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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 HIV-1 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

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

  • 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].

KALETRA should not be administered once daily in combination with carbamazepine, phenobarbital, or phenytoin [see DRUG INTERACTIONS].

Concomitant Therapy: Efavirenz, Nevirapine, 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, 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.

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].

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 and OVERDOSAGE].

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:

*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)

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-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 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]
* 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.

HOW SUPPLIED

Dosage Forms And Strengths

  • KALETRA Tablets, 200 mg lopinavir/50 mg ritonavir
    Yellow, film-coated, ovaloid tablets debossed with the “a” logo and the 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 “a” logo and the 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 “a” logo and the 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 “a” logo and the 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 amber-colored 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.

KALETRA Tablets, 200 mg lopinavir/50 mg ritonavir Manufactured by AbbVie LTD, Barceloneta, PR 00617 for AbbVie Inc., North Chicago, IL 60064 USA KALETRA Tablets, 100 mg lopinavir/25 mg ritonavir and KALETRA Oral Solution AbbVie Inc., North Chicago, IL 60064 USA. November 2013

Last reviewed on RxList: 11/21/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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