Adult Dosing
Treatment of HIV infection (Therapy-naive patients)
- Tabs: 400/100 mg (2 x 200/50 mg tabs) PO bid or 800/200 mg (4 x 200/50 mg tabs) PO Daily
- Oral soln: 400/100 mg (5 mL) PO bid or 800/200 mg (10 mL) PO daily in patients with less than three lopinavir resistance-associated substitutions
- Do not use daily dosing in patients with less than three lopinavir resistance-associated substitutions, pregnancy, or in patients receiving concomitant therapy with nevirapine, efavirenz, amprenavir, nelfinavir, carbamazepine, phenobarbital or phenytoin
Treatment of HIV infection (Therapy-experienced patients)
- Tabs: 400/100 mg (2 x 200/50 mg tabs) PO bid
- Oral soln: 400/100 mg (5 mL) PO bid
Treatment of HIV infection with concomitant therapy of efavirenz, fosamprenavir, nelfinavir, or nevirapine
- Tabs: 500/125 mg (2 x 200/50 mg + 1 x 100/25 tab) PO bid
- Oral soln: 533/133 mg (6.5 mL) mg PO bid
Pediatric Dosing
Treatment of HIV infection without concomitant therapy
- Administration of tablets or oral solution once-daily in pediatric patients <18 yrs is not recommended
- 2 wks-6 months: Oral soln: 16/4 mg/kg/dose PO bid or 300/75 mg/m2 PO bid
- 6 months-18 yrs and <15 kg: Oral soln:12/3 mg/kg/dose PO bid or 230/57.5 mg/m2 PO bid
- 6 months-18 yrs and 15-40 kg: Oral soln:10/2.5 mg/kg/dose PO bid or 230/57.5 mg/m2 PO bid [Max: 400/100 mg PO bid]
- <18 yrs and >40 kg: 400/100 mg (4x 100/25 tabs or 2 x 200/50 tabs or 5 mL soln) PO bid
Treatment of HIV infection with concomitant efavirenz, fosamprenavir, nelfinavir, or nevirapine
- Administration of tablets or oral solution once-daily in pediatric patients <18 yrs is not recommended
- 6 months-18 yrs and <15 kg: 13/3.25 mg/kg/dose PO bid or 300/75 mg/m2dose PO bid
- 6 months-18 yrs and 15-45 kg: 11/2.75 mg/kg/dose PO bid or 300/75 mg/m2dose PO bid
- <18 yrs and >45 kg: Use adult dosage
[Outline]
- Increased plasma concentrations of concomitant medications have occurred on initiating treatment in patients receiving medications metabolized by CYP3A or initiating medications metabolized by CYP3A in patients already maintained on lopinavir/ritonavir drug combination. Increase or prolonged therapeutic or adverse effects, potentially leading to severe, life-threatening or fatal events have occurred due to higher plasma concentrations of concomitant medications. Consider potential for drug-drug interactions prior to and during therapy. Consider reviewing other medications taken by patients and monitor patients for adverse effects
- Patients with developed triglyceride elevations, receiving lopinavir/ritonavir are prone to pancreatitis. Rare occasions of fatalities have occurred. Patients with advanced HIV-1 disease are at increased risk of elevated triglycerides and pancreatitis, and patients having history of pancreatitis are at increased risk for recurrence during therapy
- Consider pancreatitis on occurrence of clinical symptoms such as nausea, vomiting, abdominal pain or abnormalities in laboratory values such as increased serum lipase or amylase values. Evaluate patients exhibiting these signs or symptoms and suspend therapy with lopinavir/ritonavir and/or other antiretroviral therapy as clinically appropriate
- Patients with underlying hepatitis B or C or marked elevations in transaminases prior to therapy are highly susceptible for developing or worsening of transaminase elevations or hepatic decompensation
- Hepatic dysfunction including some fatalities have been reported during post marketing surveillance; patients with advanced HIV-1 disease taking multiple concomitant medications in the setting of underlying chronic hepatitis or cirrhosis are more susceptible
- Perform appropriate laboratory tests prior to initiating therapy and monitor patients closely during treatment. Consider increased AST/ALT monitoring in the patients with underlying chronic hepatitis or cirrhosis, especially during the first several months of treatment
- New onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, diabetic ketoacidosis and hyperglycemia may occur in HIV-infected patients receiving protease inhibitor. Persistent hyperglycemia has occurred even on discontinuation of therapy. Patients may require either initiation or dose adjustments of insulin or oral hypoglycemic agents for treatment of these events
