LOPIMUNE Tablets
Each film-coated tablet contains
Lopinavir 200 mg
Ritonavir 50 mg

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

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

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

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

Adult Patients:

Therapy-Naive Patients:
LOPIMUNE tablets 400/100 mg (given as two 200/50 mg tablets) twice-daily taken with or without food.

LOPIMUNE tablets 800/200 mg (given as four 200/50 mg tablets) once-daily taken with or without food.

Therapy-Experienced Patients:
Once-daily administration of LOPIMUNE is not recommended in therapy-experienced patients.

LOPIMUNE tablets 400/100 mg (given as two 200/50 mg tablets) twice-daily taken with or without food.

Concomitant Therapy: Efavirenz, nevirapine, (fos)amprenavir or nelfinavir: [ see WARNINGS AND PRECAUTIONS: Drug interactions ]

LOPIMUNE tablets 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 LOPIMUNE tablets. The recommended dose of LOPIMUNE 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.

Pediatrics patients:

LOPIMUNE tablets 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 LOPIMUNE , transcription of the medication order, dispensing information and dosing instructions to minimize the risk for medication errors, overdose, [see OVERDOSAGE ] and underdose.

Prescribers should calculate the appropriate dose of LOPIMUNE 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 LOPIMUNE 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)

Before prescribing LOPIMUNE 200/50 mg tablets, children should be assessed for the ability to swallow intact tablets. If a child is unable to reliably swallow a LOPIMUNE tablet, an alternate formulation should be prescribed.

6 Months to 18 Years:
Without Concomitant Efavirenz, Nevirapine, (Fos)amprenavir or Nelfinavir:

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.

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

A dose increase of lopinavir to 300/75 mg/m 2 is needed when co-administered with efavirenz, nevirapine, (fos)amprenavir, or nelfinavir in children (both treatment-naive 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 1 provides the dosing recommendations for pediatric patients 6 months to 18 years of age based on body weight or body surface area for LOPIMUNE tablets when given in combination with efavirenz, nevirapine, (fos)amprenavir, or nelfinavir.

Table 1. Pediatric Dosing Recommendations for Patients 6 Months to 18 Years of Age Based on Body Weight or Body Surface Area for LOPIMUNE Tablets With Concomitant Efavirenz † , Nevirapine, (Fos)amprenavir † or Nelfinavir †

* Lopinavir/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.

LOPIMUNE is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g. Stevens-Johnson syndrome, erythema multiforme) to any of its ingredients, including ritonavir.

Co-administration of LOPIMUNE is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions.

Co-administration of LOPIMUNE is contraindicated with potent CYP3A inducers where significantly reduced lopinavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance and cross-resistance. These drugs are listed in Table 2.

Table: 2 Drugs That Are Contraindicated With LOPIMUNE

a See Drug Interactions for coadministration of sildenafil in patients with erectile dysfunction.

b See Drug Interactions, Table 3 for parenterally administered midazolam

LOPIMUNE --------------- Container of 60`s