Lopinavir and Ritonavir

LOPINAVIR AND RITONAVIR — lopinavir and ritonavir tablet, film coated
Camber Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE

Lopinavir and ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older.
Limitations of Use:
• Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir tablets. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir tablets [see Microbiology (12.4)].

2 DOSAGE AND ADMINISTRATION

2.1 General Administration Recommendations

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

2.3 Dosage Recommendations in Adults

Lopinavir and ritonavir tablets can be given in once daily or twice daily dosing regimen at dosages noted in Tables 1 and 2. Lopinavir and ritonavir tablets once daily dosing regimen is not recommended in:

• 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)].
• In combination with carbamazepine, phenobarbital, or phenytoin [see Drug Interactions (7.3)].
• In combination with efavirenz, nevirapine, or nelfinavir [see Drug Interactions (7.3) and Clinical Pharmacology ( 12.3)].
• In pediatric patients younger than 18 years of age [see Dosage and Administration (2.4)]. • In pregnant women [see Dosage and Administration ( 2.5),Use in Specific Populations (8.1)and Clinical Pharmacology (12.3)].

Table 1. Recommended Dosage in Adults — Lopinavir and Ritonavir Tablets Once Daily Regimen

Lopinavir and Ritonavir Tablets Dosage Form Recommended Dosage
200 mg/50 mg Tablets 800 mg/200 mg (4 tablets) once daily

Table 2. Recommended Dosage in Adults – Lopinavir and Ritonavir Tablets Twice Daily Regimen

Lopinavir and Ritonavir Tablets Dosage Form Recommended Dosage
200 mg/50 mg Tablets 400 mg/100 mg (2 tablets) twice daily

The dose of lopinavir and ritonavir tablets must be increased when administered in combination with efavirenz, nevirapine or nelfinavir. Table 3 outlines the dosage recommendations for twice daily dosing when lopinavir and ritonavir tablets are taken in combination with these agents.

Table 3. Recommended Dosage in Adults — Lopinavir and Ritonavir Tablets Twice Daily Regimen in Combination with Efavirenz, Nevirapine, or Nelfinavir

Lopinavir and Ritonavir Tablets Dosage Form Recommended Dosage
200 mg/50 mg Tablets and 100 mg/25 mg Tablets 500 mg/125 mg (2 tablets of 200 mg/50 mg + 1 tablet of 100 mg/25 mg) twice daily

2.4 Dosage Recommendations in Pediatric Patients

Lopinavir and ritonavir tablets are not recommended for once daily dosing in pediatric patients younger than 18 years of age. Lopinavir and ritonavir 100/25 mg tablets should be considered only in children who have reliably demonstrated the ability to swallow the intact tablet.
Lopinavir and ritonavir oral solution is not recommended in 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)].
Lopinavir and ritonavir oral solution contains alcohol and propylene glycol. 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)].
Pediatric Dosage Calculations
Calculate the appropriate dose of lopinavir and ritonavir tablets 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:

lopiandritotabfig

The lopinavir and ritonavir tablets 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 (m 2) × Prescribed lopinavir dose (mg/m 2) = Administered lopinavir dose (mg)

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

Volume of lopinavir and ritonavir solution (mL) = Administered lopinavir dose (mg) ÷ 80 (mg/mL) Tablet Dosage Recommendation in Pediatric Patients Older than 6 Months to Less than 18 Years:

Table 5 provides the dosing recommendations for pediatric patients older than 6 months to less than 18 years of age based on body weight or body surface area for lopinavir and ritonavir tablets.

Table 5. Lopinavir and Ritonavir Tablet Daily Dosage Recommendations in Pediatric Patients ˃ 6 Months to < 18 Years of Age Without Concomitant Efavirenz, Nevirapine, or Nelfinavir

Body Weight (kg) Body Surface Area (m 2)* 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
* Lopinavir and ritonavir oral solution is available for children with a BSA less than 0.6 m 2 or those who are unable to reliably swallow a tablet.

Concomitant Therapy: Efavirenz, Nevirapine, or Nelfinavir

Dosing recommendations using tablets

Table 7 provides the dosing recommendations for pediatric patients older than 6 months to less than 18 years of age based on body weight or body surface area for lopinavir and ritonavir tablets when given in combination with efavirenz, nevirapine, or nelfinavir.

Table 7. Lopinavir and Ritonavir Tablet Daily Dosage Recommendations for Pediatric Patients ˃ 6 Months to < 18 Years of Age With Concomitant Efavirenz†, Nevirapine, or Nelfinavir

Body Weight (kg) Body Surface Area (m 2)* 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
> 45 ≥1.7 5 [see Dosage and Administration (2.4)]
*Lopinavir and ritonavir oral solution is available for children with a BSA less than 0.6 m 2 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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