for: HIV Infection
Cimduo (lamivudine and tenofovir disoproxil fumarate) is a combination of two nucleo(t)side reverse transcriptase inhibitors indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. CIMDUO 300MG/300MG TAB 30
lamivudine/tenofovir disop fum ORAL TABLET 300-300 MG CIMDUO- lamivudine and tenofovir disoproxil fumarate tablet, film coat
BOXED WARNING(WHAT IS THIS?)
WARNING: POST TREATMENT ACUTE EXACERBATIONS OF HEPATITIS B
Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine or tenofovir disoproxil fumarate, components of CIMDUO. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment [see WARNINGS AND PRECAUTIONS (5.2)].
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use CIMDUO safely and effectively. See full prescribing information for CIMDUO.
CIMDUO� (lamivudine and tenofovir disoproxil fumarate) tablets, for oral use
Initial U.S. Approval: 2018
WARNING: POST TREATMENT ACUTE EXACERBATIONS OF HEPATITIS B SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with HBV and human immunodeficiency virus (HIV-1) and have discontinued lamivudine and tenofovir disoproxil fumarate. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment. (5.2)
INDICATIONS AND USAGE
CIMDUO is a two-drug combination of lamivudine (3TC) and tenofovir disoproxil fumarate (TDF), both nucleo(t)side reverse transcriptase inhibitors and is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg. (1)
DOSAGE AND ADMINISTRATION
Testing: Prior to initiation and during treatment with CIMDUO, patients should be tested for hepatitis B virus infection, and estimated creatinine clearance, urine glucose, and urine protein should be obtained. ( 2.1)
Recommended dose: One tablet taken orally once daily with or without food. ( 2.2)
Renal Impairment: Not recommended in patients with CrCL less than 50 mL/min or patients with end-stage renal disease requiring hemodialysis. ( 2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 300 mg lamivudine and 300 mg tenofovir disoproxil fumarate (equivalent to 245 mg of tenofovir disoproxil). (3)
CIMDUO is contraindicated in patients with previous hypersensitivity to any of the components of this product. ( 4)
WARNINGS AND PRECAUTIONS
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 clearance, serum phosphorus, urine glucose and urine protein before initiating treatment with tenofovir and periodically during treatment. Avoid administering CIMDUO with concurrent or recent use of nephrotoxic drugs. ( 5.3)
Hepatic decompensation, some fatal, has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy and interferon- and ribavirin-based regimens. Monitor for treatment-associated toxicities. Discontinue CIMDUO, as medically appropriate, and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both. ( 5.4)
Pancreatitis: Use with caution in pediatric patients with a history of pancreatitis or other significant risk factors for pancreatitis. Discontinue CIMDUO as clinically appropriate. ( 5.5)
Decreases in Bone Mineral Density (BMD): Observed in HIV-infected patients. Consider assessment of BMD in patients with a history of pathologic fracture or other risk factors for osteoporosis or bone loss. ( 5.6)
Immune Reconstitution Syndrome: Observed in HIV-infected patients. May necessitate further evaluation and treatment. ( 5.7)
Redistribution/Accumulation of Body Fat: Observed in HIV-infected patients receiving antiretroviral combination therapy. ( 5.8)
Triple Nucleoside-Only Regimens: Early virologic failure has been reported in HIV-infected patients. Monitor carefully and consider treatment modification. ( 5.9)
Most common adverse reactions (> 10% with CIMDUO) are headache, pain, depression, diarrhea, and rash. ( 6)
To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH.
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)
USE IN SPECIFIC POPULATIONS
Lactation: Breastfeeding not recommended due to potential for HIV transmission. ( 8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.