KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

The following points should be considered when initiating therapy with KALETRA:

• The use of other active agents with KALETRA is associated with a greater likelihood of treatment response [see CLINICAL PHARMACOLOGY and Clinical Studies].
• Genotypic or phenotypic testing and/or treatment history should guide the use of KALETRA [see CLINICAL PHARMACOLOGY]. The number of baseline primary protease inhibitor mutations affects the virologic response to KALETRA [see CLINICAL PHARMACOLOGY].
• Once-daily administration of KALETRA is not recommended for therapy-experienced adult patients or any pediatric patients.

KALETRA tablets may be taken with or without food. The tablets should be swallowed whole and not chewed, broken, or crushed.

KALETRA oral solution must be taken with food.

Adult Patients

Therapy-Naive Patients

• KALETRA tablets 400/100 mg (given as two 200/50 mg tablets) twice-daily taken with or without food.
• KALETRA oral solution 400/100 mg (5 mL) twice-daily taken with food.
• KALETRA tablets 800/200 mg (given as four 200/50 mg tablets) once-daily taken with or without food.
• KALETRA oral solution 800/200 mg (10 mL) once-daily taken with food.

When initiating treatment with KALETRA in therapy-naive patients, it should be noted the incidence of diarrhea was greater with KALETRA capsules once-daily compared to KALETRA capsules twice-daily in Study 418 (57% vs. 35% - reactions of all grades; 16% vs. 5% - reactions of at least moderate severity) [See ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION].

Therapy-Experienced Patients

Once-daily administration of KALETRA is not recommended in therapy-experienced patients.

• KALETRA tablets 400/100 mg (given as two 200/50 mg tablets) twice-daily taken with or without food.
• KALETRA oral solution 400/100 mg (5 mL) twice-daily taken with food.

Concomitant Therapy: Efavirenz, nevirapine, (fos)amprenavir or nelfinavir

[See CLINICAL PHARMACOLOGY and DRUG INTERACTIONS]

KALETRA tablets and oral solution should not be administered as a once-daily regimen in combination with efavirenz, nevirapine, (fos)amprenavir or nelfinavir.

• KALETRA 400/100 mg (given as two 200/50 mg tablets) can be used twice-daily in combination with these drugs with no dose adjustment in antiretroviral-naive patients.
• A dose increase of KALETRA tablets to 600/150 mg (given as three 200/50 mg tablets) twicedaily may be considered when used in combination with efavirenz, nevirapine, (fos)amprenavir without ritonavir, or nelfinavir in treatment-experienced patients where decreased susceptibility to lopinavir is clinically suspected (by treatment history or laboratory evidence). A dose increase is recommended for all patients who use KALETRA oral solution. The recommended dose of KALETRA oral solution is 533/133 mg (6.5 mL) twice-daily taken with food when used in combination with efavirenz, nevirapine, (fos)amprenavir or nelfinavir.

Pediatric Patients

KALETRA tablets and oral solution should not be administered once-daily in pediatric patients < 18 years of age.

Healthcare professionals should pay special attention to accurate calculation of the dose of KALETRA, transcription of the medication order, dispensing information and dosing instructions to minimize the risk for medication errors, overdose, [see OVERDOSAGE] and underdose.

Prescribers should calculate the appropriate dose of KALETRA for each individual child based on body weight (kg) or body surface area (BSA) and should not exceed the recommended adult dose.

Body surface area (BSA) can be calculated as follows:

*BSA (m²)= √Ht(Cm) x Wt (kg)/3600

The KALETRA dose can be calculated based on weight or BSA:

Based on Weight:

Patient Weight (kg) x Prescribed lopinavir dose (mg/kg) = Administered lopinavir dose (mg)

Based on BSA:

Patient BSA (m²) x Prescribed lopinavir dose (mg/m²) = Administered lopinavir dose (mg)

If KALETRA oral solution is used, the volume (mL) of KALETRA solution can be determined as follows:

Volume of KALETRA solution (mL) = Administered lopinavir dose (mg) / 80 (mg/mL)

The dose of the oral solution should be administered using a calibrated dosing syringe.

Before prescribing KALETRA 100/25 mg tablets, children should be assessed for the ability to swallow intact tablets. If a child is unable to reliably swallow a KALETRA tablet, the KALETRA oral solution formulation should be prescribed.

14 Days to 6 Months:

In pediatric patients 14 days to 6 months of age, the recommended dosage of lopinavir/ritonavir using KALETRA oral solution is 16/4 mg/kg or 300/75 mg/m² twice daily. Prescribers should calculate the appropriate dose based on body weight or body surface area.

Because no data exists for dosage when administered with efavirenz, nevirapine, (fos)amprenavir, or nelfinavir, it is recommended that KALETRA not be administered in combination with these drugs in patients < 6 months of age.

