Kaletra

Kaletra Manufacturers

• State Of Florida Doh Central Pharmacy
  

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  Kaletra | State Of Florida Doh Central Pharmacy

  

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  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.

  2.1 Adult Patients

  Therapy-Naïve 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.

  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 (12.3) and Drug Interactions (7.3)]

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

  A dose increase is recommended for all patients who use KALETRA tablets. The recommended dose of KALETRA tablets is 500/125 mg (such as two 200/50 tablets and one 100/25 mg tablet) twice daily in combination with efavirenz, nevirapine, (fos)amprenavir or nelfinavir. 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. 2.2 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 ( 10)] 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:

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

  Based on Weight:

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

  Based on BSA:

  Patient BSA (m2) × 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, Nevirapine, (Fos)amprenavir, or Nelfinavir Body Weight (kg) Body Surface Area (m2)* Recommended number of
  100/25 mg Tablets Twice Daily

  * 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.

  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)

  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-naïve and treatment-experienced) 6 months to 18 years of age, not to exceed the recommended adult dose. 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.

  
  

  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† Body Weight (kg) Body Surface Area (m2)* Recommended number of
  100/25 mg Tablets Twice Daily

  * 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.

  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 4 or 6 (or two or three 200/50 mg tablets) see Dosage and Administration, Adult Patients (2.1)

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• Remedyrepack Inc.
  

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  Kaletra | Remedyrepack Inc.

  

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  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.

  2.1 Adult Patients   KALETRA tablets 400/100 mg (given as two 200/50 mg tablets) twice daily.   KALETRA oral solution 400/100 mg (5 mL) twice daily.   KALETRA tablets 800/200 mg (given as four 200/50 mg tablets) once daily in patients with less than three lopinavir resistance-associated substitutions.   KALETRA oral solution 800/200 mg (10 mL) once daily in patients with less than three lopinavir resistance-associated substitutions.

    Once daily administration of KALETRA is not recommended for adult patients with three or more of the following lopinavir resistance-associated substitutions: L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V [see Clinical Pharmacology ( 12.4 )] .

    KALETRA should not be administered once daily in combination with carbamazepine, phenobarbital, or phenytoin [see Drug Interactions (7.0)] .

  Concomitant Therapy: Efavirenz, Nevirapine, Amprenavir or Nelfinavir

  [see Clinical Pharmacology (12.3) and [Drug Interactions (7.3)]

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

  A dose increase is recommended for all patients who use KALETRA tablets. The recommended dose of KALETRA tablets is 500/125 mg (such as two 200/50 tablets and one 100/25 mg tablet) twice daily in combination with efavirenz, nevirapine, amprenavir or nelfinavir. 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 when used in combination with efavirenz, nevirapine, amprenavir or nelfinavir. 2.2 Pediatric Patients

  KALETRA tablets and oral solution should not be administered once daily in pediatric patients greater then 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 (10)] 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:
  

  
  

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

  Based on Weight:

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

  Based on BSA:

  Patient BSA (m2) × 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, amprenavir, or nelfinavir, it is recommended that KALETRA not be administered in combination with these drugs in patients greater then  6 months of age.

  
  

  6 Months to 18 Years:

  Without Concomitant Efavirenz, Nevirapine, Amprenavir 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, amprenavir, 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 greater then 15 kg is 12/3 mg/kg given twice daily and the dosage for patients  less then 15 kg to 40 kg is 10/2.5 mg/kg given twice daily.

  Dosing recommendations using tablets

  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, Nevirapine, Amprenavir, or Nelfinavir Body Weight (kg) Body Surface Area (m2)* Recommended number of
  100/25 mg Tablets Twice Daily

  * 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.

  15 to 25 less then 0.6 to greater then  0.9 2 less then25 to 35 less then 0.9 to greater then  1.4 3 less then 35  less then 1.4 4 (or two 200/50 mg tablets)

  Concomitant Therapy: Efavirenz, Nevirapine, Amprenavir, 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, amprenavir, or nelfinavir in children (both treatment-naïve 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 greater then 15 kg is 13/3.25 mg/kg given twice daily and the dosage for patients less then 15 kg to 45 kg is 11/2.75 mg/kg given twice daily.

  Dosing recommendations using tablets

  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, 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, Amprenavir† or Nelfinavir† Body Weight (kg) Body Surface Area (m2)* Recommended number of
  100/25 mg Tablets Twice Daily

  * 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.

  15 to 20 less then 0.6 to  greater then  0.8 2 less then 20 to 30  less then 0.8 to greater then  1.2 3 less then 30 to 45 less then 1.2 to  greater then 1.7 4 (or two 200/50 mg tablets)  less then 45  less then 1.7 5 [see Dosage and Administration, Adult Patients (2.1)]

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• Rebel Distributors Corp
  

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  Kaletra | Rebel Distributors Corp

  

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  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.

