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lopinavir/ritonavir

Kaletra · ATC code J05AR10

Also known as: Lopinavir / Ritonavir

Key facts
Active substance
lopinavir/ritonavir (INN: lopinavir / ritonavir)
Drug class
Efavirenz/lamivudine/tenofovir
ATC code
J05AR10
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Kaletra (80 mg + 20 mg) / ml oral solution · Kaletra 200 mg/50 mg film-coated tablets · Kaletra 100 mg/25 mg film-coated tablets
Marketing authorisation holder
AbbVie Deutschland GmbH & Co. KG
Information as of
2026-10-29

Key facts

Lopinavir/ritonavir (Kaletra) is a fixed combination of an HIV protease inhibitor with ritonavir as a pharmacokinetic booster, used with other antiretrovirals to treat HIV-1 infection.

What it is used for

  • Kaletra oral solution: in combination with other antiretrovirals for HIV-1 infected adults, adolescents and children aged from 14 days and older.
  • Kaletra 200 mg/50 mg tablets: in combination with other antiretrovirals for HIV-1 infected adults, adolescents and children above the age of 2 years.
  • In protease inhibitor-experienced patients, the choice should be based on resistance testing and treatment history.

Dosing

  • Kaletra tablets, adults and adolescents: 400/100 mg (two 200/50 mg tablets) twice daily with or without food; in selected adults with very few PI mutations, 800/200 mg once daily. Tablets are swallowed whole.
  • Kaletra oral solution, adults and adolescents: 5 ml (400/100 mg) twice daily with food.
  • Kaletra oral solution, children 2 weeks to 6 months: 16/4 mg/kg (0.2 ml/kg) or 300/75 mg/m2 twice daily with food; older children are dosed by body weight or body surface area (see the full text).
  • Children 40 kg or greater or with a BSA greater than 1.4 m2 may use the adult tablet dose; once-daily dosing is not used in children.
  • Dosing changes with efavirenz or nevirapine; see the full text.

Contraindications

  • Hypersensitivity to the active substances or to any of the excipients; severe hepatic insufficiency.
  • Co-administration with medicines highly dependent on CYP3A for clearance, e.g. alfuzosin, ranolazine, amiodarone, dronedarone, astemizole, terfenadine, lurasidone, pimozide, quetiapine, ergot alkaloids, cisapride, elbasvir/grazoprevir, lovastatin, simvastatin, lomitapide, avanafil, sildenafil for pulmonary arterial hypertension; see the full text for the complete list.
  • St John's wort must not be combined.

Important warnings

  • Patients with chronic hepatitis B or C or pre-existing liver dysfunction are at increased risk of severe hepatic reactions; laboratory testing before and close monitoring during treatment.
  • Pancreatitis has been reported, including with hypertriglyceridaemia; therapy is suspended if pancreatitis is diagnosed.
  • Modest PR interval prolongation; rare 2nd or 3rd degree AV block in patients with structural heart disease or drugs that prolong the PR interval.
  • Increased bleeding in patients with haemophilia; immune reconstitution inflammatory syndrome; increases in weight, lipids and glucose.
  • For infants, total amounts of alcohol and propylene glycol from all medicines should be considered (oral solution).

Side effects

  • Most common: diarrhoea, nausea, vomiting, hypertriglyceridaemia and hypercholesterolaemia.
  • Gastrointestinal effects may occur early, lipid elevations later.
  • Pancreatitis and rare PR interval increases have been reported.

Interactions

  • Lopinavir and ritonavir inhibit CYP3A and may raise levels of medicines metabolised by CYP3A.
  • Kaletra can also induce some enzymes (CYP2C9, CYP2C19, glucuronidation), lowering levels of other medicines.
  • Co-administration with simeprevir or sofosbuvir/velpatasvir/voxilaprevir is not recommended.

Pregnancy and breastfeeding

  • Lopinavir/ritonavir has been evaluated in over 3000 pregnant women, including over 1000 during the first trimester; animal and clinical data should be considered.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Turkey

  • Kaletra YumuşakABBVİE TIBBİ İLAÇLAR SAN. VE TİC. LTD. ŞTİ. · 1 register entry
  • OrvicalWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 11 more European countries
Estonia
Lopinavir/Ritonavir Ranbaxy, Lopinavir/Ritonavir Sun
France
Lopinavir/Ritonavir Dextreg
Iceland
Kaletra, Lopinavir/Ritonavir Mylan, Lopinavir/Ritonavir Viatris
Latvia
Lopinavir/ Ritonavir Ranbaxy, Lopinavir/ Ritonavir Sun
Liechtenstein
Kaletra, Lopinavir/Ritonavir Viatris
Lithuania
Lopinavir / Ritonavir Sun, Lopinavir /Ritonavir Ranbaxy
Netherlands
Lopinavir/Ritonavir Accord
Norway
Kaletra, Lopinavir/Ritonavir Viatris
Portugal
Lopinavir + Ritonavir Farmoz
Slovenia
Lopinavir/Ritonavir Accord
Spain
Lopinavir / Ritonavir Accord

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Kaletra – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/kaletra-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. Wikidata (CC0): ATC J05AR.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.