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The following adverse reactions are discussed in other sections of the labeling:

  • Lactic acidosis and severe hepatomegaly with steatosis [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
  • Severe acute exacerbations of hepatitis B [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
  • Hepatic decompensation in patients co-infected with HIV-1 and Hepatitis C [see WARNINGS AND PRECAUTIONS].
  • Pancreatitis [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical trials in patients have not been specifically performed with DUTREBIS. Common adverse reactions to each individual component (lamivudine and raltegravir) are summarized below.

Adult Subjects

Lamivudine

See the lamivudine full prescribing information for complete clinical trial information.

In four controlled clinical trials with lamivudine coadministered with zidovudine in adults, the most common reported adverse reactions (incidence greater than or equal to 15%, all grades) were headache, nausea, malaise and fatigue, nasal signs and symptoms, diarrhea, and cough.

Raltegravir

See the raltegravir full prescribing information for complete clinical trial information.

In Phase 3 clinical trials with raltegravir in treatment-naïve or treatment-experienced adults, the most common reported adverse reactions (incidence greater than or equal to 2%) of at least moderate intensity (greater than or equal to Grade 2) were insomnia, headache, dizziness, nausea, and fatigue.

Creatine kinase elevations were observed in subjects who received raltegravir. Myopathy and rhabdomyolysis have been reported. Monitor patients at increased risk of myopathy or rhabdomyolysis, such as patients receiving concomitant medications known to cause these conditions and patients with a history of rhabdomyolysis, myopathy or increased serum creatine kinase.

Pediatric Subjects

Lamivudine

See the lamivudine full prescribing information for complete clinical trial information.

In controlled clinical trials with lamivudine oral solution coadministered with zidovudine in pediatric subjects 3 months to 18 years of age, the most common reported adverse reactions (incidence greater than or equal to 15%, all grades) were fever and cough.

Raltegravir

See the raltegravir full prescribing information for complete clinical trial information.

Raltegravir has been studied in 126 antiretroviral treatment-experienced HIV-1 infected children and adolescents 2 to 18 years of age, in combination with other antiretroviral agents in IMPAACT P1066 [see Use in Specific Populations]. Of the 126 patients, 96 received the recommended dose of raltegravir.

In these 96 children and adolescents, frequency, type and severity of drug-related adverse reactions through W eek 24 were comparable to those observed in adults.

Postmarketing Experience

See the full prescribing information for lamivudine and raltegravir for postmarketing information.