Raltegravir

Table of contents

  • Brand Names
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Caution and personalized dose adjustment in patients with the following genotypes
  • Substrate of
  • Inhibits
  • Drug Interactions
  • Nutrition/Nutraceutical Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names

Europe

Austria: Isentress; Belgium: Isentress; Bulgaria: Isentress; Czech Republic: Isentress; Denmark: Isentress; Estonia: Isentress; Finland: Isentress; France: Isentress; Germany: Isentress; Greece: Isentress; Hungary: Isentress; Ireland: Isentress; Italy: Isentress; Latvia: Isentress; Lithuania: Isentress; Luxembourg: Isentress; Malta: Isentress; Netherlands: Isentress; Poland: Isentress; Portugal: Isentress; Romania: Isentress; Slovakia: Isentress; Slovenia: Isentress; Spain: Isentress; Sweden: Isentress; UK: Isentress.

North America

Canada: Isentress; USA: Isentress.

Asia

Japan: Isentress.

Drug combinations

Chemistry

Raltegravir Potassium: C~20~H~20~FKN~6~O~5~. Mw: 482.51. (1) 4-Pyrimidinecarboxamide, N-[(4-fluorophenyl)methyl]-1,6-dihydro-5-hydroxy-1-methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino]ethyl]-6-oxo-, monopotassium salt; (2) Potassium 4-[(4-fluorobenzyl)carbamoyl]-1-methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino]ethyl]-6-oxo-1,6-dihydropyrimidin-5-olate. CAS-871038-72-1; CAS-518048-05-0 (raltegravir). (2007)

Pharmacologic Category

Antiretrovirals; Integrase Inhibitors. (ATC-Code: J05AX08).

Mechanism of action

Viral cDNA strand produced by reverse transcriptase is processed and inserted into human genome by enzyme HIV-1 integrase. Raltegravir inhibits catalytic activity of integrase, thus preventing integration of proviral gene into human DNA.

Therapeutic use

Treatment of HIV-1 infection in combination with other antiretroviral agents in treatment-experienced patients with virus that shows multidrug resistance and active replication.

Pregnancy and lactiation implications

There are no adequate, well-controlled studies in pregnant women; available data insufficient to recommend use in pregnancy. Excretion in breast milk unknown (contraindicated in nursing women).

Unlabeled use

Contraindications

Hypersensitivity to raltegravir or any other component of the formulation.

Warnings and precautions

Patients may develop immune reconstitution syndrome resulting in occurrence of inflammatory response to indolent or residual opportunistic infection. Grade 2-4 creatine kinase (CK) increases observed and myopathy and rhabdomyolysis reported (use caution in risk factors for CK elevations and/or skeletal muscle abnormalities). Use caution with medications known to induce (e.g. rifampin) or inhibit (e.g. atazanavir) UGT1A1 glucuronidation, as serum levels/therapeutic effects may be reduced or increased, respectively.

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