CIMDUO

Lamivudine After oral administration of 2 mg/kg of 3TC twice a day to 9 adults with HIV-1, the peak serum 3TC concentration (C max ) was 1.5 ± 0.5 mcg/mL (mean ± SD). The area under the plasma concentration versus time curve (AUC) and C max increased in proportion to oral dose over the range from 0.25 to 10 mg/kg and absolute bioavailability in 12 adult patients was 86% ± 16% (mean ± SD) for the 150-mg tablet and 87% ± 13% for the oral solution. Binding of 3TC to human plasma proteins is low (< ...

14.1 Clinical Efficacy in Patients with HIV-1 Infection Treatment-Naïve Adult Patients

Trial 903Data through 144 weeks are reported for Trial 903, a double-blind, active-controlled multicenter trial comparing EFV 600 mg + 3TC 300 mg + TDF 300 mg vs. EFV 600 mg + 3TC 300 mg + stavudine (d4T) 40 mg in 600 antiretroviral-naïve subjects. Subjects had a mean age of 36 years (range 18-64); 74% were male, 64% were Caucasian, and 20% were Black. The mean baseline CD4+ cell count was 279 cells/mm 3 (range 3-956) and median baseline plasma HIV-1 RNA was 77,600 copies/mL (range 417-5,130,000). Subjects ...

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

• Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions (5.1) ] .
• Exacerbations of Hepatitis B [see Boxed Warning , Warnings and Precautions (5.2) ] .
• New Onset or Worsening Renal Impairment [see Warnings and Precautions (5.3) ] .
• Hepatic Decompensation in Patients Co-infected with HIV-1 and Hepatitis C [see Warnings and Precautions (5.4) ] .
• Pancreatitis [see Warnings and Precauti...

CIMDUO is contraindicated in patients with a previous hypersensitivity reaction to any of the components contained in the formulation.

• CIMDUO is contraindicated in patients with previous hypersensitivity to any of the components of this product. ( 4 )

• Lactic Acidosis/Severe Hepatomegaly with Steatosis: Discontinue treatment in patients who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. ( 5.1 )
• New Onset or Worsening Renal Impairment: Can include acute renal failure and Fanconi syndrome. Assess estimated creatinine clearance before initiating treatment with tenofovir disoproxil fumarate, a component of CIMDUO. In patients at risk for renal dysfunction, assess estimated creatinine clearan...

7 DRUG INTERACTIONS

• Atazanavir: Atazanavir should be coadministered with ritonavir when coadministered with CIMDUO. ( 7.2 )
• HIV-1 Protease Inhibitors: Monitor for evidence of tenofovir toxicity when CIMDUO is coadministrated with atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir. ( 7.2 )
• Sorbitol: Avoid chronic administration of sorbitol with CIMDUO.( 7.5 ) 7.1 Drugs Affectin...