Lopimune - called Kaletra

Ritonavir/Lopinavir - chemical Name

WHAT IS LOPINAVIR?

Lopinavir is a drug used as part of antiretroviral therapy (ART). Lopinavir is a protease inhibitor. Lopinavir used to be called ABT-378. It is manufactured by Abbott Laboratories. The amount of Lopinavir in the blood stream stays much higher if it is taken with a small amount of ritonavir, another protease inhibitor. Kaletra® is a combination of lopinavir and ritonavir in the same tablet. In the developing world, Kaletra is sold as Aluvia.

Protease inhibitors prevent the protease enzyme from working. HIV protease acts like a chemical scissors. It cuts the raw material for HIV into specific pieces needed to build a new virus. Protease inhibitors "gum up" these scissors.

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HIV/AIDS-Related Uses

Lopinavir/ritonavir in capsule and oral solution form was approved by the FDA on September 15, 2000, for use with other antiretrovirals in the treatment of HIV infection in adults and children 6 months of age or older. Lopinavir/ritonavir in tablet form was approved by the FDA on October 28, 2005. In March 2006, the capsule form of the medicine was phased out in the U.S. in favor of the new tablet. Lopinavir alone quickly breaks down in the body. Ritonavir slows down this process and increases the time that lopinavir stays in the bloodstream.

This medicine does not cure or prevent HIV infection or AIDS and does not reduce the risk of passing the virus to other people.

Adult Dosing

Tablets (200 mg lopinavir/50 mg ritonavir)

• 400/100 mg BID
• 800/200 mg QD*

Abbreviations: BID = twice daily; QD = once daily

* QD dosing is recommended only for treatment-naive adults. Lopinavir/ritonavir should not be administered once-daily in regimens that include efavirenz, nevirapine, amprenavir, fosamprenavir, or nelfinavir.
Oral solution not recommended for adults.

Recommended Daily Dose

The recommended dose of lopinavir/ritonavir in treatment-experienced adults is 2 tablets (400 mg/100 mg) twice daily taken with or without food or 5 ml of oral solution twice daily taken with food. The recommended doses of lopinavir/ritonavir in treatment-naive adults are 2 tablets (400 mg/100 mg) twice daily taken with or without food or 4 tablets (800 mg/200 mg) once daily taken with or without food.

No dosing adjustment in treatment-naive patients is necessary when lopinavir/ritonavir tablets are administered as part of a twice-daily regimen with efavirenz, nevirapine, amprenavir, fosamprenavir, or nelfinavir. A dose increase should also be considered when lopinavir/ritonavir in tablet form is used in combination with efavirenz, nevirapine, fosamprenavir without ritonavir, or nelfinavir in certain treatment-experienced patients. Lopinavir/ritonavir should not be used once daily in combination with efavirenz, nevirapine, amprenavir, fosamprenavir, or nelfinavir. When lopinavir/ritonavir in oral solution or capsule form is used twice daily in combination with efavirenz or nevirapine, the lopinavir/ritonavir dose should be increased. Dosing of lopinavir/ritonavir in children is based on weight. Some patients may benefit from different doses of lopinavir/ritonavir. Patients should always take lopinavir/ritonavir as prescribed by their doctors.

Possible Side Effects

Along with its desired effects, this medicine can cause some serious unwanted effects. Individuals should tell a doctor if they have any of the following side effects: disease of the pancreas (symptoms include bloating; chills; constipation; darkened urine; fast heartbeat; fever; indigestion; loss of appetite; pains in stomach, side, or back; yellow eyes or skin), diabetes, or high blood sugar (symptoms include blurred vision, dry mouth, fruity mouth odor, increased hunger or thirst, increased urination, fainting, nausea, stomachache, sweating, tiredness, trouble breathing, or unusual weight loss). Other serious side effects include body fat changes, high cholesterol, and increased bleeding in hemophilia patients. Individuals should tell a doctor if they have any of these side effects.

Other side effects may not be serious and may lessen or disappear with continued use of the medicine. Less serious side effects of this medicine include diarrhea, headache, nausea, rash, trouble sleeping, vomiting, and weakness. Diarrhea may occur more frequently in patients taking lopinavir/ritonavir once daily. Individuals should tell a doctor if these side effects continue or are bothersome.