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Kaletra Tablets

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Kaletra Tablets




Indications
Dosage
How Supplied

INDICATIONS

KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV1 infection in adults and pediatric patients (14 days and older).

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 Microbiology and Clinical Studies].
  • Genotypic or phenotypic testing and/or treatment history should guide the use of KALETRA [see Microbiology]. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to KALETRA [see Microbiology].

DOSAGE AND ADMINISTRATION

General Administration Recommendations

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.

Dosage Recommendations In Adults

Considerations in Determining KALETRA Once Daily vs. Twice Daily Dosing Regimen
  1. KALETRA can be given as once daily or twice daily dosing regimen in patients with less than three lopinavir resistance-associated substitutions.
  2. KALETRA must be given as twice daily dosing regimen in patients with three or more resistance-associated substitutions.
  3. Table 1 includes the recommended once daily dosing regimen and Tables 2 and 3 include the recommended twice daily dosing regimen.
KALETRA once daily dosing regimen is not recommended in

The dose of KALETRA must be increased when administered in combination with efavirenz, nevirapine or nelfinavir. Table 3 outlines the dosage recommendations for twice daily dosing when KALETRA is taken in combination with efavirenz, nevirapine or nelfinavir.

Table 1: Recommended Dosage in Adults- KALETRA Once Daily Regimen

KALETRA Dosage Form Recommended Dosage Total KALETRA Dosage per Day
200/50 mg Tablet 4 tablets orally once daily 800/200 mg
400/100 mg Oral Solution 10 mL orally once daily 800/200 mg

Table 2: Recommended Dosage in Adults - KALETRA Twice Daily Regimen

KALETRA Dosage Form Recommended Dosage Total KALETRA Dosage per Day
200/50 mg Tablet 2 tablets orally twice daily 800/200 mg
400/100 mg Oral Solution 5 mL orally twice daily 800/200 mg

Table 3: Recommended Dosage in Adults - KALETRA Twice Daily Regimen in Combination with Efavirenz, Nevirapine, or Nelfinavir

KALETRA Dosage Form Recommended Dosage Total KALETRA Dosage per Day
200/50 mg Tablet and 100/25 mg Tablet 2 KALETRA 200/50 mg tablets and 1 KALETRA 100/25 mg tablet orally twice daily 1000/250 mg
400/100 mg Oral Solution 6.5 mL orally twice daily 1000/250 mg

Dosage Recommendations In Pediatric Patients

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

KALETRA oral solution should not be administered to neonates before a postmenstrual age (first day of the mother's last menstrual period to birth plus the time elapsed after birth) of 42 weeks and a postnatal age of at least 14 days has been attained [see WARNINGS AND PRECAUTIONS].

KALETRA oral solution contains 42.4% (v/v) alcohol and 15.3% (w/v) propylene glycol. Special attention should be given to accurate calculation of the dosage of KALETRA, transcription of the medication order, dispensing information and dosing instructions to minimize the risk for medication errors, and overdose. This is especially important for infants and young children. Total amounts of alcohol and propylene glycol from all medicines that are to be given to pediatric patients 14 days to 6 months of age should be taken into account in order to avoid toxicity from these excipients [see WARNINGS AND PRECAUTIONS and OVERDOSAGE].

Pediatric Dosage Calculations

Calculate the appropriate dose of KALETRA for each individual pediatric patient based on body weight (kg) or body surface area (BSA) to avoid underdosing or exceeding 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) Χ Prescribed lopinavir dose (mg/kg) = Administered lopinavir dose (mg)

Based on BSA:

Patient BSA (m²) Χ 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) χ 80 (mg/mL)

Dosage Recommendation in Pediatric Patients 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. Table 4 summarizes the recommended daily dosing regimen for pediatric patients 14 days to 6 months.

It is recommended that KALETRA not be administered in combination with efavirenz, nevirapine, or nelfinavir in patients < 6 months of age.

Table 4: Recommended KALETRA Oral Daily Dosage in Pediatric Patients 14 days to 6 months

Patient Age Based on Weight (mg/kg) Based on BSA (mg/m²) Frequency
14 days to 6 months 16/4 300/75 Given twice daily

Dosage Recommendation in Pediatric Patients 6 Months to 18 Years

Without Concomitant Efavirenz, Nevirapine, or Nelfinavir

Dosing Recommendations Using Oral Solution

In children 6 months to 18 years of age, the recommended dosage of lopinavir/ritonavir using KALETRA oral solution without concomitant efavirenz, nevirapine, or nelfinavir is 230/57.5 mg/m² given twice daily, not to exceed the recommended adult dose (400/100 mg [5 mL] twice daily). 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 5 summarizes the recommended daily dosing regimen for pediatric patients 6 months to 18 years.