- Prolongs PR interval. Cases of second or third degree atrioventricular block have occurred. Post-marketing cases of QT interval prolongation and torsade de pointes have occurred. Avoid use in patients with congenital long QT syndrome, hypokalemia, and with other drugs that prolong the QT interval
- Immune reconstitution syndrome has occurred in patients treated with combination antiretroviral therapy. Further evaluation and treatment is necessary in patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections
- Redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and cushingoid appearance, have occurred in patients receiving antiretroviral therapy
- Lipid elevations have occurred in patients receiving this drug. Perform triglyceride and cholesterol test prior to initiating therapy and at periodic intervals during therapy. Manage lipid disorders as clinically appropriate taking into account any potential drug-drug interactions with lopinavir/ritonavir and HMG-CoA reductase inhibitors
- Acute hemolytic anemia has occurred in patients. Patients with hemophilia A and B treated with protease inhibitors are prone to spontaneous bleeding
- Potential for resistance/cross-resistance exists
- Concomitant use with salmeterol, voriconazole fluticasone not recommended
- Use of oral solution in neonates and preterm babies not recommended due to potential propylene glycol associated toxicity
Cautions: Use cautiously in:
- Hepatic impairment
- Ischemic heart disease
- Cardiomyopathy
- Structural heart disease
- Congenital QT syndrome
- Cardiac conduction disturbances
- Diabetes mellitus
- Pancreatitis
- Hemophilia
- Hypokalemia
- Concomitant use with drugs that prolong the PR interval
- Concomitant use with colchicine with renal or hepatic impairment
Pregnancy Category:C
Breastfeeding: HIV-infected mothers should generally not breastfeed their infants. In countries in which no acceptable, feasible, sustainable and safe replacement feeding is available, exclusive breastfeeding for 6 months is recommended for HIV-infected mothers to reduce the risk of HIV transmission from the mother to the infant compared with mixed feeding. In these settings, abrupt weaning at 4 months does not reduce the risk of HIV transmission or produce an overall health benefit compared to continued breastfeeding, and increases the risk of infant death in HIV-infected infants. Extended antiretroviral prophylaxis in breastfed infants with antiretroviral reduces the rate of HIV transmission during breastfeeding by about half, but the optimal regimen and duration of prophylaxis has not yet been defined. Antiretroviral prophylaxis in breastfed infants with antiretroviral drugs has been successfully used as part of a regimen that decreases mother-to-child transmission about half, but the optimal regimen and duration of prophylaxis has not yet been defined. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 27 January 2011). Centers for disease control and prevention recommends mothers avoiding breast-feeding their infants as risk for postnatal transmission of HIV-1 infection exists. Manufacturer advises to instruct infected mothers to avoid breast-feeding during therapy because of both the potential for HIV-1 transmission and the potential for serious adverse reactions in nursing infants.
US Trade Name(s)
US Availability
kaletra (lopinavir/ritonavir)
- CAPS: 133.3 mg/33.3 mg
- SOLN: [400 mg/100 mg]/5 mL
Canadian Trade Name(s)
Canadian Availability
kaletra (lopinavir/ritonavir)
UK Trade Name(s)
UK Availability
kaletra (lopinavir/ritonavir)
Australian Trade Name(s)
Australian Availability
kaletra (lopinavir/ritonavir)
- SOLN: [400 mg/100 mg]/5 mL
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Kaletra 200-50 MG TABS [Bottle] (ABBOTT)
30 mg = $199.99
90 mg = $575.99 - Kaletra 100-25 MG TABS [Bottle] (ABBOTT)
30 mg = $103.99
90 mg = $279.98 - Kaletra 400-100 MG/5ML SOLN [Bottle] (ABBOTT)
160 5ml = $419.98
480 5ml = $1212.84
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
