Indication and Important Safety Information About KALETRA

KALETRA® (lopinavir/ritonavir) is always used in combination with other anti-HIV medicines to treat people with human immunodeficiency virus (HIV) infection. KALETRA is a combination of two medicines. They are lopinavir and ritonavir. KALETRA is a type of medicine called an HIV protease (PRO-tee-ase) inhibitor. KALETRA is for adults and for children age 6 months and older.

Once daily dosing of KALETRA in combination with other anti-HIV medicines is not recommended for people with previous HIV treatment and has not been evaluated in children (6 months to 12 years of age).

KALETRA does not cure HIV infection or AIDS and does not reduce the risk of passing HIV to others.

KALETRA should not be taken by patients who have had an allergic reaction to KALETRA or any of its ingredients, including lopinavir or ritonavir.

Taking KALETRA with certain drugs can cause serious problems or death. KALETRA should not be taken with dihydroergotamine, ergonovine, ergotamine, and methylergonovines such as Cafergot®, Migranal®, D.H.E. 45®, Ergotrate Maleate, and Methergine, as well as Halcion®, Hismanal®, Orap®, Propulsid®, Seldane®, or Versed®.

KALETRA should also not be taken with rifampin, also known as Rimactane®, Rifadin®, Rifater®, or Rifamate®, or with Flonase®, or products containing St. John's wort (Hypericum perforatum). Once daily KALETRA should not be taken with Agenerase®, Sustiva®, Viracept®, Viramune®, Dilantin®, Phenobarbital, or Tegretol®.

Do not take KALETRA with the cholesterol-lowering medicines Mevacor® (lovastatin), or Zocor® (simvastatin) because of possible serious reactions. There is also an increased risk of drug interactions between KALETRA and Crestor® (rosuvastatin) or Lipitor® (atorvastatin); talk to your doctor before you take any of these cholesterol-reducing medicines with KALETRA.

Particular caution should be used when taking Viagra®, Cialis®, or Levitra®, since the interaction with KALETRA may result in an increase in their related side effects. Discuss all medicines, including those without a prescription and herbal products you are taking or plan to take, with your doctor or pharmacist.

Pancreatitis and liver problems, which can be fatal, have been reported in patients receiving KALETRA. Tell your doctor if you have nausea, vomiting, or abdominal pain, which may be signs of pancreatitis, or if you have or have had liver disease such as hepatitis B or C.

In patients taking protease inhibitors, increased bleeding (in patients with hemophilia) and diabetes/high blood sugar have occurred.

Changes in body fat have been seen in some patients receiving antiretroviral therapy. The cause and long term health effects of these conditions are not known at this time. Some patients receiving KALETRA have had large increases in triglycerides and cholesterol.

Varying degrees of cross-resistance among protease inhibitors have been observed.

The most commonly reported side effects of moderate severity are: abdominal pain, abnormal bowel movements, diarrhea, feeling weak or tired, headache, and nausea. Children taking KALETRA may sometimes get a skin rash. This is not a complete list of reported side effects.

Diarrhea may be more common in patients taking Kaletra capsules once daily compared to the twice-daily dose (57% vs. 35% of mild to severe events and possibly related to the drug; and 16% vs. 5% of at least moderate severity and possibly related to the drug as found in a clinical study).

KALETRA oral solution contains alcohol.

KALETRA tablets should be stored at room temperature. Exposure of this product to high humidity outside the pharmacy container for longer than 2 weeks is not recommended.

Refrigerated KALETRA oral solution remains stable until the expiration date printed on the label. If stored at room temperature up to 77°F (25°C), KALETRA oral solution should be used within 2 months.

Avoid exposure to excessive heat.