rhythm, large increases in triglycerides and cholesterol, diabetes, high blood sugar, changes in body fat, and/or increased bleeding in people with hemophilia.

Some patients may develop signs and symptoms of serious infections they already have after starting anti-HIV medicines.

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.

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.

Please see the additional sections of KALETRA USE AND IMPORTANT SAFETY FACTS for more details.

See additional Important Safety Information and full Prescribing Information including Medication Guide for details.

Reference: KALETRA [package insert].

"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.

Medicines you should not take with KALETRA

The list of drug interactions below is not complete. You must tell your doctor about all of the 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.

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®).

See additional Important Safety Information and full Prescribing Information including Medication Guide for details.

Reference: KALETRA [package insert].

"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 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).

The list of drug interactions below is not complete. You must tell your doctor about all of the medicines you are taking or planning to take, including those without a prescription, vitamins, and herbal products.

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®).

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. 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.

See additional Important Safety Information and full Prescribing Information including Medication Guide for details.

Reference: KALETRA [package insert].

"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.

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.

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. Tell 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.

Babies taking KALETRA oral solution may have side effects. KALETRA oral solution contains propylene glycol and a large amount of alcohol. Call your doctor right away if your baby appears too sleepy or their breathing has changed.

See additional Important Safety Information and full Prescribing Information including Medication Guide for details.

Reference: KALETRA [package insert].

"KALETRA and 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 while taking KALETRA. 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.

See additional Important Safety Information and full Prescribing Information including Medication Guide for details.

Reference: KALETRA [package insert].

"Common Side Effects"

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.

See additional Important Safety Information and full Prescribing Information including Medication Guide for details.

Reference: KALETRA [package insert].

"What is KALETRA?"

KALETRA 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).

See additional Important Safety Information and full Prescribing Information including Medication Guide for details.

Reference: KALETRA [package insert].

"Helpful Resources"

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.

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).

See additional Important Safety Information and full Prescribing Information including Medication Guide for details.

Reference: KALETRA [package insert].