Brand Name: Arava®
Active Ingredient: lopinavir/ritonavir
Strength(s): 133.3/33.3mg Capsules, 80/20mg/ml Oral Solution and 200/50mg Tablets
Dosage Form(s): Capsules, Oral Solution and Tablets
Company Name: Abbott Pharmaceuticals
Availability: Prescription only
Date Approved by FDA: September 15, 2000

Patient Information Sheet
Lopinavir/Ritonavir (marketed as Kaletra)

What is Kaletra used for?
 Kaletra is always used in combination with other anti-HIV drugs to treat people with human immunodeficiency virus (HIV) infection. Kaletra is for adults and children 6 months and older.
 Kaletra does not cure HIV infection or AIDS. The long-term effects of Kaletra are not known at this time. You may continue to develop infections and other complications associated with HIV disease.
 Kaletra does not reduce the risk of transmitting HIV to others through sexual contact or blood contamination. Continue to practice safe sex, and do not use or share dirty needles.
Who should not take Kaletra?
Together with your doctor, you need to decide whether Kaletra is right for you.
 Taking certain drugs with Kaletra could cause serious side effects that could cause death. Before you start Kaletra you must tell your doctor about ALL the drugs you are taking or are planning to take. These include other prescription and non-prescription medicines and herbal supplements such as St. John’s wort.
 For more information about medicines you should not take with Kaletra, and medicines that require dosage adjustments click on the link below to Kaletra’s approved labeling and patient information.
 Do not take Kaletra if you have had a serious allergic reaction to Kaletra or any of its ingredients, including ritonavir or lopinavir.
Special Warnings with Kaletra:
 Kaletra may cause liver problems. Liver disease such as Hepatitis B and Hepatitis C may worsen when Kaletra is taken. In studies, it is unclear if Kaletra caused these liver problems because some patients had other illnesses or were taking other medications.
 Some people taking Kaletra develop serious problems with their pancreas (pancreatitis), which may cause death. You have a higher chance of having pancreatitis if you have had it before. Tell your doctor if have nausea, vomiting, or abdominal pain. These may be signs of pancreatitis.
 Changes in body fat happen in some people taking anti-HIV medicines. These changes may include increased amount of fat in the upper back and neck ("buffalo hump"), breast and abdomen (stomach area). Loss of fat from the face, legs, and arms may also happen. The cause and long-term health effects of these conditions are not known at this time.
 Some patients with hemophilia have increased bleeding with this type of drug.
 If you are taking oral contraceptives ("the pill") to prevent pregnancy, you should use an additional or different type of contraception since Kaletra may reduce the effectiveness of oral contraceptives.
What should I tell my doctor or healthcare provider?
Tell your doctor or healthcare provider if you:
 are trying to become pregnant, are already pregnant, or are breast-feeding
 have liver problems
 have diabetes or an increase in thirst or frequent urination
 have hemophilia
What are some possible side effects of Kaletra? (This is NOT a complete list of side effects reported with Kaletra. Your healthcare provider can discuss with you a more complete list of side effects.)
The most commonly reported side effects that are thought to be drug related are:
 abnormal stools (bowel movements)
 diarrhea
 feeling weak/tired
 headache
 nausea
 children taking Kaletra may sometimes get a skin rash
For more detailed information about Kaletra, ask your healthcare provider.
Date Posted: 5/24/01 Updated: 12/29/04