  2.1 Adult Patients KALETRA tablets 400/100 mg (given as two 200/50 mg tablets) twice daily. KALETRA oral solution 400/100 mg (5 mL) twice daily. KALETRA tablets 800/200 mg (given as four 200/50 mg tablets) once daily in patients with less than three lopinavir resistance-associated substitutions. KALETRA oral solution 800/200 mg (10 mL) once daily in patients with less than three lopinavir resistance-associated substitutions.

  Once daily administration of KALETRA is not recommended for adult patients with three or more of the following lopinavir resistance-associated substitutions: L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V [see Clinical Pharmacology ( 12.4)].

  KALETRA should not be administered once daily in combination with carbamazepine, phenobarbital, or phenytoin [see Drug Interactions (7.0)].

  Concomitant Therapy: Efavirenz, Nevirapine, Amprenavir or Nelfinavir

  [see Clinical Pharmacology (12.3) and [Drug Interactions (7.3)]

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

  A dose increase is recommended for all patients who use KALETRA tablets. The recommended dose of KALETRA tablets is 500/125 mg (such as two 200/50 tablets and one 100/25 mg tablet) twice daily in combination with efavirenz, nevirapine, amprenavir or nelfinavir. 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 when used in combination with efavirenz, nevirapine, amprenavir or nelfinavir. 2.2 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 (10)] 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:

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

  Based on Weight:

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

  Based on BSA:

  Patient BSA (m2) × 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, 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, Amprenavir 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, amprenavir, 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.

  Dosing recommendations using tablets

  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, Nevirapine, Amprenavir, or Nelfinavir Body Weight (kg) Body Surface Area (m2)* Recommended number of
  100/25 mg Tablets Twice Daily

  * 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.

  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)

  Concomitant Therapy: Efavirenz, Nevirapine, Amprenavir, 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, amprenavir, or nelfinavir in children (both treatment-naïve 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 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, 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, Amprenavir† or Nelfinavir† Body Weight (kg) Body Surface Area (m2)* Recommended number of
  100/25 mg Tablets Twice Daily

  * 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.

  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 and Administration, Adult Patients (2.1)]

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• Pd-rx Pharmaceuticals, Inc.
  

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  Kaletra | Pd-rx Pharmaceuticals, Inc.

  

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  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.

  2.1 Adult Patients KALETRA tablets 400/100 mg (given as two 200/50 mg tablets) twice daily. KALETRA oral solution 400/100 mg (5 mL) twice daily. KALETRA tablets 800/200 mg (given as four 200/50 mg tablets) once daily in patients with less than three lopinavir resistance-associated substitutions. KALETRA oral solution 800/200 mg (10 mL) once daily in patients with less than three lopinavir resistance-associated substitutions.

  Once daily administration of KALETRA is not recommended for adult patients with three or more of the following lopinavir resistance-associated substitutions: L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V [see Clinical Pharmacology ( 12.4)].

  KALETRA should not be administered once daily in combination with carbamazepine, phenobarbital, or phenytoin [see Drug Interactions (7)].

  Concomitant Therapy: Efavirenz, Nevirapine, Amprenavir or Nelfinavir

  [see Clinical Pharmacology (12.3) and [Drug Interactions (7.3)]

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

  A dose increase is recommended for all patients who use KALETRA tablets. The recommended dose of KALETRA tablets is 500/125 mg (such as two 200/50 tablets and one 100/25 mg tablet) twice daily in combination with efavirenz, nevirapine, amprenavir or nelfinavir. 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 when used in combination with efavirenz, nevirapine, amprenavir or nelfinavir. 2.2 Pediatric Patients

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

  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 (5.2)].

  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 dose 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 (5.2) and Overdosage (10)].

  Prescribers should calculate the appropriate dose of KALETRA for each individual child 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:

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

  Based on Weight:

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

  Based on BSA:

  Patient BSA (m2) × 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, 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, Amprenavir 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, amprenavir, 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.

  Dosing recommendations using tablets

  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, Nevirapine, Amprenavir, 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, Amprenavir, 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, amprenavir, or nelfinavir in children (both treatment-naïve 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 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, 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, Amprenavir† 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 and Administration, Adult Patients (2.1)] * 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.

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• Hhs/program Support Center/supply Service Center
  

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  Kaletra | Hhs/program Support Center/supply Service Center

  

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  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.

  2.1 Adult Patients KALETRA tablets 400/100 mg (given as two 200/50 mg tablets) twice daily. KALETRA oral solution 400/100 mg (5 mL) twice daily. KALETRA tablets 800/200 mg (given as four 200/50 mg tablets) once daily in patients with less than three lopinavir resistance-associated substitutions. KALETRA oral solution 800/200 mg (10 mL) once daily in patients with less than three lopinavir resistance-associated substitutions.

