RILOVIA 100/25 and RILOVIA 200/50 are indicated for the treatment of HIV-1 infected adults, in combination with other antiretroviral agents.
Most experience with lopinavir/ritonavir tablets is derived from the use of the product in antiretroviral therapy naïve patients. Data in heavily pretreated protease inhibitor experienced patients are limited. There are limited data on salvage therapy on patients who have failed therapy with RILOVIA 100/25 and RILOVIA 200/50.
RILOVIA 100/25 and RILOVIA 200/50 tablets should be prescribed by doctors who are experienced in the treatment of HIV infection.
RILOVIA 100/25 and RILOVIA 200/50 tablets should be swallowed whole and not chewed, broken or crushed.
RILOVIA DS (200 mg/50 mg)
Adult and adolescent use: The recommended dosage of RILOVIA DS is two 200/50 mg tablets twice daily taken with or without food.
RILOVIA (100 mg/25 mg)
Children less than 2 years of age: RILOVIA 100/25 and RILOVIA 200/50 are not recommended for use in children below 2 years of age due to insufficient data on safety and efficacy.
Paediatric use (2 years of age and above): The adult dose of RILOVIA 100/25 and RILOVIA 200/50 (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.
The following table contains dosing guidelines for RILOVIA (100/25 mg) tablets based on BSA.
| Paediatric Dosing Guidelines | |
|---|---|
| Body Surface Area (m²) | Recommended number of RILOVIA (100/25 mg) tablets twice-daily |
| ≥1,4 | 4 tablets (400/100 mg) |
* Body surface area can be calculated with the following equation:
BSA (m²) = √ (Height (cm) X Weight (kg) / 3600)
Children less than 2 years of age: RILOVIA 100/25 and RILOVIA 200/50 are not recommended for use in children below 2 years of age due to insufficient data on safety and efficacy.
Concomitant therapy: Efavirenz or nevirapine
The following table contains dosing guidelines for RILOVIA 100/25 and RILOVIA 200/50 based on BSA when used in combination with efavirenz or nevirapine in children.
| Paediatric Dosing Guidelines with concomitant efavirenz or nevirapine | |
|---|---|
| Body Surface Area (m²) | Recommended number of RILOVIA (100/25 mg) tablets twice-daily. The adequate dosing may be achieved with the two available strengths of lopinavir/ritonavir tablets: RILOVIA (100/25 mg) and RILOVIA DS (200/50 mg.)* |
| ≥1,4 | 500/125 mg |
* RILOVIA 100/25 and RILOVIA 200/50 tablets must not be chewed, broken or crushed.
Hepatic impairment: In HIV-infected patients with mild to moderate hepatic impairment, an increase of approximately 30% in lopinavir exposure has been observed. No data are available in patients with severe hepatic impairment.
RILOVIA 100/25 and RILOVIA 200/50 should not be given to these patients.
Renal impairment: No dose adjustment is necessary in patients with renal impairment. Caution is warranted when RILOVIA 100/25 and RILOVIA 200/50 are used in patients with severe renal impairment.
There is limited human experience of overdose with RILOVIA 100/25 and RILOVIA 200/50.
There is no specific antidote for overdose with RILOVIA 100/25 and RILOVIA 200/50. Treatment of overdose with RILOVIA 100/25 and RILOVIA 200/50 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 RILOVIA 100/25 and RILOVIA 200/50 are highly protein bound, dialysis is unlikely to be beneficial in significant removal of the active substance.
Store at or below 30°C. Store in the original container. Do not remove from the carton until required for use. Keep the bottles tightly closed.
KEEP THIS MEDICINE OUT OF REACH AND SIGHT OF CHILDREN
RILOVIA 100/25 film-coated tablets will be packed in High Density Polyethylene (HDPE) bottle (Pill jar) pack (marketable pack) with white opaque polypropylene (PP) tamper evident closure with inbuilt desiccant packed into a carton in pack size of 56’s, 112’s and 120’s*.
RILOVIA 100/25 film-coated tablets will be packed in High Density Polyethylene (HDPE) bottle (Pill jar) pack (marketable pack) with white opaque polypropylene (PP) tamper evident closure with inbuilt desiccant in pack sizes of 56’s, 112’s and 120’s*.
RILOVIA 200/50 film-coated tablets will be packed in high density polyethylene (HDPE) bottle (Pill jar) pack (marketable pack) with white opaque polypropylene (PP) tamper evident closure with inbuilt desiccant packed into a carton in pack size of 112’s and 120’s*.
RILOVIA 200/50 film-coated tablets will be packed in high density polyethylene (HDPE) bottle (Pill jar) pack (marketable pack) with white opaque polypropylene (PP) tamper evident closure with inbuilt desiccant in pack sizes of 112’s and 120’s*.
High density polyethylene (HDPE) bottle pack (marketable pack) comprising of white opaque HDPE bottle with white opaque polypropylene (PP) child resistant closure with aluminium induction sealing wad packed into a carton in pack size of 112’s and 120’s*. Separate desiccant is included in the final pack.
High density polyethylene (HDPE) bottle pack (marketable pack) comprising of white opaque HDPE bottle with white opaque polypropylene (PP) child resistant closure with aluminium induction sealing wad in pack sizes of 112’s and 120’s*.
* Not all packs may be marketed.
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