6 Months to 18 Years:

Without Concomitant Efavirenz, Nevirapine, (Fos)amprenavir or Nelfinavir

In children 6 months to 18 years of age, the recommended dosage of lopinavir/ritonavir using KALETRA oral solution without concomitant efavirenz, nevirapine, (fos)amprenavir or nelfinavir is 230/57.5 mg/m² given twice daily, not to exceed the recommended adult dose. If weight-based dosing is preferred, the recommended dosage of lopinavir/ritonavir for patients < 15 kg is 12/3 mg/kg given twice daily and the dosage for patients ≥ 15 kg to 40 kg is 10/2.5 mg/kg given twice daily.

Table 1 provides the dosing recommendations for pediatric patients 6 months to 18 years of age based on body weight or body surface area for KALETRA tablets.

Table 1. Pediatric Dosing Recommendations for Patients 6 Months to 18 Years of Age Based on Body Weight or Body Surface Area for KALETRA Tablets Without Concomitant Efavirenz, Neviraprine, (Fos)amprenavir, or Nelfinavir

Concomitant Therapy: Efavirenz, Nevirapine, (Fos)amprenavir, or Nelfinavir

A dose increase of KALETRA to 300/75 mg/m² is needed when co-administered with efavirenz, nevirapine, (fos)amprenavir, or nelfinavir in children (both treatment-naive and treatmentexperienced) 6 months to 18 years of age, not to exceed the recommended adult dose. If weightbased dosing is preferred, the recommended dosage for patients < 15 kg is 13/3.25 mg/kg given twice daily and the dosage for patients ≥ 15 kg to 45 kg is 11/2.75 mg/kg given twice daily.

Table 2 provides the dosing recommendations for pediatric patients 6 months to 18 years of age based on body weight or body surface area for KALETRA tablets when given in combination with efavirenz, nevirapine, (fos)amprenavir, or nelfinavir.

Table 2. Pediatric Dosing Recommendations for Patients 6 Months to 18 Years of Age Based on Body Weight or Body Surface Area for KALETRA Tablets With Concomitant Efavirenz., Nevirapine, (Fos)amprenavir. or Nelfinavir†

Dosage Forms and Strengths

• KALETRA Tablets, 200 mg lopinavir/50 mg ritonavir Yellow, film-coated, ovaloid tablets debossed with the corporate Abbott “A” logo and the Abbo-Code KA providing 200 mg lopinavir/50 mg ritonavir.
• KALETRA Tablets, 100 mg lopinavir/25 mg ritonavir Pale yellow, film-coated, ovaloid tablets debossed with the corporate Abbott “A” logo and the Abbo-Code KC providing 100 mg lopinavir/25 mg ritonavir.
• KALETRA Oral Solution Light yellow to orange colored liquid containing 400 mg lopinavir/100 mg ritonavir per 5 mL (80 mg lopinavir/20 mg ritonavir per mL).

Storage And Handling

KALETRA® (lopinavir/ritonavir) Film-Coated tablets and Oral Solution are available in the following strengths and package sizes:

KALETRA Tablets, 200 mg lopinavir/50 mg ritonavir

Yellow film-coated ovaloid tablets debossed with the corporate Abbott “A” logo and the Abbo-Code KA:

Bottles of 120 tablets....................................... (NDC 0074-6799-22)

Recommended Storage

Store KALETRA film-coated tablets at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°to 86°F)[see USP controlled room temperature]. Dispense in original container or USP equivalent tight container (250 mL or less). For patient use: exposure of this product to high humidity outside the original container or USP equivalent tight container (250 mL or less) for longer than 2 weeks is not recommended.

KALETRA Tablets, 100 mg lopinavir/25 mg ritonavir

Pale yellow film-coated ovaloid tablets debossed with the corporate Abbott “A” logo and the Abbo- Code KC:

Bottles of 60 tablets ....................... (NDC 0074-0522-60)

Recommended Storage

Store KALETRA film-coated tablets at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°to 86°F)[see USP controlled room temperature]. Dispense in original container or USP equivalent tight container (100 mL or less). For patient use: exposure of this product to high humidity outside the original container or USP equivalent tight container (100 mL or less) for longer than 2 weeks is not recommended.

KALETRA Oral Solution

KALETRA (lopinavir/ritonavir) oral solution is a light yellow to orange colored liquid supplied in ambercolored multiple-dose bottles containing 400 mg lopinavir/100 mg ritonavir per 5 mL (80 mg lopinavir/20 mg ritonavir per mL) packaged with a marked dosing cup in the following size:

160 mL bottle.....................(NDC 0074-3956-46)

Recommended Storage

Store KALETRA oral solution at 2°-8°C (36°-46°F) until dispensed. Avoid exposure to excessive heat. For patient use, refrigerated KALETRA oral solution remains stable until the expiration date printed on the label. If stored at room temperature up to 25°C (77°F), oral solution should be used within 2 months.

Abbott Laboratories, North Chicago, IL 60064, U.S.A. Rev. 6/2008. FDA revision date: 6/20/2008

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