  Once daily administration of KALETRA is not recommended for adult patients with three or more of the following lopinavir resistance-associated substitutions: L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V [see Clinical Pharmacology ( 12.4)].

  KALETRA should not be administered once daily in combination with carbamazepine, phenobarbital, or phenytoin [see Drug Interactions (7)].

  Concomitant Therapy: Efavirenz, Nevirapine, Amprenavir or Nelfinavir

  [see Clinical Pharmacology (12.3) and [Drug Interactions (7.3)]

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

  A dose increase is recommended for all patients who use KALETRA tablets. The recommended dose of KALETRA tablets is 500/125 mg (such as two 200/50 tablets and one 100/25 mg tablet) twice daily in combination with efavirenz, nevirapine, amprenavir or nelfinavir. 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 when used in combination with efavirenz, nevirapine, amprenavir or nelfinavir. 2.2 Pediatric Patients

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

  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 (5.2)].

  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 dose 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 (5.2) and Overdosage (10)].

  Prescribers should calculate the appropriate dose of KALETRA for each individual child 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:

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

  Based on Weight:

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

  Based on BSA:

  Patient BSA (m2) × 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, 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, Amprenavir 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, amprenavir, 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.

  Dosing recommendations using tablets

  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, Nevirapine, Amprenavir, 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, Amprenavir, 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, amprenavir, or nelfinavir in children (both treatment-naïve 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 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, 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, Amprenavir† 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 and Administration, Adult Patients (2.1)] * 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.

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  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.

  2.1 Adult Patients KALETRA tablets 400/100 mg (given as two 200/50 mg tablets) twice daily. KALETRA oral solution 400/100 mg (5 mL) twice daily. KALETRA tablets 800/200 mg (given as four 200/50 mg tablets) once daily in patients with less than three lopinavir resistance-associated substitutions. KALETRA oral solution 800/200 mg (10 mL) once daily in patients with less than three lopinavir resistance-associated substitutions.

  Once daily administration of KALETRA is not recommended for adult patients with three or more of the following lopinavir resistance-associated substitutions: L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V [see Clinical Pharmacology (12.4)].

  KALETRA should not be administered once daily in combination with carbamazepine, phenobarbital, or phenytoin [see Drug Interactions (7)].

  Concomitant Therapy: Efavirenz, Nevirapine, Amprenavir or Nelfinavir

  [see Clinical Pharmacology (12.3) and [Drug Interactions (7.3)]

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

  A dose increase is recommended for all patients who use KALETRA tablets. The recommended dose of KALETRA tablets is 500/125 mg (such as two 200/50 tablets and one 100/25 mg tablet) twice daily in combination with efavirenz, nevirapine, amprenavir or nelfinavir. 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 when used in combination with efavirenz, nevirapine, amprenavir or nelfinavir. 2.2 Pediatric Patients

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

  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 (5.2)].

  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 dose 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 (5.2) and Overdosage (10)].

  Prescribers should calculate the appropriate dose of KALETRA for each individual child 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:

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

  Based on Weight:

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

  Based on BSA:

  Patient BSA (m2) × 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, 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, Amprenavir 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, amprenavir, 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.

  Dosing recommendations using tablets

  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, Nevirapine, Amprenavir, 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, Amprenavir, 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, amprenavir, or nelfinavir in children (both treatment-naïve 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 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, 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, Amprenavir† 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 and Administration, Adult Patients (2.1)] * 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.

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  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.

  2.1 Adult Patients KALETRA tablets 400/100 mg (given as two 200/50 mg tablets) twice daily. KALETRA oral solution 400/100 mg (5 mL) twice daily. KALETRA tablets 800/200 mg (given as four 200/50 mg tablets) once daily in patients with less than three lopinavir resistance-associated substitutions. KALETRA oral solution 800/200 mg (10 mL) once daily in patients with less than three lopinavir resistance-associated substitutions.

  Once daily administration of KALETRA is not recommended for adult patients with three or more of the following lopinavir resistance-associated substitutions: L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V [see Clinical Pharmacology ( 12.4)].

  KALETRA should not be administered once daily in combination with carbamazepine, phenobarbital, or phenytoin [see Drug Interactions (7)].

  Concomitant Therapy: Efavirenz, Nevirapine, Amprenavir or Nelfinavir

  [see Clinical Pharmacology (12.3) and [Drug Interactions (7.3)]

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

  A dose increase is recommended for all patients who use KALETRA tablets. The recommended dose of KALETRA tablets is 500/125 mg (such as two 200/50 tablets and one 100/25 mg tablet) twice daily in combination with efavirenz, nevirapine, amprenavir or nelfinavir. 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 when used in combination with efavirenz, nevirapine, amprenavir or nelfinavir. 2.2 Pediatric Patients

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

  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 (5.2)].

