raltegravir
Isentress · ATC code J05AJ01
Brand names: Isentress, Raltegravir Axiromed, Raltegravir Beta, Raltegravir Hormosan, Raltegravir Viatris, Raltegravir Zentiva
- Key facts
- Active substance
- raltegravir
- Drug class
- Direct acting antiviral
- ATC code
- J05AJ01
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- ISENTRESS 400 mg film-coated tablets · ISENTRESS 600 mg film-coated tablets · ISENTRESS 25 mg chewable tablets / ISENTRESS 100 mg chewable tablets · ISENTRESS 100 mg granules for oral suspension
- Marketing authorisation holder
- Merck Sharp & Dohme B.V.
- Information as of
- 2026-10-28
Key facts
Raltegravir is an HIV integrase inhibitor used in combination with other antiretroviral medicines to treat HIV-1 infection (Isentress).
What it is used for
- Isentress 400 mg film-coated tablets, chewable tablets and granules: in combination with other antiretrovirals for the treatment of HIV-1 infection.
- Isentress 600 mg film-coated tablets: in combination for HIV-1 infection in adults and paediatric patients weighing at least 40 kg.
Dosing
- Isentress 400 mg tablet: adults and children of at least 25 kg, 400 mg twice daily, with or without food; do not chew, crush or split.
- Isentress 600 mg tablet: adults and children of at least 40 kg, 1,200 mg (two 600 mg tablets) once daily for treatment-naïve patients or those virologically suppressed on 400 mg twice daily.
- Chewable tablets (children at least 11 kg, maximum 300 mg twice daily) and granules (from birth) are dosed by weight; details: see the full text. The formulations are not interchangeable.
- No dose adjustment in renal impairment or mild to moderate hepatic impairment; caution in severe hepatic impairment and in the elderly.
Contraindications
- Hypersensitivity to the active substance or any excipient.
Important warnings
- Relatively low genetic barrier to resistance; whenever possible combine with two other active antiretrovirals.
- Depression including suicidal ideation, particularly with a psychiatric history.
- Severe, potentially fatal skin and hypersensitivity reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.
- Myopathy and rhabdomyolysis; use with caution with a relevant history.
- Immune reactivation syndrome may occur when combination antiretroviral therapy is started.
Side effects
- Most frequent: headache, nausea and abdominal pain.
- Most frequent serious: immune reconstitution syndrome and rash; rhabdomyolysis uncommonly.
- Discontinuation due to adverse reactions was 5% or less in trials.
Interactions
- Raltegravir is mainly glucuronidated via UGT1A1; strong inducers such as rifampicin lower levels (if unavoidable, doubling the dose can be considered in adults).
- Aluminium and/or magnesium antacids reduce raltegravir levels; co-administration is not recommended.
- Raltegravir is not expected to affect CYP enzymes or P-glycoprotein.
Pregnancy and breastfeeding
- Raltegravir 400 mg twice daily can be used during pregnancy if clinically needed; 1,200 mg once daily is not recommended in pregnancy.
- Women living with HIV should not breast-feed, to avoid transmission.
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.
Common questions – ask Medelix
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)
- IsentressMerck Sharp & Dohme B.V. · EMEA/H/C/000860
Source: European Medicines Agency (EMA), product information
Germany
- Raltegravir AxiromedMedical Valley Invest Ab · 1 register entry
- Raltegravir BetaBetapharm Arzneimittel Gmbh · 2 register entries
- Raltegravir HormosanHormosan Pharma Gmbh · 1 register entry
- Raltegravir ViatrisViatris Germany Gmbh · 1 register entry
- Raltegravir ZentivaZentiva Pharma Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Turkey
- IsentressMERCK SHARP DOHME İLAÇLARI LTD. ŞTİ. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 21 more European countries
- Bulgaria
- Raltegravir Viatris, Ралтегравир Зентива
- Croatia
- Raltegravir Viatris
- Cyprus
- Raltegravir Viatris
- Denmark
- Raltegravir Viatris, Raltegravir Zentiva
- Estonia
- Raltegravir Viatris, Raltegravir Zentiva
- Finland
- Raltegravir Viatris, Raltegravir Zentiva
- France
- Raltegravir Biogaran, Raltegravir Viatris, Raltegravir Zentiva, Raltégravir Biogaran, Raltégravir Dz
- Greece
- Ralpecin, Raltegravir Viatris
- Iceland
- Isentress, Raltegravir Day Zero, Raltegravir Zentiva
- Italy
- Raltegravir Dr. Reddy’s, Raltegravir Mylan
- Latvia
- Raltegravir Viatris, Raltegravir Zentiva
- Liechtenstein
- Isentress
- Lithuania
- Raltegravir Zentiva
- Malta
- Raltegravir Viatris
- Netherlands
- Raltegravir Rockmed Pharma, Raltegravir Viatris, Raltegravir Zentiva
- Norway
- Isentress, Raltegravir Viatris, Raltegravir Zentiva
- Poland
- Raltegravir Viatris
- Portugal
- Raltegravir Mylan, Raltegravir Zentiva
- Romania
- Raltegravir Viatris, Raltegravir Zentiva
- Spain
- Raltegravir Dr. Reddys, Raltegravir Zentiva
- Sweden
- Raltegravir Zentiva
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.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Isentress – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/isentress-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC J05AJ.
Editorial: Medelix editorial team · last updated 2026-10-28 · 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.