Table 5: Recommended KALETRA Oral Daily Dosage in Pediatric Patients 6 months to 18 years

Patient Age Based on Weight (mg/kg) Based on BSA (mg/m²) Frequency
6 months to 18 years < 15 kg 12/3 230/57.5 Given twice daily
≥ 15 kg to 40 kg 10/2.5

Dosing Recommendations Using Tablets

Table 6 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 6: 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, Nevirapine, or Nelfinavir

Body Weight (kg) Body Surface Area (m²)* Recommended number of 100/25 mg Tablets Twice Daily
15 to 25 ≥ 0.6 to < 0.9 2
> 25 to 35 ≥ 0.9 to < 1.4 3
> 35 ≥ 1.4 4 (or two 200/50 mg tablets)
* KALETRA oral solution is available for children with a BSA less than 0.6 m² or those who are unable to reliably swallow a tablet.

Concomitant Therapy: Efavirenz, Nevirapine, or Nelfinavir

Dosing Recommendations Using Oral Solution

A dose increase of KALETRA to 300/75 mg/m² using KALETRA oral solution is needed when co-administered with efavirenz, nevirapine, or nelfinavir in children (both treatment-naοve and treatment-experienced) 6 months to 18 years of age, not to exceed the recommended adult dose (533/133 mg [6.5 mL] twice daily). If weight-based 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.

Dosing Recommendations Using Tablets

Table 7 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, or nelfinavir.

Table 7: 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, or Nelfinavir†

Body Weight (kg) Body Surface Area (m²)* Recommended number of 100/25 mg Tablets Twice Daily
15 to 20 ≥ 0.6 to < 0.8 2
> 20 to 30 ≥ 0.8 to < 1.2 3
> 30 to 45 ≥ 1.2 to < 1.7 4 (or two 200/50 mg tablets)
> 45 ≥ 1.7 5 [see Dosage Recommendations in Adults]
* KALETRA oral solution is available for children with a BSA less than 0.6 m² or those who are unable to reliably swallow a tablet.
† Please refer to the individual product labels for appropriate dosing in children.

Dosage Recommendations In Pregnancy

Administer 400/100 mg of KALETRA twice daily in pregnant patients with no documented lopinavir-associated resistance substitutions. Once daily KALETRA dosing is not recommended in pregnancy [see Use in Specific Populations and CLINICAL PHARMACOLOGY].

  • There are insufficient data to recommend dosing in pregnant women with any documented lopinavir-associated resistance substitutions.
  • No dosage adjustment of KALETRA is required for patients during the postpartum period.
  • Avoid use of KALETRA oral solution in pregnant women [see Use In Specific Populations].

HOW SUPPLIED

Dosage Forms And Strengths

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

Storage And Handling

KALETRA® (lopinavir and ritonavir) tablets and oral solution are available in the following strengths and package sizes:

KALETRA Tablets, 200 mg Lopinavir And 50 mg Ritonavir

Yellow film-coated ovaloid tablets debossed with the “a” logo and the code KA:

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

Recommended Storage

Store KALETRA 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 And 25 mg Ritonavir

Pale yellow film-coated ovaloid tablets debossed with the “a” logo and the code KC:

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

Recommended Storage

Store KALETRA 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 and ritonavir) oral solution is a light yellow to orange colored liquid supplied in amber-colored multiple-dose bottles containing 400 mg lopinavir and 100 mg ritonavir per 5 mL (80 mg lopinavir and 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.

KALETRA Tablets, 200 mg lopinavir and 50 mg ritonavir Manufactured by AbbVie LTD, Barceloneta, PR 00617 for AbbVie Inc., North Chicago, IL 60064 USA. KALETRA Tablets, 100 mg lopinavir and 25 mg ritonavir and KALETRA Oral Solution AbbVie Inc., North Chicago, IL 60064 USA. Revised: January 2015

Last reviewed on RxList: 2/9/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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