Dolutegravir /Lamivudine

Dosing

1 tab PO once daily

1 tab = Dolutegravir 50 mg/ Lamivudine 300 mg목동병원에서만 사용함

Safety and efficacy in pediatric patients have not been established목동병원에서만 사용함

Mild or moderate hepatic impairment No dose adjustment

Severe hepatic impairment Not recommended

CrCl 30-49CrCl <30If new or worsening symptoms, dose adjustment of lamivudine recommended; use individual components if reduced lamivudine dose is necessaryNot recommended

General Information

Treatment of HIV infection.

Black Box Warning: All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating dolutegravir/lamivudine. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If dolutegravir/lamivudine is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV. Severe acute exacerbations of HBV have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued lamivudine. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment.

Test for HBV prior to or when initiating therapy.

Monitor for hepatotoxicity in all patients and for signs of severe acute exacerbations of HBV in patients who are coinfected with HIV-1 and HBV and have discontinued lamivudine; monitor with both clinical and laboratory follow-up for at least several months after stopping treatment.

Monitor for suspected lactic acidosis and severe hepatomegaly with steatosis.

Monitor for hypersensitivity reactions including rash, constitutional findings, and organ dysfunction, including liver injury.

Common

  • Diarrhea

  • Nausea

  • Headache

  • Insomnia

  • Fatigue

Serious

  • Lactic acidosis

  • Hepatitis B exacerbation

  • Hepatotoxicity

  • Injury of liver

  • Immune reconstitution syndrome

Contraindications:

  • Defetilide

Drug interactions:

  • Etravirine

  • Carbamazepine

  • Fosamprenavir/Ritonavir

  • Rifampin

  • Tipranavir

  • Metformin

  • Sorbitol

  • Horsetail

  • Select UGTenzyme inducers

  • CYP3A4 substrates

  • Efavirenz

  • Cabotegravir

  • Dasabuvir

  • Medications containing polyvalent cations

  • Phenobarbital

  • St. John's wort

  • Orlistat

  • Nevirapine

  • Oxcarbazepine

  • Phenytoin

  • Dalfampridine

Antimicrobial class: Antiretroviral, Integrase inhibitor, Nucleoside reverse transcriptase inhibitor

Average serum half life: 14 hours (Dolutegravir), 13-19 hours (Lamivudine)

Precautions: Monitoring recommended in hepatitis B or C, hepatotoxicity, liver injury and lactic acidosis and severe hepatomegaly with steatosis.

Discontinue use immediately if hypersensitivity reactions develop.

Immune reconstitution syndrome has been reported with combination antiretroviral therapy; further evaluation and treatment may be required.

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