  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 dose 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 (5.2) and Overdosage (10)].

  Prescribers should calculate the appropriate dose of KALETRA for each individual child 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:

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

  Based on Weight:

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

  Based on BSA:

  Patient BSA (m2) × 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, 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, Amprenavir 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, amprenavir, 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.

  Dosing recommendations using tablets

  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, Nevirapine, Amprenavir, 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, Amprenavir, 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, amprenavir, or nelfinavir in children (both treatment-naïve 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 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, 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, Amprenavir† 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 and Administration, Adult Patients (2.1)] * 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.

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  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.

  2.1 Adult Patients KALETRA tablets 400/100 mg (given as two 200/50 mg tablets) twice daily. KALETRA oral solution 400/100 mg (5 mL) twice daily. KALETRA tablets 800/200 mg (given as four 200/50 mg tablets) once daily in patients with less than three lopinavir resistance-associated substitutions. KALETRA oral solution 800/200 mg (10 mL) once daily in patients with less than three lopinavir resistance-associated substitutions.

  Once daily administration of KALETRA is not recommended for adult patients with three or more of the following lopinavir resistance-associated substitutions: L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V [see Clinical Pharmacology ( 12.4)].

  KALETRA should not be administered once daily in combination with carbamazepine, phenobarbital, or phenytoin [see Drug Interactions (7)].

  Concomitant Therapy: Efavirenz, Nevirapine, Amprenavir or Nelfinavir

  [see Clinical Pharmacology (12.3) and [Drug Interactions (7.3)]

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

  A dose increase is recommended for all patients who use KALETRA tablets. The recommended dose of KALETRA tablets is 500/125 mg (such as two 200/50 tablets and one 100/25 mg tablet) twice daily in combination with efavirenz, nevirapine, amprenavir or nelfinavir. 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 when used in combination with efavirenz, nevirapine, amprenavir or nelfinavir. 2.2 Pediatric Patients

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

  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 (5.2)].

  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 dose 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 (5.2) and Overdosage (10)].

  Prescribers should calculate the appropriate dose of KALETRA for each individual child 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:

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

  Based on Weight:

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

  Based on BSA:

  Patient BSA (m2) × 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, 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, Amprenavir 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, amprenavir, 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.

  Dosing recommendations using tablets

  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, Nevirapine, Amprenavir, 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, Amprenavir, 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, amprenavir, or nelfinavir in children (both treatment-naïve 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 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, 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, Amprenavir† 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 and Administration, Adult Patients (2.1)] * 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.

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• Cardinal Health
  

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  Kaletra | Cardinal Health

  

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  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.

  2.1 Adult Patients KALETRA tablets 400/100 mg (given as two 200/50 mg tablets) twice daily. KALETRA oral solution 400/100 mg (5 mL) twice daily. KALETRA tablets 800/200 mg (given as four 200/50 mg tablets) once daily in patients with less than three lopinavir resistance-associated substitutions. KALETRA oral solution 800/200 mg (10 mL) once daily in patients with less than three lopinavir resistance-associated substitutions.

  Once daily administration of KALETRA is not recommended for adult patients with three or more of the following lopinavir resistance-associated substitutions: L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V [see Microbiology (12.4)].

  KALETRA should not be administered once daily in combination with carbamazepine, phenobarbital, or phenytoin [see Drug Interactions (7)].

  Concomitant Therapy: Efavirenz, Nevirapine, or Nelfinavir

  [see Clinical Pharmacology (12.3) and [Drug Interactions (7.3)]

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

  A dose increase is recommended for all patients who use KALETRA tablets. The recommended dose of KALETRA tablets is 500/125 mg (such as two 200/50 tablets and one 100/25 mg tablet) twice daily in combination with efavirenz, nevirapine, or nelfinavir. 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 when used in combination with efavirenz, nevirapine, or nelfinavir. 2.2 Pediatric Patients

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

  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 (5.2)].

  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 dose 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 (5.2) and Overdosage (10)].

  Prescribers should calculate the appropriate dose of KALETRA for each individual child 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:

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

  Based on Weight:

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

  Based on BSA:

  Patient BSA (m2) × 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, 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, 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.

  Dosing recommendations using tablets

  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, 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-naïve 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 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, 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, 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 and Administration, Adult Patients (2.1)] * 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.

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  Kaletra | Guangdong Cr. Shunfeng Pharmaceutical Co Ltd

  

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  Adult and children 2 years of age and older. Apply liberally to affected area not more than 5 times daily and 5-8 times per day for some severe cases or follow doctor's instruction.

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