Classes
DEA Class; Rx
Common Brand Names; Dutrebis
- HIV, ART Combos
Description
Lamivudine: Nucleoside reverse transcriptase inhibitor (NRTI); following phosphorylation, inhibits HIV reverse transcriptase by viral DNA chain termination; cytosine analog
Raltegravir: Integrase inhibitor; inhibits catalytic activity of HIV-1 integrase, an HIV encoded enzyme required for viral replication
Indications
Indicated for use in combination with other antiretroviral products for the treatment of HIV-1 infection in adults and pediatric patients aged ≥6 years weighing at ≥30 kg
Contraindications
Hypersensitivity
Adverse Effects
Lamivudine
- Cough
- Diarrhea
- Fatigue and malaise
- Fever (pediatric)
- Headache
- Musculoskeletal pain
- Nausea
- Nervous system neuropathy
- Pancreatitis
- Peripheral neuropathy
- Nasal S/S
- Vomiting
Raltegravir
- Total cholesterol increased (16%)
Warnings
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of NRTIs alone or in combination, including lamivudine and other antiretrovirals
Post-treatment exacerbations of hepatitis in patients with HIV-1 and hepatitis B virus coinfection reported
Pancreatitis reported; use with caution in pediatric patients with a history or prior antiretroviral nucleoside exposure, a history of pancreatitis, or other risk factors for pancreatitis; discontinue immediately if signs or symptoms of pancreatitis occur
Hepatic decompensation reported with used with interferon- or ribavirin-based regimens; ribavirin can reduce the phosphorylation of pyrimidine NRTIs such as lamivudine
Severe, potentially life-threatening, and fatal skin reactions reported with raltegravir, including Stevens-Johnson syndrome and toxic epidermal necrolysis; hypersensitivity reactions have also been reported and were characterized by rash, constitutional findings, and sometimes, organ dysfunction, including hepatic failure; discontinue if signs or symptoms occur
Immune reconstitution syndrome reported with combination antiretroviral therapy and may include an inflammatory response to indolent or residual opportunistic infections or emergence of autoimmune disorders (eg, Grave disease, polymyositis, Guillain-Barré syndrome)
Pregnancy and Lactation
Pregnancy Category: C
Lactation: Breastfeeding is not recommended while taking lamivudine/raltegravir; additionally it is recommended that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1
Maximum Dosage
1 tablet (150 mg/300 mg) PO BID
How supplied
Lamivudine/raltegravir
tablet
- 150mg/300mg
- Approved, but not commercially available in the United States