Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
Kaletra is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children above the age of 2 years.
The choice of Kaletra to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients (see sections 4.4 and 5.1).
Kaletra should be prescribed by physicians who are experienced in the treatment of HIV infection.
Kaletra tablets must be swallowed whole and not chewed, broken or crushed.
The standard recommended dosage of Kaletra tablets is 400/100 mg (two 200/50 mg) tablets twice daily taken with or without food. In adult patients, in cases where once-daily dosing is considered necessary for the management of the patient, Kaletra tablets may be administered as 800/200 mg (four 200/50 mg tablets) once daily with or without food. The use of a once-daily dosing should be limited to those adult patients having only very few protease inhibitor (PI) associated mutations (i.e. less than 3 PI mutations in line with clinical trial results, see section 5.1 for the full description of the population) and should take into account the risk of a lesser sustainability of the virologic suppression (see section 5.1) and higher risk of diarrhoea (see section 4.8) compared to the recommended standard twice-daily dosing. An oral solution is available to patients who have difficulty swallowing. Refer to the Summary of Product Characteristics for Kaletra oral solution for dosing instructions.
The adult dose of Kaletra tablets (400/100 mg twice daily) may be used in children 40 kg or greater or with a Body Surface Area (BSA)* greater than 1.4 m². For children weighing less than 40 kg or with a BSA between 0.5 and 1.4 m² and able to swallow tablets, please refer to the Kaletra 100 mg/25 mg tablets Summary of Product Characteristics. For children unable to swallow tablets, please refer to the Kaletra oral solution Summary of Product Characteristics. Based on the current data available, Kaletra should not be administered once daily in paediatric patients (see section 5.1)
* Body surface area can be calculated with the following equation:
BSA (m²) = √ (Height (cm) X Weight (kg) / 3600)
The safety and efficacy of Kaletra in children aged less than 2 years have not yet been established. Currently available data are described in section 5.2 but no recommendation on a posology can be made.
The following table contains dosing guidelines for Kaletra tablets based on BSA when used in combination with efavirenz or nevirapine in children.
|\2<>_.Paediatric dosing guidelines with
concomitant efavirenz or nevirapine|
| Body Surface Area (m²) | Recommended lopinavir/ritonavir dosing (mg) twice daily. The adequate dosing may be achieved with the two available strengths of Kaletra tablets: 100/25 mg and 200/50 mg.* |
|---|---|
| ≥0.5 to <0.8 | 200/50 mg |
| ≥0.8 to <1.2 | 300/75 mg |
| ≥1.2 to <1.4 | 400/100 mg |
| ≥1.4 | 500/125 mg |
* Kaletra tablets must not be chewed, broken or crushed.
In HIV-infected patients with mild to moderate hepatic impairment, an increase of approximately 30% in lopinavir exposure has been observed but is not expected to be of clinical relevance (see section 5.2). No data are available in patients with severe hepatic impairment. Kaletra must not be given to these patients (see section 4.3).
Since the renal clearance of lopinavir and ritonavir is negligible, increased plasma concentrations are not expected in patients with renal impairment. Because lopinavir and ritonavir are highly protein bound, it is unlikely that they will be significantly removed by haemodialysis or peritoneal dialysis.
Kaletra tablets are administered orally and must be swallowed whole and not chewed, broken or crushed. Kaletra tablets can be taken with or without food.
To date, there is limited human experience of acute overdose with Kaletra.
The adverse clinical signs observed in dogs included salivation, emesis and diarrhoea/abnormal stool. The signs of toxicity observed in mice, rats or dogs included decreased activity, ataxia, emaciation, dehydration and tremors.
There is no specific antidote for overdose with Kaletra. Treatment of overdose with Kaletra is to consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. If indicated, elimination of unabsorbed active substance is to be achieved by emesis or gastric lavage. Administration of activated charcoal may also be used to aid in removal of unabsorbed active substance. Since Kaletra is highly protein bound, dialysis is unlikely to be beneficial in significant removal of the active substance.
Bottle packs: 4 years.
Blister packs: 3 years.
This medicinal product does not require any special storage conditions.
High density polyethylene (HDPE) bottles closed with propylene caps. Each bottle contains 120 tablets.
Two pack sizes are available:
Blisters packs – polyvinyl chloride (PVC) blisters with fluoropolymer foil backing
Two pack sizes are available:
Not all pack sizes may be marketed.
No special requirements.
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